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[ "Inclusion Criteria:", " Histologically confirmed HER2 overexpressing (IHC 3+ and/or FISH +) metastatic breast cancer with measurable disease. Patients with either HER2 3+ positive tumors by immunohistochemistry (Dako Herceptest®) or gene amplification (> 2 copies) by fluorescence in-situ hybridation (FISH) are eligible.", " Progression following at least 8 weeks of standard doses of Herceptin or a Herceptin containing regimen.", " Off Herceptin for a minimum of 2 weeks.", " Patients must have measurable disease as defined by RECIST guidelines (the lesion that will be biopsied on study cannot be the only measurable lesion).", " Life expectancy > 3 months", " Age 18 years", " ECOG performance status 2", " Adequate bone marrow function as indicated by the following:", " ANC 1500/µL", " Platelets 100,000/µL", " Hemoglobin 9 g/dL", " Adequate liver function, as indicated by bilirubin 1.5 x ULN, AST or ALT <2x ULN.", " Adequate renal function, as indicated by creatinine <1.5 x upper limit of normal (ULN)", " Ability to understand and the willingness to sign a written informed consent.", " Adequate birth control: Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation and must have a negative serum or urine pregnancy test within 1 week prior to beginning treatment on this trial. Pregnant and nursing patients are excluded because the effects of the combination of Rapamycin on a fetus or nursing child are unknown. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.", " Fasting serum cholesterol <350 mg/d L and triglycerides < 400 mg/ d L.", " Biopsy is required but patients or physicians may opt out of this part of the trial if sufficient justification is provided. Justification must be provided to the PI in writing indicating excessive physical risk or psychological trauma if biopsy is undertaken.", "Exclusion Criteria:", " Active infection or treatment for systemic infections within 14 days of enrollment", " Patients with active brain metastases requiring treatment, inclusive but not limited to surgery, radiation, and corticosteroids (patients with asymptomatic non- progressing brain metastasis who have completed treatment 30 days before enrollment and without evidence of progression on a post treatment MRI may be considered for the study).", " Pregnant or lactating women", " Prior chemotherapy within the last 4 weeks (last 6 weeks for nitrosureas/mitomycin)", " Prior radiation therapy within the last 4 weeks; prior radiation therapy to indicator lesion (unless objective disease recurrence or progression within the radiation portal has been documented since completion of radiation).", " Prior therapy with rapamycin, rapamycin analogs, or experimental agents targeting mTOR.", " Concomitant malignancies or previous malignancies within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.", " Ejection fraction <50% or below the lower limit of the institutional normal range, whichever is lower", " Hypersensitivity to trial medications", " Patients may not be receiving any other investigational agents within 30 days before enrollment.", " 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.", " Pregnant women are excluded from this study because the investigational agents may have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with these agents, breastfeeding should be discontinued if the mother is treated.", " HIV-positive patients are ineligible because these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy and the potential pharmacokinetic interaction between antiretroviral therapy and the investigational agents.", " Use of all herbal and alternative medications within 4 weeks. All herbal and alternative medications should be discontinued while on study, these include but not limited to: Hydrastis canadensis (goldenseal) - Uncaria tomentosa (cat's claw) - Echinacea angustifolia roots - trifolium pratense (wild cherry) - matricaria chamomila (chamomile) - Glycyrrhiza glabra (licorice) - dillapiol - naringenim.", " Use of any of these medications within 4 weeks; cyclosporine, diltiazen, ketoconazole, rifampin, fluconazole, delavirdine, nicardipine, pioglitazone, and sulfonamides, erythromycin, clarithromycin, itraconazole, erythromycin, metoclopramide, nevirapine, phenobarbital, phenytoin, indinavir, fosamprenavir, nefazadone, St Johns Wort.", " Consumption of grapefruit juice is prohibited during the study.", " Use of warfarin (Coumadin), immunosuppressive agents or chronic oral, intravenous or topical steroid" ]

[ "INTERVENTION 1: ", " Moderated Group", " one 12-week online support group led by a professional healthcare provider", "INTERVENTION 2: ", " Non-facilitated (Peer-led)", " 12-week online support in a peer-led format" ]

[ "INTERVENTION 1: ", " Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue", " One arm diagnostic using 1 mCi of 125-I Methylene blue dye to find sentinel lymph nodes" ]

[ "Adverse Events 1:", " Total: 56/199 (28.14%)", " AGRANULOCYTOSIS 1/199 (0.50%)", " ANAEMIA 1/199 (0.50%)", " BONE MARROW FAILURE 1/199 (0.50%)", " FEBRILE NEUTROPENIA 11/199 (5.53%)", " LEUKOPENIA 1/199 (0.50%)", " NEUTROPENIA 1/199 (0.50%)", " PANCYTOPENIA 1/199 (0.50%)", " ACUTE MYOCARDIAL INFARCTION 1/199 (0.50%)", " ATRIAL FLUTTER 1/199 (0.50%)", " ATRIAL THROMBOSIS 0/199 (0.00%)", " CARDIAC FAILURE 3/199 (1.51%)", "Adverse Events 2:", " Total: 66/198 (33.33%)", " AGRANULOCYTOSIS 0/198 (0.00%)", " ANAEMIA 0/198 (0.00%)", " BONE MARROW FAILURE 0/198 (0.00%)", " FEBRILE NEUTROPENIA 27/198 (13.64%)", " LEUKOPENIA 0/198 (0.00%)", " NEUTROPENIA 2/198 (1.01%)", " PANCYTOPENIA 1/198 (0.51%)", " ACUTE MYOCARDIAL INFARCTION 0/198 (0.00%)", " ATRIAL FLUTTER 0/198 (0.00%)", " ATRIAL THROMBOSIS 1/198 (0.51%)", " CARDIAC FAILURE 4/198 (2.02%)" ]

[ "Adverse Events 1:", " Total: 3/8 (37.50%)", " Anaemia 0/8 (0.00%)", " Febrile neutropenia 0/8 (0.00%)", " Polycythaemia 0/8 (0.00%)", " Acute coronary syndrome 0/8 (0.00%)", " Vertigo 0/8 (0.00%)", " Eyelid oedema 1/8 (12.50%)", " Constipation 0/8 (0.00%)", " Diarrhoea 0/8 (0.00%)", " Nausea 0/8 (0.00%)", " Stomatitis 0/8 (0.00%)", " Upper gastrointestinal haemorrhage 0/8 (0.00%)", " Vomiting 0/8 (0.00%)", " Chest pain 0/8 (0.00%)", "Adverse Events 2:", " Total: 2/6 (33.33%)", " Anaemia 0/6 (0.00%)", " Febrile neutropenia 0/6 (0.00%)", " Polycythaemia 0/6 (0.00%)", " Acute coronary syndrome 0/6 (0.00%)", " Vertigo 0/6 (0.00%)", " Eyelid oedema 0/6 (0.00%)", " Constipation 0/6 (0.00%)", " Diarrhoea 0/6 (0.00%)", " Nausea 0/6 (0.00%)", " Stomatitis 0/6 (0.00%)", " Upper gastrointestinal haemorrhage 0/6 (0.00%)", " Vomiting 0/6 (0.00%)", " Chest pain 1/6 (16.67%)" ]

[ "Adverse Events 1:", " Total: 1/3 (33.33%)", " Pericardial effusion [1]0/3 (0.00%)", " Abdominal muscle wall hemorrhage [2]0/3 (0.00%)", " Dehydration [3]0/3 (0.00%)", " Gastroenteritis 0/3 (0.00%)", " Dehydration 0/3 (0.00%)", " Vomiting [4]0/3 (0.00%)", " Colonic perforation [5]0/3 (0.00%)", " Abdominal pain 0/3 (0.00%)", " Chemical meningitis 0/3 (0.00%)", " Lung infection 0/3 (0.00%)", " Wound infection 0/3 (0.00%)", "Adverse Events 2:", " Total: 2/3 (66.67%)", " Pericardial effusion [1]0/3 (0.00%)", " Abdominal muscle wall hemorrhage [2]0/3 (0.00%)", " Dehydration [3]0/3 (0.00%)", " Gastroenteritis 0/3 (0.00%)", " Dehydration 0/3 (0.00%)", " Vomiting [4]0/3 (0.00%)", " Colonic perforation [5]0/3 (0.00%)", " Abdominal pain 0/3 (0.00%)", " Chemical meningitis 0/3 (0.00%)", " Lung infection 0/3 (0.00%)", " Wound infection 1/3 (33.33%)" ]

[ "Adverse Events 1:", " Total: 148/1755 (8.43%)", " Anaemia * 1/1755 (0.06%)", " Neutropenia * 0/1755 (0.00%)", " Thrombocytopenia * 0/1755 (0.00%)", " Thrombocytopenic purpura * 1/1755 (0.06%)", " Acute cardiac event * 1/1755 (0.06%)", " Aortic valve incompetence * 1/1755 (0.06%)", " Arrhythmia * 1/1755 (0.06%)", " Atrial fibrillation * 1/1755 (0.06%)", " Cardiac failure * 0/1755 (0.00%)", " Cardiac tamponade * 0/1755 (0.00%)", "Adverse Events 2:", " Total: 64/868 (7.37%)", " Anaemia * 2/868 (0.23%)", " Neutropenia * 2/868 (0.23%)", " Thrombocytopenia * 1/868 (0.12%)", " Thrombocytopenic purpura * 0/868 (0.00%)", " Acute cardiac event * 0/868 (0.00%)", " Aortic valve incompetence * 0/868 (0.00%)", " Arrhythmia * 1/868 (0.12%)", " Atrial fibrillation * 0/868 (0.00%)", " Cardiac failure * 1/868 (0.12%)", " Cardiac tamponade * 1/868 (0.12%)" ]

[ "Inclusion Criteria:", " Patients must have histologically confirmed metastatic breast cancer; tissue (a minimum of 3 slides) from the most recent biopsy is required for review and confirmation of eligibility; NOTE: material should ideally be from the metastatic disease, however material from the primary tumor is acceptable if that is all that is available", " Patients must have stage IV breast cancer", " Patients must have tumors (primary or metastatic) that stain positively for the prolactin receptor", " Patients may have measurable or evaluable disease", " Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with conventional techniques or as > 10 mm with spiral CT scan", " Evaluable disease is disease that does not meet the criteria for measurable disease; examples would include patients with effusions or bone-only disease", " Women of childbearing potential must commit to the use of effective barrier (non-hormonal) contraception while on study", " Patients must have a life expectancy of greater than 12 weeks", " Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status =< 2", " Patients may have had a prior diagnosis of cancer if it has been > 5 years since their last treatment", " Leukocytes >= 3,000/uL (microliter)", " Absolute neutrophil count >= 1,500/uL", " Platelets >= 100,000/uL", " Child Pugh score =< 10", " Patients must be able to swallow and retain oral medication", " All patients must have given signed, informed consent prior to registration on study", "Exclusion Criteria:", " Women who are pregnant or lactating are not eligible for study treatment", " Patients who are undergoing concomitant radiotherapy are NOT eligible for participation", " Patients who are receiving any other investigational agents or concurrent anticancer therapy are NOT eligible for participation; previous systemic treatment is allowed with a 2 week washout period prior to registration", " Patients who are taking any herbal (alternative) medicines are NOT eligible for participation; patients must be off any such medications by the time of registration", " Patients who are receiving concomitant D2-antagonists (such as phenothiazines, butyrophenones, thioxanthenes, or metoclopramide) are NOT eligible for participation; patients must be off any such medications by the time of registration", " Patients with known brain metastases are NOT eligible for participation", " Patients with any of the following conditions or complications are NOT eligible for participation:", " Uncontrolled hypertension", " Known hypersensitivity to ergot derivatives", " History of cardiac valvular disorders, as suggested by anatomical evidence of valvulopathy of any valve (to be determined by pre-treatment evaluation including echocardiographic demonstration of valve leaflet thickening, valve restriction, or mixed valve restriction-stenosis)", " History of pulmonary, pericardial, cardiac valvular, or retroperitoneal fibrotic disorders", " Gastrointestinal (GI) tract disease resulting in an inability to take oral medication", " Malabsorption syndrome", " Require intravenous (IV) alimentation", " History of prior surgical procedures affecting absorption", " Uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis)" ]

[ "INTERVENTION 1: ", " Arm A : iv Vinflunine Plus Capecitabine", " Vinflunine dose 280 mg/m² on day 1 of each cycle every 3 weeks, Capecitabine 825 mg/m² twice daily orally for 14 consecutive days beginning on day 1 of each cycle followed by 1 week of rest.", " vinflunine: intraveinous administration day 1 once every 3 weeks, 280 mg/m²", " Capecitabine: Arm A : 1650 mg/m² Arm B : 2500 mg/m²", "INTERVENTION 2: ", " Arm B : Capecitabine", " 1250 mg/m² twice daily orally for 14 consecutive days beginning on day 1 of each cycle followed by 1 week of rest", " Capecitabine: Arm A : 1650 mg/m² Arm B : 2500 mg/m²" ]

[ "Outcome Measurement: ", " Number of Participants With Pathologic Complete Response (pCR) in the Breast and Nodes", " pCR was defined as no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes, or sentinel node identified after neoadjuvant chemotherapy.", " Time frame: From the start of the study until the time of surgery (average of 221.9 days [standard deviation of 23.65 days] after study entry)", "Results 1: ", " Arm/Group Title: AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib", " Arm/Group Description: Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared [mg/m^2]) and cyclophosphamide (AC) (600 mg/m^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.", " Overall Number of Participants Analyzed: 93", " Measure Type: Number", " Unit of Measure: Participants 16" ]

[ "Adverse Events 1:", " Total: 18/26 (69.23%)", " Thrombocytopenia * 4/26 (15.38%)", " Neutropenia * 3/26 (11.54%)", " Epitasis * 1/26 (3.85%)", " Peripheral arterial ischemia * 1/26 (3.85%)", " Thrombosis * [1]1/26 (3.85%)", " Weakness * 1/26 (3.85%)", " Pain * [2]2/26 (7.69%)", " Febrile neutropenia * 1/26 (3.85%)", " Aspartate Aminotransferase * [3]1/26 (3.85%)", " Syncope * 1/26 (3.85%)" ]

[ "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" ]

[ "Outcome Measurement: ", " Progression Free Survival (PFS)", " PFS was assessed by the investigator based on World Health Organization (WHO) criteria using radiographic tumor evaluations. Disease progression was defined as the appearance of any new lesion not previously identified or an estimated increase of 25% or more in existent bidimensionally or unidimensionally measurable lesions or progression of an existing non-measurable lesion. For bidimensionally measurable malignant lesions with an area of at least 2.0 centimeters squared (cm^2) an increase of 1.0 cm^2 was required and for unidimensionally measurable lesions of 1.0 cm or less an increase of 0.5 cm was required. PFS was defined as the number of days between date of randomization and date of documented disease progression or date of death. Kaplan Meier estimates of PFS are presented.", " Time frame: 24 Months, End of Study (Up to 5 years)", "Results 1: ", " Arm/Group Title: Trastuzumab + Anastrozole", " Arm/Group Description: Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.", " Overall Number of Participants Analyzed: 103", " Median (95% Confidence Interval)", " Unit of Measure: Months 24 Months: 4.8 (3.7 to 7)", " End of Study: 5.8 (4.6 to 8.3)", "Results 2: ", " Arm/Group Title: Anastrozole", " Arm/Group Description: 1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.", " Overall Number of Participants Analyzed: 104", " Median (95% Confidence Interval)", " Unit of Measure: Months 24 Months: 2.4 (2 to 4.6)", " End of Study: 2.9 (2.1 to 4.5)" ]

[ "INTERVENTION 1: ", " Treatment (MEDI4736, Tremelimumab)", " Patients receive anti-B7H1 monoclonal antibody MEDI4736 IV over 1 hour and tremelimumab IV over 1 hour on day 1. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Four weeks after the last combination dose, patients continue to receive anti-B7H1 monoclonal antibody MEDI4736 every 2 weeks for up to 18 additional doses in the absence of disease progression or unacceptable toxicity. Patients achieving PD or clinical benefit (CR, PR, or SD) may be retreated with anti-B7H1 monoclonal antibody MEDI4736 for an additional 52 weeks.", " Anti-B7H1 Monoclonal Antibody MEDI4736: Given IV", " Laboratory Biomarker Analysis: Correlative studies", " Pharmacological Study: Correlative studies", " Tremelimumab: Given IV" ]

[ "INTERVENTION 1: ", " Zoledronic Acid 5 mg IV", " Zometa (Zoledronic Acid) 5 mg IV given over 15 minutes as a one time dose. Follow-up at month 1 & every 2 months to month 12 for serum & urine markers of bone destruction (NTx & CTx)." ]

[ "Outcome Measurement: ", " Mean Total MRI Functional Tumor Volume (FTV) Change From Baseline to Month 3 (V3)", " Mean total MRI FTV change from baseline to month 3 (V3): For patients with more than one measureable lesion on the MRI, the sum over all measureable lesions on the MRI was calculated at each time point. V3 was calculated by subtracting the total MRI FTV measured (i.e. the sum over all lesions present with MRI FTV measurements) at 3 months from the total MRI FTV measured at baseline. For V3 the raw change in the volume will be calculated for each patient and a mean and 95% confidence interval will be constructed using two-sided t-tests.", " Time frame: up to 3 months from start of treatment", "Results 1: ", " Arm/Group Title: Letrozole + MRI", " Arm/Group Description: Protocol Therapy will consist of 6 months of letrozole, administered orally at a dose of 2.5 mg/day. Patients will have a bilateral MRI for disease evaluation at months 3 and 6.", " Overall Number of Participants Analyzed: 68", " Mean (95% Confidence Interval)", " Unit of Measure: cubic centimeters -1.93 (-2.87 to -0.98)" ]

[ "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" ]

[ "INTERVENTION 1: ", " Accelerated Partial Breast Brachytherapy", " Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.", " Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions." ]

[ "INTERVENTION 1: ", " Arm I (Cranial Microcurrent Electrical Stimulation [CES])", " Patients receive a CES unit (Alpha-Stim® 100 Microcurrent Stimulator) that passes microcurrent levels of biphasic electrical stimulation via ear-lobe electrodes. The CES unit is preset to provide 1 hour of 100 μA (sub-sensory level), modified square-wave biphasic stimulation on a 50% duty cycle at .05 Hz, and to automatically turn off at the end of 1 hour. Patients use their CES unit once daily in weeks 1-18.", " energy-based therapy: Given once a day for 18 weeks", "INTERVENTION 2: ", " Arm II (Sham CES)", " Patients receive a CES unit as in arm I, but the ear-lobe electrodes do not pass electrical current. Patients use their CES unit once daily in weeks 1-18.", " sham intervention: Given once a day for 18 weeks" ]

[ "Adverse Events 1:", " Total: 4/26 (15.38%)", " Disseminated intravascular coagulation 1/26 (3.85%)", " Cardiac failure congestive 1/26 (3.85%)", " Breast cellulitis 1/26 (3.85%)", " Cellulitis 1/26 (3.85%)", " Acute myeloid leukaemia 1/26 (3.85%)", " Seizure 0/26 (0.00%)", " Pulmonary embolism 1/26 (3.85%)", "Adverse Events 2:", " Total: 2/24 (8.33%)", " Disseminated intravascular coagulation 0/24 (0.00%)", " Cardiac failure congestive 0/24 (0.00%)", " Breast cellulitis 0/24 (0.00%)", " Cellulitis 1/24 (4.17%)", " Acute myeloid leukaemia 0/24 (0.00%)", " Seizure 1/24 (4.17%)", " Pulmonary embolism 0/24 (0.00%)" ]

[ "INCLUSION CRITERIA", " Males and Females 18 years old diagnosed with HER2 positive breast cancer", " Scheduled to receive neoadjuvant or adjuvant trastuzumab (Herceptin®) therapy (anthracycline-containing regimens are permitted). Patients receiving Herceptin® with their chemotherapy are permitted for eligibility work-up. Taxanes are permitted. Trastuzumab (Herceptin®) therapy may be given with or after primary chemotherapy. Pertuzumab may be used in conjunction with trastuzumab.", " Left Ventricular Ejection Fraction (LVEF) 50% by MUGA scan or echocardiogram", " Adequate renal function for administration of trastuzumab-containing chemotherapy regimen.", " Sitting systolic blood pressure of > 90 mm Hg", " Pulse 60 beats/minute", " Not pregnant or breastfeeding", " Female patients of childbearing potential, who are sexually active, must have a negative pregnancy test before starting the study", " Both men and women must be willing to use effective contraception during the study. Teratogenicity is documented for both active study agents", " Able to swallow capsules", "EXCLUSION CRITERIA:", " Patients with metastatic disease", " Prior treatment with trastuzumab or anthracyclines prior to this chemotherapy regimen", " Current treatment with angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), such as losartan, β-blockers or digoxin", " Known cardiac history: heart failure, myocardial infarction, radiation-induced cardiac dysfunction", " Known allergy to either ACE inhibitors or β-blockers", " History of bronchial asthma or related bronchospastic conditions", " Hereditary or idiopathic angioedema", " History of severe hypersensitivity reactions to drugs or other causes, i.e. bee stings", " This protocol does not exclude patients who are participating on other investigational studies. Refer to the local IRB guidelines." ]

[ "Inclusion Criteria:", " Patients with cytologically confirmed breast cancer with biopsy showing invasive or non-invasive (DCIS) at least 1.0 cm greatest diameter on imaging", " Surgical patients undergoing lumpectomy, subtotal or total mastectomy", " 18 years of age or greater", " female", " available tissue blocks from diagnostic biopsy", " negative pregnancy test, medical history of surgical sterilization, or 1 year post menopausal", " must be willing to forego surgery for minimum of 5 days", " ability and willingness to sign written consent", " if hypertensive, on stable dose of medication at least 30 days", " if diabetic, well controlled (HbA1C < 8.5 within past 60 days or documented FPG < 140 mg/dl for 3 consecutive days", " ECOG status < 2 or Karnofsky of 60% or greater", "Exclusion Criteria:", " previous or current malignancy, excluding non-melanomic skin cancer", " evidence of distant metastatic disease", " history of chemotherapy, biologic or radiotherapy with 6 months of biopsy", " usage of herbal supplements or alternative medications not approved by the FDA within 1 week of starting study drug. LEAG or related ginseng products, and combination products containing ginseng, should be discontinued within 6 weeks of starting study drug", " history of allergic reactions attributed to compounds of similar chemical or biologic composition to LEAG", " history of chronic inflammatory process, including, but not limited to, rheumatoid arthritis and lupus. This includes patients on concurrent systemic steroids or anti-inflammatory medications", " active bleeding or a pathological condition that carries a high risk of bleeding", " any swallowing dysfunction", " uncontrolled intercurrent illness", " poorly controlled diabetes (control indicated with HbA1c < 8.5 within past 60 days or documented fasting blood glucose < 140 mg/dl for three consecutive days)", " known diabetics who have experienced episodes of symptomatic hypoglycemia in the last 6 months are also considered poorly controlled and will be excluded from study participation.", " uncontrolled hypertension (SBP > 140 mmHg or DBP > 90 mmHG)", " pregnant or breast feeding women Women must be willing to use birth control throughout study duration.", " current investigational medications or treatment with an investigational agent within 6 weeks prior to biopsy", " current coumadin therapy or who have been treated with coumadin within the 2 weeks prior to biopsy", " current monoamine oxidase inhibitors treatment" ]

[ "Inclusion Criteria:", " Female patient 18 years of age", " Histologically proven stage II or III adenocarcinoma of the breast", " Must be candidate for neoadjuvant treatment (Tumor size 2 cm, T2, T3, T4 and/or clinical N1 or N2).", " HER-2/neu 1+ or 2+ by immunohistochemistry", " Must have operable tumor.", " Performance status of 2 or better per SWOG criteria", " LVEF 55% by echocardiogram performed within 4 weeks prior to treatment initiation", " If patient of childbearing potential, pregnancy test is negative", " Patients with reproductive potential must use an effective method to avoid pregnancy for the duration of the trial.", " Adequate bone marrow function: ANC > 1500/mm3, platelet count > 100,000/mm3, and hemoglobin > 9 g/dL", " Adequate kidney function: serum creatinine of < 1.5mg/dl and/or creatinine clearance of > 60 mL/min", " Adequate hepatic function: transaminases < 2.5 x upper limit of normal and total bilirubin < 1.5 mg/dL", " Must be informed of the investigational nature of the study and must sign an informed consent in accordance with the institutional rules.", " Pretreatment lab values must be performed within 14 days of patient registration, and other baseline studies (with the exception of mammogram) must be performed within 30 days of patient registration.", "EXCLUSION CRITERIA:", " Patient with metastatic breast cancer.", " Women with tumors that are HER-2 neu 0+ or 3+ by immunohistochemistry", " Women with HER 2 FISH amplified tumors (FISH ratio >2.2)", " Patients who have had prior endocrine therapy for > 4 weeks or chemotherapy for this breast cancer will be excluded.", " Locally advanced, inoperable tumors will be excluded.", " The presence of any other medical or psychiatric disorder that, in the opinion of the treating physician, would contraindicate the use of drugs in this protocol or place the subject at undue risk for treatment complications.", " History of significant cardiac disease, cardiac risk factors or uncontrolled arrhythmias", " Ejection fraction < 55%", " Pregnancy or lactation", " Patients with inadequate laboratory values (as defined above) are excluded from study.", " Patients with NCI common toxicity criteria (CTC) grade 2 or greater peripheral neuropathy are excluded from study.", " Patients with active infection are excluded from study.", " Patients with concomitant or previous malignancies within the last 5 years, are excluded from the study. Exceptions include: adequately treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, and ductal carcinoma in situ (DCIS).", " Patients with emotional limitations are excluded from study." ]

[ "Inclusion Criteria:", " At least 18 years of age", " Willing and able to provide informed consent", " Reporting daily hot flashes", " Able to read, write, and speak English", " Postmenopausal to limit sample variability (> 12 months amenorrhea)", " Greater then 1 month but < 5 years post-treatment (surgery, radiation, chemotherapy) for non-metastatic breast cancer.", " These criteria allow inclusion of women successfully treated for recurrent breast cancer since there is no known reason to exclude them. Menopausal status is assessed using self-reports due to problems in reliably measuring follicle-stimulating hormone levels and estradiol in tamoxifen users.", "Exclusion Criteria:", " Exclusion criteria are current depression, history of migraines or hepatitis, abnormal chemistry profile (e.g., sodium, potassium, glucose), or a positive urine drug screen for illegal substances." ]

[ "Inclusion Criteria:", " Women with diagnosis of breast malignancy", " Women whom requires left chest wall post-mastectomy radiation with or without bolus", " Age 18 years.", " Performance status ECOG </=3", " Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately Ability to understand and the willingness to sign a written informed consent.", " Patient must be able to maintain a 30 second breath hold.", " Conventional chest wall radiation delivery dose of 50.4 Gy/ 28 fractions with or without a boost (boost will not be evaluated for endpoints)", "Exclusion Criteria:", " 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.", " Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants." ]

[ "Inclusion Criteria:", " Histologically confirmed, measurable, invasive breast carcinoma T >2cm, Nany, M0.", " Patients with node-negative, ER or PR-positive tumors 4 cm in size whose tumors are low risk (defined as a score of 0-17) on an Oncotype DX profile are not eligible.", " 19 years of age or greater", " Known ER, PR and HER-2 status (FISH assay to be done on specimens with 2+ or 3+ immunohistochemical staining for HER-2): patients with gene amplification on FISH study will be considered to be HER-2 positive. Patients for this study must be FISH negative if immunohistochemical stain is 2+ or 3+ positive; patients with negative, 0 or 1+ immunohistochemical stain for HER-2 are eligible.", " Known axillary nodal status: aspiration cytology or biopsy", " Documented menopausal status premenopausal (having menstrual periods or FSH <35) or postmenopausal ( 12 months since last menstrual period with intact uterus and at least one ovary or FSH 35 or previous bilateral oophorectomy", " Non-pregnant if premenopausal (negative serum or urine pregnancy test within 7 days of starting chemotherapy) and not breast feeding", " Patients with reproductive potential must use an adequate contraceptive method (e.g., abstinence, intrauterine device, barrier device with spermicide or surgical sterilization) during treatment and for three months after completing treatment.", " Life expectancy of less than 12 weeks", " Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored Avastin cancer study", " Pregnant or lactating women.", " History of cardiac disease, with New York Heart Association Grade II or greater or clinical evidence of congestive heart failure.", " Serious comorbid medical conditions which would impair the ability to receive chemotherapy on time", " Previous invasive cancer within the last 5 years", " Altered mental status or dementia which would interfere with understanding of informed consent and ability to comply with study and follow-up procedures.", " Hypersensitivity to Doxil, doxorubicin, cyclophosphamide, cremophore (contained in teniposide, cyclosporine, and vitamin K), or to any component of Avastin", " Inadequately controlled hypertension (defined as blood pressure of >150/100 mmHg on antihypertensive medication)", " Unstable angina pectoris", " History of myocardial infarction or unstable angina within 12 months prior to beginning therapy", " History of stroke or TIA at any time", " Clinically significant vascular (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis, aortic dissection) or peripheral vascular disease with 6 months prior to beginning therapy", " History of hemoptysis (greater than or equal to 1/2 teaspoon of bright red blood per episode) within 1 month prior to beginning therapy", " Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)", " Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to beginning therapy or anticipation of need for major surgical procedure during the course of the study", " Patients must have a 2-d echocardiogram indicating an ejection fraction of > 50% within 42 days prior to first dose of study drug. The method used at baseline must be used for later monitoring.", " No distant metastases on bone scan and on CT scans of chest and abdomen (no metastasis on optional PET scan is an acceptable alternative; if PET scan is done for any reason it must show no evidence of distant metastasis). Baseline PET scan is recommended but not required for all patients.", " No CNS metastasis", " Hbg 9 gm, platelets 100,000, granulocytes 1000, total or direct bilirubin 1.2, creatinine 2.0 and urine protein:creatinine ratio <1.0", " No prior chemotherapy or radiotherapy and 4 weeks of prior antiestrogen or aromatase inhibitor therapy", " No concomitant hormone replacement (i.e. estrogen or progestin) therapy", " PS less than or equal to one", "Exclusion Criteria:", " Minor surgical procedure (excluding placement of a vascular access device) such as fine needle aspiration or core needle biopsy within 7 days of beginning therapy", " Urine protein:creatinine ratio 1.0 at initial screening", " Known hypersensitivity to any component of Avastin", " History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months of beginning therapy", " Serious, non-healing wound, active ulcer, or untreated bone fracture", " Any prior history of hypertensive crisis or hypertensive encephalopathy", " Known CNS metastasis, except for treated brain metastasis. Treated brain metastases are defined as having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period. Anticonvulsants (stable dose) are allowed. Treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS; Gamma Knife, LINAC, or equivalent) or a combination as deemed appropriate by the treating physician. Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to Day 1 will be excluded." ]

[ "INTERVENTION 1: ", " Treatment (Vaccine Therapy+ex Vivo-expanded T Cells)", " Patients receive HER2/neu peptide vaccine admixed with sargramostim (GM-CSF) ID on days 1, 8, and 15. Beginning 2 weeks later, patients undergo leukapheresis to isolate and collect peripheral blood mononuclear cells for T-cell expansion.", " Patients receive cyclophosphamide IV once on day -1 and autologous ex vivo-expanded HER2-specific T cell IV over 30 minutes on day 1. Treatment repeats every 7-10 days for up to three immunizations. Patients receive a booster HER2/neu peptide vaccine 1 month after the final T-cell infusion, followed by 2 additional booster vaccines at 2-month intervals.", " HER-2/neu peptide vaccine: Given ID", " leukapheresis: Undergo leukapheresis", " ex vivo-expanded HER2-specific T cells: Given IV", " cyclophosphamide: Given IV", " sargramostim: Given ID", " laboratory biomarker analysis: Correlative study" ]

[ "INTERVENTION 1: ", " PET Guided Biopsy", " No comparison group. All enrolled participants were expected to undergo PET guided biopsy." ]

[ "Adverse Events 1:", " Total: 59/373 (15.82%)", " Neutropenia 14/373 (3.75%)", " Febrile neutropenia 10/373 (2.68%)", " Leukopenia 1/373 (0.27%)", " Anaemia 2/373 (0.54%)", " Lymphadenopathy 0/373 (0.00%)", " cardiac failure 2/373 (0.54%)", " Atrial fibrillation 1/373 (0.27%)", " Pericardial effusion 2/373 (0.54%)", " Cardiac failure congestive 1/373 (0.27%)", " Cardiomyopathy 0/373 (0.00%)", "Adverse Events 2:", " Total: 69/377 (18.30%)", " Neutropenia 17/377 (4.51%)", " Febrile neutropenia 10/377 (2.65%)", " Leukopenia 4/377 (1.06%)", " Anaemia 2/377 (0.53%)", " Lymphadenopathy 1/377 (0.27%)", " cardiac failure 1/377 (0.27%)", " Atrial fibrillation 1/377 (0.27%)", " Pericardial effusion 0/377 (0.00%)", " Cardiac failure congestive 0/377 (0.00%)", " Cardiomyopathy 1/377 (0.27%)" ]

[ "INTERVENTION 1: ", " Study Participants", " There are no arms or subgroups in this study." ]

[ "INTERVENTION 1: ", " Celecoxib", " Randomized to receive celecoxib daily for 12 months", "INTERVENTION 2: ", " Placebo", " Randomized to receive placebo daily for 12 months" ]

[ "Adverse Events 1:", " Total: 12/66 (18.18%)", " Palpitations * 1/66 (1.52%)", " Haematemesis * 1/66 (1.52%)", " Performance status decreased * 1/66 (1.52%)", " Hepatic failure * 1/66 (1.52%)", " Cellulitis * 1/66 (1.52%)", " Device related infection * 1/66 (1.52%)", " Pneumonia * 1/66 (1.52%)", " Pneumonia pneumococcal * 1/66 (1.52%)", " Femur fracture * 0/66 (0.00%)", " Hypokalaemia * 1/66 (1.52%)", " Back pain * 2/66 (3.03%)" ]

[ "INTERVENTION 1: ", " CMRM vs UMRM", "[Not Specified]" ]

[ "INTERVENTION 1: ", " A: Exemestane", " ARM A: Patients will be treated with exemestane.", " Exemestane: 25 mg daily by mouth for 6 to 12 months.", "INTERVENTION 2: ", " B: Docetaxel and Cytoxan", " ARM B: Patients will be treated with docetaxel and cytoxan.", " Docetaxel: Docetaxel (75 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).", " Cytoxan: Cytoxan (600 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks)." ]

[ "Adverse Events 1:", " Total: 146/573 (25.48%)", " Anaemia 4/573 (0.70%)", " Disseminated intravascular coagulation 0/573 (0.00%)", " Neutropenia 1/573 (0.17%)", " Thrombocytopenia 0/573 (0.00%)", " Acute coronary syndrome 1/573 (0.17%)", " Angina pectoris 1/573 (0.17%)", " Atrial fibrillation 2/573 (0.35%)", " Atrial flutter 0/573 (0.00%)", " Cardiac arrest 1/573 (0.17%)", " Cardiac failure 0/573 (0.00%)", "Adverse Events 2:", " Total: 101/570 (17.72%)", " Anaemia 3/570 (0.53%)", " Disseminated intravascular coagulation 1/570 (0.18%)", " Neutropenia 1/570 (0.18%)", " Thrombocytopenia 1/570 (0.18%)", " Acute coronary syndrome 0/570 (0.00%)", " Angina pectoris 1/570 (0.18%)", " Atrial fibrillation 0/570 (0.00%)", " Atrial flutter 1/570 (0.18%)", " Cardiac arrest 0/570 (0.00%)", " Cardiac failure 1/570 (0.18%)" ]

[ "Adverse Events 1:", " Total: 13/74 (17.57%)", " neutropenia 1/74 (1.35%)", " left ventricular dysfunction 1/74 (1.35%)", " fistula enterovesical 1/74 (1.35%)", " constipation and hypokalemia 1/74 (1.35%)", " nausea, vomiting and burning abdominal pain 2/74 (2.70%)", " Infection 1/74 (1.35%)", " febrile neutropenia 3/74 (4.05%)", " speech impairment 1/74 (1.35%)", " dyspnea, pain 1/74 (1.35%)", " hemorrhage/bleeding 2/74 (2.70%)" ]

[ "Adverse Events 1:", " Total: 11/50 (22.00%)", " Anemia 3/50 (6.00%)", " Febrile neutropenia 1/50 (2.00%)", " Arrythmia 1/50 (2.00%)", " Ileus 1/50 (2.00%)", " Nausea 1/50 (2.00%)", " Pain-Abdominal 1/50 (2.00%)", " Vomiting 1/50 (2.00%)", " Bronchial infection 1/50 (2.00%)", " Sepsis 1/50 (2.00%)", " Neutropenia 2/50 (4.00%)", " Platelet count decreased 1/50 (2.00%)", " Dehydration 1/50 (2.00%)", " Arthralgia 1/50 (2.00%)" ]

[ "Adverse Events 1:", " Total: 20/52 (38.46%)", " Febrile bone marrow aplasia * 5/52 (9.62%)", " Febrile neutropenia * 6/52 (11.54%)", " Leukopenia * 6/52 (11.54%)", " Atrial tachycardia * 1/52 (1.92%)", " Vomiting * 1/52 (1.92%)", " Tooth loss * 1/52 (1.92%)", " Hyperthermia * 1/52 (1.92%)", " Malaise * 1/52 (1.92%)", " Pyrexia * 1/52 (1.92%)", " Impaired healing * 3/52 (5.77%)", " Inflammation * 1/52 (1.92%)" ]

[ "Adverse Events 1:", " Total: 25/60 (41.67%)", " Anaemia * 1/60 (1.67%)", " Febrile neutropenia * 2/60 (3.33%)", " Idiopathic thrombocytopenic purpura * 1/60 (1.67%)", " Thrombocytopenia * 3/60 (5.00%)", " Cardiac failure * 1/60 (1.67%)", " Cardiac failure acute * 1/60 (1.67%)", " Cardiogenic shock * 1/60 (1.67%)", " Left ventricular dysfunction * 1/60 (1.67%)", " Anal fistula * 1/60 (1.67%)" ]

[ "Adverse Events 1:", " Total: 4/26 (15.38%)", " Febrile neutropenia * 1/26 (3.85%)", " Gastric volvulus * 20/26 (0.00%)", " General Malaise * 21/26 (3.85%)", " Hospitalisation for intrapleuric chemotherapy and thoracentesis * 21/26 (3.85%)", " Acute renal failure * 21/26 (3.85%)", "Adverse Events 2:", " Total: 1/28 (3.57%)", " Febrile neutropenia * 0/28 (0.00%)", " Gastric volvulus * 21/28 (3.57%)", " General Malaise * 20/28 (0.00%)", " Hospitalisation for intrapleuric chemotherapy and thoracentesis * 20/28 (0.00%)", " Acute renal failure * 20/28 (0.00%)" ]

[ "Inclusion Criteria:", " Patients with histologically confirmed HER-2/neu-overexpressing adenocarcinoma of the breast; this is defined as HER-2+ by immunohistochemistry (IHC) 3+ staining or Fluorescence In-Situ Hybridization (FISH). Prior adjuvant Trastuzumab therapy is permitted. Patients must not be eligible for therapy of known curative potential for metastatic breast cancer if it is identified during the course of the study.", " Patients may have measurable or evaluable disease.", " Stable central nervous system (CNS) disease that has been adequately treated and is not under active treatment allowed.", " Age 18 years or older.", " Able to give informed consent.", " Patients with an Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1.", " No systemic oral steroids administered within 28 days prior to initiating treatment on protocol. Topical, ocular, and nasal steroids are allowed, as are those applied to mucus membranes.", " No prior or currently active autoimmune disease requiring management with systemic immunosuppression. This includes inflammatory bowel disease, systemic vasculitis, scleroderma, psoriasis, multiple sclerosis, hemolytic anemia or immune-mediated thrombocytopenia, rheumatoid arthritis, systemic lupus erythematosus, Sjogren's syndrome, sarcoidosis, or other rheumatologic disease. Asthma or chronic obstructive pulmonary disease that does not require daily systemic corticosteroids is acceptable.", " Not pregnant, and on appropriate birth control if of child-bearing potential.", " No history of other malignancies within the prior five years (excluding a history of carcinoma in situ of the cervix, superficial non-melanoma skin cancer, and superficial bladder cancer).", " Adequate bone marrow reserve with absolute neutrophil count (ANC) > 1000 and platelets > 100,000.", " Adequate renal function with serum creatinine < 2.0.", " Adequate hepatic reserve with serum bilirubin < 2.0, aspartate transaminase (AST) and alanine aminotransferase (ALT) < 2X the upper limit of normal, and alkaline phosphatase < 5X the upper limit of normal. Serum bilirubin > 2.0 is acceptable in the setting of known Gilbert's syndrome.", " Adequate cardiac reserve with a cardiac ejection fraction within the lower limit of facility normal by MUGA, or 45% by echocardiogram.", " No active major medical or psychosocial problems that could be complicated by study participation.", " HIV negative.", "Exclusion Criteria:", " No histologic documentation of breast adenocarcinoma.", " Breast adenocarcinoma that is not amplified for HER-2/neu gene expression by at least 2-fold by FISH analysis, or that is less than IHC 3+ when FISH negative.", " Cardiac dysfunction documented by an ejection fraction less than the lower limit of the facility normal by multi-gated acquisition (MUGA) scan, or 45% by echocardiogram.", " Symptomatic intrinsic lung disease or extensive tumor involvement of the lungs resulting in dyspnea at rest.", " History of autoimmune disease as detailed above.", " Systemic oral corticosteroid treatment within 28 days prior to initiating treatment on study.", " Uncontrolled medical problems.", " Evidence of active acute or chronic infection.", " Chemotherapy, radiation therapy, or biologic therapy (except Trastuzumab) within 28 days prior to initiating treatment on study. Hormonal therapy and supportive therapy with bisphosphonates will be allowed.", " Participation in an investigational new drug trial within 28 days prior to initiating treatment on study.", " Pregnant or breast feeding.", " Hepatic, renal, or bone marrow dysfunction as detailed above.", " Concurrent malignancy or history of other malignancy within the last five years except as noted above.", " Corn allergy.", " Known severe hypersensitivity to Trastuzumab (excluding mild to moderate infusion reactions that are easily managed and do not recur)." ]

[ "Adverse Events 1:", " Total: 2/38 (5.26%)", " Febrile neutropenia 0/38 (0.00%)", " Abdominal pain 1/38 (2.63%)", " Skin infection 0/38 (0.00%)", " Seizure 1/38 (2.63%)" ]

[ "Adverse Events 1:", " Total: 92/490 (18.78%)", " Anaemia * 1/490 (0.20%)", " Anaemia of malignant disease * 0/490 (0.00%)", " Febrile neutropenia * 0/490 (0.00%)", " Neutropenia * 0/490 (0.00%)", " Thrombocytopenia * 4/490 (0.82%)", " Angina pectoris * 0/490 (0.00%)", " Atrial fibrillation * 1/490 (0.20%)", " Cardiomyopathy * 1/490 (0.20%)", " Coronary artery disease * 0/490 (0.00%)", " Pericardial effusion * 0/490 (0.00%)", "Adverse Events 2:", " Total: 99/488 (20.29%)", " Anaemia * 1/488 (0.20%)", " Anaemia of malignant disease * 1/488 (0.20%)", " Febrile neutropenia * 2/488 (0.41%)", " Neutropenia * 1/488 (0.20%)", " Thrombocytopenia * 1/488 (0.20%)", " Angina pectoris * 1/488 (0.20%)", " Atrial fibrillation * 0/488 (0.00%)", " Cardiomyopathy * 0/488 (0.00%)", " Coronary artery disease * 1/488 (0.20%)", " Pericardial effusion * 2/488 (0.41%)" ]

[ "Outcome Measurement: ", " Number of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Partial Response (PR), as Assessed by the Independent Review Committee (IRC)", " OR is defined as the number of participants achieving either a confirmed CR or PR, per Response Evaluation Criteria in Solid Tumors (RECIST, v 1.0). Best OR is defined as the best response recorded from the start of treatment until progressive disease (PD)/recurrence. CR is defined as the disappearance of all target lesions (TLs) and non-TLs. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL(s), as assessed by the IRC. PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of >= 1 new lesions or unequivocal progression of existing non-TLs. Responses were confirmed at subsequent assessments made >=28 days after the original response. Participants with an unknown or missing response are treated as non-responders.", " Time frame: From the date of the first dose of investigational product to the first documented evidence of a confirmed CR or PR (up to Study Week 103)", "Results 1: ", " Arm/Group Title: Lapatinib 1500 mg QD", " Arm/Group Description: Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.", " Overall Number of Participants Analyzed: 69", " Measure Type: Number", " Unit of Measure: Participants CR: 0", "PR: 15", "Results 2: ", " Arm/Group Title: Lapatinib 500 mg BID", " Arm/Group Description: Participants received lapatinib 500 mg orally BID. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.", " Overall Number of Participants Analyzed: 69", " Measure Type: Number", " Unit of Measure: Participants CR: 0", "PR: 18" ]

[ "INTERVENTION 1: ", " Lapatinib Plus Capecitabine", " Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.", "INTERVENTION 2: ", " Trastuzumab Plus Capecitabine", " Participants received an IV infusion of trastuzumab 8 mg/kg on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal." ]

[ "INTERVENTION 1: ", " Behavioral Dietary Intervention", " Beginning 2-4 weeks after completion of lumpectomy, patients receive food diaries to complete for 7-10 days. Dietary counselors then give patients guidelines for dietary modifications to reduce caloric intake by 25% of their normal diet. Patients follow caloric restricted diet for 10 weeks (2 weeks prior to radiation therapy, during 6 weeks of radiation therapy, and at least 2 weeks after radiation therapy). Patients undergo radiation therapy QD 5 days a week for 6 weeks.", " Behavioral dietary intervention: Receive caloric restricted dietary intervention", " Therapeutic conventional surgery: Undergo definitive lumpectomy", " Radiation therapy: Undergo radiation therapy", " Counseling intervention: Receive dietary counseling", " Quality-of-life assessment: Ancillary studies" ]

[ "INCLUSION CRITERIA", " Female", " Histologically-confirmed Her2neu positive breast cancer, by either Immunohistochemistry (IHC) 3+ or Fluorescence In Situ Hybridization (FISH)+", " Stage II/III breast cancer including any large primary tumor (> 2 cm), tumors of any size associated with skin or chest wall involvement, tumors of any size with axillary lymph node involvement, (T2-T4, N0-N2) and those with ipsilateral subclavicular or supraclavicular lymph nodes).", " At least one bi-dimensional, measurable indicator lesion.", " Between 18 and 70 years of age", " Eastern Cooperative Oncology Group (ECOG) performance status 2 / Karnofsky 60% at screening and on the first day of treatment.", " Informed consent must be obtained prior to registration.", " Cardiac ejection fraction within the institutional range of normal as measured by multigated acquisition (MUGA) or echocardiography (ECHO) scan.", " Absolute neutrophil count > 1,500/mm³", " Hemoglobin > 8.0 g/dL", " Platelet count > 100,000/mm³", " Creatinine within normal institutional limits", " Total Bilirubin equal to or less than institutional upper limit of normal (ULN)", " Aspartate aminotransferase (AST); alanine aminotransferase (ALT); and alkaline phosphatase must be within the range allowing for eligibility. In determining eligibility the more abnormal of the two values (AST or ALT) should be used.", " Eligibility of patients receiving medications or substances known to affect, or with the potential to affect the activity or pharmacokinetics of GW572016 will be determined following review of their use by the Principal Investigator", " Antacid use is prohibited 1 hour before and 1 hour after GW572016 dosing.", " All herbal (alternative) medicines are prohibited.", " Medications prohibited during the administration of lapatinib .", " Women of child-bearing potential must have negative pregnancy test and 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.", " Peripheral neuropathy: must be < grade 1", " Able to swallow and retain oral medication", " EXCLUSION CRITERIA", " Evidence of disease outside the breast or chest wall, except for ipsilateral axillary , supraclavicular, or infraclavicular lymph nodes.", " Prior chemotherapy, immunotherapy, or hormonal therapy for breast cancer.", " More than 3 months between histologic diagnosis and registration on this study.", " History of other malignancy within the last 5years, except curatively treated basal cell carcinoma of the skin or carcinoma in situ of the cervix.", " Psychological, familial, sociological or geographical conditions which do not permit weekly medical follow-up and compliance with the study protocol. Those who are medically-unstable, including but not limited to active infection, acute hepatitis, deep vein thrombosis requiring anticoagulant therapy, gastrointestinal bleeding, uncontrolled hypercalcemia, uncontrolled diabetes, dementia, seizures, superior vena cava syndrome, and those whose circumstances do not permit completion of the study or the required follow-up.", " Congestive heart failure, abnormal left ventricular ejection fraction (LVEF), angina pectoris, uncontrolled cardiac arrhythmias, or other significant heart disease, or who have had a myocardial infarction within the past year.", " Pregnant or lactating", " Of childbearing potential and not employing adequate contraception", " History of allergic reactions attributed to compounds of similar chemical or biologic composition to GW572016.", " HIV-positive and receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with lapatinib. Appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated.", " GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis).", " History of severe hypersensitivity reaction to taxotere or other drugs formulated with polysorbate 80.", " Current active hepatic or biliary disease (with exception of patients with Gilberts syndrome, asymptomatic gallstones, or stable chronic liver disease per investigator assessment )." ]

[ "Adverse Events 1:", " Total: 17/145 (11.72%)", " ANAEMIA 0/145 (0.00%)", " LEUKOPENIA 2/145 (1.38%)", " NEUTROPENIA 1/145 (0.69%)", " LEUKOCYTOSIS 1/145 (0.69%)", " THROMBOCYTOPENIA 1/145 (0.69%)", " FEBRILE NEUTROPENIA 1/145 (0.69%)", " THROMBOTIC THROMBOCYTOPENIC PURPURA 0/145 (0.00%)", " DISSEMINATED INTRAVASCULAR COAGULATION 0/145 (0.00%)", " CARDIAC FAILURE 1/145 (0.69%)", " ATRIAL FIBRILLATION 1/145 (0.69%)", "Adverse Events 2:", " Total: 11/144 (7.64%)", " ANAEMIA 1/144 (0.69%)", " LEUKOPENIA 0/144 (0.00%)", " NEUTROPENIA 0/144 (0.00%)", " LEUKOCYTOSIS 0/144 (0.00%)", " THROMBOCYTOPENIA 0/144 (0.00%)", " FEBRILE NEUTROPENIA 1/144 (0.69%)", " THROMBOTIC THROMBOCYTOPENIC PURPURA 1/144 (0.69%)", " DISSEMINATED INTRAVASCULAR COAGULATION 1/144 (0.69%)", " CARDIAC FAILURE 0/144 (0.00%)", " ATRIAL FIBRILLATION 0/144 (0.00%)" ]

[ "Adverse Events 1:", " Total: 22/79 (27.85%)", " Anaemia 0/79 (0.00%)", " Right ventricular dysfunction 1/79 (1.27%)", " Diarrhoea 1/79 (1.27%)", " Vomiting 2/79 (2.53%)", " Abdominal pain 0/79 (0.00%)", " Colonic obstruction 0/79 (0.00%)", " Dysphagia 1/79 (1.27%)", " Nausea 1/79 (1.27%)", " Mucosal inflammation 1/79 (1.27%)", " Performance status decreased 1/79 (1.27%)", " Sudden death 1/79 (1.27%)", "Adverse Events 2:", " Total: 13/76 (17.11%)", " Anaemia 1/76 (1.32%)", " Right ventricular dysfunction 0/76 (0.00%)", " Diarrhoea 0/76 (0.00%)", " Vomiting 2/76 (2.63%)", " Abdominal pain 1/76 (1.32%)", " Colonic obstruction 1/76 (1.32%)", " Dysphagia 0/76 (0.00%)", " Nausea 1/76 (1.32%)", " Mucosal inflammation 0/76 (0.00%)", " Performance status decreased 0/76 (0.00%)", " Sudden death 0/76 (0.00%)" ]

[ "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" ]

[ "Outcome Measurement: ", " Number of Participants With Objective Response Based on Data Review Committee's Assessment", " Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST). CR is defined as disappearance of all target and non-target lesions. PR is defined as 30% decrease in sum of the longest dimensions (LDs) of the target lesions taking as reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat evaluation 4 weeks after initial documentation of response.", " Time frame: Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8.", "Results 1: ", " Arm/Group Title: SUNITINIB+CAPECITABINE", " Arm/Group Description: Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.", " Overall Number of Participants Analyzed: 63", " Measure Type: Number", " Unit of Measure: participants Total Number of Participants with CR+PR: 19", " Complete Response (CR): 0", " Partial Response (PR): 19" ]

[ "DISEASE CHARACTERISTICS:", " Previously diagnosed with primary breast cancer", " Must have received 4½ - 6 years of aromatase inhibitor therapy (e.g., letrozole, anastrozole, or exemestane), either as initial therapy or after prior tamoxifen citrate, including treatment received as part of clinical trial CAN-NCIC-MA17", " Completed aromatase inhibitor therapy 2 years ago", " No metastatic or recurrent disease, contralateral breast cancer, or ductal carcinoma in situ in either breast, as determined by the following:", " Clinical examination of the breast area, axillae, and neck within the past 60 days", " Mammogram within the past 12 months*", " Chest x-ray within the past 60 days", " Bone scan, if alkaline phosphatase > 2 times normal and/or there are symptoms of metastatic disease AND confirmatory x-ray, if bone scan results are questionable, within the past 60 days", " Abdominal ultrasound, liver scan, or CT scan of the abdomen within the past 60 days, if ALT, AST, or alkaline phosphatase > 2 times normal NOTE: *A baseline mammogram is not required for patients who have undergone bilateral complete mastectomy", " Hormone-receptor status:", " Estrogen receptor positive (ER+) and/or progesterone receptor positive (PR+) primary tumor at the time of diagnosis, defined as a tumor receptor content of > 10 fmol/mg protein or receptor positive by immunocytochemical assay (for patients not previously enrolled on clinical trial CAN-NCIC-MA17)", " ER+ and/or PR+ primary tumor OR hormone receptor status of primary tumor unknown (for patients previously enrolled on clinical trial CAN-NCIC-MA17)", " PATIENT CHARACTERISTICS:", " Menopausal status not specified", " ECOG performance status 0-2", " Life expectancy 5 years", " WBC > 3.0 x 10^9/L OR granulocyte count (polymorphs + bands) 1.5 times 10^9/L", " Platelet count > 100 x 10^9/L", " AST and/or ALT < 2 times upper limit of normal (ULN)*", " Alkaline phosphatase < 2 times ULN*", " Able (i.e. sufficiently fluent) and willing to complete quality-of-life questionnaires in either English or French (NCIC CTG participating centers)", " Inability to complete questionnaires due to illiteracy in English or French, loss of sight, or other equivalent reason allowed", " Accessible for treatment and follow-up", " No other prior or concurrent malignancy except adequately treated, superficial squamous cell or basal cell skin cancer, carcinoma in situ of the cervix, or other cancer treated > 5 years ago that is presumed cured NOTE: *Elevated levels allowed provided imaging examinations have ruled out metastatic disease", " PRIOR CONCURRENT THERAPY:", " See Disease Characteristics", " No concurrent selective estrogen receptor modulator (e.g., raloxifene, idoxifene)", " No other concurrent anticancer therapy" ]

[ "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%)" ]

[ "Inclusion Criteria", " Patients diagnosed with metastatic breast cancer", " Patients that either have received previous treatment with anthracyclines and/or taxanes or not (either as advance or in metastatic disease).", " The patient is ambulatory with a functional ECOG < 2 status (see Appendix 2).", " Patient presents, at least one lesion measurable according to RECIST criteria (see Appendix 3)", " Patients with a life expectancy of at least 3 months.", " Patients that agree to and are able to fulfill the requirements of the whole protocol through the whole study.", "Exclusion criteria:", " Patients that have previously shown unexpected severe reactions to therapy with fluoropyrimidines or with a known sensitivity to 5-fluorouracile.", " Patients previously treated with capecitabine.", " Patients with organ transplants.", " Other diseases or severe affections:", " Patients with previous convulsions, central nervous system diseases or psychiatric diseases, including dementia, that the investigator might consider clinically significant and which adversely affect therapeutic compliance.", " Patients with severe intellectual impairment, unable to carry out basic daily routines and established depression.", " Clinical significant cardiac disease (e. g. . congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmia not fully controlled with medication) or myocardial infarction within the last 12 months.", " Severe renal impairment (baseline creatinine clearance < 30 ml/min)", " Patients with signs of metastasis in the CNS. Patients with a history of uncontrolled convulsions, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug intake should be excluded.", " Patients with an active infection.", " Patients with a history of other neoplasias during the previous five years, except for basal cell skin cancer or cervical cancer in situ, both cured.", " Patients showing the following laboratory values:", " Neutrophil count < 555 x 109/l", " Platelet count< 100 x 109/l", " Serum creatinine > 1,5 x upper normality limit", " seric bilirubin > 2,0 x upper normality limit", " ALAT, ASAT > 2,5 x upper normality limit or > 5 x upper normality limit in case of liver metastases", " Alkaline phosphatase > 2,5 x upper normality limit > 5 x upper normality limit in case of liver metastases o > 10 x upper normality limit in case of bone metastases.", " Patients under radiotherapy four weeks prior to the initiation of the study treatment, or under previous radiotherapy on the marker lesions be measured during the study (new marker lesions that appear in previously irradiated areas are accepted) or patients who are receiving programmed radiotherapy.", " Patients under major surgery within 4 weeks prior to study treatment or who have not completely recovered from the effects of major surgery.", " Patients who lack upper gastrointestinal tract physical integrity or with malabsorption syndrome.", " Patients who have received more than two cycles of chemotherapy for the metastatic disease.", " Patients Her2 + per FISH ó +++ Immunohistochemistry" ]

[ "Inclusion Criteria:", " Estrogen receptor or progesterone receptor positive breast cancer", " Premenopausal with regular menstrual cycles", "Exclusion Criteria:", " Current oral contraceptives" ]

[ "Outcome Measurement: ", " Overall Response Rate (ORR)", " ORR was defined as the percentage of participants achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.", " Time frame: Disease was evaluated radiologically at baseline and every 9 weeks on treatment; Maximum treatment duration was 38 cycles/26 months (Cohort 1) and 17 cycles/12 months (Cohort 2)", "Results 1: ", " Arm/Group Title: Cohort 1: HR+/HER2-", " Arm/Group Description: Eribulin: 1.4 mg/m2 administered intravenously over 2-5 minutes on days 1 and 8 of each 21 day cycle", " Participants remained on single agent eribulin until disease progression or withdrawal for other reasons.", " Overall Number of Participants Analyzed: 45", " Measure Type: Number", " Unit of Measure: percentage of participants 35.6 (24 to 49)", "Results 2: ", " Arm/Group Title: Cohort 2: TNBC", " Arm/Group Description: Eribulin: 1.4 mg/m2 administered intravenously over 2-5 minutes on days 1 and 8 of each 21 day cycle", " Participants remained on single agent eribulin until disease progression or withdrawal for other reasons.", " Overall Number of Participants Analyzed: 38", " Measure Type: Number", " Unit of Measure: percentage of participants 13.2 (5 to 26)" ]

[ "Adverse Events 1:", " Total: 14/81 (17.28%)", " Neutropenia1/81 (1.23%)", " Cataract1/81 (1.23%)", " Ascites1/81 (1.23%)", " Gastritis Hemorrhagic1/81 (1.23%)", " Nausea1/81 (1.23%)", " Stomatitis2/81 (2.47%)", " Malaise1/81 (1.23%)", " Oedema1/81 (1.23%)", " Pain1/81 (1.23%)", " Pyrexia1/81 (1.23%)", " Infection2/81 (2.47%)", " Upper Limb Fracture1/81 (1.23%)", " Dehydration1/81 (1.23%)", " Hypercalcemia1/81 (1.23%)" ]

[ "Adverse Events 1:", " Total: 127/368 (34.51%)", " ANAEMIA 3/368 (0.82%)", " LEUKOPENIA 0/368 (0.00%)", " NEUTROPENIA 0/368 (0.00%)", " COAGULOPATHY 3/368 (0.82%)", " LYMPHADENOPATHY 0/368 (0.00%)", " THROMBOCYTOPENIA 2/368 (0.54%)", " BONE MARROW FAILURE 0/368 (0.00%)", " FEBRILE NEUTROPENIA 4/368 (1.09%)", " DISSEMINATED INTRAVASCULAR COAGULATION 0/368 (0.00%)", " ATRIAL FLUTTER 0/368 (0.00%)", " CARDIAC ARREST 0/368 (0.00%)", "Adverse Events 2:", " Total: 151/369 (40.92%)", " ANAEMIA 11/369 (2.98%)", " LEUKOPENIA 6/369 (1.63%)", " NEUTROPENIA 18/369 (4.88%)", " COAGULOPATHY 0/369 (0.00%)", " LYMPHADENOPATHY 1/369 (0.27%)", " THROMBOCYTOPENIA 7/369 (1.90%)", " BONE MARROW FAILURE 1/369 (0.27%)", " FEBRILE NEUTROPENIA 15/369 (4.07%)", " DISSEMINATED INTRAVASCULAR COAGULATION 1/369 (0.27%)", " ATRIAL FLUTTER 1/369 (0.27%)", " CARDIAC ARREST 1/369 (0.27%)" ]

[ "Adverse Events 1:", " Total: 47/254 (18.50%)", " Anaemia 1/254 (0.39%)", " Febrile neutropenia 1/254 (0.39%)", " Lymphadenopathy 1/254 (0.39%)", " Acute myocardial infarction 1/254 (0.39%)", " Angina pectoris 0/254 (0.00%)", " Angina unstable 0/254 (0.00%)", " Bundle branch block left 0/254 (0.00%)", " Cardiac failure 4/254 (1.57%)", " Coronary artery disease 0/254 (0.00%)", " Coronary artery stenosis 1/254 (0.39%)", "Adverse Events 2:", " Total: 56/269 (20.82%)", " Anaemia 1/269 (0.37%)", " Febrile neutropenia 0/269 (0.00%)", " Lymphadenopathy 0/269 (0.00%)", " Acute myocardial infarction 0/269 (0.00%)", " Angina pectoris 3/269 (1.12%)", " Angina unstable 1/269 (0.37%)", " Bundle branch block left 1/269 (0.37%)", " Cardiac failure 1/269 (0.37%)", " Coronary artery disease 1/269 (0.37%)", " Coronary artery stenosis 0/269 (0.00%)" ]

[ "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" ]

[ "INTERVENTION 1: ", " PD-0332991 100 mg: Dose Escalation Cohort", " 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.", "INTERVENTION 2: ", " PD-0332991 125 mg: Dose Escalation Cohort", " 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." ]

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

[ "INTERVENTION 1: ", " CMRM vs UMRM", "[Not Specified]" ]

[ "INTERVENTION 1: ", " A: Exemestane", " ARM A: Patients will be treated with exemestane.", " Exemestane: 25 mg daily by mouth for 6 to 12 months.", "INTERVENTION 2: ", " B: Docetaxel and Cytoxan", " ARM B: Patients will be treated with docetaxel and cytoxan.", " Docetaxel: Docetaxel (75 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).", " Cytoxan: Cytoxan (600 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks)." ]

[ "Adverse Events 1:", " Total: 128/425 (30.12%)", " Febrile neutropenia *2/425 (0.47%)", " Anaemia *2/425 (0.47%)", " Pancytopenia *2/425 (0.47%)", " Coagulopathy *1/425 (0.24%)", " Idiopathic thrombocytopenic purpura *0/425 (0.00%)", " Microangiopathic haemolytic anaemia *1/425 (0.24%)", " Neutropenia *0/425 (0.00%)", " Pericardial effusion *1/425 (0.24%)", " Acute coronary syndrome *1/425 (0.24%)", "Adverse Events 2:", " Total: 129/406 (31.77%)", " Febrile neutropenia *6/406 (1.48%)", " Anaemia *0/406 (0.00%)", " Pancytopenia *0/406 (0.00%)", " Coagulopathy *0/406 (0.00%)", " Idiopathic thrombocytopenic purpura *1/406 (0.25%)", " Microangiopathic haemolytic anaemia *0/406 (0.00%)", " Neutropenia *1/406 (0.25%)", " Pericardial effusion *1/406 (0.25%)", " Acute coronary syndrome *0/406 (0.00%)" ]

[ "Inclusion Criteria:", " History of biopsy-proven HER-2-overexpressing breast cancer and radiographic evidence of metastatic disease. The HER-2 status can be determined either by immunohistochemistry (score, 3+) or by fluorescence in situ hybridization.", " History of trastuzumab resistance, defined as the development of progressive disease after trastuzumab-based therapy for metastatic breast cancer. Patient may not have received more than 2 prior trastuzumab-based regimens and one lapatinib-based regimen (either as single agent or in combination with chemotherapy)for metastatic breast cancer. Patients who develop metastatic disease during or after adjuvant or neoadjuvant trastuzumab are eligible.", " Performance status 0-2 (by Eastern Cooperative Oncology Group (ECOG) scale).", " Absolute neutrophil count (ANC) 1500/µl or higher; Platelets 100,000/µl or higher; Hemoglobin 9.0 gm/dL or higher; Serum creatinine 2.0 mg/dL or lower; Total bilirubin 1.5 mg/dL or lower; Serum glutamic pyruvic transaminase (SGPT) up to 3* upper limit of normal; Alkaline phosphatase up to 3* upper limit of normal; Calcium 11.0 mg/dL or lower.", " Age 18 years or older.", " Patients must not be pregnant. A pregnancy test will be obtained if the patient is a woman of child-bearing potential, defined as a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months (i.e., who has had menses at any time in the preceding 24 consecutive months).", " Patients must have signed an informed consent document stating that they understand the investigational nature of the proposed treatment.", " Patients must have measurable disease using Response Evaluation Criteria in Solid Tumors (RECIST). Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension with longest diameter >/= 20 mm using conventional techniques or >/= 10 mm with spiral computed tomography (CT) scan.", " Patients may not be receiving any other investigational agents, and must not have received investigational agents within 15 days of enrollment.", " Left ventricular ejection fraction determined by echocardiogram or multigated acquisition (MUGA) (cardiac scan) must be 50% or higher.", "Exclusion Criteria:", " 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", " Prior treatment with any investigational drug within the preceding 15 days", " Chronic treatment with systemic steroids or another immunosuppressive agent", " Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases, and patients diagnosed with brain mets or leptomeningeal disease (LMD) within 3 months.", " Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin.", " A known history of HIV seropositivity", " Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)", " Patients with an active, bleeding diathesis or on oral anti-vitamin K medication (except low dose coumadin)", " Patients who have received prior treatment with an mTor inhibitor.", " History of noncompliance to medical regimens.", " Patients unwilling to or unable to comply with the protocol.", " Patients who are receiving any other investigational agents", " Patients exhibiting confusion, disorientation, or having a history of major psychiatric illness that may impair the understanding of the informed consent." ]

[ "DISEASE CHARACTERISTICS:", " History of histologically confirmed breast cancer, meeting 1 of the following staging criteria:", " Ductal carcinoma in situ", " Stage I-III invasive breast cancer", " At least 3 months since completion of all intended local and systemic therapy, including mastectomy or lumpectomy with or without radiotherapy, adjuvant chemotherapy, and/or endocrine therapy", " May have declined recommended treatment provided all treatment intended/agreed upon by the patient and treating physician was completed 3 months ago", " At least 1 healthy intact breast", " No prior radiotherapy or mastectomy", " Prior biopsies allowed", " Any hormone-receptor status", " PATIENT CHARACTERISTICS:", " Female", " Pre- or post-menopausal", " ECOG performance status 0-2", " Not pregnant or nursing", " Negative pregnancy test", " Fertile patients must use effective nonhormonal contraception", " No active liver disease", " AST and ALT 3 times upper limit of normal", " Creatinine clearance 30 mL/min", " No prior hypersensitivity to any 3-hydroxyl-3-methylglutaryl-Coenzyme A (HMG-CoA) reductase inhibitor or any of its components", " No other concurrent infectious, inflammatory, or autoimmune diseases (at the discretion of principal investigator)", " PRIOR CONCURRENT THERAPY:", " See Disease Characteristics", " No daily alcohol use > 3 standard drinks per day", " Standard drink defined as 10 grams of alcohol, which is equivalent to 285 mL of beer, 530 mL of light beer, 100 mL of wine, or 30 mL of liquor", " No selective estrogen receptor modulator or aromatase inhibitor within the past 3 months", " No hormone replacement therapy (HRT) within the past 3 months", " No prior estrogen and/or progesterone HRT 5 years in duration", " Vaginal estrogen preparations allowed", " No concurrent HRT", " No other cholesterol-lowering drug, including a statin, within the past 3 months", " No concurrent itraconazole, ketoconazole, nefazodone, cyclosporine, HIV protease inhibitors, clarithromycin, erythromycin, mibefradil, carbamazepine, bosentan, chaparral, amiodarone, or verapamil", " No concurrent daily grapefruit juice consumption > 8 ounces per day", " No other concurrent agents or therapies intended to treat or prevent in situ or invasive breast cancer" ]

[ "DISEASE CHARACTERISTICS:", " Histologically confirmed invasive mammary carcinoma", " Stage IV disease", " Basal-like disease (triple-negative, hormone-refractory, HER2-negative)", " No locally recurrent breast cancer", " No symptomatic brain metastases", " Patients with a history of brain metastases are eligible provided they are clinically stable for > 3 weeks after completion of radiotherapy and are not taking steroids or therapeutic anticonvulsants that are cytochrome P450 3A4 (CYP3A4) modifiers", " Patients with asymptomatic brain metastases are eligible provided they are not taking prophylactic anticonvulsants that are CYP3A4 modifiers", " PATIENT CHARACTERISTICS:", " Pre- or post-menopausal", " European Cooperative Oncology Group (ECOG) performance status 0-1", " Life expectancy 6 months", " Absolute neutrophil count (ANC) 1,000/mm^3", " Platelet count 100,000/mm^3", " Creatinine 1.5 times upper limit of normal (ULN)", " Total bilirubin 1.5 times ULN ( 3 times ULN in the presence of liver metastasis)", " Direct bilirubin will be measured in patients with Gilbert syndrome", " serum glutamate oxaloacetate transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) 1.5 times ULN ( 3 times ULN in the presence of liver metastasis)", " Alkaline phosphatase 3 times ULN (in the presence of liver metastasis)", " Not pregnant or nursing", " Negative pregnancy test", " Fertile patients must use effective barrier contraception during and for 3 months after completion of study treatment", " Able to swallow and retain oral medication", " No malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel", " No concurrent uncontrolled illness including, but not limited to, any of the following:", " Ongoing or active infection requiring parenteral antibiotics", " Impaired lung function (chronic obstructive pulmonary disease or lung conditions requiring oxygen therapy)", " New York Heart Association class III-IV congestive heart failure", " Unstable angina pectoris, angioplasty, stenting, or myocardial infarction within the past 6 months", " Uncontrolled hypertension (systolic BP > 180 mm Hg or diastolic BP > 100 mm Hg, found on 2 consecutive measurements separated by a 1-week period and despite adequate medical support)", " Clinically significant cardiac arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia that is symptomatic or requires treatment [grade 3 according to NCI Common Toxicity Criteria for Adverse Events v3.0])", " Uncontrolled diabetes (hyperosmolar state, ketoacidosis, etc.)", " Psychiatric illness or social situations that would compromise patient safety or limit compliance with study requirements including maintenance of a compliance/pill diary", " No symptomatic neuropathy grade 2", " No other invasive cancer within the past 5 years except for completely resected basal cell or squamous cell carcinoma of the skin or successfully treated cervical carcinoma in situ", " No hypersensitivity to paclitaxel or drugs using the vehicle Cremophor, Chinese hamster ovary cell products, or other recombinant human antibodies", " No history of hepatitis B or C", " PRIOR CONCURRENT THERAPY:", " See Disease Characteristics", " Recovered from prior therapy", " Prior total cumulative life-time dose of doxorubicin 360 mg/m^2 or epirubicin 640 mg/m^2", " No more than 4 prior chemotherapy treatments in the metastatic setting (not including endocrine therapy or single-agent biologic therapy)", " At least 2 weeks since prior investigational drugs", " At least 14 days since prior and no concurrent herbal or dietary supplements", " At least 14 days since prior and no concurrent CYP3A4 inducers", " At least 7 days since prior and no concurrent CYP3A4 inhibitors", " Concurrent radiotherapy to painful bone metastases or areas of impending bone fracture allowed provided radiotherapy is initiated before study entry", " No other concurrent anticancer therapy (chemotherapy, radiotherapy, surgery, immunotherapy, hormonal therapy, biologic therapy)" ]

[ "Adverse Events 1:", " Total: 5/32 (15.63%)", " Leukopenia 1/32 (3.13%)", " Neutropenia 1/32 (3.13%)", " Cataract 1/32 (3.13%)", " Infection 1/32 (3.13%)", " Upper respiratory tract infection 1/32 (3.13%)", " Completed suicide 1/32 (3.13%)" ]

[ "Adverse Events 1:", " Total: 4/6 (66.67%)", " Anemia 0/6 (0.00%)", " Takotsubo cardiomyopathy 1/6 (16.67%)", " Pericardial effusion 0/6 (0.00%)", " Vertigo 1/6 (16.67%)", " Retinal vein occlusion 0/6 (0.00%)", " Gastroenteritis 1/6 (16.67%)", " Vomiting 1/6 (16.67%)", " Diarrhea 0/6 (0.00%)", " Death 2/6 (33.33%)", " Bile duct dilatation 0/6 (0.00%)", " Hepatic hemorrhage 0/6 (0.00%)", "Adverse Events 2:", " Total: 25/52 (48.08%)", " Anemia 1/52 (1.92%)", " Takotsubo cardiomyopathy 0/52 (0.00%)", " Pericardial effusion 2/52 (3.85%)", " Vertigo 0/52 (0.00%)", " Retinal vein occlusion 1/52 (1.92%)", " Gastroenteritis 0/52 (0.00%)", " Vomiting 0/52 (0.00%)", " Diarrhea 1/52 (1.92%)", " Death 9/52 (17.31%)", " Bile duct dilatation 1/52 (1.92%)", " Hepatic hemorrhage 1/52 (1.92%)" ]

[ "Inclusion Criteria:", " Participant is willing and able to give informed consent for participation in the study;", " Female, aged 18 years or above;", " Diagnosed with breast cancer (invasive or dcis);", " Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study;", " Undergoing mastectomy breast surgery.", "Exclusion Criteria:", " Patients with a Pacemaker or implanted device;", " Patients requiring an MRI scan prior to surgery;", " Patients with known coagulopathy or receiving anticoagulant medication including warfarin, heparin, clopidogrel or rivaroxaban;", " Patients receiving Neoadjuvant chemotherapy;", " Patients who are pregnant or lactating;", " Patients scheduled for immediate breast reconstruction;", " Patients who have received Sienna (iron oxide) injection in the previous six months;", " Patients with an existing breast haematoma close to the target lesion." ]

[ "Inclusion Criteria:", " Self-identified Black, African or African American women of 18 years of age with proven diagnosis of advanced adenocarcinoma of the breast (locoregionally recurrent or metastatic disease)", " ER-positive and/or PgR-positive tumor based on local laboratory results", " HER2-negative breast cancer based on local laboratory results (test to be used as per local practice)", " Patients must be appropriate candidates for letrozole or fulvestrant therapy", " Eastern Cooperative Oncology Group (ECOG) performance status 0-2", " Adequate bone marrow function:", " Absolute Neutrophil Count (ANC) 1,000/mm3 (1.0 x 109/L);", " Platelets 100,000/mm3 (100 x 109/L);", " Hemoglobin 9 g/dL (90 g/L).", "Exclusion Criteria:", " Current use of food or drugs known to be potent inhibitors or inducers of CYP3A4", " Active uncontrolled or symptomatic brain metastases. Previously treated and clinically stable, as per Investigator's judgment, brain metastases are permitted.", " Previous CDK4/6 inhibitor", "-" ]

[ "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" ]

[ "Inclusion Criteria:", " Women at any age with early stage breast cancer (stage I-II) and American Society of Anesthesiologists (ASA) score of I-II.", "Exclusion Criteria:", " Ductal carcinoma in situ (DCIS; stage 0 cancer),", " Advanced or distant metastatic stage,", " Receiving any neoadjuvant therapy,", " History of receiving any antibiotics within prior 3 months,", " History of immunodeficiency,", " Having a remote infection,", " History of reaction to study antibiotics,", " Denial of signing the consent form." ]

[ "Inclusion Criteria:", " Age 18 years", " Stage 1-4 invasive breast cancer that is histologically confirmed at MSKCC", " Status post mastectomy with axillary exploration (sentinel node biopsy and/or axillary lymph node dissection) to receive PMRT", " ECOG Performance Status of 0 or 1", "Exclusion Criteria:", " Male", " Patients with clinical evidence of gross disease", " Patients who are pregnant or breastfeeding", " Prior radiation therapy to the ipsilateral chest wall or thorax", " Patients requiring a chest wall boost", " Concurrent chemotherapy (biologic agents are allowed)", " Psychiatric illness that would prevent the patient from giving informed consent", " Inability or unwillingness to comply with skin care instructions and follow-up", " Allergy to either Eucerin or MF", " Residual grade >1 skin toxicity, cellulitis, or incompletely healed wound(s) at intended site of study drug application at the time of the start of RT", " Medical condition such as uncontrolled infection (including HIV), uncontrolled diabetes mellitus, or connective tissue diseases (lupus, systemic sclerosis, or other collagen vascular diseases)", " Treatment with palliative or pre-operative radiation" ]

[ "Adverse Events 1:", " Total: 80/260 (30.77%)", " Anaemia * 2/260 (0.77%)", " Febrile neutropenia * 0/260 (0.00%)", " Neutropenia * 2/260 (0.77%)", " Thrombocytopenia * 0/260 (0.00%)", " Bundle branch block right * 0/260 (0.00%)", " Pericardial effusion * 0/260 (0.00%)", " Cardiopulmonary failure * 0/260 (0.00%)", " Aplasia * 0/260 (0.00%)", " Eye symptom * 1/260 (0.38%)", " Abdominal discomfort * 0/260 (0.00%)", "Adverse Events 2:", " Total: 71/267 (26.59%)", " Anaemia * 2/267 (0.75%)", " Febrile neutropenia * 1/267 (0.37%)", " Neutropenia * 0/267 (0.00%)", " Thrombocytopenia * 1/267 (0.37%)", " Bundle branch block right * 1/267 (0.37%)", " Pericardial effusion * 5/267 (1.87%)", " Cardiopulmonary failure * 1/267 (0.37%)", " Aplasia * 1/267 (0.37%)", " Eye symptom * 0/267 (0.00%)", " Abdominal discomfort * 1/267 (0.37%)" ]

[ "Adverse Events 1:", " Total: 13/74 (17.57%)", " neutropenia 1/74 (1.35%)", " left ventricular dysfunction 1/74 (1.35%)", " fistula enterovesical 1/74 (1.35%)", " constipation and hypokalemia 1/74 (1.35%)", " nausea, vomiting and burning abdominal pain 2/74 (2.70%)", " Infection 1/74 (1.35%)", " febrile neutropenia 3/74 (4.05%)", " speech impairment 1/74 (1.35%)", " dyspnea, pain 1/74 (1.35%)", " hemorrhage/bleeding 2/74 (2.70%)" ]

[ "Inclusion Criteria:", " Patients must be able and willing to give written informed consent prior to any study related procedures", " Ambulatory, female patients with an age 18 years", " Patients with histologically or cytologically proven diagnosis of breast cancer who are eligible for neoadjuvant or adjuvant chemotherapy.", " Patients who are planned and eligible to receive/ receiving myelosuppressive chemotherapy regimen that contains at least one chemotherapeutic agent from docetaxel/ paclitaxel / doxorubicin/ cyclophosphamide/ epirubicin", " Patients who have not received any hematopoietic growth factors (e.g. G-CSF, PegGCSF, erythropoietin) or cytokines (e.g. interleukins, interferons) anytime in the past", " Patients with baseline WBC LLN/ 3.5 x 109/L, ANC of 1.5 x 109/L, platelet count 100 x 109/L and hemoglobin 8.5 g/dL", " Patients with ECOG Performance status of 2", " Patient who have estimated life expectancy of more than six months", " No evidences of hemorrhage", "Exclusion Criteria:", " 1 Male patients", " 2. Hypersensitivity to any of the study drugs or its components like E.coli proteins or similar product", " 3. Patients weighing <45 Kg", " 4. Patients with myeloid malignancies and myelodysplasia or evidence of metastatic disease in bone marrow or brain", " 5. Patients currently receiving radiation therapy or have completed radiation therapy within 4 weeks before study entry or likely to receive radiotherapy during the study", " 6. Patients with prior bone marrow or stem cell transplantation", " 7. Patients with chronic use of oral corticosteroids (Except 20 mg/day dose of prednisolone/ equivalent steroids), immunotherapy, monoclonal antibody therapy and/or biological therapy or use of any other pegylated drug.", " 8. Patients with history of systemic antibiotic use within 72 hours prior to chemotherapy", " 9. Patients with any active infection which may require systemic antimicrobial therapy. Patients with inadequate hepatic and renal function [defined as Alkaline Phosphatase > 2.5 X Upper limits of normal (ULN), serum SGOT > 2.5 X ULN, SGPT > 2.5 X ULN, Total bilirubin > 1.5 X ULN and Creatinine > 1.5 X ULN of the reference range at the screening assessment]", " 10. Patients with seropositivity for HIV or HBV or HCV", " 11. Known cases of Sickle Cell Anemia", " 12. Patients with radiographic evidence of active pulmonary infections and/or recent history of pneumonia within 1 month of screening", " 13. Patients with clinically evident splenomegaly confirmed subsequently by ultrasonography", " 14. Patients with any other clinically significant disease(s) which, in the opinion of the investigator, could compromise the patient's involvement in the study or overall interpretation of the data. [for e.g. uncontrolled hematologic, renal, hepatic, endocrine, neurologic, psychiatric, metabolic, pulmonary, cardiovascular disease/impaired functioning or history of any autoimmune disease]", " 15. Patients who have participated in another therapeutic clinical study within the past 30 days prior to screening, or are likely to simultaneously participate in another therapeutic clinical study", " 16. Patients who are doubtful to comply with study procedures for mental, psychological or social reasons.", " 17. Women of child-bearing potential who are not willing to follow a reliable & effective contraceptive measure during the course of the study & at least 3 months after the last dose of study drug.", " 18. Pregnant and Breast feeding women." ]

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

[ "INTERVENTION 1: ", " All Study Participants, PA Compression Image Sets", " All image sets (30 patient-assisted compression image sets) were evaluated for acceptability of overall clinical image quality by two (2) readers.", "INTERVENTION 2: ", " All Study Participants, TC Compression Image Sets", " All image sets (30 TC compression image sets) were evaluated for acceptability of overall clinical image quality by two (2) readers." ]

[ "Outcome Measurement: ", " Incidence of Treatment-emergent AE's", " [Not Specified]", " Time frame: 2 years", "Results 1: ", " Arm/Group Title: MM-111 + Herceptin", " Arm/Group Description: MM-111 will be combined with Herceptin", " MM-111 and Herceptin: For Phase 1: Dose escalation cohorts, MM-111 and Herceptin are administered weekly or bi-weekly via IV", " Overall Number of Participants Analyzed: 16", " Measure Type: Number", " Unit of Measure: participants 16" ]

[ "Outcome Measurement: ", " Number of Participants With Trastuzumab-Induced Cardiotoxicity After 52 Weeks of Treatment", " Reduction in incidence of trastuzumab-induced cardiotoxicity after 52 weeks of treatment as measured by preservation of Left Ventricular Ejection Fraction (LVEF). Number of Patients who experienced a cardiotoxicity.", " Time frame: 2 years", "Results 1: ", " Arm/Group Title: Arm I Lisinopril", " Arm/Group Description: Patients receive oral lisinopril once daily.", " lisinopril: Given orally", " Overall Number of Participants Analyzed: 152", " Measure Type: Count of Participants", " Unit of Measure: Participants 45 29.6%", "Results 2: ", " Arm/Group Title: Arm II Coreg CR ", " Arm/Group Description: Patients receive oral Coreg CR once daily.", " Coreg CR : Given orally", " Overall Number of Participants Analyzed: 147", " Measure Type: Count of Participants", " Unit of Measure: Participants 43 29.3%" ]

[ "Inclusion Criteria:", " Women 18-75 years old with newly diagnosed breast cancer who are considered candidates for breast conserving surgery (i.e. lumpectomy).", "Exclusion Criteria:", " Children (<18 years old)", " Pregnant or Lactating women", " Diabetic patients (Type I or II)", " Patients who are scheduled for a sentinel node procedure using radioactive Tc-99m within 24 hours of PEM", " Patients who have NOT undergone a standard of care bilateral breast MRI at UC." ]

[ "INTERVENTION 1: ", " Vorinostat +Trastuzumab", " Trastuzumab: 6 mg/kg once on Day 1, infused over 90 minutes, every 3 weeks;", " Vorinostat 200 mg of SAHA orally twice a day, daily for 14 days out of a 21-day cycle" ]

[ "INTERVENTION 1: ", " Cohort 1: Eribulin Mesylate With Filgrastim as Needed", " Participants initially received doxorubicin (60 mg/m^2) plus cyclophosphamide (600 mg/m^2) intravenously (IV) on Day 1, of every 14-day cycle for 4 cycles. Eribulin mesylate was administered following the doxorubicin plus cyclophosphamide regimen at a dose of 1.4 mg/m^2 IV over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle for 4 cycles (Cycles 5 to 8). In this Cohort growth factors, subcutaneous pegfilgrastim (6 mg) or filgrastim, could be used with eribulin therapy at the physician's discretion if neutropenia occurred that recovered to Grade 2.", "INTERVENTION 2: ", " Cohort 2: Eribulin Mesylate With Prophylactic Filgrastim", " Participants initially received doxorubicin (60 mg/m^2) plus cyclophosphamide (600 mg/m^2) IV on Day 1, of every 14-day cycle for 4 cycles. Eribulin mesylate was administered following the doxorubicin plus cyclophosphamide regimen at a dose of 1.4 mg/m^2 IV over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle for 4 cycles (Cycles 5 to 8). In this Cohort filgrastim was used with eribulin therapy at a dose of 300 micrograms for participants 60 kg or 480 micrograms for participants >60 kg, administered subcutaneously on Days 3 and 4 and Days 10 and 11 of each eribulin cycle." ]

[ "Inclusion Criteria:", " females, 18 or older", " recurrent or progressive locally advanced, or 'triple negative' metastatic breast cancer", " paraffin-embedded tissue block must be available", " measurable disease", " prior chemotherapy with an anthracycline, a taxane, or both (neoadjuvant, adjuvant, or metastatic setting)", " 0, 1 or 2 chemotherapies in the metastatic setting", " adequate organ function", "Exclusion Criteria:", " Metastatic disease confined to bone only", " Symptomatic CNS metastasis", " Concurrent medical condition which may increase the risk of toxicity", " Unable to take oral medication" ]

[ "Outcome Measurement: ", " Number of Participants (Par.) With Any Recurrence of the Initial Disease, Second Primary Cancer, Contralateral Breast Cancer, or Death (Disease-free Survival [DFS])", " DFS=interval between the date of randomization and the date of the first occurrence of an objective disease recurrence, a second primary cancer, or death from any cause. The date of the event is the earliest date of the occurrence of any of the following: local recurrence (LR) following mastectomy; LR in ipsilateral breast following lumpectomy; regional recurrence; distant recurrence; contralateral breast cancer, including ductal carcinoma in situ; other second primary cancer (excluding squamous or basal cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the cervix, or lobular carcinoma in situ of the breast); death from any cause without a prior event. Par. who started additional anti-cancer adjuvant therapy prior to the recurrence of their disease were to be censored. Par. who did not withdraw from the study and did not experience a specified event or death were to be censored (follow-up ongoing) at the last visit date available at which progression was assessed.", " Time frame: From randomization until date of the first occurrence of an objective disease recurrence, a second primary cancer, or death from any cause (assessed up to 6 years; 1 year of treatment, 5 years of follow-up [median of 5.3 years for final analysis])", "Results 1: ", " Arm/Group Title: Lapatinib 1500 mg", " Arm/Group Description: Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.", " Overall Number of Participants Analyzed: 1571", " Measure Type: Number", " Unit of Measure: Participants Any recurrence or death: 252", " Censored, New Anti-cancer Agent/Radiotherapy: 1", " Censored, Follow-up Ended: 1318", "Results 2: ", " Arm/Group Title: Placebo", " Arm/Group Description: Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.", " Overall Number of Participants Analyzed: 1576", " Measure Type: Number", " Unit of Measure: Participants Any recurrence or death: 290", " Censored, New Anti-cancer Agent/Radiotherapy: 1", " Censored, Follow-up Ended: 1285" ]

[ "Inclusion Criteria:", " A subject will be eligible for study participation if all of the following criteria are met at Screening:", " Is informed, has been given ample time and opportunity to read about participation in the study and has signed and dated the written informed consent form approved by an Independent Ethics committee (IEC) prior to any study related activities", " Females 18 years", " Histologically confirmed and documented invasive breast cancer", " Breast cancer without evidence of distant metastases (Stage 4) based on staging work-up", " Chemotherapy naive, who have not received chemotherapy in the neoadjuvant setting and who are candidates for chemotherapy in the adjuvant setting of taxane/cyclophosphamide-based regimen, e.g., TAC, as background chemotherapy", " Zubrod/WHO/ECOG performance status 2", " Adequate bone marrow, hepatic, and renal function reserve as evidenced by:", " Hemoglobin 10 mg/dl", " ANC 1.5 x 10^9/L", " Platelet count of 100 x 10^9/L", " Total bilirubin 2 mg/dl", " Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) 3 x the upper limit of normal (ULN) of the reference lab", " Serum creatinine of 1.5 x ULN for reference lab or estimated glomerular filtration rate (eGFR) of 60 mg/min", " Body mass index (BMI) of 19 to 40 kg/m^2 , inclusive", " Subjects of childbearing potential, and their partners, agree to pregnancy prevention throughout the duration of the study (through the Follow-up Visit). Specific type of pregnancy prevention should be discussed with, and acceptable to, the treating oncologist in the context of the tumoral hormone receptor status. Subjects and their partners must agree to use of an effective method of contraception, to avoid impregnation of females throughout the course of the study", " Medically acceptable forms of birth control can include, with approval of the treating physician:", " Barrier methods (condom or diaphragm with spermicide)", " Intrauterine device (IUD)", " Hormone contraceptives (such as oral [pill], injection, skin patch, implant, cervical ring)", " Subjects using oral contraceptives must be on a stable regimen for at least 3 months prior to Screening. Sexually active subjects must use contraception while on HSP-130 from admission to the final Follow-up Visit", " Able to understand verbal or written instructions and comply with all study requirements, to communicate effectively with study personnel and is available for the planned duration of the study", "Exclusion Criteria:", " A subject will NOT be eligible for study participation if any of the following criteria are met at Screening:", " Previous G-CSF exposure, including filgrastim, lenograstim, pegfilgrastim, lipegfilgrastim, granulocyte/macrophage colony stimulating growth factor (GM-CSF), or any other branded or biosimilar G-CSF", " Prior autologous stem cell harvest of any type", " Drug sensitivity, allergic reaction, or known hypersensitivity or idiosyncratic reaction to E. coli - derived proteins, filgrastim, other G-CSFs, or pegylated agents", " Known hypersensitivity to docetaxel, polysorbate 80, or doxorubicin", " For subjects receiving doxorubicin, no concurrent use of inhibitors and inducers of CYP3A4, CYP2D6, and/or P-gp or with trastuzumab due to increased risk of cardiac dysfunction", " Chemotherapy other than that included in this study (taxane/cyclophosphamide-based regimen, e.g., TAC or TC) or neoadjuvant chemotherapy; or known immunosuppressive agents including chronic oral corticosteroid use, or radiation therapy within 4 weeks of first dose of HSP-130, prior bone marrow or stem cell transplantation, or malignancy within 5 years", " Known HER2 + ( overexpressing breast cancer)", " Known triple negative (estrogen receptor-negative, progesterone receptor-negative and HER2-negative) breast cancer", " Grade 2 underlying neuropathy", " Current diagnosis of active tuberculosis or other severe infection, such as sepsis, abscesses or opportunistic infections", " Treatment with systemically active antibiotics within 72 hours before chemotherapy", " Known infection with HIV", " Known sickle cell disease", " Known severe persistent drug-induced myelosuppression", " New York Heart Association (NYHA) class III or IV heart failure, severe uncontrolled cardiac disease (unstable angina, clinically significant ECG abnormalities) or MI within the previous 6 months before the first administration of HSP-130", " Any malignancy other than breast cancer, with exception of adequately treated squamous or basal cell carcinoma of the skin or cervical carcinoma in situ, within 5 years before the first administration of the HSP-130", " Current or recent treatment (within 30 days before the first administration of the HSP-130) with any other investigational medicinal product", " Pregnancy or lactation; Subjects planning to be pregnant or to breastfeed before, during, or within 12 months after administration of the HSP-130 are not permitted to enroll in the study", " Received a live, live-attenuated, or non-live vaccine within 4 weeks before the first administration of the HSP-130", " Patient has evidence of any other coexisting disease or medical or psychological condition, metabolic dysfunction, physical examination finding or clinical lab finding giving reasonable suspicion of a disease or condition that contraindicated the use of an HSP-130, or patient is high risk for treatment complication" ]

[ "Inclusion Criteria:", " Patients must have histologically-confirmed adenocarcinoma of the breast with operable or inoperable stage 1c (primary tumor > 1.0 cm), II or III disease.", " Measurable disease by physical examinations or diagnostic breast imaging (mammography, ultrasonography or MR).", " Pre-treatment core or incisional biopsy. Patients may not have had definitive primary surgery.", " Male or female, 18 years of age or older.", " ECOG performance status 0 or 1.", " Adequate organ function as defined in the protocol.", "Exclusion Criteria:", " Prior radiation therapy, cytotoxic therapy or systemic therapy for breast cancer. Prior use of tamoxifen or raloxifene as chemoprevention is allowed but must be discontinued prior to study entry.", " Metastatic (Stage IV) breast cancer", " Patients who have had only a pre-treatment fine needle aspiration (FNA) are excluded.", " Current therapeutic treatment on another clinical trial with an investigational agent.", " Any of the following within the 6 months prior to starting study treatment: -myocardial infarction -severe/unstable angina -coronary/peripheral artery bypass graft -congestive heart failure -cerebrovascular accident including transient ischemic attack -pulmonary embolus", " Ongoing cardiac dysrhythmias of NCI CTCAE grade >=2, atrial fibrillation of any grade, or QTc interval >450 msec for males or >470 msec for females.", " Hypertension that cannot be controlled by medications.", " Current treatment with therapeutic doses of any anti-coagulant. Prophylactic use of anticoagulants is allowed.", " Known human immunodeficiency virus (HIV) infection.", " Pregnancy or breastfeeding. All female patients with reproductive potential must have a negative pregnancy test prior to first day of study medication.", " Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study." ]

[ "Adverse Events 1:", " Total: 4/33 (12.12%)", " Diarrhea 1/33 (3.03%)", " Intracranial hemorrhage 1/33 (3.03%)", " Ischemia cerebrovascular 1/33 (3.03%)", " Confusion 1/33 (3.03%)", " Skin disorder 1/33 (3.03%)" ]

[ "Adverse Events 1:", " Total: 5/11 (45.45%)", " Nausea 1/11 (9.09%)", " Vomiting 1/11 (9.09%)", " Fever 1/11 (9.09%)", " skin infection [1]1/11 (9.09%)", " Hip fracture 0/11 (0.00%)", " Confusion 1/11 (9.09%)", "Adverse Events 2:", " Total: 1/12 (8.33%)", " Nausea 0/12 (0.00%)", " Vomiting 0/12 (0.00%)", " Fever 0/12 (0.00%)", " skin infection [1]0/12 (0.00%)", " Hip fracture 1/12 (8.33%)", " Confusion 0/12 (0.00%)" ]

[ "Inclusion Criteria:", " Female with a diagnosis of, non-inflammatory breast adenocarcinoma and be referred for post-operative radiotherapy without concurrent chemotherapy.", " Participants must be at least 21 years of age.", " Participants must not be pregnant.", " Participants can be from any racial or ethnic origin.", " Breast adenocarcinoma could have been treated by either lumpectomy or mastectomy with or without adjuvant or neoadjuvant chemotherapy or hormonal treatment.", " Participants with in situ breast cancer are eligible.", " Participants who are prescribed concurrent hormone treatment with radiation treatment are eligible.", " Participants must be scheduled to receive five sessions of radiation therapy per week (1 session per day) for at least four weeks using standard (1.8-2.0 Gy per session)or Canadian (2.2-2.5 Gy per session)irradiation fractionation.", " A time period of three weeks must elapse after chemotherapy and surgery before beginning the study.", " The total dose prescribed to the whole breast should be 50 Gy or greater.", " Participants must be able to understand English and able to complete assessment forms (all assessment forms are in English).", " Participants must be able to swallow medication.", " Topical skin agents, e.g., Aquaphor, Cetaphil, or other emollients, are allowed either PRN or prophylactically.", " Participant must give informed consent.", "Exclusion Criteria:", " Patients with bilateral breast cancer are not eligible.", " Patients who have had previous radiation therapy to the breast or chest are not eligible.", " Patients who are prescribed chemotherapy concurrently with radiation treatment are not eligible.", " Patients who will be receiving treatment with Herceptin (trastuzumab), anti-coagulants, or anti-human epidermal growth factor receptor (EGFR) drugs, e.g. Iressa (gefitinib), Erbitux (cetuximab, C225), concurrently with their radiation therapy are not eligible.", " Patients cannot have had breast reconstructions, implants, and/or expanders.", " Patients with known radiosensitivity syndromes (e.g., Ataxia-telangiectasia) are not eligible.", " Patients with collagen vascular disease, vasculitis, unhealed surgical sites, or breast infections are not eligible.", " Patients whose baseline blood tests meet the following criteria are not eligible: greater than or equal to Grade 2 change Hemoglobin (i.e., 25% decrease from baseline); greater than or equal to Grade 1 change in Platelets (i.e., less than 75,000/mm3); greater than or equal to Grade 2 change in PT and PTT(i.e., 1.5-2x upper level normal (ULN)); greater than or equal to Grade 1 change in AST, ALT (i.e., greater than 2.5x ULN); greater than or equal to Grade 1 change in Bilirubin (i.e., greater than 1.5x ULN); greater than or equal to Grade 1 change in Creatinine (i.e., greater than 2x ULN)." ]

[ "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." ]

[ "Outcome Measurement: ", " Number of Participants With Dose Limiting Toxicities (DLTs) Graded Using National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4.0 (NCI CTCAE v4.0)", " The following events, if considered to be study-treatment-related by the Investigator, were considered a DLT:", " Hematologic:", " Grade 4 neutropenia lasting 8 days;", " Febrile neutropenia Grade 3 or Grade 4; or", " Grade 4 thrombocytopenia requiring platelet transfusion, or Grade 3 thrombocytopenia with bleeding", " Non-hematologic:", " Grade 4 toxicity;", " Grade 3 symptomatic hepatic toxicities lasting >48 hours, or Grade 3 asymptomatic hepatic toxicities lasting 7 days; or", " Grade 3 non-hematologic, non-hepatic organ toxicity, with exceptions", " Other:", " Any treatment delays for 14 days due to unresolved toxicity;", " Grade 5 treatment-related adverse event (AE);", " A dose reduction of study treatment during the DLT evaluation period.", " Time frame: Cycle 1 Day 1 through end of Cycle 3 and Cycle 6 Day 1 through end of Cycle 7 (Up to ~150 days from first dose of first combination regimen); Each cycle was 21 days.", "Results 1: ", " Arm/Group Title: Cohort A: KNp / KAC", " Arm/Group Description: Participants received pembrolizumab (K) 200 mg on Cycle 1 Day 1 followed by pembrolizumab 200 mg in Cycles 2-5 on Day 1 (once every 3 weeks; Q3W) PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (once each week; QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via intravenous (IV) infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.", " Overall Number of Participants Analyzed: 10", " Measure Type: Count of Participants", " Unit of Measure: Participants 2 20.0%", "Results 2: ", " Arm/Group Title: Cohort B: KNpCb (Regimen 1) / KAC", " Arm/Group Description: Participants first received KNpCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 100 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at Area Under the Curve (AUC) 6 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.", " Overall Number of Participants Analyzed: 10", " Measure Type: Count of Participants", " Unit of Measure: Participants 4 40.0%" ]

[ "Outcome Measurement: ", " Progression Free Survival (PFS)", " PFS was defined as the time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments by RECIST, v1.1 or death on study (<=30 days after the last dose of study treatment regimen) from any cause, whichever occurred first.", " Time frame: Baseline up to 30 days after the last dose of study drug administration (Clinical Cut Off Date: 07 June 2016)", "Results 1: ", " Arm/Group Title: Ipatasertib and Paclitaxel", " Arm/Group Description: Participants randomised to receive paclitaxel 80 mg/m^2, intravenously on Days 1, 8, and 15 along with ipatasertib 400 mg, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.", " Overall Number of Participants Analyzed: 62", " Median (90% Confidence Interval)", " Unit of Measure: Months 6.18 (4.57 to 7.33)", "Results 2: ", " Arm/Group Title: Placebo and Paclitaxel", " Arm/Group Description: Participants randomised to receive paclitaxel 80 mg/m^2, intravenously on Days 1, 8, and 15 along with placebo matching ipatasertib, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.", " Overall Number of Participants Analyzed: 62", " Median (90% Confidence Interval)", " Unit of Measure: Months 4.93 (3.58 to 5.36)" ]

[ "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%)" ]

[ "INTERVENTION 1: ", " Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue", " One arm diagnostic using 1 mCi of 125-I Methylene blue dye to find sentinel lymph nodes" ]

[ "INTERVENTION 1: ", " Whole Breast Irradiation (WBI)", " Conventional whole breast irradiation (WBI)", " Whole breast irradiation (WBI): Conventional whole breast irradiation (WBI)", "INTERVENTION 2: ", " Partial Breast Irradiation (APBI)", " Accelerated partial breast irradiation (APBI)", " Accelerated partial breast irradiation (APBI): Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT)" ]

[ "Inclusion Criteria:", " Histologically or cytologically confirmed invasive breast cancer, preoperative stages II-III per AJCC 6th edition, based on baseline evaluation by clinical examination and/or breast imaging", " Patients must have completed preoperative (neoadjuvant) chemotherapy with a standard chemotherapy regimen. No more chemotherapy should be planned.", " Patients must have completed definitive resection of primary tumor with adequate excision of gross disease.", " For patients receiving adjuvant radiation therapy, treatment must be completed prior to initiation of protocol therapy.", " Patients must have the presence of significant residual invasive disease on pathologic review following their preoperative chemotherapy.", " LVEF > institutional limits of normal after preoperative chemotherapy, as assessed by ECHO or nuclear medicine gated study, within 30 days prior to initiating protocol-based treatment.", " ECOG performance status 0-1", "Exclusion Criteria:", " Inadequate organ function, as measured by laboratory assessment after preoperative chemotherapy and within 14 days of beginning protocol-based treatment", " Patients with metastatic disease are ineligible.", " Known HIV infection", " Patients may not be pregnant, expect to become pregnant, plan to conceive a child while on study, or breastfeeding", " Uncontrolled intercurrent illness", " Non-healing wounds or major surgical procedures (such as breast surgery) other than that for venous access device or diagnostic study are not permitted within 28 day prior to enrollment", " History of abdominal fistula, GI perforation, intra-abdominal abscess, or serious, non-healing wound, ulcer, or bone fracture within 6 months prior to initiating bevacizumab", " Patients with any history of arterial thromboembolic events, including transient ischemic attack (TIA), cerebrovascular event (CVA), unstable angina, or myocardial infarction (MI) within the past 6 months. Patients with clinically significant peripheral arterial disease should also be excluded", " History of bleeding diathesis or coagulopathy", " History of grade 3 or 4 allergic reactions to compounds of similar chemical or biologic composition to cyclophosphamide (such as other alkylating agents) or methotrexate (such as other antimetabolites)", " Prior history of malignancy treated without curative intent, excluding nonmelanomatous skin cancer", " Patients with large or rapidly accumulating pleural or abdominal effusions", " Current use of anticoagulants is allowed as long as patients have been on a stable dose for more than two weeks with stable INR", " Chronic therapy with full dose aspirin (< 325 mg/day) or standard non-steroidal anti-inflammatory agents is allowed", " Patients may not receive other investigational agents while on study" ]

[ "INTERVENTION 1: ", " Phase 1", " Azacitidine (Vidaza): 50mg/m2, 75mg/m2 or 100mg/m2 daily for 5 days for each 4-week cycle", " Nab-paclitaxel (Abraxane): 100mg/m2 weekly for 3 weeks of each 4-week cycle" ]

[ "Outcome Measurement: ", " Overall Survival (OS) of Patients", " To compare Overall Survival (OS) of patients who receive 145 mg/m2 NKTR-102 given once every 21 days (q21d) with OS of patients who receive Treatment of Physician's Choice (TPC). Overall survival is defined as the time from the date of randomization to the date of death from any cause. Patients will be followed until their date of death or until final database closure. Patients who are lost-to-follow-up or are alive at the time of analysis will be censored at the time they were last known to be alive or at the date of event cut-off for OS analysis.", " Time frame: Within 3 years from study start", "Results 1: ", " Arm/Group Title: NKTR-102", " Arm/Group Description: In Group A, NKTR-102 will be administered at a dose level of 145 mg/m2 on a q21d schedule as a 90-minute intravenous (IV) infusion on Day 1 of each treatment cycle.", " Overall Number of Participants Analyzed: 92", " Median (95% Confidence Interval)", " Unit of Measure: months 7.8 (6.1 to 10.2)", "Results 2: ", " Arm/Group Title: Treatment of Physician's Choice (TPC)", " Arm/Group Description: In Group B, TPC will be administered per standard of care. Patients randomized to TPC will receive single-agent IV chemotherapy, limited to choice of one of the following 7 agents: eribulin, ixabepilone, vinorelbine, gemcitabine, paclitaxel, docetaxel, or nab-paclitaxel.", " Overall Number of Participants Analyzed: 86", " Median (95% Confidence Interval)", " Unit of Measure: months 7.5 (5.8 to 10.4)" ]

[ "Adverse Events 1:", " Total: 47/254 (18.50%)", " Anaemia 1/254 (0.39%)", " Febrile neutropenia 1/254 (0.39%)", " Lymphadenopathy 1/254 (0.39%)", " Acute myocardial infarction 1/254 (0.39%)", " Angina pectoris 0/254 (0.00%)", " Angina unstable 0/254 (0.00%)", " Bundle branch block left 0/254 (0.00%)", " Cardiac failure 4/254 (1.57%)", " Coronary artery disease 0/254 (0.00%)", " Coronary artery stenosis 1/254 (0.39%)", "Adverse Events 2:", " Total: 56/269 (20.82%)", " Anaemia 1/269 (0.37%)", " Febrile neutropenia 0/269 (0.00%)", " Lymphadenopathy 0/269 (0.00%)", " Acute myocardial infarction 0/269 (0.00%)", " Angina pectoris 3/269 (1.12%)", " Angina unstable 1/269 (0.37%)", " Bundle branch block left 1/269 (0.37%)", " Cardiac failure 1/269 (0.37%)", " Coronary artery disease 1/269 (0.37%)", " Coronary artery stenosis 0/269 (0.00%)" ]

[ "Adverse Events 1:", " Total: 17/40 (42.50%)", " Anaemia 2/40 (5.00%)", " Febrile Neutropenia 3/40 (7.50%)", " Neutropenia 2/40 (5.00%)", " Thrombocytopenia 5/40 (12.50%)", " Pericardial Effusion 1/40 (2.50%)", " Abdominal Pain Lower 1/40 (2.50%)", " Disease Progression 6/40 (15.00%)", " Fatigue 1/40 (2.50%)", " Pyrexia 3/40 (7.50%)", " Septic Shock 1/40 (2.50%)", " Streptococcal Infection 1/40 (2.50%)" ]

[ "Adverse Events 1:", " Total: 1/3 (33.33%)", " Pain 0/3 (0.00%)", " Cellulitis 0/3 (0.00%)", " Influenza 0/3 (0.00%)", " Osteomyelitis 0/3 (0.00%)", " Pneumonia 0/3 (0.00%)", " Humerus Fracture 0/3 (0.00%)", " Brain Oedema 0/3 (0.00%)", " Cerebral Haemorrhage 0/3 (0.00%)", " Convulsion 0/3 (0.00%)", " Dysarthria 0/3 (0.00%)", " Hepatic Encephalopathy 0/3 (0.00%)", " Confusional State 0/3 (0.00%)", " Dyspnoea 1/3 (33.33%)", "Adverse Events 2:", " Total: 1/1 (100.00%)", " Pain 0/1 (0.00%)", " Cellulitis 0/1 (0.00%)", " Influenza 0/1 (0.00%)", " Osteomyelitis 0/1 (0.00%)", " Pneumonia 0/1 (0.00%)", " Humerus Fracture 0/1 (0.00%)", " Brain Oedema 0/1 (0.00%)", " Cerebral Haemorrhage 0/1 (0.00%)", " Convulsion 0/1 (0.00%)", " Dysarthria 0/1 (0.00%)", " Hepatic Encephalopathy 0/1 (0.00%)", " Confusional State 0/1 (0.00%)", " Dyspnoea 0/1 (0.00%)" ]

[ "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%)" ]

[ "Adverse Events 1:", " Total: 12/63 (19.05%)", " Febrile neutropenia * [1]4/63 (6.35%)", " Congestive heart failure * [2]1/63 (1.59%)", " Cardiac-ischemia/infarction * 1/63 (1.59%)", " Vomiting * [1]1/63 (1.59%)", " Acute Pharyngitis * 1/63 (1.59%)", " Infection * 3/63 (4.76%)", " Neutrophil count decreased * [1]1/63 (1.59%)", " Pneumonitis/pulmonary infiltrates * [3]1/63 (1.59%)" ]

[ "INTERVENTION 1: ", " Letrozole", " Letrozole, 2.5 mg daily for six months" ]

[ "INTERVENTION 1: ", " Celecoxib", " Randomized to receive celecoxib daily for 12 months", "INTERVENTION 2: ", " Placebo", " Randomized to receive placebo daily for 12 months" ]

[ "Outcome Measurement: ", " Time to Disease Progression (Initial Treatment)", " Time to disease progression (TTDP) at initial treatment was defined as the number of months between date of randomization and the date of first documented disease progression or the date of death due to disease under study, whichever came first. TTDP censored at earliest of: 1) date of death not due to disease; or 2) date of last contact for participants alive without disease progression; or 3) start date of other anti-tumor therapy; or 4) first dose date of crossover treatment.", " Time frame: Randomization date to the earliest date of first documented disease progression date or the date of death if the participant died due to study disease (up to 82 months)", "Results 1: ", " Arm/Group Title: Gemcitabine Plus Docetaxel", " Arm/Group Description: gemcitabine 1000 milligrams per meter squared (mg/m2) intravenous, days 1 and 8 every 21 days plus docetaxel 75 mg/m2, intravenous, day 1 every 21 days.", " Treatment continues until progression of disease at which time crossover treatment begins.", " Overall Number of Participants Analyzed: 239", " Median (95% Confidence Interval)", " Unit of Measure: months 9.28 (7.73 to 10.79)", "Results 2: ", " Arm/Group Title: Docetaxel Plus Capecitabine", " Arm/Group Description: docetaxel 75 mg/m2, intravenous, day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth twice a day, days 1-14 every 21 days. Treatment continues until progression of disease, at which time crossover treatment begins.", " Overall Number of Participants Analyzed: 236", " Median (95% Confidence Interval)", " Unit of Measure: months 8.88 (7.37 to 11.05)" ]

[ "Outcome Measurement: ", " Effects of Coenzyme Q10 on Fatigue (as Measured by POMS-F) 24 Weeks Following Randomization", " POMS-F is the Profile of Mood States - fatigue scale. It ranges from 0 to 28; higher values indicate greater fatigue.", " Time frame: 24 weeks", "Results 1: ", " Arm/Group Title: Arm 1 - CoQ10 & Vitamin E", " Arm/Group Description: CoQ10 100mg capsule combined with Vitamin E 100 IU taken orally three times per day.", " Overall Number of Participants Analyzed: 122", " Least Squares Mean (Standard Error)", " Unit of Measure: units on a scale 6.96 (0.71)", "Results 2: ", " Arm/Group Title: Arm 2 - Placebo & Vitamin E", " Arm/Group Description: Placebo-Vitamin E 100 mg/day in 3 doses", " Overall Number of Participants Analyzed: 114", " Least Squares Mean (Standard Error)", " Unit of Measure: units on a scale 8.33 (0.79)" ]

[ "Adverse Events 1:", " Total: 7/39 (17.95%)", " Gastroenteritis viral 1/39 (2.56%)", " Parainfluenzae virus infection 1/39 (2.56%)", " Seizure 4/39 (10.26%)", " Headache 1/39 (2.56%)", " Hydrocephalus 1/39 (2.56%)", " Hypertension 1/39 (2.56%)" ]

[ "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:", " " ]

[ "Inclusion Criteria:", " Patients with cytologically confirmed breast cancer with biopsy showing invasive or non-invasive (DCIS) at least 1.0 cm greatest diameter on imaging", " Surgical patients undergoing lumpectomy, subtotal or total mastectomy", " 18 years of age or greater", " female", " available tissue blocks from diagnostic biopsy", " negative pregnancy test, medical history of surgical sterilization, or 1 year post menopausal", " must be willing to forego surgery for minimum of 5 days", " ability and willingness to sign written consent", " if hypertensive, on stable dose of medication at least 30 days", " if diabetic, well controlled (HbA1C < 8.5 within past 60 days or documented FPG < 140 mg/dl for 3 consecutive days", " ECOG status < 2 or Karnofsky of 60% or greater", "Exclusion Criteria:", " previous or current malignancy, excluding non-melanomic skin cancer", " evidence of distant metastatic disease", " history of chemotherapy, biologic or radiotherapy with 6 months of biopsy", " usage of herbal supplements or alternative medications not approved by the FDA within 1 week of starting study drug. LEAG or related ginseng products, and combination products containing ginseng, should be discontinued within 6 weeks of starting study drug", " history of allergic reactions attributed to compounds of similar chemical or biologic composition to LEAG", " history of chronic inflammatory process, including, but not limited to, rheumatoid arthritis and lupus. This includes patients on concurrent systemic steroids or anti-inflammatory medications", " active bleeding or a pathological condition that carries a high risk of bleeding", " any swallowing dysfunction", " uncontrolled intercurrent illness", " poorly controlled diabetes (control indicated with HbA1c < 8.5 within past 60 days or documented fasting blood glucose < 140 mg/dl for three consecutive days)", " known diabetics who have experienced episodes of symptomatic hypoglycemia in the last 6 months are also considered poorly controlled and will be excluded from study participation.", " uncontrolled hypertension (SBP > 140 mmHg or DBP > 90 mmHG)", " pregnant or breast feeding women Women must be willing to use birth control throughout study duration.", " current investigational medications or treatment with an investigational agent within 6 weeks prior to biopsy", " current coumadin therapy or who have been treated with coumadin within the 2 weeks prior to biopsy", " current monoamine oxidase inhibitors treatment" ]

[ "Inclusion Criteria:", " To be included in this study, you must meet the following criteria:", " Metastatic breast cancer confirmed by biopsy", " Prior adjuvant/neoadjuvant treatment allowed", " Measurable disease", " Able to perform activities of daily living with minimal assistance", " Age 18 years or older", " Adequate bone marrow, liver and kidney function", " Normal heart function", " Written informed consent", "Exclusion Criteria:", " You cannot participate in this study if any of the following apply to you:", " Pre-existing moderate peripheral neuropathy", " History of significant heart disease", " Meningeal metastases.", " Prior chemotherapy for metastatic breast cancer", " No measurable disease (including bone only, pleural effusions, etc.)", " Receiving Herceptin therapy.", " Women who are pregnant or lactating.", " Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have." ]

[ "Adverse Events 1:", " Total: 7/7 (100.00%)", " Febrile neutropenia 3/7 (42.86%)", " Cardiac failure 1/7 (14.29%)", " Neutrophil count decreased 1/7 (14.29%)", " Muscular weakness 1/7 (14.29%)", " Epistaxis 1/7 (14.29%)", " Interstitial lung disease 1/7 (14.29%)", " Pleural effusion 2/7 (28.57%)" ]

[ "Adverse Events 1:", " Total: 8/101 (7.92%)", " Vertigo * 1/101 (0.99%)", " Infected lymphocele * 1/101 (0.99%)", " Ejection fraction decreased * 5/101 (4.95%)", " Lymphoedema * 1/101 (0.99%)" ]

[ "Adverse Events 1:", " Total: 8/28 (28.57%)", " Neutropenia 3/28 (10.71%)", " Hepatitis acute 1/28 (3.57%)", " Pneumonia 1/28 (3.57%)", " Septic shock 1/28 (3.57%)", " Femur fracture 1/28 (3.57%)", " Infected neoplasm 1/28 (3.57%)", " Deep vein thrombosis 1/28 (3.57%)" ]

[ "Adverse Events 1:", " Total: 1/24 (4.17%)", " Pericardial effusion *1/24 (4.17%)", " Other cardiac disorder *0/24 (0.00%)", " Ejection fraction decrease *0/24 (0.00%)", " Hypertension *0/24 (0.00%)", " Salivary gland infection *0/24 (0.00%)", " Pleural effusion *0/24 (0.00%)", "Adverse Events 2:", " Total: 6/30 (20.00%)", " Pericardial effusion *1/30 (3.33%)", " Other cardiac disorder *1/30 (3.33%)", " Ejection fraction decrease *1/30 (3.33%)", " Hypertension *1/30 (3.33%)", " Salivary gland infection *1/30 (3.33%)", " Pleural effusion *2/30 (6.67%)" ]

[ "Outcome Measurement: ", " Percent Change (Between Baseline and Month 12) in Mammographic Density by the Boyd Method Compared Between Arms", " To evaluate change in mammographic density using the Boyd method after one year of vitamin D supplementation compared to placebo in premenopausal women. The percent change in breast density will be reported here.", " Time frame: 12 months", "Results 1: ", " Arm/Group Title: Placebo", " Arm/Group Description: Patients receive oral placebo once daily for 12 months.", " Overall Number of Participants Analyzed: 46", " Mean (Standard Deviation)", " Unit of Measure: percent change -3.4 (7.1)", "Results 2: ", " Arm/Group Title: Vitamin D", " Arm/Group Description: Patients receive oral vitamin D (2000 IU) once daily for 12 months.", " Overall Number of Participants Analyzed: 40", " Mean (Standard Deviation)", " Unit of Measure: percent change -1.4 (11.9)" ]

[ "Outcome Measurement: ", " Percent of Participants With Central Nervous System (CNS) Progression Free Survival (PFS)", " The study team will assess the percent of participants without CNS progression at 3 months. The study team will generate a Kaplan- Meier curve of CNS PFS and estimate the PFS and 95% confidence interval (CI) of the PFS. Response and progression by MR were evaluated using WHO/modified McDonald's criteria.", " Time frame: At 12 weeks", "Results 1: ", " Arm/Group Title: Eribulin Mesylate", " Arm/Group Description: The recommended starting dose of eribulin mesylate is 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle. An MRI will be completed at week 1, week 12 and every 12 weeks after cycles 4+ while on study eribulin mesylate", " Eribulin Mesylate: Most subjects will begin eribulin mesylate at 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.", " MRI: An MRI will be completed at week 1, week 12 and every 12 weeks after cycles 4+ while on study eribulin mesylate", " Pre-Medication: Zofran: Zofran at 8mg orally. Given at the discretion of the treating physician", " Pre-Medication: Decadron: decadron at 8mg orally. Given at the discretion of the treating physician", " Overall Number of Participants Analyzed: 9", " Measure Type: Number", " Unit of Measure: percentage of participants 88.9 (51 to 99.7)" ]

[ "INTERVENTION 1: ", " Nipple Reconstruction Cylinder", " Nipple reconstruction: Biodesign® Nipple Reconstruction Cylinder" ]

[ "INTERVENTION 1: ", " Arm 1: BREASTChoice (Decision Tool)", " Investigators recruited patients scheduled for a plastic/reconstruction consult. Investigators identified patients who completed a mastectomy, or were scheduled for one, and considering reconstruction, but didn't have an appointment with a plastic/reconstructive surgeon. A study team member called the patient to determine their interest and offered for them to come to their scheduled appointment 30 minutes early to meet a coordinator or offered them the option to complete pre-appointment procedures at home. Patients randomized using computer random assignment. If the patient didn't have an appointment, she scheduled a convenient time to complete study procedures with research staff. Patients interacted with the decision tool. They were asked to answer a survey. After the appointment, the team collected information consult duration, decision process quality, and measures of shared decision making. Patient participation was approximately 30 minutes.", "INTERVENTION 2: ", " Arm 2: Enhanced Usual Care (Surgical Care Booklet)", " Investigators recruited patients scheduled for plastic/reconstruction consultation. Investigators identified patients who completed or scheduled a mastectomy, and considering reconstruction, but didn't have an appointment with a plastic/reconstructive surgeon. A study team member called the patient to determine their interest and offered for them to come to their scheduled appointment 30 minutes early to meet a coordinator or to complete the pre-appointment procedures at home. Patients were randomized using computer random assignment. If the patient didn't have an appointment, she scheduled a convenient time to complete study procedures with research staff. Patients interacted with American Society of Plastic Surgeons booklet \"Breast Reconstruction.\" They were asked to answer a survey. After the appointment, the team collected information about consult duration, decision process quality, and measures of shared decision making. Patient participation was approximately 30 minutes." ]

[ "Outcome Measurement: ", " Percent Change From Baseline to Week 13 in Creatinine-adjusted Urinary N-telopeptide (uNTx/Cr)", " Percent change from Baseline to Week 13 in Urinary N-telopeptide corrected by creatinine (uNTx/Cr) calculated using ((Week 13 value - Baseline value) / Baseline value ) x 100.", " Time frame: Baseline and Week 13", "Results 1: ", " Arm/Group Title: Bisphosphonate IV Q4W", " Arm/Group Description: Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion", " Overall Number of Participants Analyzed: 38", " Mean (Standard Deviation)", " Unit of Measure: Percent change -10.19 (208.84)", "Results 2: ", " Arm/Group Title: Denosumab 30 mg Q4W", " Arm/Group Description: Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)", " Overall Number of Participants Analyzed: 40", " Mean (Standard Deviation)", " Unit of Measure: Percent change -52.87 (95.14)" ]

[ "Inclusion Criteria:", " Female, 18-100 years old", " Not pregnant or breastfeeding", " Pre-study radiologic documentation of:", " size 5 cm", " unicentric, unilateral", " suspicious mass or calcification", " BIRADS classification IV", " location of abnormality > 1 cm from skin", " Ductal or Infiltrating Ductal Carcinoma", " Grade I-III on final pathology", " Good general health", " Zubrod Performance Status of 0,1, or 2", " No previous chemotherapy", " No palpable axillary or supraclavicular lymph nodes", " If prior non-breast malignancy, must have > 5 year disease-free survival", "Exclusion Criteria:", " Patient < 18 y/o or > 100 y/o", " Pregnant or breastfeeding", " Male", " Breast implants", " Multicentric disease or bilateral disease", " Lesions > 5 cm in diameter", " Lesions < 1.0 cm from the skin", " Previous prior radiation to the breast", " Need for mastectomy", " Diffuse microcalcifications (as determined by the Investigator)" ]

[ "INTERVENTION 1: ", " Arm I Low Dose DHEA", " Participants apply a low dose (3.25 mg) of vaginal prasterone (dehydroepiandrosterone [DHEA]) gel once daily (QD), at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.", "INTERVENTION 2: ", " Arm II High Dose DHEA", " Participants apply a high dose (6.5 mg) of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study." ]

[ "INTERVENTION 1: ", " Arm 1 (Patients With Pain)", " Duloxetine 30 mg daily x 1 week, then 60 mg daily x 4 weeks, then 30 mg daily x 2 weeks.", " Duloxetine: Subjects will receive 30 mg duloxetine orally for 7 days, then 60 mg duloxetine orally for 28 days, then 30 mg duloxetine orally x 14 days.", "INTERVENTION 2: ", " Arm 2 (Patients Without Pain -- Control)", " Patient reported pain and symptoms assessment for comparison at baseline." ]

[ "Inclusion Criteria:", " Histologically-confirmed operable ER+ and/or PR+ invasive breast cancer or ductal carcinoma in situ (DCIS), who undergo core needle biopsy followed by surgical excision at least 2 weeks after enrollment", " Postmenopausal status defined as cessation of menses for >1 year or FSH > 20 mIU/mL (within the past month)", " Age 21 years", " No prior chemotherapy, radiation therapy, or surgery within 6 months of study entry", " Signed informed consent", "Exclusion Criteria:", " Treatment with other investigational drugs within 6 months of study entry", " Other serious intercurrent medical illness" ]

[ "Outcome Measurement: ", " Clinical Benefit Rate, in Centrally Confirmed Androgen Receptor (AR)+ Subjects", " To estimate the clinical benefit rate (defined as complete response, partial response, or stable disease) according to RECIST 1.1, in subjects with estrogen receptor positive/androgen receptor positive (ER+/AR+) BC who have centrally confirmed AR+ status. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR; Clinical Benefit Rate (CBR)= CR + PR + SD.", " Time frame: 24 weeks", "Results 1: ", " Arm/Group Title: GTx-024 9 mg", " Arm/Group Description: Drug: GTx-024 GTx-024 softgel capsules will be administered once daily to a total dose of 9 mg", " GTx-024: To determine whether either or both doses result in an acceptable clinical benefit rate.", " Overall Number of Participants Analyzed: 50", " Measure Type: Number", " Unit of Measure: participants 16", "Results 2: ", " Arm/Group Title: GTx-024 18 mg", " Arm/Group Description: Drug: GTx-024 GTx-024 softgel capsules will be administered once daily to a total dose of 18 mg", " GTx-024: To determine whether either or both doses result in an acceptable clinical benefit rate.", " Overall Number of Participants Analyzed: 52", " Measure Type: Number", " Unit of Measure: participants 15" ]

[ "Adverse Events 1:", " Total: 22/123 (17.89%)", " Cardiac Ischemia/Infarction [1]1/123 (0.81%)", " Pain - Chest 2/123 (1.63%)", " Dehydration 2/123 (1.63%)", " Death [2]1/123 (0.81%)", " Weakness 1/123 (0.81%)", " Pain - Liver 1/123 (0.81%)", " Infection - Skin [3]3/123 (2.44%)", " Infection - Gastrointestinal [4]1/123 (0.81%)", " Infection - Vein [5]2/123 (1.63%)", " Infection - Pneumonia 1/123 (0.81%)" ]

[ "INTERVENTION 1: ", " All Study Participants: Patient Assisted Compression", " All subjects will undergo standard of care imaging on one breast. The other breast will be imaged using Patient-Assisted Compression (PAC), followed by Technologist-controlled (TC) Compression.", " Patient-Assisted Compression (PAC): The technologist will properly position the breast and apply minimum compression. The subject will be instructed to apply compression as the technologist ensures the breast tissue is in appropriate position and tautness. The technologist will then guide the subject to achieve appropriate compression level, sufficient but not excessive, and the image will be acquired. This will be done for both standard views CC & MLO.", "INTERVENTION 2: ", " All Study Participants: Technologist Compression", " All subjects will undergo standard of care imaging on one breast. The other breast will be imaged using Patient-Assisted Compression (PAC), followed by Technologist-controlled (TC) Compression.", " Technologist-Controlled (TC) Compression: TC compression will be conducted per standard of care practices at the site." ]

[ "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: ", " Treatment Schedule (Weekly)", " Arm C, Docetaxel and Gemcitabine (Weekly):", " Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.", " Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.", " Arm D, Paclitaxel and Gemcitabine (Weekly):", " Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.", " Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.", "INTERVENTION 2: ", " Treatment Schedule (3 Weekly)", " Arm A, Docetaxel and Gemcitabine (3 Weekly):", " Docetaxel: 75 mg/m², 60 min IV infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.", " Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.", " Arm B, Paclitaxel and Gemcitabine (3 Weekly):", " Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.", " Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD." ]

[ "INTERVENTION 1: ", " Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy)", " Patients receive vorinostat PO QD for 2 weeks followed by AI therapy comprising anastrozole PO QD, letrozole PO QD, OR exemestane PO QD for 6 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.", " vorinostat: Given PO", " laboratory biomarker analysis: Correlative studies", " biopsy: Optional correlative studies", " F-18 16 alpha-fluoroestradiol: Correlative studies", " positron emission tomography: Correlative studies", " anastrozole: Given PO", " letrozole: Given PO", " exemestane: Given PO", " gene expression analysis: Correlative studies" ]

[ "Outcome Measurement: ", " Recurrence-free Survival", " 2 years for the primary analysis + 3 additional years for secondary analysis (From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years)", " Time frame: 5 years", "Results 1: ", " Arm/Group Title: Ketorolac 30 mg", " Arm/Group Description: Active drug to be compared with placebo", " Ketorolac 30 mg IV", " Overall Number of Participants Analyzed: 96", " Measure Type: Count of Participants", " Unit of Measure: Participants 80 83.3%", "Results 2: ", " Arm/Group Title: NaCl 0.9% 3mL", " Arm/Group Description: Ketorolac 30 mg IV", " Overall Number of Participants Analyzed: 107", " Measure Type: Count of Participants", " Unit of Measure: Participants 96 89.7%" ]

[ "Adverse Events 1:", " Total: 17/145 (11.72%)", " ANAEMIA 0/145 (0.00%)", " LEUKOPENIA 2/145 (1.38%)", " NEUTROPENIA 1/145 (0.69%)", " LEUKOCYTOSIS 1/145 (0.69%)", " THROMBOCYTOPENIA 1/145 (0.69%)", " FEBRILE NEUTROPENIA 1/145 (0.69%)", " THROMBOTIC THROMBOCYTOPENIC PURPURA 0/145 (0.00%)", " DISSEMINATED INTRAVASCULAR COAGULATION 0/145 (0.00%)", " CARDIAC FAILURE 1/145 (0.69%)", " ATRIAL FIBRILLATION 1/145 (0.69%)", "Adverse Events 2:", " Total: 11/144 (7.64%)", " ANAEMIA 1/144 (0.69%)", " LEUKOPENIA 0/144 (0.00%)", " NEUTROPENIA 0/144 (0.00%)", " LEUKOCYTOSIS 0/144 (0.00%)", " THROMBOCYTOPENIA 0/144 (0.00%)", " FEBRILE NEUTROPENIA 1/144 (0.69%)", " THROMBOTIC THROMBOCYTOPENIC PURPURA 1/144 (0.69%)", " DISSEMINATED INTRAVASCULAR COAGULATION 1/144 (0.69%)", " CARDIAC FAILURE 0/144 (0.00%)", " ATRIAL FIBRILLATION 0/144 (0.00%)" ]

[ "Adverse Events 1:", " Total: 22/79 (27.85%)", " Anaemia 0/79 (0.00%)", " Right ventricular dysfunction 1/79 (1.27%)", " Diarrhoea 1/79 (1.27%)", " Vomiting 2/79 (2.53%)", " Abdominal pain 0/79 (0.00%)", " Colonic obstruction 0/79 (0.00%)", " Dysphagia 1/79 (1.27%)", " Nausea 1/79 (1.27%)", " Mucosal inflammation 1/79 (1.27%)", " Performance status decreased 1/79 (1.27%)", " Sudden death 1/79 (1.27%)", "Adverse Events 2:", " Total: 13/76 (17.11%)", " Anaemia 1/76 (1.32%)", " Right ventricular dysfunction 0/76 (0.00%)", " Diarrhoea 0/76 (0.00%)", " Vomiting 2/76 (2.63%)", " Abdominal pain 1/76 (1.32%)", " Colonic obstruction 1/76 (1.32%)", " Dysphagia 0/76 (0.00%)", " Nausea 1/76 (1.32%)", " Mucosal inflammation 0/76 (0.00%)", " Performance status decreased 0/76 (0.00%)", " Sudden death 0/76 (0.00%)" ]

[ "Adverse Events 1:", " Total: 6/8 (75.00%)", " Thrombocytopenia 1/8 (12.50%)", " Hypertension 1/8 (12.50%)", " Hepatotoxicity 3/8 (37.50%)", " Pancreatectomy * 1/8 (12.50%)" ]