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nli4ct_semeval2024

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[ "Adverse Events 1:", " Total: 16/56 (28.57%)", " Pancytopenia 0/56 (0.00%)", " Pericarditis 0/56 (0.00%)", " Abdominal pain 1/56 (1.79%)", " Anal fissure 1/56 (1.79%)", " Ascites 1/56 (1.79%)", " Constipation 0/56 (0.00%)", " Diarrhoea 1/56 (1.79%)", " Nausea 0/56 (0.00%)", " Oesophageal pain 0/56 (0.00%)", " Vomiting 0/56 (0.00%)", " Disease progression 2/56 (3.57%)", " Infusion related reaction 1/56 (1.79%)", " Pain 0/56 (0.00%)", "Adverse Events 2:", " Total: 11/37 (29.73%)", " Pancytopenia 1/37 (2.70%)", " Pericarditis 1/37 (2.70%)", " Abdominal pain 2/37 (5.41%)", " Anal fissure 0/37 (0.00%)", " Ascites 0/37 (0.00%)", " Constipation 1/37 (2.70%)", " Diarrhoea 1/37 (2.70%)", " Nausea 2/37 (5.41%)", " Oesophageal pain 1/37 (2.70%)", " Vomiting 2/37 (5.41%)", " Disease progression 2/37 (5.41%)", " Infusion related reaction 0/37 (0.00%)", " Pain 1/37 (2.70%)" ]

[ "Inclusion Criteria:", " Patient evaluated and treated at INCAN", " Patients must provide informed consent", " Patient must be 18 years of age.", " Life expectancy 6 months", " Clinical locally advance breast cancer (Stage IIB or III)", " Pathologically confirmed diagnosis of estrogen receptor (ER)-positive or progesterone receptor (PR)-positive breast cancer with ER or PR Allred Score > 4", " Patient must have an ECOG Performance Status of 0-2", " Patients must be able to swallow and retain oral medication", "Exclusion Criteria:", " Patient must not have received any prior chemotherapy, radiation therapy, or biologic therapy for invasive breast cancer within the past five years", " Patient must not be pregnant or nursing", " Patient must not have had any prior malignancy except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the patient has been disease-free for five years.", " Women of childbearing age unable or unwilling to use contraception" ]

[ "Inclusion Criteria:", " Premenopausal, estrogen receptor positive women, aged 20 years and over, with operable and measurable breast cancer who have provided written informed consent", "Exclusion Criteria:", " Medical history of chemotherapy or endocrine therapy for breast cancer, or with treatment history of radiotherapy. Unwillingness to stop taking any drug known to affect sex hormone status (including hormone replacement therapy (HRT)." ]

[ "Adverse Events 1:", " Total: 10/76 (13.16%)", " Sickle cell anaemia with crisis 1/76 (1.32%)", " Diarrhoea 1/76 (1.32%)", " Pyrexia 1/76 (1.32%)", " Chest pain 1/76 (1.32%)", " Complication associated with device 1/76 (1.32%)", " General physical health deterioration 0/76 (0.00%)", " Device related infection 2/76 (2.63%)", " Pneumonia 1/76 (1.32%)", " Atypical pneumonia 1/76 (1.32%)", " Dehydration 1/76 (1.32%)", "Adverse Events 2:", " Total: 3/75 (4.00%)", " Sickle cell anaemia with crisis 0/75 (0.00%)", " Diarrhoea 0/75 (0.00%)", " Pyrexia 1/75 (1.33%)", " Chest pain 0/75 (0.00%)", " Complication associated with device 0/75 (0.00%)", " General physical health deterioration 1/75 (1.33%)", " Device related infection 0/75 (0.00%)", " Pneumonia 1/75 (1.33%)", " Atypical pneumonia 0/75 (0.00%)", " Dehydration 0/75 (0.00%)" ]

[ "Adverse Events 1:", " Total: 16/56 (28.57%)", " Pancytopenia 0/56 (0.00%)", " Pericarditis 0/56 (0.00%)", " Abdominal pain 1/56 (1.79%)", " Anal fissure 1/56 (1.79%)", " Ascites 1/56 (1.79%)", " Constipation 0/56 (0.00%)", " Diarrhoea 1/56 (1.79%)", " Nausea 0/56 (0.00%)", " Oesophageal pain 0/56 (0.00%)", " Vomiting 0/56 (0.00%)", " Disease progression 2/56 (3.57%)", " Infusion related reaction 1/56 (1.79%)", " Pain 0/56 (0.00%)", "Adverse Events 2:", " Total: 11/37 (29.73%)", " Pancytopenia 1/37 (2.70%)", " Pericarditis 1/37 (2.70%)", " Abdominal pain 2/37 (5.41%)", " Anal fissure 0/37 (0.00%)", " Ascites 0/37 (0.00%)", " Constipation 1/37 (2.70%)", " Diarrhoea 1/37 (2.70%)", " Nausea 2/37 (5.41%)", " Oesophageal pain 1/37 (2.70%)", " Vomiting 2/37 (5.41%)", " Disease progression 2/37 (5.41%)", " Infusion related reaction 0/37 (0.00%)", " Pain 1/37 (2.70%)" ]

[ "Inclusion Criteria:", " Non-metastatic primary invasive breast cancer overexpressing HER2 (determined by immunohistochemistry 3+ or positive fluorescence in situ hybridization test) that has been histologically confirmed, adequately excised, axillary node positive or negative, and tumor size at least T1c according to Tumor/Node/Metastasis (TNM) staging", " Completion of at least 4 cycles of (neo-)adjuvant systemic chemotherapy, definitive surgery, and radiotherapy, if applicable", " Known hormone receptor status", " Baseline left ventricular ejection fraction (LVEF) greater than or equal to ( ) 55 percent (%)", "Exclusion Criteria:", " Prior invasive breast carcinoma", " Other malignancies except for curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix", " Clinical T4 tumors", " Cumulative doxorubicin exposure greater than (>) 360 milligrams per meter-squared (mg/m^2) or epirubicin >720 mg/m^2 or any prior anthracyclines unrelated to the present breast cancer", " Peripheral stem cell or bone marrow stem cell support", " Prior mediastinal irradiation except for internal mammary node irradiation for the present breast cancer", " Non-irradiated internal mammary nodes or supraclavicular lymph node involvement", " Prior anti-HER2 therapy for any other reason or other prior biologic or immunotherapy for breast cancer", " Concurrent anti-cancer treatment in another investigational trial", " Serious cardiac or pulmonary conditions/illness, or any other conditions that could interfere with planned treatment", " Poor hematologic, hepatic, or renal function", " Pregnancy or lactation", " Women of childbearing potential or less than 1 year post-menopause unwilling to use adequate contraceptive measures" ]

[ "INCLUSION CRITERIA (Disease Characteristics):", " Diagnosis of breast cancer", " Stage I or II disease", " No more than 10 positive lymph nodes", " First-time diagnosis", " Under the age of 50 at diagnosis", " Finished active treatment within the past 2 months", " English-speaking only", " Must live within 30 miles of Magee Women's Hospital, Pittsburgh, Pennsylvania", " INCLUSION CRITERIA (Patient Characteristics):", " Female patients only", " Must be able to communicate", " EXCLUSION CRITERIA (Patient Characteristics):", " Other prior malignancies except skin cancer", " PRIOR CONCURRENT THERAPY:", " See Disease Characteristics" ]

[ "DISEASE CHARACTERISTICS:", " At increased risk for the development or recurrence of breast cancer, defined as an estradiol level 9 pg/mL", " No evidence of suspicious or malignant disease, based on the following examinations:", " Clinical bilateral breast examination within the past 6 months", " Bilateral* mammogram within 3 months before randomization OR within 30 days after randomization", " Pelvic exam normal within the past 5 years", " General physical exam within the past 6 months NOTE: *Unilateral mammogram of the uninvolved breast for patients with prior invasive breast cancer or ductal carcinoma in situ (DCIS)", " Bone density scan within 2 standard deviations from normal within the past 30 days", " Bone density scan 2 standard deviations below normal allowed if approved by the study physician", " At least 1 breast that has not been previously treated with radiotherapy or surgery (for patients with prior invasive breast cancer or DCIS)", " Hormone receptor status:", " Not specified", " PATIENT CHARACTERISTICS:", " Age", " 35 and over", " Sex", " Female", " Menopausal status", " Postmenopausal, defined by any of the following criteria:", " At least 12 months without spontaneous menstrual bleeding", " Prior hysterectomy and bilateral salpingo-oophorectomy", " 55 years of age with a prior hysterectomy with or without oophorectomy", " < 55 years of age with a prior hysterectomy without oophorectomy OR the status of the ovaries is unknown AND follicle-stimulating hormone (FSH) level is in the postmenopausal range", " Performance status", " Normal activity must not be restricted for a significant portion of the day", " Life expectancy", " At least 10 years", " Hematopoietic", " Complete blood count with differential normal", " Prior benign neutropenia allowed provided the granulocyte count is 1,500/mm^3", " Hepatic", " Bilirubin normal", " Alkaline phosphatase normal", " SGOT and SGPT normal", " Renal", " Creatinine normal", " Cardiovascular", " No uncontrolled cardiovascular disease", " Other", " Not pregnant", " No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix", " No osteoporosis", " No hyperlipidemia", " No mental health status resulting in cognitive or emotional impairment that would preclude study participation", " PRIOR CONCURRENT THERAPY:", " Biologic therapy", " Not specified", " Chemotherapy", " Not specified", " Endocrine therapy", " More than 30 days since prior AND no concurrent use of any of the following hormonal agents:", " Estrogen or progesterone replacement therapy", " Oral contraceptives", " Raloxifene or other plasma estrogen receptor modulators (SERMs)", " Androgens (e.g., danazol)", " Luteinizing hormone-releasing hormone (LHRH) analogs (e.g., goserelin or leuprolide)", " Prolactin inhibitors (e.g., bromocriptine)", " Antiandrogens (e.g., cyproterone)", " More than 60 days since prior AND no concurrent tamoxifen", " No prior aromatase inhibitors (for patients with prior invasive breast cancer or DCIS)", " No concurrent phytoestrogenic dietary supplements (e.g., soy, ginseng, or other natural products)", " Dietary soy allowed", " Radiotherapy", " See Disease Characteristics", " Surgery", " See Disease Characteristics", " No prior bilateral mastectomy", " Other", " More than 60 days since prior treatment for invasive breast cancer or DCIS", " More than 30 days since prior bisphosphonates or calcitonin", " No prior or concurrent participation on a treatment study for invasive breast cancer or DCIS", " No concurrent participation in any other cancer prevention study or osteoporosis prevention study involving pharmacologic agents", " No concurrent calcitonin", " No concurrent bisphosphonate therapy", " Concurrent cholecalciferol (vitamin D) and calcium to augment bone mineral density allowed" ]

[ "INCLUSION CRITERIA:", " Undergoing core needle biopsy for a breast abnormality suspicious for breast cancer.", " Has undergone a core needle biopsy demonstrating breast cancer and has not yet had any further therapy, provided the core needle biopsy is available for analysis.", " No prior therapy for breast cancer within the past 5 years.", " 18 years of age or older.", " Ability to understand and the willingness to sign a written informed consent document.", "EXCLUSION CRITERIA:", " History of parathyroid disease, hypercalcemia, or kidney stones.", " Supplemental vitamin D other than from a standard multiple vitamin or from standard formulations of calcium and vitamin D (eg, calcium citrate with vitamin D) within the prior 6 months.", " History of renal failure requiring dialysis or kidney transplantation.", " Pregnant or nursing", " Receiving supplemental calcium > 1200 mg calcium per day during study.", " Initial treatment of breast cancer will not be with breast-conserving surgery or mastectomy.", " Locally-advanced breast cancer", " Plans for neoadjuvant chemotherapy, hormonal therapy, or other systemic therapy", " Plans for preoperative radiation therapy", " Plans for breast cancer surgery, and does not allow for at least 10 days of vitamin D intervention.", " Any condition potentially interfering with subjects ability to comply with taking study medication.", " Any medical condition that would potentially interfere with vitamin D absorption, such as celiac sprue, ulcerative colitis.", " Current participation in another research study that would increase risk to subject, in the opinion of the investigators" ]

[ "Inclusion Criteria:", " Requiring adjuvant or post mastectomy radiation therapy with tangential fields or 3-fields", " Adequate pulmonary function", " Presence of 5 cc of the heart or liver with the simulation fields", " Karnofsky Performance Status (KPS) equal to or greater than 70", "Exclusion Criteria:", " Pregnant women", " Patients who have had previous ipsilateral breast or thoracic radiation therapy" ]

[ "Outcome Measurement: ", " Level of EGFR Expression", " Estimated at the end of the trial Immunoreactivity will be evaluated qualitatively with regard to intensity as follows: Measured on a scale, ranging from 0-3+ 0=negative (no immunoreactivity)", "1+ - 3+ = positive:", " faint immunoreactivity (weak staining)", " intense immunoreactivity (strong staining) Immunohistochemical studies will be performed on the tumor specimen to correlate the anti-tumor efficacy of OSI-774 and bevacizumab with pre-treatment molecular characteristics.", " Time frame: Up to 12 years", "Results 1: ", " Arm/Group Title: Treatment (Erlotinib Hydrochloride, Bevacizumab)", " Arm/Group Description: Patients receive erlotinib hydrochloride PO QD on days 1-21 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.", " Overall Number of Participants Analyzed: 38", " Measure Type: Number", " Unit of Measure: participants EGFR 0: 24", "EGFR 1+: 8", "EGFR 2+: 4", " EGFR 3+: 0", " Insufficient tumor tissue: 2" ]

[ "Adverse Events 1:", " Total: 3/73 (4.11%)", " Chest Pain - cardiac 1/73 (1.37%)", " Myocarditis 1/73 (1.37%)", " Pericarditis 1/73 (1.37%)", " Ventricular tachycardia 1/73 (1.37%)", " Skin infection 0/73 (0.00%)", " Dermatitis radiation 0/73 (0.00%)", " Dyspnea 1/73 (1.37%)", "Adverse Events 2:", " Total: 3/70 (4.29%)", " Chest Pain - cardiac 0/70 (0.00%)", " Myocarditis 0/70 (0.00%)", " Pericarditis 0/70 (0.00%)", " Ventricular tachycardia 0/70 (0.00%)", " Skin infection 2/70 (2.86%)", " Dermatitis radiation 1/70 (1.43%)", " Dyspnea 0/70 (0.00%)" ]

[ "Adverse Events 1:", " Total: 4/43 (9.30%)", " Hemoglobin [1]1/43 (2.33%)", " Hemorrhage/Bleeding [2]1/43 (2.33%)", " Neutrophils/granulocytes (ANC/AGC) [3]1/43 (2.33%)", " Platelets [4]1/43 (2.33%)", " Anorexia [5]1/43 (2.33%)", " Sodium, serum-low (hyponatremia) [1]1/43 (2.33%)", " Thrombosis/thrombus/embolism [6]2/43 (4.65%)" ]

[ "INTERVENTION 1: ", " Decision Support Workshop", " The decision support workshop will be 2 hours in duration on the morning of the consultation and will be facilitated by a dedicated social worker from psycho-oncology.", " Decision Support Workshop: Incorporates the key components of shared decision-making and decision support with the philosophy of delivering supportive care to cancer patients.", " Surgeon (30 mins): treatment options for breast reconstruction with indications/ contraindications, advantages / disadvantages, expected post-operative course, aesthetic result and complications with probabilities", " Registered nurse (30 mins): preparing for surgery, postoperative recovery and how to navigate the health care system", " Social worker (30 mins): values clarification exercise", " Breast reconstruction patient volunteer (30 mins) questions and answers about her personal experience", "INTERVENTION 2: ", " Standard Care", " Routine pre-consultation education" ]

[ "INTERVENTION 1: ", " Low Dose Magnesium Oxide (800 mg/Day)", " Week 2:", " Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).", " Week 3:", " Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).", " Weeks 4-9:", " Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).", "INTERVENTION 2: ", " High Dose Magnesium Oxide (1200 mg/Day)", " Week 2:", " Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).", " Week 3:", " Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).", " Weeks 4-9:", " Patients take three 400 mg tablet of magnesium oxide orally (PO) daily (QD)." ]

[ "INTERVENTION 1: ", " No Exercise", " Multivitamin Arm + Calcitriol Arm:Calcitriol pill taken once per week", "INTERVENTION 2: ", " Exercise", " Exercise Arm: Exercise consisting of progressive walking and resistance band training", " Calcitriol+ Exercise Arm: Calcitriol pill taken once per week + Exercise" ]

[ "INTERVENTION 1: ", " AB-101", " Apply to both nipple/areola regions approximately 1 hour prior to sexual activity", " AB-101: Apply approximately 1 hour prior to sexual activity", "INTERVENTION 2: ", " Placebo", " Apply to both nipple/areola regions approximately 1 hour prior to sexual activity", " Placebo: Apply approximately 1 hour prior to sexual activity" ]

[ "Outcome Measurement: ", " Number of Participants With Dose Limiting Toxicities (DLT): Part 1 Phase 1", " DLT was classified as per common terminology criteria for adverse events (CTCAE) version 4.0 as any of the events occurring during 28 days of Cycle 1,attributed to study drug:grade 4 neutropenia(for a duration of greater than [>]7 days); febrile neutropenia (grade greater than or equal to [>=]3 neutropenia,body temperature >=38.5 degree Celsius);grade >=3 thrombocytopenia with bleeding episode;grade 4 thrombocytopenia;grade >=3 non-hematologic toxicity except grade 3 or more nausea, vomiting,electrolyte abnormality(if controllable by therapy);grade 3 QTc prolongation(>500 millisecond [msec])persist after correction of reversible cause such as electrolyte abnormalities or hypoxia. Lack of hematologic recovery (platelets less than [<]50,000/microliter [mcL],absolute neutrophil count <1,000/mcL,hemoglobin <8.0 gram/deciliter [g/dL]) or prolonged non hematologic toxicities that delays initiation of next dose by >7 days;receipt of <75 percent of planned dose in first cycle due to toxicity.", " Time frame: Lead-in period (Day -7) up to Day 28 (Cycle 1)", "Results 1: ", " Arm/Group Title: PD-0332991 100 mg: Dose Escalation Cohort", " Arm/Group Description: In Phase 1-Part 1, participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.", " Overall Number of Participants Analyzed: 6", " Measure Type: Count of Participants", " Unit of Measure: Participants 1 16.7%", "Results 2: ", " Arm/Group Title: PD-0332991 125 mg: Dose Escalation Cohort", " Arm/Group Description: In Phase 1-Part 1, participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.", " Overall Number of Participants Analyzed: 6", " Measure Type: Count of Participants", " Unit of Measure: Participants 1 16.7%" ]

[ "INTERVENTION 1: ", " Treatment Period 1", " Participants received AZD9496 - Variant A (100 mg).", "INTERVENTION 2: ", " Treatment Period 2", " Participants received AZD9496 - Reference (100 mg)." ]

[ "INTERVENTION 1: ", " Five Days of Mammosite Therapy", "[Not Specified]" ]

[ "INTERVENTION 1: ", " Bevacizumab Plus Paclitaxel", " Bevacizumab 10 mg/kg intravenous (i.v.), days 1 and 15, every 4 weeks, Paclitaxel 90 mg/m2, days 1, 8 and 15, every 4 weeks", "INTERVENTION 2: ", " Bevacizumab Plus Capecitabine", " Bevacizumab 15 mg/kg i.v., day 1, every 3 weeks, Capecitabine 1000 mg/m² twice-daily, days 1-14, every 3 weeks" ]

[ "Eligibility", " Patients must have undergone either a total mastectomy or a lumpectomy with either an axillary dissection or sentinel node biopsy. If any sentinel node is histologically positive by H & E, or histologically suspicious on H & E and confirmed positive by immunohistochemistry (IHC), then the patient must have a completion axillary dissection.", " The tumor must be invasive adenocarcinoma on histologic examination with clinical assessment T1-3, N0-1, M0.", " Patients must not be participating in any other clinical trials of systemic therapy for early-stage breast cancer. Patients may participate in the following radiation therapy trials:", " Node-positive patients may participate in the National Cancer Institute of Canada Clinical Trials Group protocol MA.20, provided the requirements of the B-34 protocol continue to be met. (Node-negative B-34 patients may not participate in MA.20.)", " Node-positive mastectomy patients may participate in Southwest Oncology Group protocol S9927, provided the requirements of the B-34 protocol continue to be met.", " Patients must have an analysis of both estrogen and progesterone receptors on the primary tumor performed prior to randomization. Tumors will be defined as ER or progesterone receptor (PgR) positive if: 1) the Dextran-coated charcoal or sucrose-density gradient method shows them to have greater than or equal to 10 fmol/mg cytosol protein, or 2) if using individual laboratory criteria they can be shown to be positive by the enzyme immunoassay method (EIA) or immunocytochemical assay. \"Marginal or borderline,\" results (i.e., those not definitively negative) will also be considered positive.", " At the time of randomization, the patient must have had the following within the past 3 months: history and physical exam, a bone scan, thoracic and lumbar spine x-rays, and a chest x-ray. Within the past 12 months patients must have had a gynecologic exam (for women who have a uterus and who will be taking tamoxifen) and a bilateral mammogram.", " At the time of randomization:", " the postoperative absolute neutrophil count (ANC) must be greater than or equal to 1500/mm3 (or less than 1500/mm3 if, in the opinion of the investigator, this represents an ethnic or racial variation of normal);", " the postoperative platelet count must be greater than or equal to 100,000;", " there must be postoperative evidence of adequate hepatic function, i.e.,", " total bilirubin at or below the upper limit of normal (ULN) for the laboratory; and", " alkaline phosphatase less than 2.5 x the ULN; and", " the serum glutamate oxaloacetate transaminase (SGOT)/ aspartate transaminase (AST) less than 1.5 x the ULN;", " there must be postoperative evidence of adequate renal function (serum creatinine within or less than the laboratory's normal range).", " Serum albumin and serum calcium must be within normal limits.", " A patient with skeletal pain is eligible for inclusion in the study if bone scan and/or roentgenological examination fails to disclose metastatic disease. Suspicious findings must be confirmed as benign by x-ray, MRI, or biopsy.", " Patients with prior nonbreast malignancies are eligible if they have been disease- free for greater than or equal to 5 years before randomization and are deemed at low risk for recurrence by their treating physicians. Patients with squamous or basal cell carcinoma of the skin that has been effectively treated, carcinoma in situ of the cervix that has been treated by surgery only, or lobular carcinoma in situ (LCIS) of the ipsilateral or contralateral breast treated by hormone therapy and/or surgery only are eligible, even if these were diagnosed within 5 years before randomization.", " Patients must have a Zubrod performance status of 0, 1, or 2.", " Special conditions for eligibility of lumpectomy patients: Irradiation and surgery. Patients treated by lumpectomy and axillary node dissection (or no axillary dissection if sentinel node biopsy is negative) to be followed by breast radiation therapy must meet all the eligibility criteria in addition to the following:", " Generally, lumpectomy should be reserved for tumors less than 5 cm. However, at the investigator's discretion, patients treated with lumpectomy for tumors greater than or equal to 5 cm are eligible.", " The margins of the resected specimen must be histologically free of invasive tumor and ductal carcinoma in situ (DCIS). For patients in whom pathologic examination demonstrates tumor present at the line of resection, additional operative procedures may be performed to obtain clear margins. This is permissible even if axillary dissection has been performed. Patients in whom tumor is still present at the resected margins after re-excision(s) must undergo total mastectomy to be eligible.", " Ineligibility.", " Significant non-malignant bone disease that is likely to interfere with the interpretation of bone x-rays.", " Ulceration, erythema, infiltration of the skin or the underlying chest wall (complete fixation), peau d'orange, or skin edema of any magnitude. (Tethering or dimpling of the skin or nipple inversion should not be interpreted as skin infiltration. Patients with these conditions are eligible.)", " Ipsilateral lymph nodes that on clinical examination are found to be fixed to one another or to other structures (cN2 disease).", " Suspicious palpable nodes in the contralateral axilla or palpable supraclavicular or infraclavicular nodes, unless there is biopsy evidence that these are not involved with tumor.", " Prior therapy for breast cancer, including irradiation, chemotherapy, biotherapy, and/or hormonal therapy, with the exception of tamoxifen. Tamoxifen may be given as adjuvant therapy before study entry, but only if it was started within 28 days before randomization. Patients who started tamoxifen within 28 days before randomization and who are being considered for chemotherapy must have their tamoxifen stopped at the start of chemotherapy.", " Prior history of breast cancer, except LCIS.", " Any sex hormonal therapy, e.g., birth control pills, ovarian hormonal replacement therapy, etc. (These patients are eligible only if this therapy is discontinued prior to randomization.) Exceptions: patients may use low-dose estrogen vaginal creams or Estring® for symptomatic vaginal dryness, raloxifene (or other selective estrogen receptor modulators [SERMs]) for the prevention of osteoporosis, and luteinizing-hormone-releasing hormone (LHRH) agonists/antagonists for the purpose of medical ovarian ablation as a component of adjuvant therapy for the breast cancer.", " Patients currently taking alendronate (Fosamax®) or other bisphosphonates or calcitonin to treat or prevent osteoporosis are not eligible.", " Non-malignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude a patient from being subjected to any of the treatment options or would prevent prolonged follow-up.", " Psychiatric or addictive disorders that would preclude obtaining informed consent.", " Pregnancy or lactation at the time of proposed randomization. This protocol excludes pregnant or lactating women because the effects of clodronate on such women have not been studied fully.", " Bilateral malignancy or a mass or mammographic abnormality in the opposite breast suspicious for malignancy unless there is biopsy proof that the mass is not malignant.", " Special conditions for ineligibility of lumpectomy patients: Irradiation and surgery. The following patients will also be ineligible:", " Patients with diffuse tumors (as demonstrated on mammography) that would not be considered surgically amenable to lumpectomy.", " Patients treated with lumpectomy in whom there is another clinically dominant mass or mammographically suspicious abnormality within the ipsilateral breast remnant. Such a mass must be biopsied and demonstrated to be histologically benign prior to randomization or, if malignant, must be surgically removed with clear margins.", " Patients in whom the margins of the resected specimen are involved with invasive tumor or ductal carcinoma in situ (DCIS). Additional surgical resections to obtain free margins are allowed. Patients in whom tumor is still present after the additional resection(s) must undergo mastectomy to be eligible." ]

[ "Outcome Measurement: ", " Number of Subjects With Clinical Benefit", " Clinical benefit was based on objective tumor assessments made according to Response Evaluation Criteria (RECIST) system of unidimensional evaluation. Includes subjects with complete response (CR), partial response (PR), and long term disease stabilization (SD) for at least 24 weeks.", " Time frame: Baseline, Week 8, 16, 24, and every 12 weeks beyond 24 up to Week 108 and every 24 weeks thereafter until 9 months following last subject last visit (LSLV)", "Results 1: ", " Arm/Group Title: Exemestane (Exemestane Alone)", " Arm/Group Description: oral dose exemestane taken with food (25 mg tablet once daily)", " Overall Number of Participants Analyzed: 49", " Measure Type: Number", " Unit of Measure: participants 24", "Results 2: ", " Arm/Group Title: Combination (Exemestane + Celecoxib)", " Arm/Group Description: oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)", " Overall Number of Participants Analyzed: 51", " Measure Type: Number", " Unit of Measure: participants 24" ]

[ "Adverse Events 1:", " Total: 20/70 (28.57%)", " NAUSEA 2/70 (2.86%)", " VOMITING 1/70 (1.43%)", " DIARRHOEA 2/70 (2.86%)", " ABDOMINAL PAIN 1/70 (1.43%)", " ABDOMINAL PAIN LOWER 1/70 (1.43%)", " FATIGUE 2/70 (2.86%)", " PYREXIA 1/70 (1.43%)", " OEDEMA PERIPHERAL 1/70 (1.43%)", " GENERAL PHYSICAL HEALTH DETERIORATION 3/70 (4.29%)", " PNEUMONIA 1/70 (1.43%)", " SINUSITIS 1/70 (1.43%)", " LOBAR PNEUMONIA 1/70 (1.43%)", "Adverse Events 2:", " " ]

[ "Adverse Events 1:", " Total: 0/3 (0.00%)", " Febrile Neutropenia * 0/3 (0.00%)", " Neutropenia * 0/3 (0.00%)", " Sudden Death * 0/3 (0.00%)", " Bacterial Infection * 0/3 (0.00%)", " Bronchitis * 0/3 (0.00%)", " Sepsis * 0/3 (0.00%)", " Lymphoedema * 0/3 (0.00%)", "Adverse Events 2:", " Total: 6/41 (14.63%)", " Febrile Neutropenia * 1/41 (2.44%)", " Neutropenia * 1/41 (2.44%)", " Sudden Death * 1/41 (2.44%)", " Bacterial Infection * 1/41 (2.44%)", " Bronchitis * 1/41 (2.44%)", " Sepsis * 1/41 (2.44%)", " Lymphoedema * 1/41 (2.44%)" ]

[ "Adverse Events 1:", " Total: 2/4 (50.00%)", " Atrial fibrillation 0/4 (0.00%)", " Dehydration 1/4 (25.00%)", " Fatigue (asthenia, lethargy, malaise) 1/4 (25.00%)", " Pain - Back 1/4 (25.00%)", " Urinary tract infection 0/4 (0.00%)", " Dyspnea (shortness of breath) 0/4 (0.00%)", " Pericardial effusion 0/4 (0.00%)", " Thrombosis 0/4 (0.00%)", " Skin infection 0/4 (0.00%)", " Rash: hand-foot skin reaction 0/4 (0.00%)", "Adverse Events 2:", " Total: 0/3 (0.00%)", " Atrial fibrillation 0/3 (0.00%)", " Dehydration 0/3 (0.00%)", " Fatigue (asthenia, lethargy, malaise) 0/3 (0.00%)", " Pain - Back 0/3 (0.00%)", " Urinary tract infection 0/3 (0.00%)", " Dyspnea (shortness of breath) 0/3 (0.00%)", " Pericardial effusion 0/3 (0.00%)", " Thrombosis 0/3 (0.00%)", " Skin infection 0/3 (0.00%)", " Rash: hand-foot skin reaction 0/3 (0.00%)" ]

[ "Inclusion Criteria", " Women > 18 years of age with histologically or cytologically confirmed stage I, II or III breast cancer.", " If adjuvant chemotherapy is recommended, it must be completed before study start.", " Bone marrow aspirate positive by IC/FC assay", " a. Definition of positive: > 4 MM/ml b. Timing of bone marrow aspiration to determine study eligibility: i. If patient is to receive either no adjuvant therapy or hormonal therapy alone, the aspiration may be performed at diagnosis as part of the large MM study at University of California, San Francisco, or following diagnosis if the patient received initial surgery elsewhere. This is also true for patients who have surgery following neoadjuvant therapy for breast cancer.", " ii. If the patient is to receive adjuvant chemotherapy, the aspiration will be performed at least three weeks after chemotherapy has been completed.", " Adequate renal function as defined by:", " a. Creatinine must be < upper limit of normal", " Normal liver function tests including total bilirubin, alkaline phosphatase, and aspartate aminotransferase (AST) / serum glutamic-oxaloacetic transaminase (SGOT)", " Ability to understand and sign informed consent.", " Concomitant hormonal therapy is allowed", " Concomitant radiation therapy is allowed", " Patients who have had surgery following neoadjuvant chemotherapy or hormonal therapy are eligible to participate in this trial", " Exclusion Criteria", " History of allergy to bisphosphonates. Acute phase reactions occur in up to 24% of patients and disappear with subsequent dosing. An acute phase reaction does not qualify as an allergic reaction.", " History of renal insufficiency. Renal insufficiency is defined by a serum creatinine greater than the upper limit of normal or a creatinine clearance < 50 mL/min due to any underlying cause.", " Karnofsky Performance status < 90%.", " Any significant medical condition that might interfere with treatment.", " Women participating in this study are not allowed to receive other bisphosphonate therapy during the study period, either oral or intravenous.", " Patients who are pregnant" ]

[ "Inclusion Criteria:", " Survivors: Latina, has been diagnosed with breast cancer, speaks English or Spanish, has a Caregiver who is willing to participate.", " Caregivers: a primary caregiver for a Latina breast cancer survivor, speak English or Spanish", "Exclusion Criteria:", " Inability to understand spoken English and/or Spanish and/or", " Cognitive impairment that precludes informed consent (determined by the PIs or Co-Investigators who are mental health professionals)." ]

[ "Inclusion Criteria:", " Patient had provided a signed study ICF prior to any screening procedure", " Patient was a female 18 years of age", " Patient has an ECOG performance status of 0-1", " Patient has a unilateral (multifocal or multicentric disease allowed), histologically confirmed, newly diagnosed early breast cancer >2cm by clinical examination and/or >1.5 cm confirmed by ultrasound or by MRI", " Patient has tumor tissue available for central review of ER, HER2 and PI3K status with centrally confirmed HER2-positive disease and known PI3KCA mutation status", " Patient has adequate bone marrow, renal and liver function", " Patient is able to swallow and retain oral medication", "Exclusion Criteria:", " Patient has received prior systemic treatment for currently diagnosed disease", " Patient has a known contraindications, hypersensitivity or intolerance to trastuzumab, paclitaxel or products containing cremophor", " Patient has bilateral breast cancer or metastatic disease or inflammatory breast cancer", " LVEF below 50% as determined by MUGA scan or ECHO", " Patient has active cardiac disease or a history of cardiac abnormalities as defined in the protocol", " Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BKM120", " Patient is currently receiving warfarin or other coumarin derived anti-coagulants", " Patient is currently receiving chronic treatment with corticosteroids or another immunosuppressive agents (standard premedication for paclitaxel and local applications allowed)", " Patient is currently receiving treatment with drugs known to be strong inhibitors or inducers of CYP3A", " Patient has certain scores on an anxiety and depression mood questionnaires", " Pregnant or nursing (lactating) women or patients not willing to apply apply highly effective contraception as defined in the protocol" ]

[ "Inclusion Criteria:", " Survivors: Latina, has been diagnosed with breast cancer, speaks English or Spanish, has a Caregiver who is willing to participate.", " Caregivers: a primary caregiver for a Latina breast cancer survivor, speak English or Spanish", "Exclusion Criteria:", " Inability to understand spoken English and/or Spanish and/or", " Cognitive impairment that precludes informed consent (determined by the PIs or Co-Investigators who are mental health professionals)." ]

[ "Adverse Events 1:", " Total: 50/198 (25.25%)", " Anaemia 1/198 (0.51%)", " Febrile neutropenia 1/198 (0.51%)", " Leukocytosis 1/198 (0.51%)", " Leukopenia 2/198 (1.01%)", " Neutropenia 1/198 (0.51%)", " Pancytopenia 0/198 (0.00%)", " Atrial fibrillation 0/198 (0.00%)", " Cardiac failure congestive 0/198 (0.00%)", " Palpitations 0/198 (0.00%)", " Pericardial effusion 1/198 (0.51%)", " Supraventricular tachycardia 1/198 (0.51%)", "Adverse Events 2:", " Total: 51/202 (25.25%)", " Anaemia 3/202 (1.49%)", " Febrile neutropenia 2/202 (0.99%)", " Leukocytosis 0/202 (0.00%)", " Leukopenia 0/202 (0.00%)", " Neutropenia 0/202 (0.00%)", " Pancytopenia 1/202 (0.50%)", " Atrial fibrillation 1/202 (0.50%)", " Cardiac failure congestive 1/202 (0.50%)", " Palpitations 1/202 (0.50%)", " Pericardial effusion 1/202 (0.50%)", " Supraventricular tachycardia 1/202 (0.50%)" ]

[ "INTERVENTION 1: ", " 4D Conformal Image-Guided Partial Breast RT", " This is a single arm trial designed to look at the results in women treated with partial breast irradiation twice daily for 5 days.", " 4D Conformal Image-Guided Partial Breast RT: External beam partial breast radiation to target a portion of the breast twice a day for 5 days." ]

[ "INTERVENTION 1: ", " Multicomponent Intervention", " 1.) A one-page paper-pencil agenda setting checklist completed immediately before a regularly scheduled medical oncology visit to elicit and align patient and companion perspectives regarding issues to discuss with the provider, and to stimulate discussion about the role of the companion in the visit, 2.) facilitated registration for the patient portal (for patient and family member, as desired by the patient), and 3.) education (as relevant) on access to doctor's electronic visit notes.", "INTERVENTION 2: ", " Usual Care", " Care as usual with the medical oncologist." ]

[ "Inclusion Criteria:", " Postmenopausal women, Stage III or axillary node positive", " Currently disease free of breast cancer and other invasive malignancies at the time of registration", " No concurrent use of bisphosphonates", "Exclusion Criteria:", "Metastatic disease" ]

[ "Inclusion Criteria:", " Pathologically confirmed HER2-positive MBC", " Progression of or new brain metastases after completion of whole-brain radiotherapy or stereotactic radiosurgery", " Completion of whole-brain radiotherapy or stereotactic radiosurgery more than 60 days prior to enrollment", " Stable systemic disease", " Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1", " LVEF at least 50%", " Adequate hematologic, renal, and hepatic function", " Life expectancy more than 12 weeks", "Exclusion Criteria:", " Progression of systemic disease at Screening", " Leptomeningeal disease", " History of intolerance or hypersensitivity to study drug", " Use of certain investigational therapies within 21 days prior to enrollment", " Current anthracycline use", " Unwillingness to discontinue ado-trastuzumab emtansine or lapatinib use", " Active infection", " Pregnant or lactating women", " Significant history or risk of cardiac disease", " Symptomatic intrinsic lung disease or lung involvement", " History of other malignancy within the last 5 years" ]

[ "Adverse Events 1:", " Total: 122/280 (43.57%)", " Agranulocytosis 0/280 (0.00%)", " Anaemia 10/280 (3.57%)", " Febrile neutropenia 30/280 (10.71%)", " Immune thrombocytopenic purpura 1/280 (0.36%)", " Leukopenia 3/280 (1.07%)", " Neutropenia 12/280 (4.29%)", " Thrombocytopenia 4/280 (1.43%)", " Acute myocardial infarction 1/280 (0.36%)", " Cardiac failure 1/280 (0.36%)", " Cataract 2/280 (0.71%)", "Adverse Events 2:", " Total: 58/282 (20.57%)", " Agranulocytosis 1/282 (0.35%)", " Anaemia 2/282 (0.71%)", " Febrile neutropenia 4/282 (1.42%)", " Immune thrombocytopenic purpura 0/282 (0.00%)", " Leukopenia 0/282 (0.00%)", " Neutropenia 3/282 (1.06%)", " Thrombocytopenia 1/282 (0.35%)", " Acute myocardial infarction 0/282 (0.00%)", " Cardiac failure 0/282 (0.00%)", " Cataract 1/282 (0.35%)", " Cataract subcapsular 1/282 (0.35%)" ]

[ "Outcome Measurement: ", " Overall Survival (OS)", " OS was measured from the date of randomization until the date of death from any cause, or the last date the participant was known to be alive. Participants who were lost to follow-up or who were alive at the date of data cutoff were censored. The censoring rules for OS were as follows: 1) if the participant was still alive at data cutoff, the date of data cutoff was considered the end date, and 2) if the participant was lost to follow-up before data cutoff, the date they were last known to be alive was considered the end date. Participants who survived past the end of the study were counted as in the full study period. If death occurred after data cutoff, the end date was to be censored at the time of data cutoff.", " Time frame: From date of randomization until date of death from any cause, assessed up to data cutoff date of 12 Mar 2012, or up to approximately 6 years", "Results 1: ", " Arm/Group Title: Eribulin Mesylate 1.4 mg/m^2", " Arm/Group Description: Eribulin mesylate 1.4 mg/m^2 intravenous (IV) infusion given over 2-5 minutes on Days 1 and 8 every 21 days.", " Overall Number of Participants Analyzed: 554", " Median (95% Confidence Interval)", " Unit of Measure: days 484 (462 to 536)", "Results 2: ", " Arm/Group Title: Capecitabine 2.5 g/m^2/Day", " Arm/Group Description: Capecitabine : Capecitabine 2.5 g/m^2/day administered orally twice daily in two equal doses on Days 1 to 14 every 21 days.", " Overall Number of Participants Analyzed: 548", " Median (95% Confidence Interval)", " Unit of Measure: days 440 (400 to 487)" ]

[ "Inclusion Criteria:", " Histologically confirmed invasive adenocarcinoma of the breast or inflammatory breast cancer, with an interval between definitive breast surgery and study registration of <60 days.", " Definitive surgical treatment must be either mastectomy or breast-conserving therapy with axillary lymph node dissection for operable breast cancer (pT1 4 [including inflammatory breast cancer], pN0 3, and M0). Margins of resected specimen from definitive surgery must be histologically free of invasive adenocarcinoma and ductal carcinoma in situ (DCIS). Lobular carcinoma in-situ does not count as a positive margin.", " Patients with 1 axillary lymph node containing metastatic adenocarcinoma measuring >0.2 mm, OR lymph node-negative patients with high-risk features", " Patients with HER2/neu positive or negative tumors (HER2 positivity must be documented by FISH positivity or IHC 3+).", " Patients who are to receive trastuzumab must have normal cardiac function (MUGA [cardiac ejection fraction >50%, or greater than or equal to the institutional lower limit of normal], or echocardiogram [ECHO] within institutional normal limits).", " Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2.", " Patients who are either chemotherapy naïve, or who have received prior chemotherapy >5 years ago.", " Patients with previous invasive cancers (including breast cancer) eligible only if treated >5 years prior to entering this study, and show no evidence of recurrent disease.", " Adequate bone marrow function", " Adequate liver function,", " Adequate renal function,", " Patients of childbearing potential must use an effective method of contraception that is acceptable to their study physician from the time of signing informed consent until at least 3 months after the last dose of protocol treatment, and must have a negative pre study serum pregnancy test.", " Pre-existing peripheral neuropathy must be less than or equal to grade 1 by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 criteria.", " MammoSite® brachytherapy radiation accepted when performed immediately following surgery and prior to receiving chemotherapy.", " Patients with bilateral, synchronous breast cancer, provided that one primary tumor meets the inclusion criteria.", "Exclusion Criteria:", " Patients who are pregnant or breastfeeding.", " M1 metastatic disease.", " Patients requiring neoadjuvant chemotherapy.", " Life expectancy of greater than 6 months.", " History of cardiac disease, with a New York Heart Association (NYHA) Class II or greater CHF", " Myocardial infarction (MI) or unstable angina in the past 12 months prior to Day 1 of treatment, serious arrhythmias requiring medication for treatment, any history of stroke or transient ischemic attack at any time, clinically significant peripheral vascular disease, or evidence of a bleeding diathesis or coagulopathy.", " Any investigational agent within 30 days of receiving the first dose of study drug.", " Treatment with prior trastuzumab or bevacizumab therapy.", " Concurrent treatment with any other anti-cancer therapy is not permitted.", " History of significant psychiatric disorders.", " History of active, uncontrolled infection.", " A serious, non-healing wound, ulcer, or bone fracture.", " Any other diseases, metabolic dysfunction, findings from a physical examination, or clinical laboratory test results that give reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, that may affect the interpretation of the results or that renders the patient at high risk from treatment complications." ]

[ "Inclusion Criteria:", " Written informed consent.", " Histological diagnoses of operable invasive adenocarcinoma of the breast (T1-T3). Tumors must be Human Epidermal Growth Factor Receptor 2 (HER2) negative. Patients must be free of disease in the axilla (node negative). If lymphadenectomy is done, at least 10 nodes must be examined. If sentinel node technique is used, sentinel node must be free of disease. Patients must present at least one high risk criterion (St. Gallen, 1998) as follows:", " Tumor size > 2 cm; and/or", " ER and Progesterone Receptor (PgR) negative; and/or", " Histological grade 2-3; and/or", " Age < 35 years old.", " Time window between surgery and study randomization must be less than 60 days.", " Surgery must consist of mastectomy or conservative surgery. Margins free of disease and ductal carcinoma in situ (DCIS) are required. Lobular carcinoma is not considered a positive margin.", " Patients must not present evidence of metastatic disease.", " Status of hormone receptors in primary tumor. Results must be available before the end of adjuvant chemotherapy.", " Status of HER2 in primary tumor, known before randomization. Patients with Immunohistochemistry (IHC) 0 or +1 are eligible. For patients with IHC 2+, fluorescent in situ hybridization (FISH) is mandatory and result must be negative.", " Age >= 18 and <= 70 years old.", " Performance status (Karnofsky index) >= 80.", " Normal electrocardiogram (EKG) in the 12 weeks prior to randomization. If needed, normal cardiac function must be confirmed by left ventricular ejection fraction (LVEF).", " Laboratory results (within 14 days prior to randomization):", " Hematology: neutrophils >= 1.5 x 10^9/l; platelets >= 100x 10^9/l; hemoglobin >= 10 mg/dl;", " Hepatic function: total bilirubin <= 1 upper normal limit (UNL); Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) <= 2.5 UNL; alkaline phosphatase <= 2.5 UNL. If values of AST and ALT > 1.5 UNL are associated with alkaline phosphatase > 2.5 UNL, patient is not eligible.", " Renal function: creatinine <= 175 mmol/l (2 mg/dl); creatinine clearance >= 60 ml/min.", " Complete stage workup during the 12 weeks prior to randomization (mammograms are allowed within a 20 week time window). All patients must have a bilateral mammogram, thorax x-ray, abdominal echography and/or computed tomography (CT)-scan. If bone pain, and/or alkaline phosphatase elevation, a bone scintigraphy is mandatory. This test is recommended for all patients. Other tests, as clinically indicated.", " Patients able to comply with treatment and study follow-up.", " Negative pregnancy test done in the 14 previous days to randomization.", "Exclusion Criteria:", " Prior systemic therapy for breast cancer.", " Prior therapy with anthracyclines or taxanes (paclitaxel or docetaxel) for any malignancy.", " Prior radiotherapy for breast cancer.", " Bilateral invasive breast cancer.", " Pregnant or lactating women. Adequate contraceptive methods must be used during chemotherapy and hormone therapy treatments. Negative pregnancy test in the 14 previous days to randomization.", " Any T4 or N1-3 or M1 tumor.", " HER2 positive breast cancer (IHC 3+ or positive FISH result).", " Pre-existing grade >=2 motor or sensorial neurotoxicity by the National Cancer Institute Common Toxicity Criteria (NCICTC) v-2.0.", " Any other serious medical pathology, such as congestive heart failure, unstable angina, history of myocardial infarction during the previous year, uncontrolled hypertension or high risk arrhythmias.", " History of neurological or psychiatric disorders, which could preclude the patients to free informed consent.", " Active uncontrolled infection.", " Active peptic ulcer; unstable diabetes mellitus.", " Previous or current history of neoplasms different from breast cancer, except for skin carcinoma, cervical in situ carcinoma, or any other tumor curatively treated and without recurrence in the last 10 years; ductal in situ carcinoma in the same breast; lobular in situ carcinoma.", " Concomitant treatment with other investigational products. Participation in other clinical trials with a non-marketed drug in the 20 previous days before randomization.", " Concomitant treatment with other therapy for cancer.", "Males." ]

[ "DISEASE CHARACTERISTICS:", " Histologically or cytologically confirmed adenocarcinoma of the breast", " Stage III or IV disease", " Primary or recurrent disease", " Invasive lobular carcinoma allowed", " HLA-A1, -A2, -A3, or -A31 positive", " Underwent and recovered from prior primary therapy", " Patients with no clinical or radiological evidence of disease who had a previous diagnosis of stage III or IV breast cancer must have undergone prior antineoplastic therapy including, but not limited to, surgery, chemotherapy, and radiotherapy within the past 36 months", " Must have at least one undissected axillary and/or inguinal lymph node basin", " No history of brain metastases", " Hormone receptor status", " Estrogen receptor-positive or -negative tumor", " PATIENT CHARACTERISTICS:", " ECOG performance status of 0 or 1", " Body weight > 110 lbs (without clothes)", " Male or female", " Menopausal status not specified", " Absolute neutrophil count > 1000/mm^3", " Platelet count > 100,000/mm^3", " Hemoglobin > 9 g/dL", " Hemoglobin A1c < 7%", " AST and ALT 2.5 x upper limit of normal (ULN)", " Bilirubin 2.5 x ULN", " Alkaline phosphatase 2.5 x ULN", " Creatinine 1.5 x ULN", " HIV negative", " Hepatitis C negative", " Not pregnant or nursing", " Negative pregnancy test", " Fertile patients must use effective contraception", " No known or suspected allergies to any component of the vaccine", " No active infection requiring antibiotics", " No New York Heart Association class III or IV heart disease", " No autoimmune disorders requiring cytotoxic or immunosuppressive therapy or autoimmune disorders with visceral involvement, except the following:", " Laboratory evidence of autoimmune disease (e.g., positive ANA titer) without symptoms", " Clinical evidence of vitiligo", " Other forms of depigmenting illness", " Mild arthritis requiring nonsteroidal antiinflammatory drugs", " No medical contraindication or potential problem that would preclude study participation", " PRIOR CONCURRENT THERAPY:", " More than 4 weeks since prior surgery", " More than 4 weeks since prior and no concurrent chemotherapy and radiotherapy", " More than 4 weeks since prior and no concurrent allergy desensitization injections", " More than 4 weeks since prior parenteral, oral, or inhaled corticosteroids", " No concurrent inhaled steroids (e.g., Advair® or triamcinolone acetonide)", " Prior or concurrent topical corticosteroids allowed", " More than 4 weeks since prior and no concurrent growth factors (e.g., epoetin alfa, darbepoetin alfa, or pegfilgrastim)", " More than 4 weeks since prior and no concurrent other investigational medication", " More than 4 weeks since prior and no concurrent other agents with putative immunomodulating activity except for non-steroidal anti-inflammatory agents", " Prior and concurrent hormonal therapy (e.g., tamoxifen, raloxifene, toremifene, fulvestrant, letrozole, anastrozole, or exemestane) allowed", " No prior vaccination with any synthetic peptides in this protocol", " Vaccines for infectious disease (e.g., influenza) allowed, provided they are administered 2 weeks prior to or 2 weeks after study vaccine", " Short term therapy for acute conditions not related to breast cancer allowed", " No concurrent illegal drugs" ]

[ "Inclusion Criteria:", " Ability to provide written informed consent", " Prior exposure to taxane in the adjuvant, neoadjuvant or metastatic setting", " At least one prior regimen of chemotherapy in the setting of metastatic breast cancer; no upper limit on the number of prior endocrine regimens for metastatic breast cancer, however no more than 6 chemotherapeutic regimens may have been given in the metastatic setting", " Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2", " Patients must have baseline imaging within 30 days prior to the start of therapy and satisfy one of the following:", " Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria", " At least one non lymph node lesion of >= 1.0 cm or lymph node >= 1.5 cm in short axis by computerized tomography (CT) scan (CT scan thickness no greater than 5 mm which is serially measurable according to RECIST 1.1 using either computerized tomography (CT) or magnetic resonance imaging (MRI)", " Lesions that have had radiotherapy must show evidence of progressive disease (PD) based on RECIST 1.1 to be deemed a target lesion", " Non-measurable disease by RECIST 1.1 criteria (includes bone only disease and lesions < 10 mm or lymph nodes < 15 mm in short axis) with rising serum CA15-3 or CA 27.29 or CEA documented by two consecutive measurements taken at least 14 days apart with the most recent measurement being within 42 days prior to registration. The second CA 15-3 or CA 27.29 value must have at least a 20% increase over the first and for CA 15-3 or CA27.29 be greater than or equal to 40 units/mL or for CEA be greater than or equal to 4 ng/mL", " Absolute neutrophil count >= 1,500/mm^3", " Hemoglobin >= 10 g/dL", " Platelets >= 100,000/mm^3", " Creatinine =< 1.5 x upper limit of normal (ULN)", " Total bilirubin =< 1.5 x ULN", " Alkaline phosphatase =< 3.0 x ULN; up to 5 x ULN is acceptable if due to bone metastases in the absence of liver metastases", " Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3.0 x institutional upper limit of normal, unless due to liver metastases (=< 5 x ULN)", " Women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation", " Life expectancy of > 12 weeks", "Exclusion Criteria:", " Prior treatment with eribulin", " Plan to administer any other systemic antitumor including endocrine therapy except for following standard of care treatment:", " Trastuzumab at standard dosing human epidermal growth factor receptor 2 (HER2) positive tumors", " Denosumab or bisphosphonates to treat metastatic bone disease", " Plan to administer concurrent radiation therapy now or for progressive symptoms during treatment", " Patients with known central nervous system (CNS) metastases must have stable disease off steroids after treatment with surgery or radiation therapy", " Second primary malignancy that is clinically detectable or clinically significant at the time of consideration for study enrollment", " Patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic and/or moderate (creatinine clearance [CrCl] 30-50 mL/min) renal impairment", " Radiotherapy within 14 days of study treatment", " Major surgery within 21 days of study treatment; minor surgery within 2 weeks of study treatment; placement of vascular access device and biopsies allowed and is not considered major or minor surgery", " Treatment with any systemic chemotherapy or investigational agents within 3 weeks of the start of study treatment; endocrine treatment must be stopped prior to initiating study treatment; subjects must have recovered from toxicities of prior therapy", " Patients with peripheral neuropathy > grade 2 regardless of etiology", " Significant cardiovascular impairment: congestive heart failure > class II according to the New York Heart Association (NYHA), unstable angina or myocardial infarction within 6 months of enrollment, or serious cardiac arrhythmia (> grade 2)", " Concomitant severe or uncontrolled medical disease", " Significant psychiatric or neurologic disorder which would compromise participation in the study", " Pregnant or breast-feeding females" ]

[ "INTERVENTION 1: ", " Treatment Gel + Oral Placebo", " 4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.", " oral placebo: Oral placebo taken daily for 4-10 weeks.", " afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks.", "INTERVENTION 2: ", " Placebo Gel + Oral Treatment", " Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).", " tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.", " placebo gel: Placebo gel applied to breasts daily for 4-10 weeks." ]

[ "INTERVENTION 1: ", " Flaxseed", " Patients receive 1 Nutrigrad™ flaxseed bar containing 7.5 grams flaxseed, 410 mg lignans,once daily.", "INTERVENTION 2: ", " Placebo", " Patients Identical looking bar with same calorie and total fat content but without flaxseed or lignans once daily." ]

[ "INCLUSION CRITERIA", " PART 1:", " confirmed pathologic diagnosis of a solid tumor not curable with available therapies for which neratinib plus capecitabine is a reasonable treatment option.", " PART 2:", " confirmed histologically and/or cytologically confirmed diagnosis of breast cancer, metastatic or locally advanced.", " erbB-2 gene amplified tumor (FISH or CISH) or erbB-2 overexpression (IHC 3+, or IHC2+ with FISH or CISH confirmation), based on local testing, or based on centralized FISH testing prior to day 1.", " disease progression on or following at least 1 prior trastuzumab containing treatment regimen (at least 6 weeks) for metastatic or locally advanced disease. (Prior adjuvant trastuzumab is allowed but not required). A 2 week period is required between the last dose of trastuzumab treatment and first dose of the test article.", " Prior treatment with a taxane in the neoadjuvant, adjuvant, locally advanced, and/or metastatic disease treatment setting.", " PARTS 1 and 2:", " At least 1 measurable lesion as defined by RECIST criteria.", " LVEF within institutional range of normal as measured by multi-gated acquisition (MUGA) or echocardiogram (ECHO).", " EXCLUSION CRITERIA", " PART 2:", " prior treatment with capecitabine, lapatinib (20 subjects with prior lapatinib exposure will be enrolled) or any erbB-2 targeted agents except trastuzumab. Treatment with erbB-2 targeted therapy must exceed 2 weeks (14 days) in order to be exclusionary.", " prior treatment with anthracyclines with a cumulative dose of doxorubicin of greater than 400 mg/m², epirubicin dose of greater than 800 mg/m², or the equivalent dose for other anthracyclines.", " PARTS 1 and 2:", " Subjects with bone as the only site of disease.", " Active uncontrolled or symptomatic central nervous system (CNS) metastases, as indicated by clinical symptoms, cerebral edema, and/or progressive growth. Subjects with a history of CNS metastases or cord compression are allowable if they have been considered definitively treated and are off anticonvulsants and steroids for at least 4 weeks before the first dose of test article.", " Any other cancer within 5 years prior to screening with the exception of adequately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin." ]

[ "Adverse Events 1:", " Total: 6/168 (3.57%)", " FEBRILE NEUTROPENIA 3/168 (1.79%)", " ENTERITIS 1/168 (0.60%)", " PERIPHERAL NEUROPATHY 2/168 (1.19%)", " DEPRESSION 1/168 (0.60%)" ]

[ "Adverse Events 1:", " Total: 14/67 (20.90%)", " Febrile Neutropenia * 5/67 (7.46%)", " Anemia * 3/67 (4.48%)", " Neutropenia * 0/67 (0.00%)", " Leukopenia * 0/67 (0.00%)", " Sinus Tachycardia * 0/67 (0.00%)", " Diarrhea * 2/67 (2.99%)", " Nausea * 1/67 (1.49%)", " Vomiting * 1/67 (1.49%)", " Pancreatitis * 1/67 (1.49%)", " Pyrexia * 1/67 (1.49%)", " Bacteremia * 0/67 (0.00%)", " Breast Cellulutis * 0/67 (0.00%)", "Adverse Events 2:", " Total: 5/33 (15.15%)", " Febrile Neutropenia * 0/33 (0.00%)", " Anemia * 0/33 (0.00%)", " Neutropenia * 0/33 (0.00%)", " Leukopenia * 0/33 (0.00%)", " Sinus Tachycardia * 0/33 (0.00%)", " Diarrhea * 0/33 (0.00%)", " Nausea * 1/33 (3.03%)", " Vomiting * 1/33 (3.03%)", " Pancreatitis * 0/33 (0.00%)", " Pyrexia * 1/33 (3.03%)", " Bacteremia * 0/33 (0.00%)", " Breast Cellulutis * 0/33 (0.00%)" ]

[ "Adverse Events 1:", " Total: 9/33 (27.27%)", " Febrile neutropenia * 1/33 (3.03%)", " Cardiac failure * 1/33 (3.03%)", " Pyrexia * 2/33 (6.06%)", " Chest pain * 1/33 (3.03%)", " Medical device complication * 1/33 (3.03%)", " Cellulitis * 1/33 (3.03%)", " Sepsis * 1/33 (3.03%)", " Hip fracture * 1/33 (3.03%)", " Back pain * 1/33 (3.03%)", " Menorrhagia * 1/33 (3.03%)", " Thrombosis * 1/33 (3.03%)", "Adverse Events 2:", " " ]

[ "Adverse Events 1:", " Total: 10/48 (20.83%)", " NEUTROPENIA 1/48 (2.08%)", " THROMBOCYTOPENIA 0/48 (0.00%)", " VOLUME BLOOD DECREASED 1/48 (2.08%)", " FIBRILLATION ATRIAL 1/48 (2.08%)", " HYPOTENSION 1/48 (2.08%)", " ABDOMINAL PAIN 1/48 (2.08%)", " APPETITE DECREASED 0/48 (0.00%)", " DEHYDRATION 4/48 (8.33%)", " DIARRHEA 4/48 (8.33%)", " NAUSEA 3/48 (6.25%)", " VOMITING 2/48 (4.17%)", " FEVER 1/48 (2.08%)", " RIGORS 0/48 (0.00%)", "Adverse Events 2:", " Total: 5/53 (9.43%)", " NEUTROPENIA 1/53 (1.89%)", " THROMBOCYTOPENIA 1/53 (1.89%)", " VOLUME BLOOD DECREASED 0/53 (0.00%)", " FIBRILLATION ATRIAL 0/53 (0.00%)", " HYPOTENSION 0/53 (0.00%)", " ABDOMINAL PAIN 0/53 (0.00%)", " APPETITE DECREASED 1/53 (1.89%)", " DEHYDRATION 0/53 (0.00%)", " DIARRHEA 0/53 (0.00%)", " NAUSEA 1/53 (1.89%)", " VOMITING 1/53 (1.89%)", " FEVER 1/53 (1.89%)", " RIGORS 1/53 (1.89%)" ]

[ "INTERVENTION 1: ", " IUS Alone", "IUS alone imaging", "INTERVENTION 2: ", " Imagio (IUS+OA)", "IUS+OA imaging" ]

[ "INTERVENTION 1: ", " Placebo", " Subjects will be randomly selected to receive saline (placebo), administered to the breast area to cover the intercostal nerves supplying the breast tissue during surgery.", " Saline: If randomized to this arm, subjects will receive an intraoperative injection of saline. (2.5 mg/ml)", "INTERVENTION 2: ", " 0.25 % Bupivacaine w/ Epinephrine & 4mg Dexamethasone", " Subjects will be randomly selected to receive selective block with a local anesthetic solution containing 0.25 % bupivacaine (2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasone. The injection will be performed in certain locations of the breast area to cover the intercostal nerves supplying the breast tissue.", " Subjects will be randomly selected to receive the local anesthetic solution containing 0.25 % bupivacaine (2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasoneadministered to the breast area to cover the intercostal nerves supplying the breast tissue during surgery.", " 0.25 % bupivacaine (2.5 mg/ml) w/ 1:100,000 epinephrine & 4 mg dexamethasone: If randomized to this arm, subjects will receive a selective block with a local anesthetic solution containing 0.25 % bupivacaine.", "(2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasone intraoperatively." ]

[ "Inclusion Criteria:", " Female gender;", " Age 18 years;", " Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1", " Histologically confirmed invasive breast cancer:", " Primary tumor greater than 1 cm diameter, measured by clinical examination and mammography or ultrasound.", " Any N,", " No evidence of metastasis (M0) (isolated supra-clavicular node involvement allowed);", " Over expression and/or amplification of HER2 in the invasive component of the primary tumor and confirmed by a certified laboratory prior to randomization.", " Known hormone receptor status.", " Hematopoietic status:", " CBC not less than .75 of institutional lower limit. Absolute neutrophil count 1,5 x 10^9/L, Platelet count 100 x 10^9/L, Hemoglobin at least 9 g/dl,", " Hepatic status:", " Serum total bilirubin 2 x upper limit of normal (ULN). In the case of known Gilbert's syndrome, a higher serum total bilirubin (< 1.5 x ULN) is allowed, Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) 3.5 times ULN, Alkaline phosphatase 2.5 times ULN, Renal status: Creatinine 1.5mg/dL,", " Cardiovascular: Baseline left ventricular ejection fraction (LVEF) ³ 50% measured by echocardiography (ECHO) or Multiple Gate Acquisition (MUGA) scan,", " Negative serum or urine β-hCG pregnancy test at screening for patients of childbearing potential within 2-weeks (preferably 7 days) prior to randomization.", " Fertile patients must use effective contraception (barrier method - condoms, diaphragm - also in conjunction with spermicidal jelly, or total abstinence. Oral, injectable, or implant hormonal contraceptives are not allowed)", " Signed informed consent form (ICF)", " Patient accepts to make available tumor samples for submission to central laboratory to conduct translational studies as part of this protocol.", "Exclusion Criteria:", " Previous (less than 5 years) or current history of malignant neoplasms, except for curatively treated: Basal and squamous cell carcinoma of the skin; Carcinoma in situ of the cervix.", " Patients with a prior malignancy diagnosed more than 5 years prior to randomization may enter the study.", " Preexisting peripheral neuropathy grade 2", " Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ( 180/110), unstable diabetes mellitus, dyspnea at rest, or chronic therapy with oxygen;", " Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject's safety;", " Unresolved or unstable, serious adverse events from prior administration of another investigational drug;", " Dementia, altered mental status, or any psychiatric condition that would prevent the understanding or rendering of ICF;", " Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Subjects with ulcerative colitis are also excluded;", " Concurrent neoadjuvant cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy other than the trial therapies);", " Concurrent treatment with an investigational agent or participation in another therapeutic clinical trial;", " Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to trastuzumab Emtansine, trastuzumab, lapatinib, paclitaxel, abraxane or their components;", " Pregnant or lactating women;", " Concomitant use of CYP3A4 inhibitors or inducers", " Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g. active or uncontrolled infection, uncontrolled diabetes) that could cause unacceptable safety risks or compromise compliance with the protocol", " Patients have an active infection and require IV or oral antibiotics.", " Pregnant or breast-feeding women", " Patients unwilling or unable to comply with the protocol" ]

[ "Inclusion Criteria :", " women with primary breast cancer, without ongoing support for substance use.", " An AUDIT-C score >1 or more than one cigarette smoked per day.", " Individuals able to consent to benefit of intervention focused on substance use. (Karnofsky Index >70).", " Exclusion Criteria :", " Patients who currently use substances for which a second-line care is already committed.", " Patients with a Karnofsky index <70." ]

[ "Adverse Events 1:", " Total: 58/438 (13.24%)", " Febrile neutropenia 13/438 (2.97%)", " Neutropenia 5/438 (1.14%)", " Anaemia 0/438 (0.00%)", " Thrombocytopenia 0/438 (0.00%)", " Haemolytic anaemia 1/438 (0.23%)", " Leukopenia 1/438 (0.23%)", " Cardiac failure congestive 0/438 (0.00%)", " Supraventricular tachycardia 0/438 (0.00%)", " Myocardial infarction 1/438 (0.23%)", " Vertigo 0/438 (0.00%)", "Adverse Events 2:", " Total: 56/437 (12.81%)", " Febrile neutropenia 10/437 (2.29%)", " Neutropenia 7/437 (1.60%)", " Anaemia 2/437 (0.46%)", " Thrombocytopenia 1/437 (0.23%)", " Haemolytic anaemia 0/437 (0.00%)", " Leukopenia 0/437 (0.00%)", " Cardiac failure congestive 3/437 (0.69%)", " Supraventricular tachycardia 1/437 (0.23%)", " Myocardial infarction 0/437 (0.00%)", " Vertigo 1/437 (0.23%)" ]

[ "INTERVENTION 1: ", " Hypnotherapy", " Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.", "INTERVENTION 2: ", " Gabapentin", " Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily)." ]

[ "INTERVENTION 1: ", " Digital Breast Tomosynthesis", " Digital Breast Tomosynthesis + Synthetic Mammography (DBT)", " The DBT was independently read by two radiologists. A consensus meeting decided whether to recall the woman or not.", " Women selected for further assessment (positive screening exam) was recalled.", " Digital Breast Tomosynthesis + Synthetic Mammography: Two-view tomosynthesis performed with GE SenoClaire 3D Breast Tomosynthesis.", "INTERVENTION 2: ", " Digital Mammography", " The digital mammograms was independently read by two radiologists. A consensus meeting decided whether to recall the woman or not.", " Women selected for further assessment (positive screening exam) was recalled.", " Digital mammography: Two-view digital mammography performed with GE SenoClaire 3D Breast Tomosynthesis." ]

[ "INTERVENTION 1: ", " FFDM Plus DBT", " Breast Images with FFDM and DBT FFDM Plus DBT: FujiFilm Aspire Cristalle System.", " This endpoint will be evaluated qualitatively. The Pass Criteria require adequate performance in non-cancer cases (recall rate) and in cancer cases (detection rate).", "INTERVENTION 2: ", " Full-Field Digital Mammography (FFDM)", " Breast Images with FFDM alone FFDM: FujiFilm Aspire Cristalle System.", " This endpoint will be evaluated qualitatively. The Pass Criteria require adequate performance in non-cancer cases (recall rate) and in cancer cases (detection rate)." ]

[ "INTERVENTION 1: ", " Active Control Group", " Health Education Active Control Group", "INTERVENTION 2: ", " My Surgical Success Treatment Group", " My Surgical Success Intervention Group" ]

[ "Inclusion Criteria:", " Non-metastatic primary invasive breast cancer overexpressing HER2 (determined by immunohistochemistry 3+ or positive fluorescence in situ hybridization test) that has been histologically confirmed, adequately excised, axillary node positive or negative, and tumor size at least T1c according to Tumor/Node/Metastasis (TNM) staging", " Completion of at least 4 cycles of (neo-)adjuvant systemic chemotherapy, definitive surgery, and radiotherapy, if applicable", " Known hormone receptor status", " Baseline left ventricular ejection fraction (LVEF) greater than or equal to ( ) 55 percent (%)", "Exclusion Criteria:", " Prior invasive breast carcinoma", " Other malignancies except for curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix", " Clinical T4 tumors", " Cumulative doxorubicin exposure greater than (>) 360 milligrams per meter-squared (mg/m^2) or epirubicin >720 mg/m^2 or any prior anthracyclines unrelated to the present breast cancer", " Peripheral stem cell or bone marrow stem cell support", " Prior mediastinal irradiation except for internal mammary node irradiation for the present breast cancer", " Non-irradiated internal mammary nodes or supraclavicular lymph node involvement", " Prior anti-HER2 therapy for any other reason or other prior biologic or immunotherapy for breast cancer", " Concurrent anti-cancer treatment in another investigational trial", " Serious cardiac or pulmonary conditions/illness, or any other conditions that could interfere with planned treatment", " Poor hematologic, hepatic, or renal function", " Pregnancy or lactation", " Women of childbearing potential or less than 1 year post-menopause unwilling to use adequate contraceptive measures" ]

[ "INCLUSION CRITERIA (Disease Characteristics):", " Diagnosis of breast cancer", " Stage I or II disease", " No more than 10 positive lymph nodes", " First-time diagnosis", " Under the age of 50 at diagnosis", " Finished active treatment within the past 2 months", " English-speaking only", " Must live within 30 miles of Magee Women's Hospital, Pittsburgh, Pennsylvania", " INCLUSION CRITERIA (Patient Characteristics):", " Female patients only", " Must be able to communicate", " EXCLUSION CRITERIA (Patient Characteristics):", " Other prior malignancies except skin cancer", " PRIOR CONCURRENT THERAPY:", " See Disease Characteristics" ]

[ "Inclusion criteria:", " Female patients 18 years of age.", " Written informed consent given.", " Histologically confirmed Stage IV breast cancer with at least one bone metastasis radiologically confirmed.", " Previous treatment with zoledronic acid every 3-4 weeks, for 9-12 infusions over no more than 15 months.", " Eastern Cooperative Oncology Group (ECOG) performance status 2 .", " Life expectancy 1 year.", "Exclusion criteria:", " More than 3 months since last infusion of Zoledronic Acid (Zometa®).", " Treatments with other bisphosphonate than Zoledronic Acid (Zometa®) at any time prior to study entry.", " Serum creatinine > 3 mg/dL (265 μmol/L) or calculated (Cockcroft-Gault formula) creatinine clearance (CLCr) < 30 mL/min CrCl = ({[140-age (years)] x weight(kg)}/ [72 x serum creatinine (mg/dL)])x 0.85", " Corrected (adjusted for serum albumin) serum calcium < 8 mg/dl (2 mmol/L) or > 12 mg/dL ( 3.0 mmol/L).", " Current active dental problem including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a recurrent or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures.", " Recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants).", " Pregnant patients (with a positive pregnancy test prior to study entry) or lactating patients. Women of childbearing potential not using effective methods of birth control (e.g. abstinence, oral contraceptives or implants, IUD, vaginal diaphragm or sponge, or condom with spermicide).", " History of non-compliance to medical regimens or potential unreliable behavior.", " Known sensitivity to study drug(s) or class of study drug(s).", " Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study", " Use of any other investigational agent in the last 30 days." ]

[ "Inclusion Criteria:", " Post-menopausal women at high risk for development of breast cancer", " On a stable dose of hormone replacement therapy", " have cytomorphologic evidence of hyperplasia +/- atypia and Ki-67 expression >1.5% in benign breast epithelial cells acquired by RPFNA", " Serum level of 25-OH vitamin D of at least 30 ng/ml prior to study entry", " Willing to have a repeat random periareolar fine needle aspiration (RPFNA) and mammogram at 6 months and 12 months (if participating in the open label portion of the study) following initiation of study drug", "Exclusion Criteria:", " Prior history of osteoporosis or osteoporotic fracture.", " Prior history of invasive breast cancer or other invasive cancer within five years from date of study entry.", " Current and chronic use of cyclooxygenase-2 (COX-2) specific inhibitors or NSAIDs", " Receiving treatment for rheumatoid arthritis or fibromyalgia", " Current history of poorly controlled migraines or perimenopausal symptoms", " Currently receiving other investigational agents.", " Receipt of more than 6 months of an aromatase inhibitor (anastrozole, exemestane, letrozole, etc.) at any time in the past." ]

[ "Inclusion Criteria:", " female participants, age >/=18 years", " advanced, inflammatory or early stage unilateral invasive breast cancer", " HER2-positive breast cancer", " baseline left ventricular ejection fraction (LVEF) >/=55%", "Exclusion Criteria:", " metastatic disease (Stage IV) or bilateral breast cancer", " previous anticancer therapy or radiotherapy for any malignancy", " other malignancy, except for carcinoma in situ of the cervix, or basal cell carcinoma", " clinically relevant cardiovascular disease", " current chronic treatment with corticosteroids of >10mg methylprednisolone or equivalent" ]

[ "Inclusion Criteria:", " Female breast cancer patients over the age of 18 will be recruited for this study. Patients enrolled in the study will meet standard criteria for whole breast XRT.", "Exclusion Criteria:", " Subjects will be excluded for a number of medical conditions that are contraindications to XRT and/or might confound the relationship among fatigue, and inflammation, including pregnancy, major psychiatric disorders, autoimmune or inflammatory disorders, chronic infectious diseases (e.g. HIV, hepatitis B or C), neurologic disorders and uncontrolled cardiovascular, metabolic, pulmonary or renal disease (as determined by medical history, physical examination and laboratory testing). Subjects with a history of a major psychiatric disorder including Schizophrenia or Bipolar Disorder or a diagnosis of Substance Abuse or Dependence within the past 1 year (as determined by standardized psychiatric interview) will be excluded. Subjects taking drugs known to affect the immune system (e.g. glucocorticoids, methotrexate) will also be excluded. Subjects using supplements or other natural products with one week of starting medications, excluding vitamins and calcium supplementation or at the discretion of the attending physician, will be excluded. Patients who have evidence of infection as determined by history, physical exam or laboratory testing (complete blood count and urinalysis) at baseline will be excluded. In addition, patients who develop evidence of infection (as determined by history, physical exam or laboratory testing) during the study will be discontinued from the study." ]

[ "DISEASE CHARACTERISTICS:", " Histologically confirmed primary adenocarcinoma of the breast", " Stage I-III disease", " No evidence of metastatic disease", " Must have undergone lumpectomy or total mastectomy for primary disease within the past 12 weeks, or have completed chemotherapy within the past 8 weeks", " Axillary evaluation per institutional standards", " Currently receiving or planning to receive standard adjuvant systemic therapy comprising chemotherapy, hormonal therapy, or combined chemotherapy/hormonal therapy for breast cancer", " Patients who are at low risk for disease recurrence and for whom adjuvant systemic therapy will not be prescribed are not eligible", " Patients who receive biologic agents only or local radiotherapy only (without chemotherapy and/or hormone therapy) are not eligible", " Additional therapies are allowed including radiotherapy and biologic agents (e.g., trastuzumab [Herceptin^®], bevacizumab, or hematopoietic growth factors)", " Neoadjuvant therapy or hormonal therapy alone is allowed provided study entry occurs 12 weeks after completion of surgery", " Patients with skeletal pain are eligible provided bone scan and/or roentgenological exam are negative for metastatic disease", " Suspicious findings must be confirmed as benign by x-ray, MRI, or biopsy", " Hormone receptor status:", " Not specified", " PATIENT CHARACTERISTICS:", " Age", " 18 and over", " Sex", " Female", " Menopausal status", " Not specified", " Performance status", " Zubrod 0-2", " Life expectancy", " Not specified", " Hematopoietic", " Not specified", " Hepatic", " Not specified", " Renal", " Creatinine 2 times upper limit of normal", " Creatinine clearance 30 mL/min", " No renal failure", " Other", " Not pregnant or nursing", " Negative pregnancy test", " Fertile patients must use effective contraception", " No history of esophageal stricture or motility disorders", " Gastroesophageal reflux disorder allowed", " No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission", " PRIOR CONCURRENT THERAPY:", " Biologic therapy", " Prior or concurrent hematopoietic growth factors allowed", " HER-2-targeted therapies allowed", " Antiangiogenics allowed", " Chemotherapy", " See Disease Characteristics", " Endocrine therapy", " See Disease Characteristics", " Radiotherapy", " Concurrent radiotherapy to the breast, chest wall, or lymph node group allowed at the discretion of the treating physician", " Surgery", " See Disease Characteristics", " Other", " Prior neoadjuvant therapy allowed", " Prior bisphosphonates for bone density allowed", " No other concurrent bisphosphonates as adjuvant therapy or for treatment of osteoporosis", " No concurrent enrollment in clinical trials with bone density as an endpoint", " Concurrent enrollment on any other locoregional or systemic therapy breast cancer study (including cooperative group studies) allowed" ]

[ "Outcome Measurement: ", " Ruxolitinib Maximum Tolerated Dose (MTD) [Phase I]", " Ruxolitinib MTD in combination with paclitaxel 80 mg/m2 intravenously (IV) weekly is determined by the number of patients who have dose limiting toxicity (DLT). See DLT primary outcome measure for definition", " If a DLT was observed in 0 of 3 patients in a cohort, then 3 patients were enrolled to the next cohort using a 5mg higher dose of ruxolitinib.", " If a DLT was observed in 1 of 3 patients in a cohort, then 3 additional patients were added, and then if no further DLTs were observed, 3 patients were enrolled to the next cohort using a 5mg higher dose of ruxolitinib.", " The MTD is identified as the level BELOW the cohort where DLT occurred in less than one third of patients within the cohort.", " If no DLT's are observed, the MTD is not reached.", " Time frame: Participants were assessed prior to each dose of paclitaxel with ruxolitinib; The observation period for MTD evaluation was the first 2 cycles of treatment. (Up to 8 weeks).", "Results 1: ", " Arm/Group Title: All Phase I Participants", " Arm/Group Description: Paclitaxel 80 mg/m2 IV weekly + Ruxolitinib orally twice daily according to the established dose escalation schedule for 4 cycles", " 1 cycle = 21 days Participants with stable disease or better will have the opportunity to continue on single agent Ruxolitinib at the established dose until disease progression, unacceptable toxicity or patient withdrawal.", " Overall Number of Participants Analyzed: 18", " Measure Type: Number", " Unit of Measure: mg 15" ]

[ "Outcome Measurement: ", " Maximum Tolerated Dose Determined by Dose-limiting Toxicities", " 1st 3 pts will be treated on arm 2. If 0/3 DLTs observed, the dose will be escalated to arm 3. If 1/3 DLTs onserved on arm 2, 3 more pts will be treated on arm 2. If no additional DLTs are observed on arm 2, the dose will be escalated to arm 3. If at most 1/6 DLTs observed on arm 3, arm 3 will be considered the MTD. If more than 1/6 DLTs observed on arm 3, the dose will be de-escalated to arm 2. If at most 1/6 DLTs observed on arm 2, arm 2 will be considered the MTD. If more than 1/6 pts on arm 2 experience a DLT, the dose will be de-escalated to arm 1. The remaining pts will be treated on arm 1 as the MTD, unless more than 1/6 DLTs, in which case the study will stop. DLT is defined as any grade III or IV non-hematologic toxicity (incl. diarrhea w\\ adequate antidiarrheal treatment & hydration & nausea/vomiting w\\ maximal antiemetic prophylaxis, as per protocol) or grade IV hematologic toxicity. DLT will be based on the 1st course of treatment according to the revised NCI CTC v 2.0", " Time frame: 21 days", "Results 1: ", " Arm/Group Title: Arm 1", " Arm/Group Description: Capecitabine 800 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,", " Overall Number of Participants Analyzed: 0", " Measure Type: Number", " Unit of Measure: Patients experiencing DLT ", "Results 2: ", " Arm/Group Title: Arm 2", " Arm/Group Description: Capecitabine 1000 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,", " Overall Number of Participants Analyzed: 3", " Measure Type: Number", " Unit of Measure: Patients experiencing DLT 0" ]

[ "INTERVENTION 1: ", " Lapatinib With Paclitaxel", " Participants received lapatinib 1500 milligrams (mg) orally once daily (OD) with paclitaxel 175 mg/meters squared (m^2) intravenously (IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.", "INTERVENTION 2: ", " Placebo With Paclitaxel", " Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal." ]

[ "INTERVENTION 1: ", " AlloDerm RTU", " Participants within this arm will have the acellular dermal matrix AlloDerm RTU implanted at the time of tissue expander placement.", "AlloDerm RTU", "INTERVENTION 2: ", " SurgiMend PRS", " Participants within this arm will have the acellular dermal matrix SurgiMend PRS implanted at the time of tissue expander placement.", "SurgiMend PRS" ]

[ "INTERVENTION 1: ", " Diagnostic FES: Average FES SUVmean >1.5, no Negative Sites", " Patients undergo [^18F] FES PET scan. Patients also undergo standard clinical fludeoxyglucose F 18 (FDG)-PET or FDG-PET/CT scan up to 14 days prior to [^18F] FES PET scan.", " Patients begin clinically indicated endocrine therapy.", " Patients are followed-up to determine response on the therapy for 6 months using clinical exams, tumor marker assays, conventional imaging and standard clinical FDG PET/CT.", " This group represents patients who had positive FES uptake at all disease sites on the baseline diagnostic FES PET scan.", " laboratory biomarker analysis: Correlative studies", "INTERVENTION 2: ", " Diagnostic FES: Patients With FES Negative Sites of Disease", " Patients undergo [^18F] FES PET scan. Patients also undergo standard clinical fludeoxyglucose F 18 (FDG)-PET or FDG-PET/CT scan up to 14 days prior to [^18F] FES PET scan.", " Patients begin clinically indicated endocrine therapy.", " Patients are followed-up to determine response on the therapy for 6 months using clinical exams, tumor marker assays, conventional imaging and standard clinical FDG PET/CT.", " This group represents patients who had some or all disease sites negative for FES uptake on the baseline diagnostic FES PET scan." ]

[ "INTERVENTION 1: ", " Treatment (Vorinostat, AI Therapy)", " Patients receive vorinostat PO 5 days a week for 3 weeks. Patients also receive AI therapy comprising either anastrozole PO daily, letrozole PO daily, or exemestane PO daily for 4 weeks. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity.", " vorinostat: Given PO", " anastrozole: Given PO", " letrozole: Given PO", " exemestane: Given PO", " positron emission tomography: Correlative studies", " F-18 16 alpha-fluoroestradiol: Correlative studies", " fludeoxyglucose F 18: Correlative studies", " laboratory biomarker analysis: Correlative studies" ]

[ "Adverse Events 1:", " Total: 3/12 (25.00%)", " Atrial fibrillation 0/12 (0.00%)", " Cardiac ischemia/infarction [1]0/12 (0.00%)", " Congestive Heart Failure [2]0/12 (0.00%)", " Diverticulitis 0/12 (0.00%)", " Cholecystitis 0/12 (0.00%)", " Hyperbilirubinemia 0/12 (0.00%)", " Urosepsis 2/12 (16.67%)", " Brain hemorrhage complicating CNS metastasis 1/12 (8.33%)", " Rash [3]0/12 (0.00%)" ]

[ "Inclusion Criteria:", " Adult patients 18 years of age.", " Locally advanced, inflammatory, or early stage, unilateral, and histologically confirmed invasive breast cancer documented at a local laboratory (patients with inflammatory breast cancer must be able to have a core needle biopsy).", " Herceptin (HER)2-positive tumor, confirmed by central testing using immunohistochemistry (IHC) and in situ hybridization (ISH) methods.", " Willingness to receive anthracycline-based chemotherapy or have received doxorubicin/cyclophosphamide (AC) OR 5-fluorouracil (FU)/epirubicin/ cyclophosphamide (FEC) in a similar dose and schedule as described in the protocol as part of neoadjuvant or adjuvant treatment.", " For women of childbearing potential and men with partners of childbearing potential, agreement to use a highly effective, non-hormonal form of contraception or 2 effective forms of non-hormonal contraception by the patient and/or partner. Contraception use must continue for the duration of study treatment and for at least 6 months after the last dose of study treatment. Male patients should use condoms for the duration of the study. Specific country requirements will be followed.", " Negative results of serum pregnancy test for premenopausal women of reproductive capacity and for women < 12 months after menopause.", " Patients may enroll before or after AC/FEC chemotherapy has completed.", " Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.", " Adequate hematologic, biochemistry, and cardiac assessments.", "Exclusion Criteria:", " Stage IV breast cancer or bilateral breast cancer.", " Pregnant or breastfeeding women.", " History of other malignancy within the previous 5 years, except contralateral breast cancer and ductal carcinoma in situ (DCIS)/lobular carcinoma in situ (LCIS), appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other cancers with outcome similar to those mentioned above.", " Radiation therapy, immunotherapy, or biotherapy within 5 years before study enrollment; non-cardiotoxic chemotherapy for malignancy treated > 5 years before study enrollment is allowed. Patients receiving AC/FEC in a similar fashion to the study treatment prescribed for adjuvant or neoadjuvant treatment of breast cancer will be allowed to enroll in the study after the completion of their AC/FEC. No other prior history of cardiotoxic chemotherapy is allowed.", " Active cardiac history.", " Current chronic daily treatment with oral corticosteroids or equivalent.", " Patients with severe dyspnea at rest or requiring supplementary oxygen therapy.", " Active, unresolved infections at screening.", " Human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection.", " Major surgery within 4 weeks before enrollment that is unrelated to the breast cancer.", " Patients for whom concomitant radiotherapy + T-DM1 may be contraindicated yet radiation therapy is planned.", " Known hypersensitivity to any of the study drugs or derivatives, including murine proteins.", " Grade 2 peripheral neuropathy at Baseline." ]

[ "Inclusion Criteria:", " Participant is able to provide signed informed consent", " Participant is female and 18 years of age or older if required by local laws or regulations", " Participant has histologically or cytologically confirmed adenocarcinoma of the breast that is now metastatic or locally-recurrent and inoperable with curative intent. Every effort should be made to make paraffin-embedded tissue or slides from the diagnostic biopsy or surgical specimen available for confirmation of diagnosis", " Participant has measurable and/or non-measurable disease", " Participants' primary and/or metastatic tumor is human epidermal growth factor receptor 2 (HER2)-negative by fluorescence in-situ hybridization (FISH) or chromogenic in-situ hybridization (CISH) or 0, 1+ overexpression by immunohistochemistry (IHC)", " Participant has not received prior chemotherapy for metastatic or locally-recurrent and inoperable breast cancer", " Participant completed (neo) adjuvant taxane therapy at least 6 months prior to randomization", " Participant completed (neo) adjuvant biologic therapy at least 6 weeks prior to randomization", " Participant completed all prior radiotherapy with curative intent 3 weeks prior to randomization", " Participant may have received prior hormonal therapy for breast cancer in the (neo) adjuvant and/or the metastatic setting 2 weeks prior to randomization", " Participant's left ventricular ejection fraction is within normal institutional ranges", " Participant has resolution to grade 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3 (NCI-CTCAE v 3.0) of all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy with the exception of peripheral neuropathy which must have resolved to grade 2", " Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1", " Participant is amenable to compliance with protocol schedules and testing", " Participant has adequate hematological functions [absolute neutrophil count (ANC) 1500 cells/microliter (mcL), hemoglobin 9 grams/deciliter (g/dL), and platelets 100,000 cells/mcL and 850,000 cells/mcL]", " Participant has adequate hepatic function [bilirubin within normal limits (WNL), aspartate transaminase (AST) and alanine transaminase (ALT) 2.5 times the upper limit of normal (ULN), or 5.0 times the ULN if the transaminase elevation is due to liver metastases, and alkaline phosphatase 5.0 times the ULN]", " Participant has serum creatinine 1.5 x ULN. If serum creatinine > 1.5 x ULN the calculated creatinine clearance should be > 40 milliliters/minute (mL/min)", " Participant's urinary protein is 1+ on dipstick or routine urinalysis (UA); if urine protein 2+, a 24-hour urine collection must demonstrate < 1000 milligrams (mg) of protein in 24 hours to allow participation in the study", " Participant must have adequate coagulation function as defined by international normalized ratio (INR) 1.5 and a partial thromboplastin time (PTT) 1.5 X ULN if not receiving anticoagulation therapy. Participants on full-dose anticoagulation must be on a stable dose of oral anticoagulant or low molecular weight heparin and if on warfarin must have a INR between 2 and 3 and have no active bleeding (defined as within 14 days of randomization) or pathological condition that carries a high risk of bleeding (such as, tumor involving major vessels or known varices)", " Women of childbearing potential must implement adequate contraception in the opinion of the investigator", " Participant has not received prior biologic therapy for metastatic or locally recurrent and inoperable breast cancer", "Exclusion Criteria:", " Participant has a concurrent active malignancy other than breast adenocarcinoma, adequately treated non melanomatous skin cancer, or other non-invasive carcinoma or in situ neoplasm. A participant with previous history of malignancy is eligible, provided that she has been disease free for > 3 years", " Participant has a known sensitivity to docetaxel or other drugs formulated with polysorbate 80", " Participant has a known sensitivity to agents of similar biologic composition as ramucirumab or other agents that specifically target vascular endothelial growth factor (VEGF)", " Participant has a history of chronic diarrheal disease within 6 months prior to randomization", " Participant has received irradiation to a major bone marrow area as defined as > 25% of bone marrow (such as, pelvic or abdominal radiation) within 30 days prior to randomization", " Participant has participated in clinical trials of experimental agents within 4 weeks prior to randomization", " Participant has a history of uncontrolled hereditary or acquired bleeding or thrombotic disorders", " Participant has active, high risk bleeding (such as, via gastric ulcers or gastric varices) within 14 days prior to randomization", " Participant has an ongoing or active infection requiring parenteral antibiotic, antifungal, or antiviral therapy", " Participant has uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, psychiatric illness/social situations, or any other serious uncontrolled medical disorders in the opinion of the investigator", " Participant has brain metastases, uncontrolled spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease", " Participant has known human immunodeficiency virus infection or acquired immunodeficiency syndrome-related illness", " Participant has pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen.", " Participant is pregnant or lactating" ]

[ "DISEASE CHARACTERISTICS:", " Histologically or cytologically confirmed diagnosis of adenocarcinoma of the breast", " Evidence of metastatic involvement (stage IV disease)", " Patients must have measurable disease", " At least one measurable lesion as defined by the Response Evaluation Criteria in Solid Tumors (RECIST)", " Treated brain metastases (surgery or radiation therapy) allowed if clinically stable", " Patients with leptomeningeal disease are ineligible", " Hormone receptor status:", " Not specified", " PATIENT CHARACTERISTICS:", " Eastern Cooperative Oncology Group (ECOG) performance status 0-2", " Male or female", " Menopausal status not specified", " Absolute neutrophil count (ANC) 1,500/mm^3", " Platelet count 100,000/mm^3", " Creatinine clearance > 50 mL/min", " Fertile patients must use effective contraception", " No history of another severe and/or life-threatening medical disease", " No other active primary malignancy", " Not pregnant or nursing", " Negative pregnancy test", " Patients with asymptomatic HIV infection are eligible", " Liver dysfunction score 9", " No pre-existing liver disease (i.e., cirrhosis or active viral hepatitis)", " No active gastrointestinal malabsorption illness", " No clinically significant cardiac disease, including the following:", " Congestive heart failure, symptomatic coronary artery disease, and cardiac arrhythmias not well controlled with medication, or myocardial infarction within the past six months", " No prior unanticipated severe reaction to fluoropyrimidine therapy, known hypersensitivity to fluorouracil, or known dihydropyrimidine dehydrogenase deficiency", " No history of uncontrolled seizures or central nervous system disorders", " No significant history of noncompliance to medical regimens", " No clinically significant psychiatric disability that would preclude study compliance", " PRIOR CONCURRENT THERAPY:", " No previous capecitabine", " Up to 3 prior cytotoxic regimens allowed for metastatic disease", " Prior noncytotoxic therapy allowed (e.g., hormonal treatment or trastuzumab)", " No other concurrent therapies intended to treat the primary condition including chemotherapy, biologic agents, or immunotherapy", " No concurrent anti-estrogen therapy, radiation therapy, or investigational systemic therapy", " No other concurrent investigational drugs", " No concurrent use of the following drugs: warfarin for full anticoagulation, cimetidine, or azidothymidine (AZT)", " Mini-dose warfarin for prophylaxis of central venous catheter thrombosis allowed", " At least 4 weeks since prior sorivudine or brivudine", " Concurrent use of bisphosphonates allowed if initiated before beginning study therapy", " Concurrent use of megestrol acetate suspension as an appetite stimulant allowed" ]

[ "Adverse Events 1:", " Total: 2/35 (5.71%)", " Gastroesophageal reflux disease * 1/35 (2.86%)", " Ductal carcinoma in situ * 1/35 (2.86%)" ]

[ "Adverse Events 1:", " Total: 22/41 (53.66%)", " Anemia 1/41 (2.44%)", " Dyspepsia 1/41 (2.44%)", " Mucositis oral 1/41 (2.44%)", " Nausea 3/41 (7.32%)", " Vomiting 1/41 (2.44%)", " Pain 3/41 (7.32%)", " Allergic reaction 1/41 (2.44%)", " Infections and infestations - Other, specify: [1]1/41 (2.44%)", " Vascular access complication 3/41 (7.32%)", " Alanine aminotransferase increased 1/41 (2.44%)" ]

[ "Outcome Measurement: ", " Phase 1b: Number of Participants With Dose-limiting Toxicities (DLTs) as Per National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 (NCI CTCAE v3.0)", " DLTs as per NCI CTCAE v3.0 were defined as:1) Neutropenia Grade 4 that lasted at least 7 days, 2) Neutropenia Grade 3 or 4 complicated by fever and/or infection (absolute neutrophil count [ANC] less than 1.0*10^9/liter [L], fever of at least 38.5 degree celsius [°C]), 3)Thrombocytopenia Grade 4, 4) Thrombocytopenia Grade 3 complicated by bleeding and/or requiring platelet or blood transfusion, 5) Non-hematological toxicity Grade 3 or higher (excluding Grade 3 nausea, and Grade 3 or 4 vomiting or diarrhea in participants who had not received optimal treatment with antiemetic and/or antidiarrheal medication; excluding laboratory abnormalities without clinical symptoms), 6) Delayed recovery from treatment-related toxicity resulting in dose delay greater than 14 days, 7) Failure to administer at least 75 percent (%) of planned study drugs during Cycle 1 as result of Grade 2 or higher treatment-related toxicity that constituted increase of at least 2 grades from baseline.", " Time frame: Cycle 1 (21 days)", "Results 1: ", " Arm/Group Title: Phase 1b (Schedule 1): Eribulin Mesilate (1.2 mg/m^2)", " Arm/Group Description: Participants received eribulin mesilate 1.2 mg/m^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).", " Overall Number of Participants Analyzed: 8", " Measure Type: Count of Participants", " Unit of Measure: Participants 1 12.5%", "Results 2: ", " Arm/Group Title: Phase 1b (Schedule 1): Eribulin Mesilate (1.6 mg/m^2)", " Arm/Group Description: Participants received eribulin mesilate 1.6 mg/m^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).", " Overall Number of Participants Analyzed: 6", " Measure Type: Count of Participants", " Unit of Measure: Participants 1 16.7%" ]

[ "Outcome Measurement: ", " Concordance of Blue Dye and Lymphoseek", " The proportion of lymph nodes detected intraoperatively by blue dye that were also detected by Lymphoseek.", " Time frame: Surgery after injections of Lymphoseek and blue dye", "Results 1: ", " Arm/Group Title: Intent-To-Treat", " Arm/Group Description: Participants received a single dose of 50 μg Lymphoseek radiolabeled with 0.5 or 2.0 mCi Tc 99m and blue dye for lymphatic mapping and surgical resection of lymph nodes.", " Overall Number of Participants Analyzed: 133", " Overall Number of Units Analyzed", " Type of Units Analyzed: Lymph Nodes Measure Type: NumberNumber (95% Confidence Interval)Unit of Measure: Proportion of Lymph Nodes: 1.0000 (0.9840 to 1.0000)" ]

[ "Outcome Measurement: ", " Percentage of Participants With Overall Response Rate (ORR)", " Overall Response Rate (ORR) was defined as the proportion of patients whose best overall response was either complete response (CR) or partial response (PR) according to RECIST 1.0 for target lesions and assessed by CT: Complete Response (CR), disappearance of all target lesions for a period of at least one month; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (ORR) = CR + PR. Only descriptive statistics.", " Time frame: From the date of randomization until the date of the first documented disease progression or date of death from any cause whichever came first, assessed for approximately 15 months", "Results 1: ", " Arm/Group Title: Everolimus + Letrozole", " Arm/Group Description: All patients received 2 tablets (5 mg each) of Everolimus (a total of 10 mg) + 1 tablet of Letrozole (2.5 mg) daily until disease progression or as described in the protocol.", " Overall Number of Participants Analyzed: 43", " Measure Type: Number", " Unit of Measure: Percentage of Participants 37.2" ]

[ "INTERVENTION 1: ", " GnRHa (Gonadotrophin-releasing Hormone Analogues) Group", " Eligible patients with breast cancer treated with GnRHa (Gonadotrophin-releasing Hormone Analogues) while receiving chemotherapy.", " Goserelin 3.6mg, or leuprorelin 3.75mg subcutaneous injection every 28 days.Initiated 1-2 weeks before chemotherapy and ended 4-8 weeks after chemotherapy.", "INTERVENTION 2: ", " None GnRHa (Gonadotrophin-releasing Hormone Analogues) Group", " Eligible patients with breast cancer treated without GnRHa (Gonadotrophin-releasing Hormone Analogues) while receiving chemotherapy." ]

[ "Adverse Events 1:", " Total: 2/60 (3.33%)", " Bronchial infection 0/60 (0.00%)", " Ankle fracture 1/60 (1.67%)", " Clear cell kidney cancer 0/60 (0.00%)", " Programmed peritoneal dialysis 1/60 (1.67%)", " Endometrial atrophy 0/60 (0.00%)", "Adverse Events 2:", " Total: 3/58 (5.17%)", " Bronchial infection 1/58 (1.72%)", " Ankle fracture 0/58 (0.00%)", " Clear cell kidney cancer 1/58 (1.72%)", " Programmed peritoneal dialysis 0/58 (0.00%)", " Endometrial atrophy 1/58 (1.72%)" ]

[ "Inclusion Criteria:", " Receiving any treatment for breast cancer or have completed acute treatment for breast cancer < 10 years ago", " Attending clinic visits in the course of follow-up care (i.e., not an initial consult visit)", " Willing to have clinic visit audio recorded", "Exclusion Criteria:", " Unable to speak English", " Eastern Cooperative Oncology Group (ECOG) Performance score > 2 OR too ill to participate as judged by physician, self-report, or observation of the research team member", " Overt cognitive dysfunction or psychiatric disturbance or severe mental illness (e.g., dementia, suicidal behavior, or psychosis), as observed or judged by the researcher or referring source." ]

[ "Inclusion Criteria - Phase 1 (Cohort A):", " Female patient 18 years", " Patient must be postmenopausal, verified by 1 of the following:", " Bilateral surgical oophorectomy", " No spontaneous menses > 1 year", " No menses for < 1 year with FSH and estradiol levels in postmenopausal range. If a study subject under the age of 60 reports prior surgery in which the ovaries were removed and if the operative report cannot be obtained to confirm bilateral salpingo-oophorectomy, the subject will have serum estradiol, LH and FSH drawn to confirm menopausal status prior to study entry", " Postmenopausal women with primary invasive breast cancer, histologically confirmed by core needle (or incisional biopsy), whose tumors are estrogen (ER) and/or progesterone (PgR) positive. Estrogen- and/or progesterone-receptor positive disease based on 10% or more nuclear staining of the invasive component of the tumor", " Stage IV disease (as defined by the AJCC Staging Manual, 6th Edition, 2002); or locally relapsed, unresectable disease", " Measurable or evaluable disease according to RECIST criteria (see appendix VII)", " Both HER2-positive and HER2-negative disease (as defined by IHC or by fluorescence in situ hybridization [FISH]). HER2+ must have had prior treatment with trastuzumab and/or lapatinib.", " ECOG performance status 0-2 (see appendix VI)", " Patients are suitable candidates for treatment with anastrozole (patients may have had any prior endocrine therapy or prior chemotherapy for treatment of their disease, either as adjuvant therapy, or as treatment for advanced disease). There is no restriction on the number of prior regimens in the phase I cohort A.", " Patient is accessible and willing to comply with treatment and follow-up", " Patient is willing to provide written informed consent prior to the performance of any study-related procedures", " Required laboratory values", " Absolute neutrophil count to 1.5 x 10^9/L", " Hemoglobin to 9.0 g/dL", " Platelet count to 100 x 10^9/L", " Creatinine 1.5 mg/dL", " Total bilirubin 1.0 x upper limit of normal (ULN)", " Alkaline phosphatase and AST/ALT within protocol parameters. In determining eligibility, the more abnormal of the two values (AST or ALT) should be used.", " Inclusion Criteria - Phase 2 (Cohort B):", " Female patient 18 years", " Patient must be postmenopausal, verified by 1 of the following:", " Bilateral surgical oophorectomy", " No spontaneous menses 1 year", " No menses for < 1 year with FSH and estradiol levels in postmenopausal range. If a study subject under the age of 60 reports prior surgery in which the ovaries were removed and if the operative report cannot be obtained to confirm bilateral salpingo-oophorectomy, the subject will have serum estradiol, LH and FSH drawn to confirm menopausal status prior to study entry", " Postmenopausal women with primary invasive breast cancer, histologically confirmed by core needle (or incisional biopsy), whose tumors are estrogen (ER) and/or progesterone (PgR) positive. Estrogen- and/or progesterone-receptor positive disease based on 10% or more nuclear staining of the invasive component of the tumor. Patients may have bilateral or multifocal invasive breast cancers. The patient may have concurrent DCIS in either breast but the DCIS will not be measured as part of the study endpoints.", " Tumor size 2 cm", " Tumor measurable either by clinical examination, mammography, MRI, or ultrasound", " HER2-negative disease (as defined by fluorescence in situ hybridization [FISH] or by IHC)", " ECOG performance status 0-1 (see Appendix VI)", " Patient is accessible and willing to comply with treatment and follow-up", " Patient is willing to provide written informed consent prior to the performance of any study-related procedures", " Required laboratory values", " Absolute neutrophil count 1.5 x 10^9/L", " Hemoglobin 9.0 g/dL", " Platelet count 70 x 10^9/L", " Creatinine 1.5 mg/dL", " Total bilirubin 1.5 x upper limit of normal (ULN)", " Alkaline phosphatase and AST/ALT 1.5 x upper limit of normal (ULN)", " Exclusion Criteria - Phase 1 (Cohort A):", " Concurrent therapy with any other non-protocol anti-cancer therapy", " Any agent with estrogenic or putatively estrogenic properties, including herbal preparations, must be stopped at least one week prior to registration.", " Ongoing, chronic administration of bisphosphonate therapy is allowed so long as such treatment was ongoing at the time of study entry.", " Current therapy with hormone replacement therapy, or any hormonal agent such as raloxifene, tamoxifen, or other selective estrogen receptor modulators (agents must be stopped prior to randomization)", " Presence of neuropathy grade 2 (NCI-CTC version 3.0) at baseline", " History of any other malignancy within the past 5 years, with the exception of non-melanoma skin cancer or carcinoma-in-situ of the cervix", " Clinically significant cardiovascular disease (e.g., hypertension [BP > 150/100], history of myocardial infarction or stroke within 6 months, unstable angina), New York Heart Association (NYHA) Grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication", " Active, uncontrolled infection requiring parenteral antimicrobials", " A history of a severe hypersensitivity reaction to anastrozole, or AZD0530 or their excipients", " Evidence of bleeding diathesis or coagulopathy.", " Resting EKG with measurable QTc interval of >480msec at 2 or more time points within a 24 hr period.", " Since AZD0530 is a substrate and inhibitor of CYP3A4, patients requiring medication with drugs listed in Appendix XI should be excluded from study.", " Any evidence of severe or uncontrolled systemic medical or psychiatric conditions (e.g. Severe hepatic impairment, interstitial lung disease [bilateral, diffuse, parenchymal lung disease]) or current unstable or uncompensated respiratory or cardiac conditions which make it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol", " Evidence of underlying pulmonary dysfunction as evidenced by oxygen saturation <90% by pulse oximetry, interstitial pulmonary infiltrates on high resolution CT scan prior to study entry and/or symptomatic pulmonary (pleural or parenchymal) metastasis.", " Exclusion Criteria - Phase 2 (Cohort B):", " Prior chemotherapy, endocrine therapy or radiotherapy for the presenting breast cancer. Prior incidence and treatment of contralateral invasive or non-invasive breast cancer is not an exclusion criterion.", " Inflammatory breast cancer, clinically defined as the presence of erythema or induration involving one-third or more of the breast, or pathologically defined as dermal lymphatic invasion", " Prior excisional biopsy or complete resection of the primary invasive tumor (prior sentinel node biopsy allowed)", " Prior ipsilateral radiation therapy for invasive or non-invasive breast cancer", " Distant metastasis is an exclusion criterion - Isolated ipsilateral supraclavicular node involvement and/or direct invasion of the primary tumor into skin is allowed", " Concurrent therapy with any other non-protocol anti-cancer therapy", " Any agent with estrogenic or putatively estrogenic properties, including herbal preparations, must be stopped at least one week prior to registration", " Current therapy with hormone replacement therapy, or any hormonal agent such as raloxifene, tamoxifen, or other selective estrogen receptor modulators (agents must be stopped for one week prior to randomization)", " Presence of neuropathy grade 2 (NCI-CTC AE version 3.0) at baseline", " History of any other malignancy within the past 5 years, with the exception of non-melanoma skin cancer or carcinoma-in-situ of the cervix", " Clinically significant cardiovascular disease (e.g. history of myocardial infarction or stroke within 6 months, unstable angina), New York Heart Association (NYHA) Grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication", " Active, uncontrolled infection requiring parenteral antimicrobials", " A history of a severe hypersensitivity reaction to anastrozole, or AZD0530 (saracatinib) or their excipients", " Evidence of bleeding diathesis or coagulopathy", " Resting EKG with measurable QTc interval of >480msec at 2 or more time points within a 24 hr period.", " AZD0530 (saracatinib) is a substrate and inhibitor of CYP3A4. Since concurrent administration of AZD0530 with other CYP3A4 substrates has been shown to be well tolerated, continuation or initiation of medically indicated drugs that are substrates of CYP3A4 is permitted at MD discretion. Drugs listed in Appendix X that are known to strongly induce or inhibit CYP3A4 activity should be discontinued prior to study entry and should not be initiated during protocol treatment.", " Any evidence of severe or uncontrolled systemic psychiatric or medical conditions (eg. Severe hepatic impairment, interstitial lung disease [bilateral, diffuse, parenchymal lung disease]) or current unstable or uncompensated respiratory or cardiac conditions which make it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol", " Evidence of underlying pulmonary dysfunction as evidenced by oxygen saturation <90% by pulse oximetry prior to study entry and/or symptomatic pulmonary (pleural or parenchymal) disease.", " Subjects unwilling or unable to undergo breast MRI as required by protocol will be excluded from study" ]

[ "Inclusion Criteria:", " Female;", " Histologically proven stage 0-III invasive carcinoma of the breast that is ER and/or PR positive by immunohistochemical staining, who are receiving a standard dose of aromatase inhibitor (AI) therapy (letrozole 2.5mg once daily or exemestane 25mg once daily or anastrozole 1mg once daily). Women with oligometastatic disease may be included at the discretion of the principal investigator. Surgical resection, chemotherapy, and radiation therapy must have been completed at the time of study enrollment, with the exception of trastuzumab;", " AI therapy has been ongoing for 2 weeks and treatment is expected to continue;", " AI-associated musculoskeletal symptoms, defined as:", " Grade 1 or higher musculoskeletal pain that developed or worsened (6 or 7 on CGICS) during AI therapy or", " Grade 1 or higher sensory neuropathy that developed or worsened (6 or 7 on CGICS) during AI therapy;", " Average pain of 4 on the 11-point Likert scale of question #5 of the Brief Pain Inventory;", " ECOG performance status 0-2;", " Willing and able to sign an informed consent document.", "Exclusion Criteria:", " Known hypersensitivity to duloxetine or any of the inactive ingredients;", " New musculoskeletal pain that is due specifically to fracture or traumatic injury;", " Treatment with monoamine oxidase inhibitors (MAO-I) within 14 days of enrollment;", " Concurrent treatment with phenothiazines (including thioridazine), propafenone, flecainide, triptans, MAO-Is, SSRIs, SNRIs, or tricyclic antidepressants;", " Currently primary psychiatric diagnosis (schizophrenia, psychosis) or suicidal ideation, history of bipolar disorder, or seizure disorder;", " Chronic liver disease, end stage renal disease, or creatinine clearance < 30 mL/min as defined by the Cockroft-Gault equation;", " Uncontrolled narrow-angle glaucoma or clinically significant coagulation disorder;", " Pregnant or breast feeding;", " History of alcohol or other substance abuse or dependence within the year prior to enrollment;", " Serious or unstable medical condition that could likely lead to hospitalization during the course of the study or compromise study participation." ]

[ "INTERVENTION 1: ", " Physician's Choice", " Physician selection from 4 standard of care metastatic breast cancer chemotherapies (eribulin or vinorelbine or gemcitabine or capecitabine), until progression or unacceptable toxicity develops.", "INTERVENTION 2: ", " Niraparib", " Niraparib 300 mg (3x100 mg capsules) once daily until progression or unacceptable toxicity develops" ]

[ "Adverse Events 1:", " Total: 20/93 (21.51%)", " Granulocytosis 1/93 (1.08%)", " Leukopenia 2/93 (2.15%)", " Angina pectoris 0/93 (0.00%)", " Atrial fibrillation 1/93 (1.08%)", " Cardiopulmonary failure 2/93 (2.15%)", " Retinal detachment 1/93 (1.08%)", " Diarrhoea 3/93 (3.23%)", " Nausea 1/93 (1.08%)", " Vomiting 1/93 (1.08%)", " Chest pain 1/93 (1.08%)", " Death 0/93 (0.00%)", " Pyrexia 1/93 (1.08%)" ]

[ "Inclusion Criteria", " Pathologically confirmed diagnosis of invasive breast cancer, determined to be a candidate for primary systemic (neoadjuvant) therapy and for surgical resection of residual primary tumor following completion of neoadjuvant therapy;", " Tumor size >2cm, measured on imaging or estimated by physical exam;", " No contraindications for primary chemotherapy;", " Planned definitive breast surgery (mastectomy or lumpectomy/breast conservation) following completion of neoadjuvant therapy;", " Age 18 years or older;", " ECOG Performance Status 2 (Karnofsky 60%; see Appendix II);", " Normal organ and marrow function as follows:", " leukocytes 3,000/μl;", " absolute neutrophil count 1,500/μl;", " platelets 100,000/μl;", " total bilirubin within normal institutional limits;", " AST(SGOT)/ALT(SGPT) 2.5 times the institutional upper limit of normal;", " creatinine within normal institutional limits; OR", " creatinine clearance 30 mL/min/1.73 m2 for patients with creatinine levels above institutional normal;", " If female, postmenopausal for a minimum of one year, OR surgically sterile, OR not pregnant, confirmed by a pregnancy test as per institutional Standard of Care (SOC), and willing to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation;", " Able to understand and willing to sign a written informed consent document and a HIPAA authorization in accordance with institutional guidelines;", " Exclusion Criteria", " Previous treatment (chemotherapy, radiation, or surgery) to involved breast; including hormone therapy;", " Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements;", " Medically unstable;", " Under age 18;", " Pregnant or nursing;", " Previous malignancy, other than basal cell or squamous cell carcinoma of the skin or in situ carcinoma of the cervix, from which the patient has been disease free for less than 5 years." ]

[ "Inclusion Criteria:", " Post-menopausal women (either through bilateral oophorectomy or amenorrhoeic for 24 months)", " Histological confirmation of Breast Cancer with documented ER+ receptor status", " Safety run-in: Relapsing during/within 12 months of completion of a single regimen of adjuvant endocrine therapy with non-steroidal AI and/ tamoxifen or progression following 1st line endocrine therapy with non-steroidal AL", " Rand phase IIa: Received at least 1 prior endocrine therapy in the metastatic setting or have relapsed during/ within 6 months of completion of adjuvant endocrine therapy (either non-steroidal AI or tamoxifen or a combination of both). Chemotherapy administered in the adjuvant setting is permitted.", " Rand phase IIa: Mandatory provision of tumour sample to confirm FGFR1 polysomy or gene amplification. At least one measurable lesion that can be accurately assessed by CT/MRI/x-ray at baseline and follow up visits", "Exclusion Criteria:", " Prior exposure to exemestane (safety run-in) / fulvestrant (randomized phase IIa), or any agent known to inhibit FGFRs.", " More than 1 prior regimen of chemotherapy for breast cancer", " ECG recordings that demonstrate significant abnormalities in cardiac rate, rhythm or conduction", " History of hypersensitivity to active or inactive excipients of AZD4547 or exemestane (safety run-in ) or fulvestrant (Randomized phase), including castor oil, or drugs with a similar chemical structure or class to AZD4547 or exemestane or fulvestrant.", " Randomized phase IIa: bleeding/blood clotting conditions that would prevent the administration of the fulvestrant injection into the buttocks" ]

[ "INTERVENTION 1: ", " Arm I (Web-Based CPM-DA)", " Patients receive a website address, a secure username and password, and instructions for using the web-based CPM-DA.", " Internet-Based Intervention: Receive web-based CPM-DA", " Survey Administration: Ancillary studies", "INTERVENTION 2: ", " Arm II (Usual Care)", " Patients undergo usual care available to patients considering CPM and receive information from a medical oncologist about CPM.", " Survey Administration: Ancillary studies" ]

[ "INTERVENTION 1: ", " Nivolumab + Daratumumab (TNBC)", " Triple-negative breast cancer (TNBC) treated with Triple-negative breast cancer (TNBC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)", "INTERVENTION 2: ", " Nivolumab + Daratumumab (NSCLC)", " Non-small cell lung cancer (NSCLC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)" ]

[ "Adverse Events 1:", " Total: 0/161 (0.00%)", " Gastrointestinal-Other 0/161 (0.00%)", " Dehydration 0/161 (0.00%)", " Renal/Genitourinary-Other 0/161 (0.00%)", "Adverse Events 2:", " Total: 1/64 (1.56%)", " Gastrointestinal-Other 1/64 (1.56%)", " Dehydration 1/64 (1.56%)", " Renal/Genitourinary-Other 1/64 (1.56%)" ]

[ "Adverse Events 1:", " Total: 13/34 (38.24%)", " Anemia 3/34 (8.82%)", " Diarrhea 7/34 (20.59%)", " Nausea 2/34 (5.88%)", " Sepsis 1/34 (2.94%)", " Urinary tract infection 1/34 (2.94%)", " Alkaline phosphatase increased 1/34 (2.94%)", " Neutrophil count decreased 2/34 (5.88%)", " Dehydration 1/34 (2.94%)", " Headache 1/34 (2.94%)", " Thromboembolic event 1/34 (2.94%)" ]

[ "Inclusion Criteria:", " Histological confirmation of invasive carcinoma of the breast.", " HER-2/neu overexpression: 3+ by immunohistochemical staining or Fluorescence in situ hybridization (FISH) (+).", " Stage IV breast cancer with measurable disease.", " Patient receiving progressive disease after Herceptin plus chemotherapy or Herceptin alone. No more than two Herceptin containing regimens.", " Zubrod performance status 0 or 1.", " Adequate hematological parameters (White Blood cells-WBC > 3,000/mm3, platelet count > 100,000/mm3), adequate renal function (serum creatinine < 2.0 mg/dl), adequate liver function (total bilirubin, aspartate aminotransferase (AST or SGOT) or alanine aminotransferase (ALT or SGPT) < 3 x normal).", "Exclusion Criteria:", " Active Brain metastasis.", " No measurable disease at the time of registration (e.g. bone only, leptomeningeal disease alone or pleural effusion alone).", " More than 2 Herceptin containing regimens in metastatic breast cancer.", " Known history of HIV positive.", " Chronic active hepatitis or cirrhosis.", " Symptomatic pulmonary disease.", " Use of steroid of non-steroidal anti-inflammatory analgesic or Cox-2 inhibitor 1 week prior to registration." ]

[ "Inclusion Criteria:", " Stage II through IIIC HER-2/erbB-2 positive breast cancer with node positive disease.", " Been treated for early breast cancer with standard of care duration of trastuzumab.", " Could have been treated neoadjuvantly but have not reached pathologic complete response.", "Exclusion Criteria:", " Positive clinical and radiologic assessments for local or regional recurrence of disease at the time of study entry.", " History of heart disease.", " Corrected QT (QTc) interval >0.45 seconds", " History of gastrointestinal disease with diarrhea as the major symptom." ]

[ "Outcome Measurement: ", " Overall Response Rate", " Overall Response Rate (ORR), subjects with CR or PR by independent review in subjects with ErbB-2-positive breast cancer treated at the MTD of neratinib in combination with vinorelbine per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions.", " Time frame: From first dose date to progression or last tumor assessment, up to four years and six months.", "Results 1: ", " Arm/Group Title: Neratinb 240 mg + Vinorelbine 25 mg/m - No Prior Lapatinib", " Arm/Group Description: Neratinib 240 mg qd + Vinorelbine 25 mg/m IV on days 1 and 8 every 3 weeks, with no prior lapatinib exposure", " Overall Number of Participants Analyzed: 64", " Measure Type: Number", " Unit of Measure: percentage of participants 35.9 (24.3 to 48.9)", "Results 2: ", " Arm/Group Title: Neratinib 240 mg + Vinorelbine 25 mg/m - Prior Lapatinib", " Arm/Group Description: Neratinib 240 mg qd + Vinorelbine 25 mg/m IV on days 1 and 8 every 3 weeks, with prior Lapatinib exposure", " Overall Number of Participants Analyzed: 15", " Measure Type: Number", " Unit of Measure: percentage of participants 13.3 (1.7 to 40.5)" ]

[ "Outcome Measurement: ", " Percent Change From Baseline of Bone Mineral Density of the Lumbar Spine (L2-l4)", " Lumbar spine (L2-L4) BMD measurements by dual energy X-ray absorptiometry (DXA) were performed after surgery and within 2 weeks prior to randomization and repeated every 6 months for the first 2 years and annually thereafter until 5 years after enrollment. The primary scanning site was the lumbar spine (L2 to L4) and the secondary scanning site was the total hip. All DXA scans were evaluated by a central reader.", " Time frame: Baseline, 24 months", "Results 1: ", " Arm/Group Title: Letrozole", " Arm/Group Description: 2.5 mg once daily (q.d.)orally for 5 years", " Overall Number of Participants Analyzed: 63", " Median (Full Range)", " Unit of Measure: Percent Change -4.63 (-14.21 to 4.32)", "Results 2: ", " Arm/Group Title: Tam-Let", " Arm/Group Description: 20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.", " Overall Number of Participants Analyzed: 68", " Median (Full Range)", " Unit of Measure: Percent Change 0.37 (-6.98 to 15.21)" ]

[ "INTERVENTION 1: ", " Pemetrexed", " 600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression" ]

[ "INTERVENTION 1: ", " Arm I (Low-dose Omega-3 Fatty Acid)", " Patients receive low-dose omega-3 fatty acid supplementation PO BID and placebo PO BID for 6 weeks.", "Omega-3 Fatty Acid: Given PO", " Placebo: Given PO", " Questionnaire Administration: Ancillary studies", " Laboratory Biomarker Analysis: Correlative studies", "INTERVENTION 2: ", " Arm II (High-dose Omega-3 Fatty Acid)", " Patients receive high-dose omega-3 fatty acid supplementation PO BID for 6 weeks.", "Omega-3 Fatty Acid: Given PO", " Questionnaire Administration: Ancillary studies", " Laboratory Biomarker Analysis: Correlative studies" ]

[ "INTERVENTION 1: ", " Cohort A", " 750mg lapatinib administered orally twice daily. Cohort A subjects had Eastern Cooperative Oncology Group (ECOG) performance status 0-1, and one or two prior trastuzumab-containing regimens, in total, for treatment of breast cancer in adjuvant and/or metastatic settings", "INTERVENTION 2: ", " Cohort B", " 750mg lapatinib administered orally twice daily. Cohort B subjects had ECOG performance status 2 and/or more than 2 prior trastuzumab-containing regimens for treatment of breast cancer in the adjuvant and/or metastatic settings." ]

[ "Adverse Events 1:", " Total: 18/70 (25.71%)", " Cardiac arrest 1/70 (1.43%)", " Pericardial effusion 1/70 (1.43%)", " Ear pain 1/70 (1.43%)", " Blurred vision 1/70 (1.43%)", " Eye disorders - Other, specify 2/70 (2.86%)", " Abdominal Pain 5/70 (7.14%)", " Colitis 1/70 (1.43%)", " Diarrhea 2/70 (2.86%)", " Nausea 2/70 (2.86%)", " Death NOS 1/70 (1.43%)", " Edema limbs 1/70 (1.43%)", " Fatigue 3/70 (4.29%)" ]

[ "Adverse Events 1:", " Total: 5/261 (1.92%)", " Cholecystitis chronic 1/261 (0.38%)", " Post procedural bile leak 1/261 (0.38%)", " Spinal column stenosis 1/261 (0.38%)", " Depression 1/261 (0.38%)", " Mania 1/261 (0.38%)", " Pulmonary embolism 1/261 (0.38%)" ]

[ "INTERVENTION 1: ", " Arm A: Endocrine Therapy (ET)", " Endocrine treatment consisting of either letrozole or fulvestrant. Patients will be randomized to receive bevacizumab 15mg/kg every 3 weeks plus endocrine treatment or endocrine treatment as a single agent. The patients will receive the assigned treatment until the progression of the disease, unacceptable toxicity or withdrawal of the consent.", " Letrozole", "Fulvestrant", "INTERVENTION 2: ", " Arm B: ET With Bevacizumab (ET-B)", " Endocrine treatment consisting of either letrozole or fulvestrant. Patients will be randomized to receive bevacizumab 15mg/kg i.v. on day 1 every 3 weeks plus endocrine treatment or endocrine treatment as a single agent. The patients will receive the assigned treatment until the progression of the disease, unacceptable toxicity or withdrawal of the consent.", " Letrozole", " Bevacizumab", "Fulvestrant" ]

[ "Adverse Events 1:", " Total: 8/44 (18.18%)", " Febrile neutropenia4/44 (9.09%)", " Rectal bleeding1/44 (2.27%)", " Chest pain2/44 (4.55%)", " Fever1/44 (2.27%)", " Catheter site infection1/44 (2.27%)", " Neutrophil count decreased1/44 (2.27%)", " Dizziness1/44 (2.27%)" ]

[ "Adverse Events 1:", " Total: 331/1634 (20.26%)", " Anemia 3/1634 (0.18%)", " Coagulation disorders 1/1634 (0.06%)", " Hemorrhage Vaginal 1/1634 (0.06%)", " Leukopenia 18/1634 (1.10%)", " Lymphadenopathy 0/1634 (0.00%)", " Lymphedema 0/1634 (0.00%)", " Pancytopenia 0/1634 (0.00%)", " Thrombocytopenia 0/1634 (0.00%)", " Arrhythmia 3/1634 (0.18%)", " Arrhythmia Ventricular 0/1634 (0.00%)", " Cardiomyopathy 1/1634 (0.06%)", "Adverse Events 2:", " Total: 520/1635 (31.80%)", " Anemia 5/1635 (0.31%)", " Coagulation disorders 0/1635 (0.00%)", " Hemorrhage Vaginal 0/1635 (0.00%)", " Leukopenia 56/1635 (3.43%)", " Lymphadenopathy 1/1635 (0.06%)", " Lymphedema 2/1635 (0.12%)", " Pancytopenia 1/1635 (0.06%)", " Thrombocytopenia 1/1635 (0.06%)", " Arrhythmia 3/1635 (0.18%)", " Arrhythmia Ventricular 1/1635 (0.06%)", " Cardiomyopathy 0/1635 (0.00%)" ]

[ "Adverse Events 1:", " Total: 8/29 (27.59%)", " Hemorrhage - Nose 1/29 (3.45%)", " Left Ventricular Systolic Dysfunction 1/29 (3.45%)", " Vomiting 1/29 (3.45%)", " Esophagitis 1/29 (3.45%)", " Pain - Abdomen 1/29 (3.45%)", " Pain - Chest 1/29 (3.45%)", " Infection - Skin 1/29 (3.45%)", " Infection - Sepsis 2/29 (6.90%)", " Creatinine 1/29 (3.45%)", " Wound Complication, Non-Infectious 1/29 (3.45%)" ]

[ "Adverse Events 1:", " Total: 8/29 (27.59%)", " Leukopenia [1]1/29 (3.45%)", " Thrombocytopenia [1]1/29 (3.45%)", " Abscess [1]1/29 (3.45%)", " Breast Abscess 1/29 (3.45%)", " Fever/Sepsis [1]1/29 (3.45%)", " Neutropenic Fever [2]1/29 (3.45%)", " Peripheral Neuropathy [1]1/29 (3.45%)", " Seizure/Syncope [1]1/29 (3.45%)", " Hematuria [1]1/29 (3.45%)", " UTI [1]1/29 (3.45%)", " Shortness of breath [1]1/29 (3.45%)" ]

[ "Adverse Events 1:", " Total: 331/1634 (20.26%)", " Anemia 3/1634 (0.18%)", " Coagulation disorders 1/1634 (0.06%)", " Hemorrhage Vaginal 1/1634 (0.06%)", " Leukopenia 18/1634 (1.10%)", " Lymphadenopathy 0/1634 (0.00%)", " Lymphedema 0/1634 (0.00%)", " Pancytopenia 0/1634 (0.00%)", " Thrombocytopenia 0/1634 (0.00%)", " Arrhythmia 3/1634 (0.18%)", " Arrhythmia Ventricular 0/1634 (0.00%)", " Cardiomyopathy 1/1634 (0.06%)", "Adverse Events 2:", " Total: 520/1635 (31.80%)", " Anemia 5/1635 (0.31%)", " Coagulation disorders 0/1635 (0.00%)", " Hemorrhage Vaginal 0/1635 (0.00%)", " Leukopenia 56/1635 (3.43%)", " Lymphadenopathy 1/1635 (0.06%)", " Lymphedema 2/1635 (0.12%)", " Pancytopenia 1/1635 (0.06%)", " Thrombocytopenia 1/1635 (0.06%)", " Arrhythmia 3/1635 (0.18%)", " Arrhythmia Ventricular 1/1635 (0.06%)", " Cardiomyopathy 0/1635 (0.00%)" ]

[ "Inclusion Criteria:", " Informed consent signed", " Capability to use internet", "Exclusion Criteria:", " Breast cancer diagnosis duting the intervention" ]

[ "Outcome Measurement: ", " Number of Participants With Dose Limiting Toxicity (DLT)", " For DLT evaluation, severity (grade) was classified according to common terminology criteria for adverse events version 4.0 (CTCAE v4.0). DLTs were defined as grade 4 neutropenia persisting for more than 7 days; grade 3 or above febrile neutropenia; grade 4 thrombocytopenia or grade 3 thrombocytopenia requiring blood transfusion; non-hematologic toxicity (excluding toxicity related to neutrophils, leukocytes, lymphocytes, platelets, CD4 lymphocytes, anemia, and bone marrow density) greater than or equal to grade 3 (Exceptions: Dose reduction was not required even when the following conditions were met: grade 3 nausea, vomiting, or diarrhea controllable with anti-emetic or anti-diarrheal medication and abnormal laboratory parameter not requiring treatment); and day 8 administration was delayed or skipped as a result of the subject did not meet the dosing riteria within cycle.", " Time frame: Up to 3 weeks", "Results 1: ", " Arm/Group Title: E7389 With Weekly Trastuzumab", " Arm/Group Description: Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously weekly, with an initial dose of 4 mg/kg followed by 2 mg/kg for the remaining doses.", " Overall Number of Participants Analyzed: 6", " Measure Type: Number", " Unit of Measure: Participants 0", "Results 2: ", " Arm/Group Title: E7389 With Tri-weekly Trastuzumab", " Arm/Group Description: Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously tri-weekly, with an initial dose of 8 mg/kg followed by 6 mg/kg for the remaining doses.", " Overall Number of Participants Analyzed: 6", " Measure Type: Number", " Unit of Measure: Participants 0" ]

[ "Inclusion Criteria:", " Histologically or cytologically confirmed invasive breast cancer, with stage IV disease", " Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension as greater than or equal to 20mm with conventional techniques or as greater than or equal to 10mm with spiral CT scan.", " Primary tumor or metastasis must overexpress HER2", " Patient must have received 1-2 prior chemotherapeutic regiments for metastatic breast cancer and must have been off treatment for at least three weeks.", " Patient must have received and progressed on at least 1 prior trastuzumab-containing regimen, but not more than 2, in the metastatic setting.", " Patients may have received prior radiation therapy", " Patients may have received hormonal therapy in the adjuvant or metastatic setting", " 18 years of age or older", " Life expectancy of greater than 6 months", " Normal organ and marrow function as defined in the protocol", " Left ventricular ejection fraction (LVEF) greater than or equal to the institutional lower limit of normal", "Exclusion Criteria:", " Treatment with any investigational drug within 4 weeks", " Long-term treatment, over 3 months, with a systemic steroid or another immunosuppressive agent", " Other malignancies within the past 3 years, except for adequately treated carcinoma of teh cervix or basal-or squamous-cell carcinoma of the skin", " Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001", " An active, bleeding diathesis or an oral anti-vitamin K medication", " Prior treatment with an mTOR inhibitor", " History of non-compliance with medical regimens", " Unwillingness or inability to comply with the protocol", " Major surgery within 2 weeks before study entry", " Patients with active brain metastases or leptomeningeal carcinomatosis", " Patients who have experienced grade 1 or grade 2 hypersensitivity reactions to prior trastuzumab therapy are eligible ONLY IF these reactions did not prevent further administration", " Severe and/or uncontrolled intercurrent medical condition, psychiatric illness or a social situation that could limit their ability to comply with the study requirements.", " Pregnant or breast-feeding women", " HIV positive patients", " Known hypersensitivity to RAD001 (everolimus) or other rapamycins" ]

[ "Inclusion Criteria:", " All study patients must have histologically confirmed invasive adenocarcinoma of the breast. Their breast cancer must be resectable clinical stage I or II breast cancer as defined by the current AJCC TNM Staging System (Greene FL, Page DL, Fleming ID, et al.: editors. AJCC cancer staging manual, 6th edition. New York: Springer; 2002).", " All patients must be able to and give informed consent indicating they are aware of the investigational nature of this treatment, prior to entry into the study.", " All subjects must be Age >18 years.", " All subject must have adequate hepatic and renal function documented prior to study entry to include: hepatic transaminases (AST or ALT) 1.5 times the upper limits of normal, total bilirubin 1.5 times the upper limits of normal, serum creatinine 1.5 times the upper limit of normal or eCRCl 60 mL/min.", "Exclusion criteria:", " Patients who have received prior or be receiving radiation therapy for their breast cancer will be excluded.", " Patients who have received prior chemotherapy or receiving chemotherapy or hormonal therapy for their breast cancer will not be included.", " Women must be surgically sterilized or post-menopausal or women of childbearing potential must be using an adequate method of contraception. Women of childbearing potential must be using at least one of the following: oral, implanted, injectable contraceptive hormones, or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or have a partner that is sterile (e.g., vasectomy). Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to start of study therapy. Women who are pregnant or breast-feeding and women of childbearing potential not using an adequate method of birth control will be excluded.", " Patients with gastrointestinal abnormalities including: inability to take oral medication, requirement for intravenous alimentation, or prior surgical procedures affecting nutrient /drug absorption will be excluded.", " A serious uncontrolled medical disorder or active infection which would impair their ability to receive study treatment will be excluded. Significant cardiac disease, including uncontrolled high blood pressure, unstable angina, and congestive heart failure, myocardial infarction within the previous 3 months or serious cardiac arrhythmias will be excluded. Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol will be excluded." ]

[ "Inclusion Criteria:", " Females 18 years of age", " Histologically confirmed breast cancer that is HER2/neu positive (3+ by IHC or FISH +) and evidence of metastatic disease. Tumor may be of any estrogen and progesterone receptor type", " Measurable disease by RECIST and an ECOG 2", " Patients with known evidence of brain metastases are eligible if they are asymptomatic and have completed all therapy (surgery, radiotherapy, and/or steroids)", " Baseline LVEF value within the institutional normal range", " Any number of prior hormonal therapy treatments in the adjuvant setting or for metastatic disease. A subject must have progressed on hormonal therapy and all hormonal therapy (including birth control pills) must be discontinued at study entry.", " Prior chemotherapy in the adjuvant setting and up to one prior chemotherapy regimen for metastatic disease is allowed.", " Patients may have received one prior trastuzumab/chemotherapy containing regimen or prior single agent trastuzumab.", " Prior radiation therapy in the adjuvant setting or for metastatic disease, provided it was not to the only site of evaluable disease.", " All prior chemotherapy, trastuzumab and radiation therapy should be completed > 2 weeks before enrollment.", " Patients receiving bisphosphonate therapy are eligible. However, if bisphosphonate were started within < 2 months prior to enrollment, the bone lesions will not be evaluated for response and the patient must have another site of metastatic disease that is either measurable or evaluable for response.", " Patients must have recovered from toxicities due to prior therapy.", " Lab values in accordance with the protocol", " Patients must be nonpregnant and nonlactating. Patients of childbearing potential must implement an effective method of contraception during the study (birth control pills are not allowed).", "Exclusion Criteria:", " Bone only disease are ineligible", " Patients who received more than 1 prior chemotherapy regimen for metastatic disease are ineligible.", " Patients with a history of other cancers except curatively-treated carcinoma of the cervix in situ or non-melanomatous skin cancer.", " Active serious infection or other underlying medical condition that would impair their ability to receive protocol treatment.", " Uncontrolled nervous system metastases", " Dementia or significantly altered mental status that would interfere with proper consenting.", " Receiving other investigational therapy." ]

[ "Outcome Measurement: ", " Rate of Breast Related Adverse Events", " Investigators evaluated each subject and each reconstructed breast for the occurrence of an adverse event from the first stage of reconstruction through the final follow-up visit. A breast related adverse event was defined as any untoward medical occurrence related to a reconstructed breast.", " Time frame: 18 months", "Results 1: ", " Arm/Group Title: Meso BioMatrix Acellular Peritoneum Matrix", " Arm/Group Description: All subjects had the Meso BioMatrix Acellular Peritoneum Matrix implanted along with a tissue expander during the first stage of breast reconstruction. After tissue expansion, the tissue expander was replaced with a breast implant during the second stage of reconstruction.", " Overall Number of Participants Analyzed: 25", " Overall Number of Units Analyzed", " Type of Units Analyzed: Reconstructed breasts Measure Type: NumberUnit of Measure: Reconstructed breasts affected: 12" ]

[ "Adverse Events 1:", " Total: 4/20 (20.00%)", " Diarrhea 1/20 (5.00%)", " Nausea 1/20 (5.00%)", " Sodium, serum-low (hyponatremia) 1/20 (5.00%)", " Death - Disease progression NOS 1/20 (5.00%)", " Dyspnea (shortness of breath) 1/20 (5.00%)", " Hypoxia 1/20 (5.00%)" ]

[ "Adverse Events 1:", " Total: 39/39 (100.00%)", " Febrile Neutropenia 1/39 (2.56%)", " Heart failure 1/39 (2.56%)", " Diarrhea 3/39 (7.69%)", " Nausea/vomiting 4/39 (10.26%)", " Mucositis 3/39 (7.69%)", " Fatigue 4/39 (10.26%)", " infection 3/39 (7.69%)", " Urinary tract infection 2/39 (5.13%)", " Musculoskeletal pain 6/39 (15.38%)", " Syncope 1/39 (2.56%)", " Insomnia 3/39 (7.69%)", " Anxiety 2/39 (5.13%)" ]

[ "Adverse Events 1:", " Total: 27/41 (65.85%)", " Febrile Neutropenia 4/41 (9.76%)", " Neutropenia 1/41 (2.44%)", " Deep Vein Thrombosis 1/41 (2.44%)", " Pulmonary embolism 1/41 (2.44%)", " Femoral Artery occlusion 1/41 (2.44%)", " Abdominal Pain 2/41 (4.88%)", " Constipation 1/41 (2.44%)", " Fatigue 2/41 (4.88%)", " Headache 1/41 (2.44%)", " Nausea 1/41 (2.44%)", " Cellulitis 1/41 (2.44%)", " Muscular Weakness 1/41 (2.44%)" ]

[ "Adverse Events 1:", " Total: 15/31 (48.39%)", " Intracardiac Thrombus 1/31 (3.23%)", " Diarrhoea 2/31 (6.45%)", " Nausea 2/31 (6.45%)", " Vomiting 2/31 (6.45%)", " Ascites 0/31 (0.00%)", " Ileus 1/31 (3.23%)", " Small Intestinal Obstruction 1/31 (3.23%)", " Multi-Organ Failure 0/31 (0.00%)", " Sepsis 1/31 (3.23%)", " Weight Decreased 1/31 (3.23%)", " Dehydration 2/31 (6.45%)", " Hypokalaemia 0/31 (0.00%)", "Adverse Events 2:", " Total: 4/31 (12.90%)", " Intracardiac Thrombus 0/31 (0.00%)", " Diarrhoea 0/31 (0.00%)", " Nausea 0/31 (0.00%)", " Vomiting 0/31 (0.00%)", " Ascites 1/31 (3.23%)", " Ileus 0/31 (0.00%)", " Small Intestinal Obstruction 0/31 (0.00%)", " Multi-Organ Failure 1/31 (3.23%)", " Sepsis 0/31 (0.00%)", " Weight Decreased 0/31 (0.00%)", " Dehydration 0/31 (0.00%)", " Hypokalaemia 1/31 (3.23%)" ]

[ "Inclusion criteria:", " Female patients 18 years of age.", " Written informed consent given.", " Histologically confirmed Stage IV breast cancer with at least one bone metastasis radiologically confirmed.", " Previous treatment with zoledronic acid every 3-4 weeks, for 9-12 infusions over no more than 15 months.", " Eastern Cooperative Oncology Group (ECOG) performance status 2 .", " Life expectancy 1 year.", "Exclusion criteria:", " More than 3 months since last infusion of Zoledronic Acid (Zometa®).", " Treatments with other bisphosphonate than Zoledronic Acid (Zometa®) at any time prior to study entry.", " Serum creatinine > 3 mg/dL (265 μmol/L) or calculated (Cockcroft-Gault formula) creatinine clearance (CLCr) < 30 mL/min CrCl = ({[140-age (years)] x weight(kg)}/ [72 x serum creatinine (mg/dL)])x 0.85", " Corrected (adjusted for serum albumin) serum calcium < 8 mg/dl (2 mmol/L) or > 12 mg/dL ( 3.0 mmol/L).", " Current active dental problem including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a recurrent or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures.", " Recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants).", " Pregnant patients (with a positive pregnancy test prior to study entry) or lactating patients. Women of childbearing potential not using effective methods of birth control (e.g. abstinence, oral contraceptives or implants, IUD, vaginal diaphragm or sponge, or condom with spermicide).", " History of non-compliance to medical regimens or potential unreliable behavior.", " Known sensitivity to study drug(s) or class of study drug(s).", " Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study", " Use of any other investigational agent in the last 30 days." ]

[ "Inclusion Criteria:", " Post-menopausal women at high risk for development of breast cancer", " On a stable dose of hormone replacement therapy", " have cytomorphologic evidence of hyperplasia +/- atypia and Ki-67 expression >1.5% in benign breast epithelial cells acquired by RPFNA", " Serum level of 25-OH vitamin D of at least 30 ng/ml prior to study entry", " Willing to have a repeat random periareolar fine needle aspiration (RPFNA) and mammogram at 6 months and 12 months (if participating in the open label portion of the study) following initiation of study drug", "Exclusion Criteria:", " Prior history of osteoporosis or osteoporotic fracture.", " Prior history of invasive breast cancer or other invasive cancer within five years from date of study entry.", " Current and chronic use of cyclooxygenase-2 (COX-2) specific inhibitors or NSAIDs", " Receiving treatment for rheumatoid arthritis or fibromyalgia", " Current history of poorly controlled migraines or perimenopausal symptoms", " Currently receiving other investigational agents.", " Receipt of more than 6 months of an aromatase inhibitor (anastrozole, exemestane, letrozole, etc.) at any time in the past." ]

[ "Inclusion Criteria:", " All tumors must be ER-, PR- and HER2-negative", " Clinical stage T2 or T3, N0-3, M0. Subjects with inflammatory breast cancer are not eligible", " For subjects with clinically negative axilla, a sentinel lymph node biopsy will be performed either up front or after preoperative therapy at the discretion of the subject's physicians; for subjects with a clinically positive axilla, a needle aspiration or core biopsy will be performed to confirm the presence of metastatic disease in the lymph nodes.", " 18 years of age or older", " Performance status (PS) of 0 or 1", " Use of an effective means of contraception in subjects of child-bearing potential", " Normal organ function as described in the protocol", "Exclusion Criteria:", " Any prior cytotoxic chemotherapy or radiation for the current breast cancer", " HER2-negative ipsilateral breast recurrence, unless prior treatment consisted of excision alone for ductal carcinoma in situ (DCIS)or breast-conserving treatment and hormonal therapy for DCIS or invasive cancer", " Life expectancy of less than 12 weeks", " Current, recent, or planned participation in an experimental durg study other than a Genentech-sponsored bevacizumab cancer study", " Renal dysfunction for which exposure to cisplatin would require dose modifications", " Steroid dependent asthma", " Peripheral neuropathy of any etiology that exceeds grade 1", " Uncontrolled diabetes", " History of malignancy treated without curative intent", " Any other pre-existing medical condition that would represent toxicity in excess of grade 1", " Inadequately controlled hypertension", " Any prior history of hypertensive crisis or hypertensive encephalopathy", " New York Heart Association (NYHA) Grade II or greater congestive hear failure", " History of myocardial infarction or unstable angina within 12 months prior to study enrollment", " Any history of stroke or transient ischemic attack at any time", " Known central nervous system (CNS) disease", " Significant vascular disease", " Symptomatic peripheral vascular disease", " Evidence of bleeding diathesis or coagulopathy", " Major surgical procedure, open biopsy, or significant traumatic injury within 21 days prior to study enrollment", " History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months prior to study enrollment", " Serious, non-healing wound, ulcer or bone fracture", " Proteinuria at screening", " Known hypersensitivity to any component of bevacizumab", " Pregnant or lactating" ]

[ "Inclusion Criteria:", " Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (ECOG performance status of 2 will be allowed if only due to debilitating bone disease)", " HER2-positive metastatic or locally advanced breast cancer", " For MBC participants:", " Documented metastatic or inoperable locally advanced (without meeting LABC criteria) disease, amenable for treatment with docetaxel", " History of disease progression within 3 months prior to study entry", " For LABC participants:", " Newly diagnosed locally advanced breast cancer, Stage IIA-IIIC (American Joint Committee on Cancer [AJCC] staging system)", "Exclusion Criteria:", " Significant cardiac disease", " Inadequate bone marrow, liver or renal function", " For MBC participants:", " Participants must not have received radiotherapy for the treatment of metastatic or locally recurrent/advanced disease other than for the relief of pain in progressing metastatic bone lesions and/or brain metastases", " Brain metastases that are untreated, symptomatic or require therapy to control symptoms; or any radiation, surgery, or other therapy to control symptoms from brain metastasis within 2 months of the first study treatment.", " For LABC participants:", " Clinically or radiologically detectable metastasis (M1 disease)", " Participants for whom surgery as primary intent procedure is the best option to treat their disease", " Participants must not have received any systemic or loco-regional anti-cancer therapy for the treatment of locally advanced disease" ]

[ "Inclusion Criteria:", " Women aged > 18 years", " Histologically documents metastatic breast cancer", " HER2 positive using Fluorescence In Situ Hybridization (FISH)", " For phase I, patients who have previously received treatment for their metastatic disease are allowed to participate.", " For the phase II portion of the study, patients must have measureable disease (> 2 cm; > 1 cm on spiral CT scan)", " Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2", " A life expectancy of > 3 months", " Use of effective means of contraception", "Exclusion Criteria:", " For Phase II, prior cytotoxic chemotherapy and/or prior Herceptin for their metastatic disease. Prior treatment in the adjuvant setting is allowed." ]

[ "Inclusion Criteria:", " Women 20 years", " Histologically or cytologically confirmed diagnosis of adenocarcinoma originating in the breast", "Exclusion Criteria:", " Number of prior chemotherapy lines of treatment in the metastatic setting 3" ]

[ "Inclusion Criteria:", " Adult participants >/=18 years of age", " HER2-positive breast cancer", " Histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease, and be a candidate for chemotherapy. Participants with locally advanced disease must have recurrent or progressive disease, which must not be amenable to resection with curative intent.", " Participants must have measurable and/or non-measurable disease which must be evaluable per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1", " Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1", " Adequate organ function as determined by laboratory results", "Exclusion Criteria:", " History of prior (or any) chemotherapy for metastatic breast cancer or recurrent locally advanced disease", " An interval of <6 months from the last dose of vinca-alkaloid or taxane cytotoxic chemotherapy until the time of metastatic diagnosis", " Hormone therapy <7 days prior to randomization", " Trastuzumab therapy and/or lapatinib (neo- or adjuvant setting) <21 days prior to randomization", " Prior trastuzumab emtansine or pertuzumab therapy" ]

[ "Adverse Events 1:", " Total: 1/22 (4.55%)", " Blood bilirubin increased 1/22 (4.55%)", " Alkaline phosphatase increased 1/22 (4.55%)" ]

[ "Adverse Events 1:", " Total: 15/122 (12.30%)", " febrile neutropenia 4/122 (3.28%)", " Neutropenia 0/122 (0.00%)", " Angina unstable 1/122 (0.82%)", " Coronary artery disease 1/122 (0.82%)", " Myocardial infarction 1/122 (0.82%)", " Diarrhoea 2/122 (1.64%)", " Colitis 1/122 (0.82%)", " Pyrexia 2/122 (1.64%)", " Chest pain 1/122 (0.82%)", " Pneumonia 1/122 (0.82%)", " Catheter site cellulitis 1/122 (0.82%)", "Adverse Events 2:", " Total: 7/34 (20.59%)", " febrile neutropenia 1/34 (2.94%)", " Neutropenia 1/34 (2.94%)", " Angina unstable 0/34 (0.00%)", " Coronary artery disease 0/34 (0.00%)", " Myocardial infarction 0/34 (0.00%)", " Diarrhoea 0/34 (0.00%)", " Colitis 0/34 (0.00%)", " Pyrexia 0/34 (0.00%)", " Chest pain 0/34 (0.00%)", " Pneumonia 1/34 (2.94%)", " Catheter site cellulitis 0/34 (0.00%)", " Infection 1/34 (2.94%)" ]

[ "Adverse Events 1:", " Total: 17/65 (26.15%)", " Febrile neutropenia 3/65 (4.62%)", " Neutropenia 2/65 (3.08%)", " Pancytopenia 1/65 (1.54%)", " Thrombocytopenia 1/65 (1.54%)", " Cardiac arrest 2/65 (3.08%)", " Myocardial infarction 1/65 (1.54%)", " Diarrhoea 5/65 (7.69%)", " Stomatitis 1/65 (1.54%)", " Vomiting 2/65 (3.08%)", " Fatigue 1/65 (1.54%)", " Jaundice 1/65 (1.54%)", " Neutropenic infection 2/65 (3.08%)" ]

[ "Adverse Events 1:", " Total: 10/50 (20.00%)", " Anaemia 0/50 (0.00%)", " Febrile neutropenia 0/50 (0.00%)", " Neutropenia 0/50 (0.00%)", " Thrombocytopenia 0/50 (0.00%)", " Diastolic dysfunction 0/50 (0.00%)", " Tachycardia 0/50 (0.00%)", " Intestinal obstruction 0/50 (0.00%)", " Nausea 1/50 (2.00%)", " Oesophageal spasm 0/50 (0.00%)", " Oesophagitis 0/50 (0.00%)", " Retching 0/50 (0.00%)", "Adverse Events 2:", " Total: 11/48 (22.92%)", " Anaemia 4/48 (8.33%)", " Febrile neutropenia 0/48 (0.00%)", " Neutropenia 2/48 (4.17%)", " Thrombocytopenia 2/48 (4.17%)", " Diastolic dysfunction 1/48 (2.08%)", " Tachycardia 1/48 (2.08%)", " Intestinal obstruction 0/48 (0.00%)", " Nausea 0/48 (0.00%)", " Oesophageal spasm 1/48 (2.08%)", " Oesophagitis 0/48 (0.00%)", " Retching 1/48 (2.08%)" ]

[ "Inclusion Criteria:", " Be willing and able to provide written informed consent/assent for the trial.", " Be 18 years of age on day of signing informed consent.", " Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion if needed. Newly obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on Day 0. Subjects for whom newly obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the Sponsor.", " Have a performance status of 0 or 1 on the ECOG Performance Scale.", " Have non-metastatic operable newly diagnosed primary invasive carcinoma of the breast that is:", " Histologically confirmed", " ER/PR negative or ER positive. ER/PR status will be evaluated with Allred score (semi-quantitative measurement) following ASCO CAP guidelines 2009.", " HER2 negative of positive. HER2 status will be evaluated using IHC followed by FISH with dual probe (ASCO CAP guidelines 2013).", " Primary tumor size greater than 1 cm, measured by any of clinical examination, mammography, ultrasound or magnetic resonance imaging", " Any clinical nodal status", " Have evaluable core biopsy for IHC", " Be willing to provide plasma/blood samples", " After neo-adjuvant chemotherapy (cohort B1 and B2) patients must have residual tumor >1cm and must be willing to provide evaluable new tumor biopsy for IHC", " Demonstrate adequate organ function, all screening labs should be performed within 14 days of treatment initiation.", " Female subject of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.", " Female subjects of childbearing potential (Section 5.7.2) must be willing to use an adequate method of contraception as outlined in Section 5.7.2 - Contraception, for the course of the study through 120 days after receiving the study medication.", " Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.", " Male subjects of childbearing potential (Section 5.7.1) must agree to use an adequate method of contraception as outlined in Section 5.7.1- Contraception, until 120 after receiving the study therapy.", " Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.", "Exclusion Criteria:", " Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of receiving the treatment dose.", " Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to receiving the trial treatment.", " Has a known history of active TB (Bacillus Tuberculosis)", " Hypersensitivity to pembrolizumab or any of its excipients.", " Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.", " Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 0 or who has not recovered (i.e., Grade 1 or at baseline) from adverse events due to a previously administered agent.", " Note: Subjects with Grade 2 neuropathy are an exception to this criterion and may qualify for the study.", " Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.", " Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.", " Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.", " Has known history of (non-infectious) pneumonitis that required steroids or current pneumonitis.", " Has an active infection requiring systemic therapy.", " Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.", " Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.", " Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.", " Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2 agent or co-inhibitory T-cell receptor therapy (e.g. OX40-CD137, CTLA-4)", " Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).", " Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).", " Has received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed." ]

[ "Inclusion Criteria:", " Subjects will only be included in the study if they meet all of the following criteria:", " Subjects who have given informed consent", " Subjects that agree not to drink alcoholic beverages or use any drugs during the study", " Subject with blood parameters within normal ranges", " Age: at least 18 years old", " Patients will only be included in the study if they meet all of the following criteria:", " Patients who have given informed consent", " Patients that agree not to drink alcoholic beverages or use any drugs during the study", " Age: at least 18 years old", " Patients with local, locally advanced or metastatic HER2+ breast carcinoma as diagnosed on biopsied tissue by immunohistochemistry or fluorescence in situ hybridization (FISH).", "Exclusion Criteria:", " Patients will not be included in the study if one of the following criteria applies:", " Pregnant patients", " Breast feeding patients", " Patients with occupational exposure to ionizing irradiation", " Patients with previous thyroid disorders", " Patients that received radiolabeled compounds with a long half-life (>7h) for diagnostic or therapeutic purposes within the last 2 days.", " Patients with absolute contra-indications for thyroid blockage with potassium iodide.", " Patients with abnormal liver: ALT/AST > 2 times normal values; bilirubin > 1.5 time normal values.", " Patients with abnormal kidney function: < 50 ml/min/1,73 m2", " Patients with recent (< 1 week) gastrointestinal disorders (CTCAE v4.0 grade 3 or 4) with diarrhea as major symptom", " Patients with any serious active infection", " Patients who have any other life-threatening illness or organ system dysfunction, which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety of the test radiopharmaceutical", " Patients who cannot communicate reliably with the investigator", " Patients who are unlikely to cooperate with the requirements of the study", " Patients at increased risk of death from a pre-existing concurrent illness", " Patients who participated already in this study", " Patients who participated in a previous trial with Anti-HER2 VHH1", " Subjects will not be included in the study if one of the following criteria applies:", " Pregnant subjects", " Breast feeding subjects", " Subjects with occupational exposure to ionizing irradiation", " Subjects with clinical significant disease or on concomitant therapy (except contraception)", " Subjects with previous thyroid disorders", " Subjects that received radiolabeled compounds with a long half-life (>7h) for diagnostic or therapeutic purposes within the last 2 days.", " Subjects with absolute contra-indications for thyroid blockage with potassium iodide.", " Subjects with abnormal liver: ALT/AST > 2 times normal values; bilirubin > 1.5 time normal values.", " Subjects with abnormal kidney function: < 50 ml/min/1,73 m2", " Subjects with recent (< 1 week) gastrointestinal disorders (CTCAE v4.0 grade 3 or 4) with diarrhea as major symptom", " Subjects with any serious active infection", " Subjects who have any other life-threatening illness or organ system dysfunction, which in the opinion of the investigator would either compromise subject safety or interfere with the evaluation of the safety of the test radiopharmaceutical", " Subjects who cannot communicate reliably with the investigator", " Subjects who are unlikely to cooperate with the requirements of the study", " Subjects at increased risk of death from a pre-existing concurrent illness", " Subjects who participated already in this study", " Subjects who participated in a previous trial with Anti-HER2 VHH1" ]

[ "Outcome Measurement: ", " Pathological Tumor Response to Neoadjuvant Chemotherapy (Taxotere and AC)", " The patients' pathological response were assessed using Chevalier's system which graded the responses into Chevalier 1, 2, 3A, 3B, 3C, 3D, and 4, defined as:", " Disappearance of all tumor either on macroscopic or microscopic assessment in both the breast and LN (pCR)", " Presence of in situ carcinoma in the breast. No invasive tumor in breast and no tumor in LN (pCR)", " Presence of invasive cancer with stromal alteration such as sclerosis or fibrosis (pPR) 3A: Subjectively > 75% therapeutic effect 3B: Subjectively between 50% - 75% therapeutic effect 3C: Subjectively between 25% - 50% therapeutic effect 3D: Subjectively < 25% therapeutic effect OR Grade 4", " No or few modification of tumoral appearance (pNR).", " Time frame: 10 years", "Results 1: ", " Arm/Group Title: A: Taxotere/Docetaxel", " Arm/Group Description: Chemotherapy In Arm A, patients will receive single agent Taxotere (100 mg/m2) every 3 weeks for 4 cycles before surgery. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by standard adjuvant AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. This is done in order to minimize Adriamycin-induced cardiotoxicity.", "Taxotere/Docetaxel: Taxotere", " doxorubicin: AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery.", " Overall Number of Participants Analyzed: 83", " Measure Type: Number", " Unit of Measure: participants 1: 3", " 2: 2", " 3A: 18", " 3B: 15", " 3C: 18", " 3D: 10", "4: 3", "N/A: 14", "Results 2: ", " Arm/Group Title: B: AC Adriamycin/Cytoxan", " Arm/Group Description: In Arm B, patients will receive AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by 4 cycles of single agent Taxotere (100 mg/m2) every 3 weeks.", "Adriamycin/Cytoxan: Adriamycin/Cytoxan", " Overall Number of Participants Analyzed: 84", " Measure Type: Number", " Unit of Measure: participants 1: 9", " 2: 1", " 3A: 15", " 3B: 18", " 3C: 15", " 3D: 8", "4: 0", "N/A: 18" ]

[ "Inclusion:", " Histologically confirmed breast cancer", " Clinically or radiographically measurable residual tumor after core biopsy", " Eastern Cooperative Oncology Group (ECOG) performance status 0-1", " Age 18 yrs", " Absolute neutrophil count 1,500/mm³", " Hemoglobin 9 g/dL", " Platelet count 100,000/ mm³", " Creatinine 1.5 times upper limit of normal (ULN)", " Urine protein:creatinine ratio < 1.0", " AST (aspartate aminotransferase) and ALT 2.5 times ULN", " Alkaline phosphatase 2.5 times ULN", " Bilirubin normal", " Women of childbearing potential must use effective contraception", " Left ventricular ejection fraction (LVEF) normal by echocardiogram or MUGA", " Exclusion:", " No residual tumor after initial biopsy", " Peripheral neuropathy of grade 2 or higher", " HER-2 neu overexpression either by IHC 3+ or FISH+", " No history of any prior treatment of breast cancer.", " No history of unstable angina or myocardial infarction within the past 12 months", " Pregnant or nursing women", " Anticoagulation therapy within the last 6 months", " History of gastrointestinal bleeding", " Recent hemoptysis", " No known hepatitis B or HIV seropositivity", " No inadequately controlled hypertension, defined as systolic blood pressure (BP) > 150 mm Hg and/or diastolic BP > 100 mm Hg despite antihypertensive medications", " History of hypertensive crisis or hypertensive encephalopathy", " New York Heart Association class II-IV congestive heart failure", " History of stroke or transient ischemic attack at any time", " Significant vascular disease (e.g., aortic aneurysm or aortic dissection)", " No symptomatic peripheral vascular disease", " Evidence of bleeding diathesis or coagulopathy", " Significant traumatic injury within the past 28 days", " History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months", " Serious, non-healing wound, ulcer, or bone fracture", " Known hypersensitivity to any component of bevacizumab" ]

[ "Inclusion Criteria:", " Woman, 18 years old or upper.", " Patient with advanced breast cancer with human epidermal growth factor receptor 2 (HER 2) positive histologically confirmed. The criteria for positivity HER 2 are:", " immuno-histochemistry (IHC) 3+ (>10% of tumor cells with complete and intense membrane staining)", " IHC 2+ with fluorescent in situ hybridization (FISH) / Chromogenic in situ hybridization (CISH) / silver-enhanced in situ hybridization (SISH) + for HER 2 amplification (*)", " FISH / CISH / SISH + for HER 2 amplification (*) (*) Defined as the ratio of copies of HER 2/neu and copies of centromere of chromosome 17 (CEP17)> 2.2, or a number of copies of HER 2/neu> 6, as per local laboratory criteria.", " Patient receiving trastuzumab with or without chemotherapy or hormonal therapy for at least 4 months.", " No evidence of disease progression (clinical and / or radiological) for at least 4 months before inclusion in the study and with a life expectancy of at least 3 months.", " Adequate performance status: Eastern Cooperative Oncology Group (ECOG) <2.", " Adequate bone marrow function, liver and kidney", " Proper cardiac function (LVEF within normal limits the center, measured by echocardiography or MUGA).", " The patient must have been informed of the study and must sign and date informed consent document for entry into the trial.", " The patient must be willing and able to comply with study procedures and be available to answer the study questionnaires.", "Exclusion Criteria:", " Patients with no advanced breast cancer.", " Breast cancer patients with tumors HER 2-negative.", " The patient has another active malignancy other than breast adenocarcinoma; are excluded the non-melanoma skin cancer or any other properly treated in situ neoplasia. Patients with a history of malignancy, if they bear> 5 years without evidence of disease could be included.", " The patient has uncontrolled brain metastases.", " Concomitant administration, or in the 4 weeks prior to study entry, of other experimental treatment.", " Known hypersensitivity to trastuzumab or to any of its components.", " Patients with severe dyspnea at rest or requiring supplemental oxygen.", " Heart disease or serious medical pathological prevent trastuzumab administration: documented history of congestive cardiac insufficiency (CCI), high-risk arrhythmias uncontrolled angina requiring medication, clinically significant valvular disease, history of myocardial infarction or evidence of transmural infarction on ECG or hypertension poorly controlled.", " Presence of any concomitant serious systemic disease that is incompatible with the study (at the discretion of the investigator).", " The patient is pregnant or lactating. Women of childbearing potential should undergo pregnancy testing blood or urine within 14 days prior to inclusion as institutional rules and use a non-hormonal contraceptive suitable: intrauterine device, barrier method (condom or diaphragm) also used in conjunction with spermicidal cream, total abstinence or surgical sterilization, during treatment with the study drugs and for 6 months following the end of treatment." ]

[ "INTERVENTION 1: ", " Active Medicine Group", " risedronate 35 mg weekly", "INTERVENTION 2: ", " Placebo Group", " Received placebo medication once weekly" ]

[ "INTERVENTION 1: ", " Standard Chemotherapy", " Patients receive cyclophosphamide-containing chemotherapy alone.", " cyclophosphamide: Part of planned chemotherapy regimen", "INTERVENTION 2: ", " Chemotherapy Plus Goserelin", " Patients receive goserelin subcutaneously once every 4 weeks beginning 1 week before start of cyclophosphamide-containing chemotherapy. Treatment continues until completion of chemotherapy in the absence of disease progression or unacceptable toxicity.", " cyclophosphamide: Part of planned chemotherapy regimen", " goserelin acetate: Given subcutaneously" ]

[ "Inclusion Criteria:", " Stage 1-2 invasive breast cancer diagnosis,", " DCIS", " Ability to read English", "Exclusion Criteria:", "Male" ]

[ "Inclusion Criteria:", " female patients, 18-70years of age;", " histologically-proven invasive breast cancer;", " no prior or current neoplasm except for non-melanoma skin cancer, or in situ cancer of the cervix;", " no distant disease/secondary cancer.", "Exclusion Criteria:", " pregnant or lactating women;", " pre-operative local treatment for breast cancer;", " prior or concurrent systemic antitumor therapy;", " clinically significant cardiac disease." ]

[ "Adverse Events 1:", " Total: 55/238 (23.11%)", " Febrile neutropenia * 5/238 (2.10%)", " Neutropenia * 6/238 (2.52%)", " Leukopenia * 1/238 (0.42%)", " Thrombocytopenia * 0/238 (0.00%)", " Anaemia * 1/238 (0.42%)", " Pancytopenia * 0/238 (0.00%)", " Cardiac failure * 1/238 (0.42%)", " Acute coronary syndrome * 0/238 (0.00%)", " Atrial fibrillation * 0/238 (0.00%)", " Cardiac failure congestive * 0/238 (0.00%)", "Adverse Events 2:", " Total: 89/245 (36.33%)", " Febrile neutropenia * 12/245 (4.90%)", " Neutropenia * 10/245 (4.08%)", " Leukopenia * 2/245 (0.82%)", " Thrombocytopenia * 5/245 (2.04%)", " Anaemia * 1/245 (0.41%)", " Pancytopenia * 1/245 (0.41%)", " Cardiac failure * 2/245 (0.82%)", " Acute coronary syndrome * 1/245 (0.41%)", " Atrial fibrillation * 1/245 (0.41%)", " Cardiac failure congestive * 2/245 (0.82%)" ]

[ "Adverse Events 1:", " Total: 21/82 (25.61%)", " Neutrophils count decreased 1/82 (1.22%)", " Cardiac ischemia/infarction 1/82 (1.22%)", " Left ventricular systolic dysfunction 1/82 (1.22%)", " Hypertension 1/82 (1.22%)", " Supraventricular and nodal arrhythmia 1/82 (1.22%)", " Anorexia 1/82 (1.22%)", " Gastrointestinal perforation 1/82 (1.22%)", " Vomiting 1/82 (1.22%)", " Dehydration 1/82 (1.22%)", " Diarrhoea 1/82 (1.22%)" ]

[ "DISEASE CHARACTERISTICS:", " Histologically or cytologically confirmed primary adenocarcinoma of the breast", " Locally recurrent or metastatic disease", " Must have HER-2-negative breast cancer or, if HER-2-positive, must be unable to receive trastuzumab (Herceptin®) or have previously received trastuzumab in the past", " Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm by conventional techniques or as > 10 mm by spiral CT scan.", " No known CNS disease", " Hormone receptor status not specified", " PATIENT CHARACTERISTICS:", "Inclusion criteria:", " Postmenopausal status not specified", " ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%", " Life expectancy > 12 weeks", " WBC 3,000/mcL", " Absolute neutrophil count 1,500/mcL", " Platelet count 100,000/mcL", " Total bilirubin normal", " AST and ALT 2.5 times upper limit of normal (ULN)", " Alkaline phosphatase 2.5 times ULN (unless bone metastasis is present in the absence of liver metastasis)", " Creatinine 1.5 mg/dL", " Not pregnant or nursing", " Negative pregnancy test", " Fertile patients must use effective contraception", " No other concurrent malignancies within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix", "Exclusion criteria:", " Pre-existing neuropathy grade 1", " Uncontrolled intercurrent illness including, but not limited to, any of the following:", " Ongoing or active infection", " Symptomatic congestive heart failure", " Unstable angina pectoris", " Cardiac arrhythmia", " Serious, non-healing wound, ulcer, or bone fracture", " Psychiatric illness/social situations that would limit compliance with study requirements", " Inadequately controlled hypertension (defined as systolic blood pressure > 150 mm Hg and/or diastolic blood pressure > 100 mm Hg on antihypertensive medications)", " History of hypertensive crisis or hypertensive encephalopathy", " New York Heart Association class II-IV congestive heart failure", " History of myocardial infarction or unstable angina within the past 6 months", " History of stroke or transient ischemic attack within the past 6 months", " Significant vascular disease (e.g., aortic aneurysm, aortic dissection)", " Symptomatic peripheral vascular disease", " Evidence of bleeding diathesis or coagulopathy", " Significant traumatic injury within the past 28 days", " History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months", " Proteinuria, as demonstrated by either urine protein:creatinine ratio 1.0 OR urine dipstick for proteinuria 2+", " Patients discovered to have 2+ proteinuria on dipstick urinalysis at baseline must demonstrate 24-hour urine protein 1g", " History of allergy or hypersensitivity to paclitaxel albumin-stabilized nanoparticle formulation, paclitaxel, bevacizumab, carboplatin, albumin, drug product excipients, or chemically similar agents", " PRIOR CONCURRENT THERAPY:", " See Disease Characteristics", " Recovered from all prior therapy", " No prior chemotherapy for locally recurrent or metastatic disease", " Prior neoadjuvant or adjuvant chemotherapy allowed", " More than 1 week since prior core biopsy or other minor surgical procedure, excluding placement of a vascular access device", " More than 4 weeks since prior and no concurrent major surgical procedure or open biopsy", " More than 4 weeks since prior radiotherapy", " More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)", " At least 1 year since prior taxane regimen", " No other concurrent investigational agents", " Concurrent anticoagulation allowed, provided the following criteria are met:", " Stable dose of warfarin or low molecular weight heparin", " INR within desired range (2-3)", " No evidence of active bleeding or coagulopathy", " No concurrent combination antiretroviral therapy for HIV-positive patients", " No other concurrent radiotherapy, chemotherapy, immunotherapy, or antitumor hormonal therapy" ]

[ "Outcome Measurement: ", " Percentage of Subjects Able to Complete > 85% of the Planned Dose on Schedule", " Feasibility will be determined by evaluating the percentage of subjects able to complete the neoadjuvant portion of the study on time with > 85% of the protocol-specified dose.", " Time frame: From the start of treatment through the neoadjuvant treatment period (approximately 20 weeks)", "Results 1: ", " Arm/Group Title: Neoadjuvant Therapy", " Arm/Group Description: Neoadjuvant therapy will consist of epirubicin (100 mg/m^2) + cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments.", " Overall Number of Participants Analyzed: 30", " Measure Type: Number", " Unit of Measure: percentage of participants 60" ]

[ "Inclusion Criteria:", " female", " subject is 25-100 years of age", " subjects has at least one breast imaging finding on mammography and/or ultrasound which is assessed as highly suggestive of malignancy and recommended to biopsy", " subject is able to provide informed consent", "Exclusion Criteria:", " subject is pregnant", " subject is actively lactating or discontinued breastfeeding less than 2 months ago", " subject has breast implants", " subject is scheduled for sentinel node procedure using radioactive Tc-99m within 24 hours of the PEM study", " subject has contraindications for core biopsy and other invasive procedures", " subject has Type I diabetes mellitus or poorly controlled Type II diabetes mellitus", " subject has had surgery or radiation therapy on the study breast or has had chemotherapy within the past 12 months", " subject has not fasted for 4-6 hours prior to the procedure and/or have a fasting blood glucose level greater than 140 mg/dl on day of PEM imaging" ]

[ "Adverse Events 1:", " Total: 158/482 (32.78%)", " Anaemia 7/482 (1.45%)", " Disseminated intravascular coagulation 1/482 (0.21%)", " Lymphadenopathy 0/482 (0.00%)", " Neutropenia 0/482 (0.00%)", " Thrombocytopenia 2/482 (0.41%)", " Anaemia 28/482 (1.66%)", " Disseminated intravascular coagulation 21/482 (0.21%)", " Febrile neutropenia 21/482 (0.21%)", " Lymphadenopathy 20/482 (0.00%)", " Neutropenia 20/482 (0.00%)", "Adverse Events 2:", " Total: 37/238 (15.55%)", " Anaemia 2/238 (0.84%)", " Disseminated intravascular coagulation 0/238 (0.00%)", " Lymphadenopathy 1/238 (0.42%)", " Neutropenia 1/238 (0.42%)", " Thrombocytopenia 0/238 (0.00%)", " Anaemia 22/238 (0.84%)", " Disseminated intravascular coagulation 20/238 (0.00%)", " Febrile neutropenia 21/238 (0.42%)", " Lymphadenopathy 21/238 (0.42%)", " Neutropenia 21/238 (0.42%)" ]

[ "INTERVENTION 1: ", " MM-111", "All participants" ]

[ "Inclusion Criteria:", " Women 20 years", " Histologically or cytologically confirmed diagnosis of adenocarcinoma originating in the breast", "Exclusion Criteria:", " Number of prior chemotherapy lines of treatment in the metastatic setting 3" ]

[ "Inclusion Criteria:", " Adult participants >/=18 years of age", " HER2-positive breast cancer", " Histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease, and be a candidate for chemotherapy. Participants with locally advanced disease must have recurrent or progressive disease, which must not be amenable to resection with curative intent.", " Participants must have measurable and/or non-measurable disease which must be evaluable per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1", " Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1", " Adequate organ function as determined by laboratory results", "Exclusion Criteria:", " History of prior (or any) chemotherapy for metastatic breast cancer or recurrent locally advanced disease", " An interval of <6 months from the last dose of vinca-alkaloid or taxane cytotoxic chemotherapy until the time of metastatic diagnosis", " Hormone therapy <7 days prior to randomization", " Trastuzumab therapy and/or lapatinib (neo- or adjuvant setting) <21 days prior to randomization", " Prior trastuzumab emtansine or pertuzumab therapy" ]

[ "Outcome Measurement: ", " Percentage of Participants With Clinical Objective Response (cOR) in the Breast, Evaluated by an Independent Radiological Evaluation Monitoring Committee", " cOR is defined as the documented evidence of complete response (CR) and partial response (PR) as assessed by ultrasound examination using Response Evaluation Criteria In Solid Tumors (RECIST). CR is defined as the disappearance of all target lesions (TLs) and non-TLs and the appearance of no new lesions (NLs). PR for TLs is defined as a >=30% decrease in the sum of the longest diameter (LD) of TLs, taking as a reference the Baseline sum LD. For non-TLs, it is defined as the persistence of >=1 non-TL and no new TLs or non-TLs.", " Time frame: From Baseline (Day 1) up to 6 months, evaluated every 12 weeks", "Results 1: ", " Arm/Group Title: Letrozole + Placebo", " Arm/Group Description: Letrozole tablets in the dose of 2.5 milligrams (mg) plus matching placebo were administered orally once daily for 6 months prior to surgery.", " Overall Number of Participants Analyzed: 48", " Measure Type: Number", " Unit of Measure: percentage of participants CR: 2", "PR: 58", "Results 2: ", " Arm/Group Title: Letrozole + Lapatinib", " Arm/Group Description: Letrozole tablets in the dose of 2.5 mg plus lapatinib ditosylate monohydrate tablets in the dose of 1500 mg were administered orally once daily for 6 months prior to surgery.", " Overall Number of Participants Analyzed: 41", " Measure Type: Number", " Unit of Measure: percentage of participants CR: 12", "PR: 54" ]

[ "DISEASE CHARACTERISTICS:", "Inclusion criteria:", " Histologically proven invasive unilateral breast cancer (regardless of the type)", " Initial clinical condition compatible with complete initial resection", " No residual macro or microscopic tumor after surgical excision", " Node-positive disease (i.e., positive sentinel node or positive axillary clearance) (N+) or node-negative disease (-) meeting the following criteria :", " Stage II or III disease", " pT >20 mm (T1-4)", " Patients must meet 1 of the following hormone-receptor criteria:", " Node-positive patients: triple-negative* tumor (HER2 negative, estrogen-receptor [ER] negative, and progesterone receptor [PR] negative) OR double-negative (HER2 negative, PR negative, and ER+)", " Node-negative patients: triple-negative* tumor only", " NOTE: *Hormone-receptor negativity is defined as ER <10% and PR <10% by IHC and HER2 negativity is defined as IHC 0-1+ OR IHC 2+ and FISH or CISH negative", " Must be able to begin chemotherapy no later than day 49 after the initial surgery", "Exclusion criteria:", " Clinically or radiologically detectable metastases (M0)", " Bilateral breast cancer or contralateral ductal carcinoma in situ", " Any metastatic impairment, including homolateral subclavicular node involvement, regardless of its type", " Any tumor T4a (cutaneous invasion, deep adherence, inflammatory breast cancer)", " HER 2 overexpression defined as IHC 3+ OR IHC 2+ and FISH or CISH positive", " Any clinically or radiologically suspect and non-explored damage to the contralateral breast", " PATIENT CHARACTERISTICS:", "Inclusion criteria:", " Female", " Pre- or postmenopausal", " ECOG performance status 0-1", " Peripheral neuropathy grade 1", " Neutrophil count 2,000/mm³", " Platelet count 100,000/mm³", " Hemoglobin >9 g/dL", " AST and ALT 1.5 times upper limit of normal (ULN)", " Alkaline phosphatase 2.5 times ULN", " Total bilirubin 1.0 times ULN", " Serum creatinine 1.5 times ULN", " LVEF 50% by MUGA scan or echocardiography", " Not pregnant or nursing", " Negative pregnancy test", " Fertile patients must use effective contraception during and for up to 8 weeks after completion of study treatment", "Exclusion criteria:", " Previous cancer (except cutaneous baso-cellular epithelioma or uterine peripheral epithelioma) in the preceding 5 years, including invasive contralateral breast cancer", " Patients with any other concurrent severe and/or uncontrolled medical disease or infection that could compromise participation in the study", " Clinically significant cardiovascular disease within the past 6 months including any of the following:", " Unstable angina", " Congestive heart failure", " Uncontrolled hypertension (i.e., blood pressure >150/90 mm Hg)", " Myocardial infarction", " Cerebral vascular accidents", " Known prior severe hypersensitivity reactions to agents containing Cremophor EL", " Patients with any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule", " Patients deprived of liberty or placed under the authority of a tutor", " PRIOR CONCURRENT THERAPY:", " At least 2 weeks since prior minor surgery (excluding breast biopsy) and adequately recovered", " At least 3 weeks since prior major surgery and adequately recovered", " No prior chemotherapy, hormonal therapy, or radiotherapy", " More than 72 hours since prior and no concurrent treatment with any of the following strong inhibitors of CYP3A4:", " Amiodarone", " Clarithromycin", " Amprenavir", " Delavirdine", " Voriconazole", " Erythromycin", " Fluconazole", " Itraconazole", " Ketoconazole", " Indinavir", " Nelfinavir", " Ritonavir", " Saquinavir", " No concurrent participation in another therapeutic trial involving an experimental drug" ]

[ "Inclusion Criteria:", " Histologically confirmed breast cancer with evidence of metastatic disease", " HER2 3+ or FISH (fluorescent in situ hybridization)+", " Age 18 years", " No prior trastuzumab, except as given in the adjuvant or neoadjuvant setting.", " No prior chemotherapy in the metastatic setting.", "Exclusion Criteria:", " CNS (central nervous system) metastases", " Prior radiation therapy within the last 4 weeks", " Pregnant (positive pregnancy test) or lactating women", " Major surgical procedure, open biopsy, non-healing wounds, or significant traumatic injury within 28 days prior to starting study or anticipation of need for major surgical procedure during the study", " Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to start of study." ]

[ "INTERVENTION 1: ", " Decision Support Workshop", " The decision support workshop will be 2 hours in duration on the morning of the consultation and will be facilitated by a dedicated social worker from psycho-oncology.", " Decision Support Workshop: Incorporates the key components of shared decision-making and decision support with the philosophy of delivering supportive care to cancer patients.", " Surgeon (30 mins): treatment options for breast reconstruction with indications/ contraindications, advantages / disadvantages, expected post-operative course, aesthetic result and complications with probabilities", " Registered nurse (30 mins): preparing for surgery, postoperative recovery and how to navigate the health care system", " Social worker (30 mins): values clarification exercise", " Breast reconstruction patient volunteer (30 mins) questions and answers about her personal experience", "INTERVENTION 2: ", " Standard Care", " Routine pre-consultation education" ]

[ "INTERVENTION 1: ", " Low Dose Magnesium Oxide (800 mg/Day)", " Week 2:", " Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).", " Week 3:", " Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).", " Weeks 4-9:", " Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).", "INTERVENTION 2: ", " High Dose Magnesium Oxide (1200 mg/Day)", " Week 2:", " Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).", " Week 3:", " Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).", " Weeks 4-9:", " Patients take three 400 mg tablet of magnesium oxide orally (PO) daily (QD)." ]