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nli4ct_semeval2024

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[ "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: ", " Progression-free Survival (PFS)", " PFS was defined as the interval from study entry until disease progression or death resulting from any cause, which ever occurred first. Progression is defined as a 20% increase in the sum of longest diameter of target lesions (per RECIST criteria).", " Time frame: Interval from randomization until disease progression or death, whichever occurs first, assessed up to 5 years", "Results 1: ", " Arm/Group Title: Arm I (Lapatinib)", " Arm/Group Description: Patients receive 1500 mg lapatinib ditosylate PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg)of each subsequent course.", " Overall Number of Participants Analyzed: 146", " Median (95% Confidence Interval)", " Unit of Measure: months 4.7 (3.7 to 5.7)", "Results 2: ", " Arm/Group Title: Arm II (Placebo)", " Arm/Group Description: Patients receive placebo PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg) of each subsequent course.", " Overall Number of Participants Analyzed: 145", " Median (95% Confidence Interval)", " Unit of Measure: months 3.8 (3.8 to 5.6)" ]

[ "Outcome Measurement: ", " Number of Participants With Overall Response (OR), Defined as Those Participants Achieving Complete Response (CR) or Partial Response (PR), Assessed Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 and Cutaneous Lesions", " RECIST-based response assessment was done at Weeks (Wks) 4 and 8 and every 8 weeks thereafter. Cutaneous disease assessment was done at Wk 4 and every 4 weeks thereafter. OR was evaluated when the skin and RECIST assessments coincided. Per RECIST, CR is the disappearance of all target and non-target lesions; PR is at least a 30 percent (%) decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference the baseline sum LD. Cutaneous disease contained non-measurable and measurable skin disease, which was assessed by skin assessment tools.", " Time frame: Baseline until disease progression/recurrence was documented, assessed for up to 66 weeks", "Results 1: ", " Arm/Group Title: Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo", " Arm/Group Description: Participants received oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) once daily (QD).", " Overall Number of Participants Analyzed: 38", " Measure Type: Number", " Unit of Measure: participants 11", "Results 2: ", " Arm/Group Title: Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg", " Arm/Group Description: Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with pazopanib 800 mg (2 x 400 mg tablets) QD.", " Overall Number of Participants Analyzed: 38", " Measure Type: Number", " Unit of Measure: participants 17" ]

[ "Adverse Events 1:", " Total: 9/2788 (0.32%)", " Anaphylaxis 5/2788 (0.18%)", " Infections and infestations - Other, specify 2/2788 (0.07%)", " Nervous system disorders - Other, specify 0/2788 (0.00%)", " Respiratory, thoracic and mediastinal disorders - Other, specify 1/2788 (0.04%)", " Thromboembolic event 1/2788 (0.04%)", "Adverse Events 2:", " Total: 8/2800 (0.29%)", " Anaphylaxis 5/2800 (0.18%)", " Infections and infestations - Other, specify 0/2800 (0.00%)", " Nervous system disorders - Other, specify 1/2800 (0.04%)", " Respiratory, thoracic and mediastinal disorders - Other, specify 1/2800 (0.04%)", " Thromboembolic event 2/2800 (0.07%)" ]

[ "For more information regarding Bristol-Myers Squibb (BMS) clinical trial participation, please visit www.BMSStudyConnect.com.", "Inclusion Criteria:", " Histologically confirmed hormone receptor positive (HR+) [(estrogen receptor (ER+) and/or progesterone receptors(PgR+)] breast cancer according to immunohistochemistry (IHC)", " Measureable or evaluable-only disease", " human epidermal growth factor receptor 2+ (HER2+) or HER2- breast cancer", " Males and females 18 years of age", " Females are post menopausal or surgically sterile", " Recurrent or progressive advanced breast cancer (locally-advanced or metastatic), that has progressed: (a) during or within 12 months after completion of adjuvant Aromatase Inhibitor (AI) treatment OR (b) during AI treatment in advanced setting (metastatic therapy)", "Exclusion Criteria:", " Pregnant or breast feeding", " >1 chemotherapy regimen for advanced disease", " Pleural or pericardial effusion", " Serious cardiac condition" ]

[ "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)." ]

[ "Inclusion Criteria:", " Female gender", " Age 18 years", " An invasive primary breast cancer of any histology arising from breast parenchyma", " Patient must be status post mastectomy or partial mastectomy with an assessment of axillary nodes via sentinel lymph node biopsy and/or axillary lymph node dissection", " Pathologic confirmation of metastatic disease in at least one regional lymph node. Regional lymph nodes are defined as the ipsilateral axillary lymph nodes, ipsilateral supraclavicular lymph nodes, and ipsilateral internal mammary lymph nodes. Thus, any T stage is allowed as long as the N stage is 1 and M stage is 0.", " Patient signed study-specific consent form.", "Exclusion Criteria:", " Patients with distant metastasis.", " Patients who are pregnant or breastfeeding.", " Patients with psychiatric or addictive disorders that would preclude obtaining informed consent.", " Time between initial diagnosis of breast cancer and start of radiation therapy exceeds 13 months.", " Estimated life expectancy judged to be less than one year by patient's treating radiation oncologist.", " Prior radiation therapy to the ipsilateral or contralateral breast or thorax.", " Primary breast cancer is a lymphoma or sarcoma histology.", " Patients with a history of non-skin malignancy <5 years prior to the diagnosis of breast cancer.", " Patients requiring radiation to the bilateral breasts." ]

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

[ "Adverse Events 1:", " Total: 3/24 (12.50%)", " Disseminated intravascular coagulation 0/24 (0.00%)", " Death NOS 0/24 (0.00%)", " Edema limbs 0/24 (0.00%)", " Fatigue 0/24 (0.00%)", " Hepatic failure 1/24 (4.17%)", " Alanine aminotransferase increased 1/24 (4.17%)", " Aspartate aminotransferase increased 1/24 (4.17%)", " Blood bilirubin increased 0/24 (0.00%)", " Ejection fraction decreased 1/24 (4.17%)", "Adverse Events 2:", " Total: 9/22 (40.91%)", " Disseminated intravascular coagulation 1/22 (4.55%)", " Death NOS 1/22 (4.55%)", " Edema limbs 1/22 (4.55%)", " Fatigue 1/22 (4.55%)", " Hepatic failure 0/22 (0.00%)", " Alanine aminotransferase increased 0/22 (0.00%)", " Aspartate aminotransferase increased 1/22 (4.55%)", " Blood bilirubin increased 1/22 (4.55%)", " Ejection fraction decreased 1/22 (4.55%)" ]

[ "Adverse Events 1:", " Total: 5/33 (15.15%)", " Left Ventricular Thrombus * 1/33 (3.03%)", " Nausea * 1/33 (3.03%)", " Acute Cholecystitis * 1/33 (3.03%)", " Renal Failure * 1/33 (3.03%)", " Pneumonia * 1/33 (3.03%)" ]

[ "Inclusion Criteria:", " Patients' recurrences must have histologically confirmed ductal carcinoma in-situ, invasive ductal, medullary, papillary, colloid (mucinous), or tubular histologies.", " Lesion size 3 cm treated with a tylectomy and whole breast irradiation (with or without tumor bed boost)", " Unifocal breast cancer recurrence", " Negative resection margins with at least a 2 mm margin from invasive and in situ cancer or a negative re-excision", " Hormonal therapy is allowed. If chemotherapy is planned, the radiation is delivered first and chemotherapy must begin no earlier than two weeks following completion of radiation.", " Signed study-specific informed consent prior to study entry.", "Exclusion Criteria:", " Patients with distant metastatic disease", " Patients with invasive lobular carcinoma, extensive lobular carcinoma in-situ, extensive ductal carcinoma in-situ (spanning more than 3 cm), or nonepithelial breast malignancies such as lymphoma or sarcoma.", " Patients with multicentric carcinoma (tumors in different quadrants of the breast or tumors separated by at least 4 cm). Palpable or radiographically suspicious contralateral axillary, ipsilateral or contralateral supraclavicular, infraclavicular, or internal mammary lymph nodes unless these are histologically or cytologically confirmed negative.", " Extensive intraductal component (EIC) by the Harvard definition, i.e. 1) more than 25% of the invasive tumor is Ductal carcinoma in situ (DCIS) and DCIS present in adjacent breast tissue. Presence of an EIC increases the chance of local recurrence, and as such, one might not be a candidate for repeat breast conservation.", " Patients with Paget's disease of the nipple.", " Patients with skin involvement.", " Patients with collagen vascular disorders, specifically systemic lupus erythematosis, scleroderma, or dermatomyositis.", " Patients with psychiatric, neurologic, or addictive disorders that would preclude obtaining informed consent.", " Other malignancy, except non-melanomatous skin cancer, < 5 years prior to participation in this study.", " Patients who are pregnant or lactating due to potential fetal exposure to radiation and unknown effects of radiation on lactating females.", " Patients with known BReast CAncer gene (BRCA)1/BRCA 2 mutations." ]

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

[ "INTERVENTION 1: ", " Palbociclib+Letrozole India Cohort", " Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment ofr each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information", "INTERVENTION 2: ", " Palbociclib+Letrozole Australia Cohort", " Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment for each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information" ]

[ "Inclusion Criteria:", " 18 years or older.", " Ipsilateral biopsy-proven invasive breast cancer <5 cm in maximal dimension by Ultrasound or Mammography.", " No abnormal axillary nodes identified on grayscale AUS, or abnormal nodes with benign subsequent FNA biopsy.", "Exclusion Criteria:", " Pregnant or nursing women", " Prior SLN dissection", " Neoadjuvant chemotherapy.", " Prior axillary lymph node surgery.", " Prior history of ipsilateral breast cancer.", "Known or suspected: Cardiac shunts", "Known or suspected: hypersensitivity to perflutren, blood, blood products or albumin", "Known or suspected: hypersensitivity to a prior OPTISON administration" ]

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

[ "Outcome Measurement: ", " Systemic Tumor Response Rates (Complete Response+Partial Response)", " The systemic tumor response refers to the response at the time of best overall response. The response criteria are specially adapted from Response Evaluation Criteria in Solid Tumor for Immunotherapies (Wolchok, et al., 2009).", " Time frame: 9 weeks from the start of the treatment of RT", "Results 1: ", " Arm/Group Title: IMQ+RT", " Arm/Group Description: This arm has been closed as of 6/4/2014.", " Weeks 1-2: RT given to one metastatic skin site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W)", " Weeks 1-8: day 1-5 of each week: imiquimod 5% cream applied to all skin sites overnight, starting on day 1 after RT, day 6-7 of each week: rest period.", " Week 9: response assessment", " Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.", " Radiation", " Imiquimod", " Overall Number of Participants Analyzed: 12", " Measure Type: Number", " Unit of Measure: proportion of tumors .25 (.06 to .57)", "Results 2: ", " Arm/Group Title: CTX/IMQ/RT", " Arm/Group Description: Week -1 (day-7): cyclophosphamide 200mg/m2 IV as single infusion", " Weeks 1-2: RT given to one metastatic skin site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W)", " Weeks 1-8: day 1-5 of each week: imiquimod 5% cream applied all sites overnight, starting on day 1 after RT, day 6-7 of each week: rest period.", " Week 9: response assessment", " Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.", " Radiation", " Imiquimod", " Cyclophosphamide", " Overall Number of Participants Analyzed: 12", " Measure Type: Number", " Unit of Measure: proportion of tumors .083 (.002 to .38)" ]

[ "Adverse Events 1:", " Total: 28/36 (77.78%)", " Lymphocytopenia 210/36 (27.78%)", " Neutropenia 29/36 (25.00%)", " Anemia 26/36 (16.67%)", " Thrombocytopenia 24/36 (11.11%)", " Hyperglycemia 27/36 (19.44%)", " Nausea 213/36 (36.11%)", " Diarrhea 211/36 (30.56%)", " Fatigue 215/36 (41.67%)", " Flu-like symptoms 26/36 (16.67%)", " Hot Flashes 25/36 (13.89%)", " AST/ALT elevation 211/36 (30.56%)", " Arthralgia 24/36 (11.11%)" ]

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

[ "Inclusion Criteria:", " HER-2 negative advanced breast cancer with chest wall metastasis confirmed by histology or cytological examination (patients who have received anthracyclines and/or paclitaxel in adjuvant chemotherapy).", " Patients with recurrence or metastasis who have received no more than two lines of chemotherapy.", " If hormone receptor is positive, endocrine therapy must have been performed for the patients with recurrence or metastasis, or the recurrence or metastasis occurred in less than two years of endocrine therapy.", " 18 years old.", " Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.", " A life expectancy of more than 3 months.", " At least one measurable site of disease confirmed by CT or MRI according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria was required.", " If the target lesions are lymph nodes, the short diameter is required to be less than 1.5cm and the target lesions are not suitable for surgical treatment; target lesions have not been in radiotherapy or recurred in the radiation field.", " Baseline blood routine examination in accordance with the following criteria: neutrophil counts more than 1.5*109/L; platelet counts greater than 100*109/L; hemoglobin greater than 9 g/dL (blood transfusion is allowed to achieve or maintain the index)", " Liver function in accordance with the following criteria: total bilirubin less than 1.5 times the upper limit of normal value; aspartate aminotransferase (AST), alanine aminotransferase (ALT) less than 2.5 times the upper limit of normal value, less than 5 times the upper limit of normal value in patients with liver metastases.", " Renal function in accordance with the following criteria: serum creatinine less than 1.25 times the upper limit of normal value, or the creatinine clearance rate calculated greater than 50 mL/min;", " Women with fertility are willing to take contraceptive measures in the trial: when seven days before the drug delivery of serum or urine pregnancy test negative.", "Exclusion Criteria:", " receiving radiation therapy 28 days before enrolled. Radiotherapy before enrollment to relieve the metastatic bone pain is allowed, but medullary bone radiated should not exceed 30% of the total amount;", " symptomatic central nervous system metastases;", " current or recent (30 days before enrollment) use of another study drug or being involved in another clinical study;", " Other malignant tumors that have occurred within 5 years (except for the cured or well-controlled cervical carcinoma in situ, skin squamous cell carcinoma, or skin basal cell carcinoma);", " With hypertension and the blood pressure cannot be reduced to the normal range through antihypertensive drug treatment (systolic blood pressure greater than or equal to 140 mmHg or diastolic blood pressure greater than or equal to 90 mmHg).", " With grade II or higher myocardial ischemia or myocardial infarction, poorly controlled arrhythmia (including QTc interval more than or equal to 450 ms for men, more than or equal to 470 ms for female);", " according to the criteria of NYHA, cardiac insufficiency of grade III and IV or left ventricular ejection fraction (LVEF) less than 50% revealed by echocardiography;", " abnormal coagulation function (INR > 1.5 or prothrombin time (PT) > ULN+4 seconds or APTT >1.5 times the ULN), with bleeding tendency or under thrombolysis or anticoagulation therapy;", " within 3 months before enrollment, clinically significant bleeding symptoms occur, or having obvious bleeding tendency, such as gastrointestinal bleeding, bleeding gastric ulcer, occult blood + + and above in baseline period, or suffering from vasculitis, et al;", " within 4 months before enrollment receiving major surgery or getting severe traumatic injury, fracture or ulcer;", " having factors that affect the absorption of the oral drugs obviously, such as the inability to swallow, chronic diarrhea and intestinal obstruction, et al;", " urine routine test with urinary protein more than ++, or 24 hour urinary protein more than 1.0 g;", " with symptomatic serous cavity effusion, which needs to be surgically managed (including pleural effusion, ascites, pericardial effusion);", " with other possible conditions that can affect the clinical research or evaluation of the results judged by the researchers." ]

[ "Outcome Measurement: ", " Tumor Response", " Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve (\"respond\"), stay the same (\"stable\"), or worsen (\"progression\") during treatment.", " Time frame: baseline to measured progressive disease", "Results 1: ", " Arm/Group Title: Dose Level 1", " Arm/Group Description: Gemcitabine at 1000 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.", " Overall Number of Participants Analyzed: 6", " Measure Type: Number", " Unit of Measure: participants Complete Response: 0", " Partial Response: 0", " Long Stable Disease: 1", " Stable Disease: 1", " Progressive Disease: 2", "Not Evaluable: 2", "Results 2: ", " Arm/Group Title: Dose Level 2", " Arm/Group Description: Gemcitabine at 1250 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.", " Overall Number of Participants Analyzed: 62", " Measure Type: Number", " Unit of Measure: participants Complete Response: 1", " Partial Response: 4", " Long Stable Disease: 4", " Stable Disease: 16", " Progressive Disease: 32", "Not Evaluable: 5" ]

[ "Adverse Events 1:", " Total: 0/3 (0.00%)", " cardiac tamponade 0/3 (0.00%)", " congestive heart failure 0/3 (0.00%)", " pulmonary emobolism 0/3 (0.00%)", "Adverse Events 2:", " Total: 2/23 (8.70%)", " cardiac tamponade 0/23 (0.00%)", " congestive heart failure 1/23 (4.35%)", " pulmonary emobolism 1/23 (4.35%)" ]

[ "Adverse Events 1:", " Total: 12/32 (37.50%)", " Anaemia 0/32 (0.00%)", " Neutropenia 1/32 (3.13%)", " Thrombocytopenia 4/32 (12.50%)", " Atrial fibrillation 1/32 (3.13%)", " Cardiac failure congestive 1/32 (3.13%)", " Myocardial ischaemia 1/32 (3.13%)", " Abdominal discomfort 0/32 (0.00%)", " Ascites 1/32 (3.13%)", " Constipation 0/32 (0.00%)", " Rectal haemorrhage 1/32 (3.13%)", " Vomiting 1/32 (3.13%)", " Fatigue 1/32 (3.13%)", "Adverse Events 2:", " Total: 8/20 (40.00%)", " Anaemia 1/20 (5.00%)", " Neutropenia 0/20 (0.00%)", " Thrombocytopenia 1/20 (5.00%)", " Atrial fibrillation 0/20 (0.00%)", " Cardiac failure congestive 0/20 (0.00%)", " Myocardial ischaemia 0/20 (0.00%)", " Abdominal discomfort 1/20 (5.00%)", " Ascites 0/20 (0.00%)", " Constipation 2/20 (10.00%)", " Rectal haemorrhage 0/20 (0.00%)", " Vomiting 0/20 (0.00%)", " Fatigue 0/20 (0.00%)" ]

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

[ "INTERVENTION 1: ", " Letrozole + MRI", " 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." ]

[ "Adverse Events 1:", " Total: 5/11 (45.45%)", " Diabetes insipidus [1]1/11 (9.09%)", " Nausea 0/11 (0.00%)", " Ileus 1/11 (9.09%)", " Dehydration 1/11 (9.09%)", " Vomiting 0/11 (0.00%)", " Pain NOS [2]2/11 (18.18%)", " Pain - abdomen 0/11 (0.00%)", " Fracture [3]0/11 (0.00%)", " Progressive Disease 1/11 (9.09%)", " CNS Ischemia 1/11 (9.09%)", " Respiratory Failure 0/11 (0.00%)", " Hypoxia 1/11 (9.09%)", "Adverse Events 2:", " Total: 8/21 (38.10%)", " Diabetes insipidus [1]0/21 (0.00%)", " Nausea 1/21 (4.76%)", " Ileus 0/21 (0.00%)", " Dehydration 1/21 (4.76%)", " Vomiting 1/21 (4.76%)", " Pain NOS [2]0/21 (0.00%)", " Pain - abdomen 1/21 (4.76%)", " Fracture [3]1/21 (4.76%)", " Progressive Disease 1/21 (4.76%)", " CNS Ischemia 1/21 (4.76%)", " Respiratory Failure 1/21 (4.76%)", " Hypoxia 1/21 (4.76%)" ]

[ "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%)" ]

[ "Outcome Measurement: ", " Retention", " Retention is the percentage of participants who stay in the study for 24 weeks.", " Time frame: 24 Weeks", "Results 1: ", " Arm/Group Title: Arm I", " Arm/Group Description: Patients receive donepezil hydrochloride PO QD.", " donepezil hydrochloride: Given PO", " Overall Number of Participants Analyzed: 31", " Mean (Standard Error)", " Unit of Measure: percentage of participants 71.0 (8.3)", "Results 2: ", " Arm/Group Title: Arm II", " Arm/Group Description: Patients receive placebo PO QD.", " Placebo: Given PO", " Overall Number of Participants Analyzed: 31", " Mean (Standard Error)", " Unit of Measure: percentage of participants 80.7 (7.2)" ]

[ "Outcome Measurement: ", " Pharmacokinetics (PK) of Oral Itraconazole", " To determine the pharmacokinetics (PK) of oral itraconazole in patients with MBC by measuring mean trough plasma levels at steady state at weeks 2 and 4.", " Time frame: pre-dose at Weeks 2 and 4", "Results 1: ", " Arm/Group Title: Itraconazole", " Arm/Group Description: oral itraconazole 200mg a day until disease progression or unacceptable toxicities.", " Overall Number of Participants Analyzed: 12", " Mean (Standard Deviation)", " Unit of Measure: ng/mL Week 2 Intraconazole Concentration: 230.7 (216.8)", " Week 4 Intraconazole Concentration: 305.8 (334.8)", " Week 2 6-OH Itraconazole Concentration: 454.8 (429.3)", " Week 4 6-OH Itraconazole Concentration: 501.6 (502.6)" ]

[ "Outcome Measurement: ", " Dose Escalation: To Evaluate the Safety and Tolerability of Escalating Doses of the MM-121 Plus Paclitaxel Combination Via Reporting of Dose-limiting Toxicity (DLT)", " To establish the safety of escalating doses of MM-121 in combination with paclitaxel in order to determine the recommended phase 2 dose. Dose-escalation conducted using standard 3+3 model to determine maximum tolerated dose. Reports of Dose-Limiting Toxicities (DLTs) were assessed to determine the MTD.", " Time frame: From date of first dose to 30 days after termination, the longest 163 weeks", "Results 1: ", " Arm/Group Title: Part 1: Dose Escalation: Cohort 1", " Arm/Group Description: MM-121 - 20 mg/kg loading dose followed by 12 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV", " Overall Number of Participants Analyzed: 7", " Measure Type: Number", " Unit of Measure: participants reporting DLTs 0", "Results 2: ", " Arm/Group Title: Part 1: Dose Escalation: Cohort 2", " Arm/Group Description: MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV", " Paclitaxel - 80mg/m2 weekly IV", " Overall Number of Participants Analyzed: 3", " Measure Type: Number", " Unit of Measure: participants reporting DLTs 1" ]

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

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

[ "Adverse Events 1:", " Total: 8/24 (33.33%)", " Restrictive Cardiomyopathy * 21/24 (4.17%)", " Palpitations * 21/24 (4.17%)", " GERD * 21/24 (4.17%)", " Fever * 21/24 (4.17%)", " Sepsis * 1/24 (4.17%)", " Urinary Tract Infection * 21/24 (4.17%)", " Influenza A * 21/24 (4.17%)", " Dehydration * 21/24 (4.17%)", " Hyponatremia * 21/24 (4.17%)", " Worsening of Hypercalcemia * 21/24 (4.17%)", " Bone Pain * 21/24 (4.17%)" ]

[ "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" ]

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

[ "Outcome Measurement: ", " Congestive Heart Failure Rate", " Clinical congestive heart failure includes patients with symptomatic decline in LVEF to at or below the lower limit of normal (LLN), or symptomatic diastolic dysfunction. 223 treated patients were included in the analysis.", " Time frame: assessed on day 1 of cycles 5, 9, 17 and 25, and at end of treatment, then every 3 months for <2 years and every 6 months for 2-3 years from study entry", "Results 1: ", " Arm/Group Title: Arm A (ddBAC > BT > B)", " Arm/Group Description: Dose dense bevacizumab, cyclophosphamide and doxorubicin, followed by paclitaxel and bevacizumab, followed by bevacizumab", " Overall Number of Participants Analyzed: 103", " Measure Type: Number", " Unit of Measure: percentage of participants 2.9 (0.6 to 8.3)", "Results 2: ", " Arm/Group Title: Arm B (ddAC > BT > B)", " Arm/Group Description: Dose dense doxorubicin and cyclophosphamide, followed by paclitaxel and bevacizumab, followed by bevacizumab", " Overall Number of Participants Analyzed: 120", " Measure Type: Number", " Unit of Measure: percentage of participants 2.5 (0.5 to 7.1)" ]

[ "Adverse Events 1:", " Total: 16/149 (10.74%)", " Anaemia 0/149 (0.00%)", " Febrile neutropenia 7/149 (4.70%)", " Neutropenia 1/149 (0.67%)", " Pancytopenia 1/149 (0.67%)", " Atrial fibrillation 2/149 (1.34%)", " Cardiac failure congestive 0/149 (0.00%)", " Abdominal pain 0/149 (0.00%)", " Diarrhoea 2/149 (1.34%)", " Dyspepsia 0/149 (0.00%)", " Gastritis haemorrhagic 0/149 (0.00%)", " Nausea 2/149 (1.34%)", "Adverse Events 2:", " Total: 20/151 (13.25%)", " Anaemia 1/151 (0.66%)", " Febrile neutropenia 4/151 (2.65%)", " Neutropenia 2/151 (1.32%)", " Pancytopenia 0/151 (0.00%)", " Atrial fibrillation 0/151 (0.00%)", " Cardiac failure congestive 1/151 (0.66%)", " Abdominal pain 1/151 (0.66%)", " Diarrhoea 3/151 (1.99%)", " Dyspepsia 1/151 (0.66%)", " Gastritis haemorrhagic 1/151 (0.66%)", " Nausea 1/151 (0.66%)" ]

[ "Adverse Events 1:", " Total: 18/364 (4.95%)", " Febrile neutropenia 3/364 (0.82%)", " Atrial fibrillation 1/364 (0.27%)", " Cardio-respiratory arrest 1/364 (0.27%)", " Sinus bradycardia 1/364 (0.27%)", " Ventricular extrasystoles 0/364 (0.00%)", " Enterocolitis 0/364 (0.00%)", " Faecaloma 0/364 (0.00%)", " Gastric ulcer perforation 0/364 (0.00%)", " Gastrointestinal toxicity 0/364 (0.00%)", " Pancreatitis acute 0/364 (0.00%)", "Adverse Events 2:", " Total: 5/361 (1.39%)", " Febrile neutropenia 0/361 (0.00%)", " Atrial fibrillation 0/361 (0.00%)", " Cardio-respiratory arrest 0/361 (0.00%)", " Sinus bradycardia 0/361 (0.00%)", " Ventricular extrasystoles 0/361 (0.00%)", " Enterocolitis 0/361 (0.00%)", " Faecaloma 0/361 (0.00%)", " Gastric ulcer perforation 0/361 (0.00%)", " Gastrointestinal toxicity 1/361 (0.28%)", " Pancreatitis acute 0/361 (0.00%)" ]

[ "Adverse Events 1:", " Total: 6/25 (24.00%)", " Neutropenia *3/25 (12.00%)", " Anemia *0/25 (0.00%)", " Febrile Neutropenia *0/25 (0.00%)", " Chest Pain *0/25 (0.00%)", " Diarrhea *1/25 (4.00%)", " Fatigue *1/25 (4.00%)", " Liver Tests *0/25 (0.00%)", " Neuropathy *0/25 (0.00%)", " Syncope *0/25 (0.00%)", " Hand and Foot Syndrome *1/25 (4.00%)", "Adverse Events 2:", " Total: 11/26 (42.31%)", " Neutropenia *3/26 (11.54%)", " Anemia *1/26 (3.85%)", " Febrile Neutropenia *1/26 (3.85%)", " Chest Pain *1/26 (3.85%)", " Diarrhea *1/26 (3.85%)", " Fatigue *0/26 (0.00%)", " Liver Tests *1/26 (3.85%)", " Neuropathy *1/26 (3.85%)", " Syncope *1/26 (3.85%)", " Hand and Foot Syndrome *1/26 (3.85%)" ]

[ "INTERVENTION 1: ", " Supportive Care (Dakin's Solution, Radiation Therapy)", " Patients apply Dakin's solution topically daily over 10 minutes within 60 minutes of radiation therapy for up to 6 weeks.", " Dakin's solution: Applied topically", " radiation therapy: Undergo radiation therapy", " questionnaire administration: Ancillary studies", " laboratory biomarker analysis: Optional correlative studies" ]

[ "INTERVENTION 1: ", " Treatment (Neoadjuvant Therapy, Adjuvant Therapy)", " See Detailed Description.", " doxorubicin hydrochloride: Given IV", " cyclophosphamide: Given PO", " paclitaxel: Given IV", " filgrastim: Given SC", " capecitabine: Given PO", " methotrexate: Given IV", " vinorelbine tartrate: Given IV", " needle biopsy: Correlative studies", " therapeutic conventional surgery: Undergo definitive breast surgery", " immunohistochemistry staining method: Correlative studies", " trastuzumab: Given IV", " tamoxifen citrate: Given PO", " letrozole: Given PO", " laboratory biomarker analysis: Correlative studies" ]

[ "INTERVENTION 1: ", " Trastuzumab/Ixabepilone/Carboplatin", " During the induction phase, patients were treated with Ixabepilone (BMS-247550) 15mg/m2 intravenously (IV) followed by carboplatin (AUC=2 IV) on days 1, 8 and 15 of a 28-day cycle for a maximum of 6 cycles. Trastuzumab was administered weekly (4mg/kg loading dose then 2mg/kg IV) starting on day 1. Routine premedication included H1 blocker (diphenhydramine 50 mg orally (PO) or IV), H2 blocker (ranitidine 150 mg PO or 50 mg IV or another equivalent H2 blocker), and at least a 5-HT3 antagonist and dexamethasone.", " After completion of 24 weekly trastuzumab doses (induction therapy), trastuzumab were given at a dose of 6 mg/kg IV every 3 weeks (maintenance therapy) beginning one week after the 24th weekly dose. Trastuzumab were repeated every 21 days until disease progression or prohibitive toxicity." ]

[ "INTERVENTION 1: ", " Stage 1 Clinical Management", " The group will receive clinical management treatment only each session.", " Clinical Management: Clinical management is a clear contrast method of psychological therapy, which is a half-structured interview and lasting for 20-25 minutes each session. Clinical management will be assigned to both experimental group and controlled group in the first stage of intervention.", " Following are major elements:", " Talk to the subjects to find their main problems; introduce knowledge and medication knowledge about cancer and depression; subjects reporting use of drugs for cancer and depression and a variety of signs and symptoms of the reaction. Encourage patients to adhere to drug treatment and to comply with this research program; The operation of CBT and clinical management should be conducted by the same person as far as possible.", "INTERVENTION 2: ", " Stage 1 CBT", " The experimental group will receive CBT each session.", " CBT and clinical management: The subjects will receive standardized CBT treatment regularly for 9 sessions(once per week in the first month and once half a month in the second and third months), and each session will last for about 60 minutes.The treatment includes three steps:Concept stage (the first and second sessions): establishment of therapeutic relationships with the subjects; Skills acquisition and repeat stage (the third session to the 8th session): clarification of sources of stress, patients' cognitive and behavioral response to stress. Application and complete price segment (the 9th session): return visit to test efficacy of psychological intervention." ]

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

[ "Adverse Events 1:", " Total: 7/113 (6.19%)", " Febrile neutropenia 1/113 (0.88%)", " Neutropenia 1/113 (0.88%)", " Anaemia 0/113 (0.00%)", " Pancytopenia 1/113 (0.88%)", " Proctitis 1/113 (0.88%)", " Device related sepsis 1/113 (0.88%)", " Gastrointestinal infection 0/113 (0.00%)", " Injection site abscess 1/113 (0.88%)", " Tooth infection 0/113 (0.00%)", " Hip fracture 0/113 (0.00%)", " Blood creatinine increased 1/113 (0.88%)", "Adverse Events 2:", " Total: 6/112 (5.36%)", " Febrile neutropenia 2/112 (1.79%)", " Neutropenia 1/112 (0.89%)", " Anaemia 1/112 (0.89%)", " Pancytopenia 0/112 (0.00%)", " Proctitis 0/112 (0.00%)", " Device related sepsis 0/112 (0.00%)", " Gastrointestinal infection 1/112 (0.89%)", " Injection site abscess 0/112 (0.00%)", " Tooth infection 1/112 (0.89%)", " Hip fracture 1/112 (0.89%)", " Blood creatinine increased 0/112 (0.00%)" ]

[ "INTERVENTION 1: ", " Cohort A - Pegylated Irinotecan to Treat NSCLC", " Patients with non-small cell lung carinoma (NSCLC) will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.", " Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)", "INTERVENTION 2: ", " Cohort C - Pegylated Irinotecan to Treat mBC", " Patients with metastatic breast cancer (MBC) to brain will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.", " Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)" ]

[ "Outcome Measurement: ", " Progression-Free Survival (PFS)", " PFS defined as time from date of randomization to date of the first documentation of objective tumor progression or death due to any cause, whichever occurred first. PFS calculated as (Months) = (first event date minus randomization date plus 1) divided by 30.4.", " Time frame: Baseline up to Month 33", "Results 1: ", " Arm/Group Title: Docetaxel + Sunitinib", " Arm/Group Description: Sunitinib 37.5 milligrams (mg) daily by oral capsule for 2 weeks followed by a 1-week off-treatment period (Schedule 2/1) with docetaxel 75 milligrams per square meter (mg/m^2) every 3 weeks, or sunitinib 37.5 mg daily in continuous dosing (in absence of docetaxel), or docetaxel 100 mg/m^2 every 3 weeks (in absence of sunitinib).", " Overall Number of Participants Analyzed: 296", " Median (95% Confidence Interval)", " Unit of Measure: months Independent radiology assessment: 8.6 (8.2 to 10.3)", " Investigator's assessment: 8.2 (7.3 to 8.6)", "Results 2: ", " Arm/Group Title: Docetaxel", " Arm/Group Description: Docetaxel 100 mg/m^2 every 3 weeks", " Overall Number of Participants Analyzed: 297", " Median (95% Confidence Interval)", " Unit of Measure: months Independent radiology assessment: 8.3 (7.7 to 9.6)", " Investigator's assessment: 6.9 (6.5 to 7.3)" ]

[ "Inclusion Criteria:", " Eligibility Criteria", " Breast cancer diagnosis: Patients must have histologically confirmed adenocarcinoma of the breast requiring comprehensive loco-regional irradiation that includes treatment to the intact breast/chest wall, supraclavicular (SCV), infraclavicular nodes (ICV), and internal mammary nodes (IMN).", " Patients must have pathologic T 1, 2, 3 or 4, N 1, 2, or 3 Stage II or III disease as defined by the AJCC Staging System, 6th edition. Patients who do not undergo axillary staging but are at risk for nodal involvement may also be treated.", " All patients must have left-sided breast cancer.", " Both men and women are eligible.", " Patients must be adults (18 years of age or older)", " For women of child-bearing age, effective contraception must be used. A written statement must be obtained that the patient is not pregnant. If there is any question of pregnancy at time of therapeutic RT or at time of each SPECT-CT scan, a pregnancy test will be done to confirm the patient is not pregnant.", " Performance status should be 0-2 by ECOG criteria.", " Patients that have received prior RT may be enrolled on the present study if the new breast lesion can be treated with no overlap of RT fields.", " Patients must be aware of the neoplastic nature of her/his disease.", " Patients must be informed of the investigational nature of this study and must sign an informed consent in accordance with the Institutional Review Board (IRB) of the University of Michigan and federal guidelines.", " Patients' blood tests should indicate they are able to tolerate radiotherapy. Tests must be done within 28 days of registration:", " CBC with differential and platelet count (Hemoglobin > 8.0 g/dl; wbc > 2000/mm3; absolute neutrophil count > 1000/mm3; platelet count > 75,000/mm3.", "Exclusion Criteria:", " Patients who are pregnant or are nursing are excluded.", " Pathologically node negative breast cancer unless treated with neo-adjuvant chemotherapy.", " Performance status > 2 by ECOG criteria", " Patients who are unable to lie on their back and raise their arm above their head in the treatment planning position for radiotherapy", " Patients with a clinically unstable medical condition", " Patients with a life-threatening disease state", " History or suspicion of serious life-threatening allergic reaction to Tc-99m imaging agents.", " Patients that have had breast-conservation surgery with positive margins or any patient with negative margins with a tumor positive for an extensive intraductal component.", " Patients that are not able to use the ABC device." ]

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

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

[ "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." ]

[ "INTERVENTION 1: ", " Arm I (Omega-3 Fatty Acid)", " Patients receive omega-3 fatty acid PO daily for 7-14 days.", "omega-3 fatty acid: Given PO", " laboratory biomarker analysis: Correlative studies", "INTERVENTION 2: ", " Arm II (Placebo)", " Patients receive placebo PO daily for 7-14 days.", " placebo: Given PO", " laboratory biomarker analysis: Correlative studies" ]

[ "INTERVENTION 1: ", " Arm I (Curcumin-based Gel)", " Patients apply curcumin-based gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.", "Curcumin-based Gel: Applied topically", " Laboratory Biomarker Analysis: Correlative studies", " Questionnaire Administration: Ancillary studies", "INTERVENTION 2: ", " Arm II (HPR Plus)", " Patients apply HPR Plus™ topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.", " Dermatologic Complications Management: Apply HPR Plus topically", " Laboratory Biomarker Analysis: Correlative studies", " Questionnaire Administration: Ancillary studies" ]

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

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

[ "INTERVENTION 1: ", " Arm I", " See Detailed Description", " tipifarnib: Given orally", " paclitaxel: Given IV", " doxorubicin hydrochloride: Given IV", " cyclophosphamide: Given IV", " pegfilgrastim: Given SC", " conventional surgery: surgical procedures performed on patients", " axillary lymph node dissection: correlative study" ]

[ "Outcome Measurement: ", " Progression-free Survival (PFS)", " Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Kaplan-Meier survival curves will be used. A 95% confidence interval for the median PFS will be calculated. A lower bound greater than 8 months would be strong evidence that Nab-Paclitaxel- bevacizumab induction therapy followed by bevacizumab-erlotinib hydrochloride maintenance therapy is superior to paclitaxel and bevacizumab. However, a median PFS of 13 months or greater (regardless of whether the 95% confidence interval for the median extends below 8 months) could also indicate promising results.", " Time frame: Time from date of registration to date of first documentation of progression or symptomatic deterioration or death due to any cause, assessed up to 8 years", "Results 1: ", " Arm/Group Title: Tx (Chemo, MoAb, and Enzyme Inhibitor)", " Arm/Group Description: INDUCTION THERAPY: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.", " MAINTENANCE THERAPY: Patients achieving complete response, partial response, or stable disease after completion of induction therapy will receive bevacizumab IV over 30-90 minutes once every 14 or 21 days and erlotinib hydrochloride PO QD in the absence of disease progression or unacceptable toxicity.", " paclitaxel albumin-stabilized nanoparticle formulation: Given IV", " bevacizumab: Given IV", " erlotinib hydrochloride: Given PO", " Overall Number of Participants Analyzed: 55", " Median (95% Confidence Interval)", " Unit of Measure: Months 9.1 (7.2 to 11.1)" ]

[ "INTERVENTION 1: ", " Arm 1: Yoga Intervention", " Yoga Intervention", " Yoga: Yoga sessions", "INTERVENTION 2: ", " Arm 2: Educational Wellness Group", " Educational Wellness Group", " Education: Educational Wellness Group" ]

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

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

[ "Inclusion Criteria:", " Female subjects participating in FMSU004A protocol with known clinical status", "Exclusion Criteria:", " Subjects with unknown clinical status not participating in FMSU004A protocol." ]

[ "Inclusion Criteria:", " To be included in this study, you must meet the following criteria:", " Locally advanced/inflammatory adenocarcinoma of the breast", " 18 years of age or older", " Normal heart function", " Able to perform activities of daily living with minimal assistance", " No prior chemotherapy for breast cancer", " Adequate bone marrow, liver and kidney function", " No evidence or history of significant cardiovascular abnormalities", " Sentinel node or axillary dissection", " Sign an informed consent form", "Exclusion Criteria:", " You cannot participate in this study if any of the following apply to you:", " Pregnant or breast feeding", " History of heart disease with congestive heart failure", " Heart attack within the previous 6 months", " Prior chemotherapy or hormone therapy for breast cancer", " History of active uncontrolled infection", " 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." ]

[ "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" ]

[ "INTERVENTION 1: ", " Healthy Volunteers", " Healthy women will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection, and SWIFT acquisition.", " Magnetic resonance imaging: Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:", " an IV line is placed by nurse,", " patient is placed in the 4 T MRI scanner at CMRR,", " initial scout images and manual linear shims are adjusted,", " Pre-contrast SWIFT T1 weighted images and T1 map are obtained,", " continuous SWIFT acquisition begins immediately before contrast injection,", " contrast injection,", " continuous SWIFT acquisition continues for 12 min after contrast,", " late enhancement images may also be obtained.", " 10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compared to prior FLASH-DCE methods.", "INTERVENTION 2: ", " Breast Cancer Patients", " Breast cancer patients who have suspected breast lesion that will be biopsied will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection and SWIFT acquisition.", " Magnetic resonance imaging: Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:", " an IV line is placed by nurse,", " patient is placed in the 4 T MRI scanner at CMRR,", " initial scout images and manual linear shims are adjusted,", " Pre-contrast SWIFT T1 weighted images and T1 map are obtained,", " continuous SWIFT acquisition begins immediately before contrast injection,", " contrast injection,", " continuous SWIFT acquisition continues for 12 min after contrast,", " late enhancement images may also be obtained.", " 10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compar" ]

[ "INTERVENTION 1: ", " Hydrophor (Group A)", " Group A (current standard of care): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Hydrophor daily, starting at the onset of radiation therapy (RT) and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Hydrophor application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Hydrophor within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.", " Hydrophor (Group A): Rehydrates dry, chapped or chafed skin", "May be used alone as a skin lubricant or protectant", "INTERVENTION 2: ", " MediHoney (Group B)", " Group B (study target): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Medihoney daily, starting at the onset of RT and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Medihoney application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Medihoney within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.", " MediHoney (Group B): It helps the body's natural healing processes in three key ways which have been shown to have healing benefits:", " Maintain a balanced environment for healing.", " Aids in reducing dermatitis.", " Reduce affected area pH.2-3" ]

[ "Adverse Events 1:", " Total: 21/107 (19.63%)", " Febrile neutropenia * 10/107 (9.35%)", " Neutropenia * 1/107 (0.93%)", " Left ventricular dysfunction * 0/107 (0.00%)", " Angina pectoris * 0/107 (0.00%)", " Cardiac failure congestive * 0/107 (0.00%)", " Diarrhoea * 2/107 (1.87%)", " Abdominal strangulated hernia * 0/107 (0.00%)", " Duodenal ulcer haemorrhage * 0/107 (0.00%)", " Pyrexia * 1/107 (0.93%)", "Adverse Events 2:", " Total: 22/107 (20.56%)", " Febrile neutropenia * 8/107 (7.48%)", " Neutropenia * 6/107 (5.61%)", " Left ventricular dysfunction * 3/107 (2.80%)", " Angina pectoris * 1/107 (0.93%)", " Cardiac failure congestive * 0/107 (0.00%)", " Diarrhoea * 0/107 (0.00%)", " Abdominal strangulated hernia * 1/107 (0.93%)", " Duodenal ulcer haemorrhage * 0/107 (0.00%)", " Pyrexia * 1/107 (0.93%)" ]

[ "Adverse Events 1:", " Total: 19/213 (8.92%)", " Pancytopenia 0/213 (0.00%)", " Anaemia 1/213 (0.47%)", " Atrial fibrillation 0/213 (0.00%)", " Cardiac failure congestive 0/213 (0.00%)", " Myocardial infarction 0/213 (0.00%)", " Supraventricular tachycardia 0/213 (0.00%)", " Diarrhoea 0/213 (0.00%)", " Colitis 0/213 (0.00%)", " Vomiting 1/213 (0.47%)", " Nausea 1/213 (0.47%)", " Enterocolitis 0/213 (0.00%)", "Adverse Events 2:", " Total: 133/416 (31.97%)", " Pancytopenia 1/416 (0.24%)", " Anaemia 0/416 (0.00%)", " Atrial fibrillation 2/416 (0.48%)", " Cardiac failure congestive 1/416 (0.24%)", " Myocardial infarction 1/416 (0.24%)", " Supraventricular tachycardia 1/416 (0.24%)", " Diarrhoea 32/416 (7.69%)", " Colitis 14/416 (3.37%)", " Vomiting 4/416 (0.96%)", " Nausea 3/416 (0.72%)", " Enterocolitis 2/416 (0.48%)" ]

[ "Adverse Events 1:", " Total: 83/680 (12.21%)", " Hemoglobin 11/680 (1.62%)", " Transfusion: Platelets 0/680 (0.00%)", " Transfusion: pRBCs 0/680 (0.00%)", " Febrile neutropenia 49/680 (7.21%)", " Edema 1/680 (0.15%)", " Ischemia/infarction 0/680 (0.00%)", " Palpitations 0/680 (0.00%)", " Pericardial effusion 0/680 (0.00%)", " Keratitis 1/680 (0.15%)", " Double vision 1/680 (0.15%)", " Colitis 1/680 (0.15%)", "Adverse Events 2:", " Total: 86/688 (12.50%)", " Hemoglobin 15/688 (2.18%)", " Transfusion: Platelets 1/688 (0.15%)", " Transfusion: pRBCs 1/688 (0.15%)", " Febrile neutropenia 41/688 (5.96%)", " Edema 0/688 (0.00%)", " Ischemia/infarction 0/688 (0.00%)", " Palpitations 1/688 (0.15%)", " Pericardial effusion 1/688 (0.15%)", " Keratitis 0/688 (0.00%)", " Double vision 0/688 (0.00%)", " Colitis 0/688 (0.00%)" ]

[ "Outcome Measurement: ", " Dose Limiting Toxicity (DLT) of Dose-escalating BYL719 in Combination With T-DM1", " DLTs of BYL719 in combination with T-DM1 will be assessed using National Cancer Institute's Common Toxicity Criteria for adverse events version 4.0 (except for hyperglycemia). A DLT is described any grade 3 or higher, clinically significant toxicity (excluding alopecia) experienced during the first 21 days following first dose of BYL719 that is determined to be at least possibly related to study medication. Lower grades may also be considered DLTs if they lead to a dose interruption of more than 7 consecutive days of BYL719. In general adverse events (AEs) will be graded according to the following:", " Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE", " Time frame: The 1st 21 days (Cycle 1) of treatment", "Results 1: ", " Arm/Group Title: Cohort -1 (250mg BYL719, 3.6mg/kg T-DM1)", " Arm/Group Description: Patients receive 250 mg PO daily PI3K inhibitor BYL719 on days 1-21 and 3.6mg/kg IV over 30-90 minutes on day 1 ado-trastuzumab emtansine (T-DM1). Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.", " PI3K inhibitor BYL719: Given PO", " Ado-trastuzumab emtansine: Given IV", " Pharmacological study: Correlative studies", " Laboratory biomarker analysis: Optional correlative studies", " Overall Number of Participants Analyzed: 3", " Measure Type: Count of Participants", " Unit of Measure: Participants Thrombocytopenia: 0 0.0%", "Rash Maculopapular: 0 0.0%", "Results 2: ", " Arm/Group Title: Cohort 1 (300mg BYL719, 3.6mg/kg T-DM1)", " Arm/Group Description: Patients receive 300 mg PO daily PI3K inhibitor BYL719 on days 1-21 and 3.6mg/kg IV over 30-90 minutes on day 1 ado-trastuzumab emtansine (T-DM1). Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.", " PI3K inhibitor BYL719: Given PO", " Ado-trastuzumab emtansine: Given IV", " Pharmacological study: Correlative studies", " Laboratory biomarker analysis: Optional correlative studies", " Overall Number of Participants Analyzed: 5", " Measure Type: Count of Participants", " Unit of Measure: Participants Thrombocytopenia: 1 20.0%", "Rash Maculopapular: 2 40.0%" ]

[ "Outcome Measurement: ", " Endoxifen Concentrations in Participants Receiving Tamoxifen Citrate Dose of 20 mg or 40 mg Stratified by the Metabolizing CYP2D6 Genotypes", " Measurements of plasma concentrations of the key active metabolite of tamoxifen, endoxifen, were measured at baseline and after 4 months of treatment; The most common CYP2D6 alleles have been grouped by functional activity classifications with descending activity: ultra-rapid (UM), extensive (EM), intermediate (IM) or poor (PM) metabolism. A given patient has two alleles, giving them 10 possible allelic combinations, or diplotypes (UM/UM, UM/EM, EM/EM, etc.). These diplotypes are collapsed into four phenotypes, UM, EM, IM or PM.", " Time frame: 4 months", "Results 1: ", " Arm/Group Title: Ultra-rapid Metabolizers", " Arm/Group Description: Those with the highest transformation of the CYP2D6 genotype to allelic activity", " Overall Number of Participants Analyzed: 5", " Mean (Standard Deviation)", " Unit of Measure: ng/mL Baseline endoxifen concentration: 5 participants", " 8.4 (4.59)", " 4-Month endoxifen concentration: 4 participants", " 15.35 (5.48)", "Results 2: ", " Arm/Group Title: Extensive Metabolizers", " Arm/Group Description: Those with the most normal transformation of the CYP2D6 genotype to allelic activity", " Overall Number of Participants Analyzed: 119", " Mean (Standard Deviation)", " Unit of Measure: ng/mL Baseline endoxifen concentration: 119 participants", " 10.00 (6.00)", " 4-Month endoxifen concentration: 106 participants", " 9.30 (5.03)" ]

[ "Outcome Measurement: ", " Progression-free Survival (PFS)", " PFS was defined as the interval from study entry until disease progression or death resulting from any cause, which ever occurred first. Progression is defined as a 20% increase in the sum of longest diameter of target lesions (per RECIST criteria).", " Time frame: Interval from randomization until disease progression or death, whichever occurs first, assessed up to 5 years", "Results 1: ", " Arm/Group Title: Arm I (Lapatinib)", " Arm/Group Description: Patients receive 1500 mg lapatinib ditosylate PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg)of each subsequent course.", " Overall Number of Participants Analyzed: 146", " Median (95% Confidence Interval)", " Unit of Measure: months 4.7 (3.7 to 5.7)", "Results 2: ", " Arm/Group Title: Arm II (Placebo)", " Arm/Group Description: Patients receive placebo PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg) of each subsequent course.", " Overall Number of Participants Analyzed: 145", " Median (95% Confidence Interval)", " Unit of Measure: months 3.8 (3.8 to 5.6)" ]

[ "Outcome Measurement: ", " Number of Participants With Overall Response (OR), Defined as Those Participants Achieving Complete Response (CR) or Partial Response (PR), Assessed Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 and Cutaneous Lesions", " RECIST-based response assessment was done at Weeks (Wks) 4 and 8 and every 8 weeks thereafter. Cutaneous disease assessment was done at Wk 4 and every 4 weeks thereafter. OR was evaluated when the skin and RECIST assessments coincided. Per RECIST, CR is the disappearance of all target and non-target lesions; PR is at least a 30 percent (%) decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference the baseline sum LD. Cutaneous disease contained non-measurable and measurable skin disease, which was assessed by skin assessment tools.", " Time frame: Baseline until disease progression/recurrence was documented, assessed for up to 66 weeks", "Results 1: ", " Arm/Group Title: Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo", " Arm/Group Description: Participants received oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) once daily (QD).", " Overall Number of Participants Analyzed: 38", " Measure Type: Number", " Unit of Measure: participants 11", "Results 2: ", " Arm/Group Title: Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg", " Arm/Group Description: Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with pazopanib 800 mg (2 x 400 mg tablets) QD.", " Overall Number of Participants Analyzed: 38", " Measure Type: Number", " Unit of Measure: participants 17" ]

[ "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." ]

[ "DISEASE CHARACTERISTICS:", " Histologically or cytologically confirmed infiltrating breast cancer", " Clinical evidence of metastatic disease", " Measurable disease, defined as at least one measurable lesion per RECIST criteria", " No non-measurable disease only, defined as all other lesions, including small lesions (longest diameter < 2 cm) and truly non-measurable lesions, including any of the following:", " Bone lesions", " Leptomeningeal disease", " Ascites", " Pleural/pericardial effusion", " Inflammatory breast disease", " Lymphangitis cutis/pulmonis", " Abdominal masses that are not confirmed and followed by imaging techniques", " Cystic lesions", " Patients with HER-2/neu positive tumors, must have received prior treatment with trastuzumab (Herceptin®) or have a contraindication for trastuzumab", " No evidence of active brain metastasis, including leptomeningeal involvement, on MRI or CT scan", " CNS metastasis controlled by prior surgery and/or radiotherapy allowed", " Must be asymptomatic for 2 months with no evidence of progression prior to study entry", " Hormone receptor status not specified", " PATIENT CHARACTERISTICS:", " Menopausal status not specified", " Life expectancy 12 weeks", " ECOG performance status 0-1", " ANC 1,500/mm³", " Platelet count 100,000/mm³", " Hemoglobin 9.0 g/dL", " AST and ALT 2.5 times upper limit of normal (ULN)", " Alkaline phosphatase 2.5 times ULN", " Total bilirubin 1.5 times ULN", " Creatinine 1.5 mg/dL", " Urine protein:creatinine ratio < 1 or urinalysis < 1+ protein", " Patients discovered to have 1+ proteinuria at baseline must demonstrate 24-hour urine protein < 1 g", " Not pregnant or nursing", " Negative pregnancy test", " Fertile patients must use effective contraception during and for 30 days after completion of study therapy", " Able to complete questionnaires alone or with assistance", " No peripheral neuropathy > grade 1", " No history of allergy or hypersensitivity to albumin-bound paclitaxel, paclitaxel, gemcitabine hydrochloride, bevacizumab, albumin, drug product excipients, or chemically similar agents", " No stage III or IV invasive, non-breast malignancy within the past 5 years", " No other active malignancy, except nonmelanoma skin cancer or carcinoma in situ of the cervix", " Patient must not be receiving other specific treatment for a prior malignancy", " No uncontrolled hypertension (i.e., blood pressure [BP] > 160/90 mm Hg on 2 occasions at least 5 minutes apart)", " Patients who have recently started or adjusted antihypertensive medications are eligible providing that BP is < 140/90 mm Hg on any new regimen for 3 different observations in 14 days", " No bleeding diathesis or uncontrolled coagulopathy", " No hemoptysis within the past 6 months", " No prior arterial or venous thrombosis within the past 12 months", " No history of cerebrovascular accident", " No history of hypertensive crisis or hypertensive encephalopathy", " No abdominal fistula or gastrointestinal perforation within the past 6 months", " No serious non-healing wound, ulcer, or fracture", " No clinically significant cardiac disease, defined as any of the following:", " Congestive heart failure", " Symptomatic coronary artery disease", " Unstable angina", " Cardiac arrhythmias not well controlled with medication", " Myocardial infarction within the past 12 months", " No comorbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for study entry or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens", " PRIOR CONCURRENT THERAPY:", " See Disease Characteristics", " No prior chemotherapy for metastatic disease", " May have received one prior adjuvant chemotherapy regimen", " Prior neoadjuvant chemotherapy allowed", " More than 6 months since prior adjuvant or neoadjuvant taxane (i.e., docetaxel or paclitaxel) therapy", " Prior hormonal therapy in either adjuvant or metastatic setting allowed", " More than 4 weeks since prior radiotherapy (except if to a non-target lesion only, or single dose radiation for palliation)", " Prior radiotherapy to a target lesion is allowed provided there has been clear progression of the lesion since radiotherapy was completed", " More than 4 weeks since prior cytotoxic chemotherapeutic agent or investigational drug", " More than 2 weeks since prior and no concurrent acetylsalicylic acid, anticoagulants, or thrombolytic agents (except for once-daily 81 mg acetylsalicylic acid)", " More than 6 weeks since prior major surgery, chemotherapy, or immunologic therapy", " More than 1 week since prior minor surgery (e.g., core biopsy)", " Placement of a vascular access device within 7 days is allowed", " More than 3 months since prior neurosurgery", " No concurrent treatment in a different clinical study in which investigational procedures are performed or investigational therapies are administered", " Trials related to symptom management (Cancer Control) which do not employ hormonal treatments or treatments that may block the path of the targeted agents used in this study may be allowed" ]

[ "Outcome Measurement: ", " Progression Free Survival (PFS) as Per RECIST v1.1 (by Local Investigator Assessment)", " PFS Results presented for all MCS110 treated patients (with and without day 8 dose), in line with phase 2 study design.", " Time frame: 4 years", "Results 1: ", " Arm/Group Title: All MCS110+Carboplatin+Gemcitabine", " Arm/Group Description: experimental. all MCS110 treated patients, with 10mg/kg intravenous infusion, on day 1 and days 1 & 8", " Overall Number of Participants Analyzed: 34", " Median (90% Confidence Interval)", " Unit of Measure: months 5.6 (4.5 to 8.7)", "Results 2: ", " Arm/Group Title: Carboplatin+Gemcitabine", " Arm/Group Description: comparator. Gemcitabine: Intravenous infusion 1000 mg/m2 Days 1 & 8 Carboplatin: Intravenous infusion AUC 2 Days 1 & 8", " Overall Number of Participants Analyzed: 16", " Median (90% Confidence Interval)", " Unit of Measure: months 5.5 (3.5 to 7.5)" ]

[ "Outcome Measurement: ", " Best Overall Response of Everolimus and Exemestane Treatment in Postmenopausal Women With Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer", " The best Overall Response (OR) for each patient is determined from the sequence of investigator overall lesion responses according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1.). To be assigned a best OR of Complete Responese (CR) at least two determinations of CR at least 4 weeks apart before progression are required. To be assigned a best OR of Partial Response (PR) at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR) are required.The Overall Response Rate (ORR) was defined as the proportion of patients with a best OR of confirmed CR or PR by week 48.", " Time frame: At 48 weeks", "Results 1: ", " Arm/Group Title: Everolimus and Exemestane", " Arm/Group Description: Postmenopausal women diagnosed with oestrogen receptor positive locally advanced or metastatic breast cancer will receive everolimus at a dose of 10mg daily p.o. and exemestane 25mg daily p.o.", " Overall Number of Participants Analyzed: 49", " Measure Type: Number", " Unit of Measure: participants Patients with measurable disease at baseline: 39", " Patients with non-measurable disease at baseline: 10", " Best at WK 48 - Complete Response (CR): 0", " Best at WK 48 - Partial Response (PR): 7", " Best at WK 48 - Stable Disease (SD): 18", " Best at WK 48 - Progressive Disease (PD): 15", "Unknown: 1", "Missing: 8" ]

[ "INTERVENTION 1: ", " Arm I (Omega-3-fatty Acid)", " Patients receive oral omega-3-fatty acid twice daily (BID) or three times daily (TID) for 24 weeks in the absence of disease progression or unacceptable toxicity", "INTERVENTION 2: ", " Arm II (Placebo)", " Patients receive oral placebo BID or TID for 24 weeks in the absence of disease progression or unacceptable toxicity" ]

[ "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." ]

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

[ "INTERVENTION 1: ", " 0.005% Estriol Vaginal Gel", " Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel, containing 50 Mcg of estriol Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration", "INTERVENTION 2: ", " Placebo Vaginal Gel", " Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel. Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration", "Placebo" ]

[ "INTERVENTION 1: ", " One-port", " intervention is placement of one-port tissue expander at time of reconstruction", " Allergen one-port tissue expander placement: patients will be randomized to receive a one port or two port tissue expander for breast reconstruction", "INTERVENTION 2: ", " Two-port", " intervention is placement of two-port tissue expander at time of reconstruction", " AlloX2 two-port tissue expander placement: patients will be randomized to receive a one port or two port tissue expander for breast reconstruction" ]

[ "INTERVENTION 1: ", " Phase I: Cyclophosphamide, Doxil, Trastuzumab", " Patients receive oral cyclophosphamide once daily on days 1-28 and pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.", " pegylated liposomal doxorubicin hydrochloride: Given IV", " cyclophosphamide: Given orally", " trastuzumab: Given IV" ]

[ "INTERVENTION 1: ", " Phase I: Dasatinib 100mg/Trastuzumab 2mg/kg/Paclitaxel 80mg/m2", " Cohort 1: Eligible patients were enrolled and treated with 4-week cycles of trastuzumab 2 mg/kg IV weekly (following a loading dose of 4 mg/kg in cycle 1) and paclitaxel 80 mg/m2 weekly x 3 weeks followed by a rest period of 7 days. Dasatinib 100mg was administered orally once daily (QD). Treatment was repeated on Day 1 of a 28-day cycle until radiographic or symptomatic progression or unacceptable toxicity occured. Only in the phase I, the first cycle lasted 38 days.", "INTERVENTION 2: ", " Phase I: Dasatinib 140mg/Trastuzumab 2mg/kg/Paclitaxel 80mg/m2", " Cohort 2: Eligible patients were enrolled and treated with 4-week cycles of trastuzumab 2 mg/kg IV weekly (following a loading dose of 4 mg/kg in cycle 1) and paclitaxel 80 mg/m2 weekly x 3 weeks followed by a rest period of 7 days. Dasatinib 140mg was administered orally once daily (QD). Treatment was repeated on Day 1 of a 28-day cycle until radiographic or symptomatic progression or unacceptable toxicity occured. Only in the phase I, the first cycle lasted 38 days." ]

[ "Inclusion Criteria:", " HER2-positive disease determined locally", " Histologically or cytologically confirmed invasive breast cancer", " Prior treatment for breast cancer in the adjuvant, unresectable, locally advanced or metastatic setting must include both chemotherapy, alone or in combination with another agent, and an anti-HER2 agent, alone or in combination with another agent", " Documented progression of incurable, unresectable, LABC, or mBC, defined by the investigator: progression must occur during or after most recent treatment for LABC/mBC or within 6 months of completing adjuvant therapy", " Measurable and/or non-measurable disease", " Left ventricular ejection fraction (LVEF) >/=50% by either echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA)", " Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2", " Adequate organ function", " Use of highly effective contraception as defined by the protocol", "Exclusion Criteria:", " History of treatment with trastuzumab emtansine", " Prior enrollment into a clinical study containing trastuzumab emtansine regardless of having received trastuzumab emtansine or not", " Peripheral neuropathy of Grade >/= 3 per National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) v 4.0", " History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage 1 uterine cancer, synchronous or previously diagnosed HER2-positive breast cancer", " History of receiving any anti-cancer drug/biologic or investigational treatment within 21 days prior to first study treatment except hormone therapy, which can be given up to 7 days prior to first study treatment; recovery of treatment-related toxicity consistent with other eligibility criteria", " History of exposure to cumulative doses of anthracyclines", " History of radiation therapy within 14 days of first study treatment. The participant must have recovered from any resulting acute toxicity (to Grade </=1) prior to first study treatment.", " Metastatic central nervous system (CNS) disease only", " Brain metastases which are symptomatic", " History of a decrease in LVEF to less than (<) 40% or symptomatic congestive heart failure (CHF) with previous trastuzumab treatment", " History of symptomatic CHF (New York Heart Association [NYHA] Classes II-IV) or serious cardiac arrhythmia requiring treatment", " History of myocardial infarction or unstable angina within 6 months of first study treatment", " Current dyspnea at rest due to complications of advanced malignancy or requirement for continuous oxygen therapy", " Current severe, uncontrolled systemic disease (clinically significant cardiovascular, pulmonary, or metabolic disease)", " Pregnancy or lactation", " Currently known active infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus", " History of intolerance (such as Grade 3-4 infusion reaction) or hypersensitivity to trastuzumab or murine proteins or any component of the product" ]

[ "Inclusion Criteria:", " Elevated risk of breast cancer defined as having at least one of the following: (1) Predicted 5-year modified Gail model risk of 1.67% or greater, (2) Lobular carcinoma in situ, (3) Known BRCA1 or BRCA2 deleterious mutation carrier, (4) Prior history of ductal carcinoma in situ, if no current tamoxifen use or prior radiation to the contralateral breast.", " Age 21 years or older.", " Postmenopausal defined as > 6 months since the last menstrual period, prior bilateral oophorectomy, or serum follicle-stimulating hormone (FSH)/luteinizing hormone (LH) values consistent with institutional normal values for the postmenopausal state.", " Baseline mammographic density 25% as assessed qualitatively by the mammographer (25-50% = \"scattered fibroglandular densities\"; >50-75% = \"heterogeneously dense breasts\"; >75% = \"extremely dense breasts\").", " Baseline serum 25-hydroxyvitamin D <32 ng/ml.", " Normal breast exam and mammogram (Breast Imaging Reporting and Data System (BIRADS) score of 1 or 2) or abnormal breast imaging with a benign breast biopsy without evidence of cancer. Normal baseline breast magnetic resonance imaging (MRI) (BIRADS score of 1, 2, or 3).", " Prior tamoxifen or raloxifene use is allowed provided treatment is discontinued at least 28 days prior to enrollment.", " At least one breast available for imaging. No bilateral breast implants.", " Willingness to not take vitamin D supplements during the one year intervention, but up to 1000mg of calcium supplementation is allowed.", " Normal serum calcium.", " Adequate renal and hepatic function: serum creatinine, bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase < 2.0 x the institutional upper limit of normal (IULN).", " Performance status of 0 or 1.", "Exclusion Criteria:", " Other prior malignancy. The following is allowed: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the participant is currently in complete remission, or any other cancer (including breast cancer) for which the participant has been disease-free for 5 years.", " History of kidney stones.", " Hypersensitivity reactions to vitamin D.", " On estrogen replacement therapy.", " Significant medical or psychiatric condition that would preclude study completion." ]

[ "Outcome Measurement: ", " Primary Endpoint : Compare Best Overall Response Rate (ORR) (According to Response Evaluation Criteria in Solid Tumor [RECIST] 1.1 Criteria) at Week 24 of MYL-1401O Plus Taxane Versus Herceptin® Plus Taxane in the ITT1 Population", " Tumor measurements were perform by centralized blinded reviewers using RECIST 1.1 criteria. Per RECIST 1.1: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to <10 mm.Partial Response (PR): >/= 30% decrease sum of the diameters of target lesions from baseline sum diameters.", " Progressive Disease (PD): </= 20% increase in the sum of the diameters of target lesions, from the smallest sum on study with at least a 5 mm absolute increase in the sum of all lesions. The appearance of one or more new lesions* denotes disease progression.", " Stable Disease (SD): Neither sufficient decrease or increase. Evaluation of Non-Target Lesions Complete Response (CR): Disappearance of all non-target lesions. Non-complete Response/Non-Progressive Disease: Persistence of one or more non-target lesions. Progressive Disease (PD): Substantial, unequivocal progression of existing non-target lesions.", " Time frame: from time of First treatment to week 24", "Results 1: ", " Arm/Group Title: Herceptin + Taxane", " Arm/Group Description: Part 1: Herceptin (trastuzumab) intravenously+ paclitaxel 80 mg/m2 weekly intravenously or docetaxel 75 mg/m2 intravenously once every three weeks (investigators choice) for 8 cycles then evaluate for primary endpoint.", " Part 2: If SD or PR, CR at cycle 9 (week 24) proceed to Herceptin (trastuzumab) alone once every 3 weeks until DP or subject withdrawal .", " Overall Number of Participants Analyzed: 228", " Measure Type: Count of Participants", " Unit of Measure: Participants Complete Response: 0 0.0%", " Partial Response: 146 64.0%", " Stable Disease: 49 21.5%", " Progressive Disease: 20 8.8%", " Not Evaluable: 13 5.7%", "Results 2: ", " Arm/Group Title: MYL-1401O Trastuzumab + Taxane", " Arm/Group Description: Part 1:Myl 1401OTrastuzumab Intravenously + paclitaxel 80 mg/m2 weekly intravenously or docetaxel 75 mg/m2 intravenously once every three weeks (investigators choice) for 8 cycles then evaluate for primary endpoint.", " Part 2: If SD or PR, CR at cycle 9 (week 24) proceed to Myl 1401O( Mylan Trastuzumab) alone once every 3 weeks until DP or subject withdrawal.", " Overall Number of Participants Analyzed: 230", " Measure Type: Count of Participants", " Unit of Measure: Participants Complete Response: 3 1.3%", " Partial Response: 157 68.3%", " Stable Disease: 48 20.9%", " Progressive Disease: 9 3.9%", " Not Evaluable: 13 5.7%" ]

[ "Outcome Measurement: ", " Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12", " Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.", " Time frame: 12 months", "Results 1: ", " Arm/Group Title: Denosumab 60 mg Q6M", " Arm/Group Description: [Not Specified]", " Overall Number of Participants Analyzed: 123", " Least Squares Mean (95% Confidence Interval)", " Unit of Measure: Percent Change from Baseline 4.8 (4.3 to 5.4)", "Results 2: ", " Arm/Group Title: Placebo", " Arm/Group Description: [Not Specified]", " Overall Number of Participants Analyzed: 122", " Least Squares Mean (95% Confidence Interval)", " Unit of Measure: Percent Change from Baseline -.7 (-1.3 to -.1)" ]

[ "INTERVENTION 1: ", " Cohort A - Pegylated Irinotecan to Treat NSCLC", " Patients with non-small cell lung carinoma (NSCLC) will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.", " Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)", "INTERVENTION 2: ", " Cohort C - Pegylated Irinotecan to Treat mBC", " Patients with metastatic breast cancer (MBC) to brain will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.", " Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)" ]

[ "INTERVENTION 1: ", " Stage 1 Clinical Management", " The group will receive clinical management treatment only each session.", " Clinical Management: Clinical management is a clear contrast method of psychological therapy, which is a half-structured interview and lasting for 20-25 minutes each session. Clinical management will be assigned to both experimental group and controlled group in the first stage of intervention.", " Following are major elements:", " Talk to the subjects to find their main problems; introduce knowledge and medication knowledge about cancer and depression; subjects reporting use of drugs for cancer and depression and a variety of signs and symptoms of the reaction. Encourage patients to adhere to drug treatment and to comply with this research program; The operation of CBT and clinical management should be conducted by the same person as far as possible.", "INTERVENTION 2: ", " Stage 1 CBT", " The experimental group will receive CBT each session.", " CBT and clinical management: The subjects will receive standardized CBT treatment regularly for 9 sessions(once per week in the first month and once half a month in the second and third months), and each session will last for about 60 minutes.The treatment includes three steps:Concept stage (the first and second sessions): establishment of therapeutic relationships with the subjects; Skills acquisition and repeat stage (the third session to the 8th session): clarification of sources of stress, patients' cognitive and behavioral response to stress. Application and complete price segment (the 9th session): return visit to test efficacy of psychological intervention." ]

[ "INTERVENTION 1: ", " Neratinib 240, Prior Trastuzumab", " Neratinib: 80mg capsules and 40mg coated tablets taken orally in prescribed dose of 240mg daily, as long as tolerated and disease does not worsen in participants with prior trastuzumab treatment.", "INTERVENTION 2: ", " Neratinib 240, No Prior Trastuzumab", " Neratinib: 80mg capsules and 40mg coated tablets taken orally in prescribed dose of 240mg daily, as long as tolerated and disease does not worsen in participants with no prior trastuzumab treatment." ]

[ "Outcome Measurement: ", " Feasibility of PBI Directed External Radiotherapy as Measured by Percentage of Participants Achieving a Dosimetrically Satisfactory Treatment Plan", " -The study will be deemed infeasible if more than 4 patients cannot be given treatment because her tumor is such that a dosimetrically satisfactory treatment plan cannot be devised for her.", " Time frame: Within 1 year of protocol registration", "Results 1: ", " Arm/Group Title: Cohort 1 (36 Gy)", " Arm/Group Description: 36 Gy in 9 fractions BID x 4 1/2 treatment days", " Partial Breast Irradiation (PBI)", " Overall Number of Participants Analyzed: 50", " Measure Type: Number", " Unit of Measure: percentage of participants 100", "Results 2: ", " Arm/Group Title: Cohort 2 (40 Gy)", " Arm/Group Description: 40 Gy in 10 fractions BID over 5 treatment days", " Partial Breast Irradiation (PBI)", " Overall Number of Participants Analyzed: 50", " Measure Type: Number", " Unit of Measure: percentage of participants 100" ]

[ "Inclusion Criteria:", " Participants with a confirmed diagnosis of clinical stage 1 or 2 breast cancer", " Participants who are undergoing breast cancer surgery with lumpectomy or mastectomy", " Participants with planned axillary sentinel node biopsy procedure", "Exclusion Criteria:", " Participants with cancer > 3 cm", " Participants with clinically positive nodes", " Participants with prior surgery for breast cancer in the index breast", " Participants who have had bilateral breast surgeries", " Thyroid dysfunction", " Hypersensitivity to iodine", " Hepatic insufficiency", " Renal insufficiency" ]

[ "Inclusion Criteria:", " Stage IIIB, IIIC, or IV erbB2 (HER2) positive breast cancer", " Prior use of Herceptin (trastuzumab), and a taxane", " Adequate cardiac and renal function", "Exclusion Criteria:", " More than 2 prior Herceptin (trastuzumab) regimens or prior use of Xeloda (capecitabine) and / or Tykerb (lapatinib) [Tyverb]", " Bone as the only site of disease", " Active central nervous system metastases (subjects should be stable and off anticonvulsants and steroids)", " Significant gastrointestinal disorder with diarrhea as major symptom" ]

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

[ "INTERVENTION 1: ", " Letrozole + MRI", " 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." ]

[ "Inclusion Criteria:", " Patients must be women with a histologically confirmed diagnosis of breast cancer that is more than 2 cm and/or lymph node positive. Histologic confirmation shall be by either core needle biopsy or incisional biopsy. Punch biopsy is allowed if invasive breast cancer is documented.", " Patients must meet one of the criteria defined below (indicate one):", " Selected Stage IIB (T3, N0, M0) or IIIA (T3, N1-2, M0) disease judged primarily unresectable by an experienced breast surgeon; or otherwise deemed - appropriate candidates for neoadjuvant treatment.", " Stage IIIB (T4, Any N, M0) or (Any T, N3, M0) disease.", " Physical examination, chest x-ray and any x-rays or scans needed for tumor assessment must be performed within 90 days prior to registration.", " All patients must have a multiple gated acquisition (MUGA) scan or echocardiogram scan performed within 90 days prior to registration and left ventricular ejection fraction (LVEF) percentage must be greater than the institutional lower limit of normal.", " Patients must have a serum creatinine and bilirubin the institutional upper limit of normal, and an serum glutamate oxaloacetate transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) 2x the institutional upper limit of normal. These tests must have been performed within 90 days prior to registration.", " Patients must have an absolute neutrophil count (ANC) of 1,500/μl and a platelet count of 100,000/μl. These tests must have been performed within 90 days prior to registration.", " Patients must have a performance status of 0-2 by Zubrod criteria", " In calculating days of tests and measurements, the day a test or measurement is done is considered Day 0. Therefore, if a test is done on a Monday, the Monday four weeks later would be considered Day 28. This allows for efficient patient scheduling without exceeding the guidelines. If Day 28 or 42 falls on a weekend or holiday, the limit may be extended to the next working day.", " All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.", "Exclusion Criteria:", " Patients with the clinical diagnosis of congestive heart failure or angina pectoris are NOT eligible.", " Pregnant or nursing women may not participate due to the possibility of fetal harm or of harm to nursing infants from this treatment regimen. Women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method. A urine pregnancy test is required for women of childbearing potential." ]

[ "INTERVENTION 1: ", " Lapatinib Plus Paclitaxel", " Participants received lapatinib 1500 mg orally OD with paclitaxel, administered as a 1-hour IV infusion at a dose of 80 mg/m^2 on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal." ]

[ "INTERVENTION 1: ", " Urea/Lactic Acid Cream", " Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily.", "INTERVENTION 2: ", " Placebo Cream", " Patients receive placebo cream applied to palms and soles twice daily." ]

[ "Outcome Measurement: ", " Percentage of Patients With Pathological Complete Response (pCR) in Patients Who Have Fatty Acid Synthase (FASN) Expression", " pCR is defined as no invasive disease in the breast of axilla at the time of definitive surgery. A patient is considered to have FASN expression if the positivity was >= 15% at the baseline or after 4-7 days of Omeprazole monotherapy. FASN expression is evaluated using immunohistochemistry in core biopsy samples. The percent of patients with FASN expression that have pCR will be calculated with an exact 95% confidence interval.", " Time frame: Up to 6 months", "Results 1: ", " Arm/Group Title: High Dose Omeprazole Treatment", " Arm/Group Description: Patients will be treated with omeprazole 80 mg orally BID beginning 4-7 days prior to chemotherapy and continuing until surgery.", " Overall Number of Participants Analyzed: 29", " Measure Type: Number", " Unit of Measure: percentage of participants 72.4 (52.8 to 87.3)" ]

[ "Outcome Measurement: ", " Central Nervous System (CNS) Progression-free Survival(PFS)", " The number of patients that are documented to have progression free survival at 3 months after treatment. Progression free is define as <25% increase in tumor area.", " PFS will be measured from the date of entry into the trial to the date of documented progression of brain metastases or death.", " Time frame: 3 months after treatment", "Results 1: ", " Arm/Group Title: Epothilone B: Group A", " Arm/Group Description: Group A: Patients with progressive, radiographically measurable parenchymal brain metastases after whole brain radiation therapy (WBRT). Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.", " Overall Number of Participants Analyzed: 45", " Measure Type: Number", " Unit of Measure: participants 12", "Results 2: ", " Arm/Group Title: Epothilone B: Group B", " Arm/Group Description: Group B: an exploratory cohort of patients, with either leptomeningeal metastases (LMD) or unirradiated, asymptomatic brain metastasis from breast cancer (BCBM).Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.", " Overall Number of Participants Analyzed: 10", " Measure Type: Number", " Unit of Measure: participants 2" ]

[ "Adverse Events 1:", " Total: 7/42 (16.67%)", " Febrile neutropenia 1/42 (2.38%)", " Left venrticular dysfunction 1/42 (2.38%)", " Cardiac valve disease 1/42 (2.38%)", " Diarrhoea 0/42 (0.00%)", " Abdominal pain 1/42 (2.38%)", " Colitis 0/42 (0.00%)", " Nausea 0/42 (0.00%)", " Vomiting 0/42 (0.00%)", " Pyrexia 0/42 (0.00%)", " Influenza like illness 1/42 (2.38%)", " Oedema peripheral 1/42 (2.38%)", " Fatigue 0/42 (0.00%)", "Adverse Events 2:", " Total: 7/42 (16.67%)", " Febrile neutropenia 0/42 (0.00%)", " Left venrticular dysfunction 1/42 (2.38%)", " Cardiac valve disease 0/42 (0.00%)", " Diarrhoea 0/42 (0.00%)", " Abdominal pain 0/42 (0.00%)", " Colitis 0/42 (0.00%)", " Nausea 0/42 (0.00%)", " Vomiting 0/42 (0.00%)", " Pyrexia 2/42 (4.76%)", " Influenza like illness 0/42 (0.00%)", " Oedema peripheral 0/42 (0.00%)", " Fatigue 0/42 (0.00%)" ]

[ "Adverse Events 1:", " Total: 21/209 (10.05%)", " Anaemia 0/209 (0.00%)", " Febrile neutropenia 0/209 (0.00%)", " Thrombocytopenia 0/209 (0.00%)", " Acute myocardial infarction 0/209 (0.00%)", " Cardiac failure 0/209 (0.00%)", " Diplopia 0/209 (0.00%)", " Gastric haemorrhage 0/209 (0.00%)", " Nausea 0/209 (0.00%)", " Oral pain 0/209 (0.00%)", " Vomiting 1/209 (0.48%)", " Mucosal inflammation 0/209 (0.00%)", " Pain 1/209 (0.48%)", "Adverse Events 2:", " Total: 29/216 (13.43%)", " Anaemia 2/216 (0.93%)", " Febrile neutropenia 2/216 (0.93%)", " Thrombocytopenia 2/216 (0.93%)", " Acute myocardial infarction 1/216 (0.46%)", " Cardiac failure 1/216 (0.46%)", " Diplopia 1/216 (0.46%)", " Gastric haemorrhage 1/216 (0.46%)", " Nausea 1/216 (0.46%)", " Oral pain 2/216 (0.93%)", " Vomiting 2/216 (0.93%)", " Mucosal inflammation 1/216 (0.46%)", " Pain 0/216 (0.00%)" ]

[ "Inclusion Criteria:", " The patient must consent to participate in the study and must have signed an approved consent form conforming with federal and institutional guidelines.", " The patient must have a life expectancy of at least 10 years and a Zubrod performance status of 0 or 1. (Comorbid conditions but not the diagnosis of breast cancer should be taken into consideration when determining life expectancy.)", " The interval between the last surgery for breast cancer staging or treatment and randomization must be no more than 84 days.", " The tumor must be invasive carcinoma of the breast on histologic examination.", " All of the following staging criteria must be met:", " By clinical and pathologic evaluation, primary tumor must be T1-3;", " By clinical evaluation, ipsilateral nodes must be cN0, cN1, or cN2a;", " By pathologic evaluation, ipsilateral nodes must be pN1 (pN1mi, pN1a, pN1b, pN1c), pN2a, pN3a, or pN3b (only if due to microscopic involvement of internal mammary node detected by sentinel lymph node dissection and with more than 3 positive axillary lymph nodes).", " Patients must have an estrogen receptor (ER) analysis performed on the primary tumor prior to randomization. If ER analysis is negative, then progesterone receptor (PgR) analysis must be performed. If ER analysis is positive, PgR analysis is desired, but not mandatory. (\"Marginal\" or \"borderline\" results [i.e., those not definitely negative] will be considered positive regardless of the methodology used.)", " Patients must have had either a lumpectomy or a total mastectomy. Patients must have completed one of the following procedures for evaluation of pathologic nodal status.", " Sentinel lymphadenectomy followed by removal of additional non-sentinel lymph nodes (This approach is strongly recommended.)", " Sentinel lymphadenectomy alone if one of the following criteria is met:", " Pathologic nodal staging based on sentinel lymphadenectomy is pN1mi or pN1b", " Surgeon elects not to remove additional non-sentinel nodes (This approach is strongly discouraged, but will not preclude participation in B-38.)", " Axillary lymphadenectomy without sentinel node isolation procedure.", " Patients must have no clinical or radiologic evidence of metastatic disease.", " Patients with either skeletal pain or alkaline phosphatase that is greater than ULN but less than or equal to 2.5 x ULN are eligible for inclusion in the study if bone scans fail to demonstrate metastatic disease. Suspicious findings on bone scan must be confirmed as benign by x-ray, MRI, or biopsy.", " Patients with aspartate transaminase (AST) or alkaline phosphatase greater than ULN are eligible for inclusion in the study if liver imaging fails to demonstrate metastatic disease and the following requirements are met at the time of randomization.", " Postoperative absolute granulocyte count (AGC) must be greater than or equal to 1200/mm3.", " Postoperative platelet count must be greater than or equal to 100,000/mm3.", " The following criteria for postoperative evidence of adequate hepatic function must be met:", " total bilirubin must be less than or equal to ULN for the lab unless the patient has a grade 1 bilirubin elevation (greater than ULN to 1.5 x ULN) due to Gilbert's disease or similar syndrome due to slow conjugation of bilirubin; and", " alkaline phosphatase must be less than or equal to 2.5 x ULN for the lab; and", " the AST must be less than or equal to 1.5 x ULN for the lab; and", " alkaline phosphatase and AST cannot both be greater than ULN.", " Postoperative serum creatinine must be less than or equal to ULN.", " At the time of randomization, the patient must have had the following: history and physical exam, EKG, and imaging of the chest within the past 3 months and bilateral mammogram within the past 6 months.", " Within 3 months prior to entry, the patient must have a baseline left ventricular ejection fraction (LVEF), measured by Multiple Gated Acquisition (MUGA) scan or echocardiogram, greater than or equal to lower limit of normal (LLN) for the facility performing the procedure and no evidence of regional wall abnormalities.", " Patients with a history of non-breast malignancies are eligible if they have been disease-free for 5 or more years prior to randomization and are deemed by their physician to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.", " Special conditions for eligibility of lumpectomy patients: radiation therapy and surgery. Patients treated by lumpectomy must meet all the eligibility criteria in addition to the following:", " Generally, lumpectomy should be reserved for tumors less than 5 cm. However, at the investigator's discretion, patients treated with lumpectomy for tumors greater than or equal to 5 cm are eligible if eligibility criteria for lumpectomy are met.", " The margins of the resected specimen must be histologically free of invasive tumor and DCIS as determined by the local pathologist. In patients for whom pathologic examination demonstrates tumor present at the line of resection, additional operative procedures may be performed to obtain clear margins. This is permissible even if axillary evaluation has been completed. Patients in whom tumor is still present at the resected margin after re-excision(s) must undergo total mastectomy to be eligible. (Patients with margins positive for lobular carcinoma in situ (LCIS) are eligible without additional resection.)", " Irradiation of regional lymph nodes is optional, but plans for radiation therapy must be declared by the investigator prior to randomization for stratification purposes.", " Special conditions for eligibility of mastectomy patients: radiation therapy o Postmastectomy chest wall and/or regional nodal irradiation is optional. Plans for radiation in mastectomy patients must be declared by the investigator prior to randomization for stratification purposes.", " Ineligibility Criteria", " Male patients are not eligible for this study. Women with one or more of the following conditions or prior therapies are also ineligible for this study:", " Tumor that has been determined to be human epidermal growth factor receptor 2 (HER2)-positive by immunohistochemistry (3+) or by fluorescent in situ hybridization (positive for gene amplification).", " Contralateral breast cancer (invasive or DCIS) or a mass or mammographic abnormality in the opposite breast suspicious for malignancy unless there is biopsy proof that the mass is not malignant.", " Primary tumor staged as T4 for any reason.", " Clinical nodal stages including cN2b and cN3 or pathologic nodal stages including pN0(i+), pN2b, pN3b with clinically apparent internal mammary nodes, or pN3c.", " Suspicious nodes in the contralateral axilla or suspicious supraclavicular nodes. Patients with these conditions are considered ineligible unless there is biopsy evidence that these are not involved with tumor.", " Prior history of breast cancer, including DCIS (patients with a history of LCIS are eligible).", " Treatment, including radiation therapy, chemotherapy, and/or hormonal therapy administered for the currently diagnosed breast cancer prior to randomization. One exception is hormonal therapy, which may have been given for up to a total of 28 days anytime after diagnosis and before study entry. In such a case, hormonal therapy must stop at or before randomization and be re-started, if indicated, following chemotherapy. A second exception is radiation therapy for patients enrolled in NSABP B-39 and assigned to partial breast irradiation (Group 2). These patients may have received RT prior to B-38 study entry.", " Prior therapy with anthracyclines or taxanes for any malignancy.", " Any sex hormonal therapy, e.g., birth control pills, ovarian hormonal replacement therapy, etc. (These patients are eligible if this therapy is discontinued prior to randomization.)", " Therapy with any hormonal agents such as raloxifene (Evista®), tamoxifen, or other selective estrogen-receptor modulators (SERMs), either for osteoporosis or breast cancer prevention. (Patients are eligible only if these medications are discontinued prior to randomization.", " Cardiac disease that would preclude the use of anthracyclines. This includes:", " history of myocardial infarction documented by elevated cardiac enzymes or regional wall abnormalities on assessment of left ventricular (LV) function;", " angina pectoris that requires the use of anti-anginal medication;", " any history of documented congestive heart failure;", " serious cardiac arrhythmia requiring medication;", " severe conduction abnormality;", " valvular disease with documented cardiac function compromise; and", " uncontrolled hypertension defined as blood pressure greater than 160/100 on antihypertensive therapy.", " Conditions that would prohibit administration of corticosteroids.", " Sensory/motor neuropathy greater than or equal to grade 2, as defined by the NCI's Common Terminology Criteria for Adverse Events Version 3.0.", " Non-malignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude a patient from receiving any of the treatment options or would prevent prolonged follow-up.", " History of hepatitis B or C.", " Pregnancy or lactation at the time of proposed randomization. Women of reproductive potential must agree to use an effective non-hormonal method of contraception.", " Concurrent treatment with other investigational agents for the treatment of breast cancer.", " Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.", " Special conditions for ineligibility of lumpectomy patients: radiation therapy and surgery", " For patients treated by lumpectomy, whole breast irradiation is required.", " The following patients will be ineligible:", " Patients with diffuse tumors (as demonstrated on mammography) treated with lumpectomy. (These patients are eligible if they undergo mastectomy.)", " Patients treated with lumpectomy in whom there is another clinically dominant mass or mammographically suspicious abnormality within the ipsilateral breast remnant. Such a mass must be biopsied and demonstrated to be histologically benign prior to randomization or, if malignant, must be surgically removed with clear margins.", " Patients in whom the margins of the resected specimen are involved with invasive tumor or DCIS." ]

[ "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%)" ]

[ "Adverse Events 1:", " Total: 15/41 (36.59%)", " Febrile neutropenia * 0/41 (0.00%)", " Diarrhea * 1/41 (2.44%)", " Stomach pain * 1/41 (2.44%)", " Fever * 2/41 (4.88%)", " Cytokine release syndrome * 1/41 (2.44%)", " Infection * 1/41 (2.44%)", " Skin infection * 2/41 (4.88%)", " Urinary tract infection * 1/41 (2.44%)", " Coagulopathy * 0/41 (0.00%)", " INR increased * 0/41 (0.00%)", " Lipase increased * 1/41 (2.44%)", "Adverse Events 2:", " Total: 2/5 (40.00%)", " Febrile neutropenia * 1/5 (20.00%)", " Diarrhea * 0/5 (0.00%)", " Stomach pain * 0/5 (0.00%)", " Fever * 0/5 (0.00%)", " Cytokine release syndrome * 0/5 (0.00%)", " Infection * 0/5 (0.00%)", " Skin infection * 0/5 (0.00%)", " Urinary tract infection * 0/5 (0.00%)", " Coagulopathy * 1/5 (20.00%)", " INR increased * 1/5 (20.00%)", " Lipase increased * 0/5 (0.00%)" ]

[ "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", "-" ]

[ "DISEASE CHARACTERISTICS:", " Clinical, mammographic, ultrasonographic, or pathologic diagnosis of unicentric and unifocal breast carcinoma", " Largest tumor lesion 5 cm", " Palpable or nonpalpable breast lesion", " Preoperative radioactive occult lesion localization, hook wire, or other method of localization required for nonpalpable lesions", " Prior (preoperative) or planned (intraoperative) sentinel node biopsy required", " At least 1 micrometastatic (i.e., no greater than 2 mm) sentinel lymph node with no extracapsular extension", " No clinical evidence of distant metastases", " No suspicious manifestation of metastases that cannot be ruled out by x-ray, MRI, or CT scan, including the following:", " Skeletal pain of unknown cause", " Elevated alkaline phosphatase", " Bone scan showing hot spots", " No palpable axillary lymph node(s)", " No Paget's disease without invasive cancer", " Hormone receptor status:", " Estrogen receptor and progesterone receptor known", " PATIENT CHARACTERISTICS:", " Age", " Any age", " Sex", " Female", " Menopausal status", " Any status", " Performance status", " Not specified", " Life expectancy", " Not specified", " Hematopoietic", " Not specified", " Hepatic", " See Disease Characteristics", " Renal", " Not specified", " Other", " Not pregnant or nursing", " No other prior or concurrent malignancy except the following:", " Adequately treated basal cell or squamous cell skin cancer", " Adequately treated carcinoma in situ of the cervix", " Adequately treated in situ melanoma", " Contralateral or ipsilateral carcinoma in situ of the breast", " No psychiatric, addictive, or other disorder that may compromise ability to give informed consent", " Geographically accessible for follow-up", " PRIOR CONCURRENT THERAPY:", " Biologic therapy", " Not specified", " Chemotherapy", " Not specified", " Endocrine therapy", " Not specified", " Radiotherapy", " Not specified", " Surgery", " See Disease Characteristics", " Other", " No prior systemic therapy for breast cancer", " More than 1 year since prior chemopreventive agent" ]

[ "INTERVENTION 1: ", " Arimidex Group", " Anastrozole(ARIMIDEX): 1 mg once daily oral dose", "INTERVENTION 2: ", " TAM Group", " Tamoxifen : 20 mg once daily oral dose" ]

[ "INTERVENTION 1: ", " Anastrozole and Simvastatin", " adjuvant therapy : laboratory analysis", " pharmacological study : laboratory analysis", " simvastatin : 40 milligram tablet PO QD for 14 days", " anastrozole : 1 milligram tablet PO QD for 14 days" ]

[ "Outcome Measurement: ", " Dose Limiting Toxicity Incidence of Neratinib in Combination With Paclitaxel", " Dose Limiting Toxicity in subjects with solid tumors treated with neratinib, administered daily, in combination with paclitaxel 80 mg/m² IV on days 1, 8, and 15 of a 28 day cycle.", " Time frame: From first dose date through day 28", "Results 1: ", " Arm/Group Title: Neratinib 160 mg + Paclitaxel 80 mg/m ", " Arm/Group Description: Neratinib 160 mg qd + Paclitaxel 80 mg/m IV on days 1, 8, and 15 of a 28 day cycle.", " Overall Number of Participants Analyzed: 3", " Measure Type: Count of Participants", " Unit of Measure: Participants 0 0.0%", "Results 2: ", " Arm/Group Title: Neratinib 240 mg + Paclitaxel 80 mg/m ", " Arm/Group Description: Neratinib 240 mg qd + Paclitaxel 80 mg/m IV on days 1, 8, and 15 of a 28 day cycle.", " Overall Number of Participants Analyzed: 5", " Measure Type: Count of Participants", " Unit of Measure: Participants 0 0.0%" ]

[ "Outcome Measurement: ", " Number of Participants With Dose Limiting Toxicities (DLT)", " Number of participants with DLT in the first cycle (28 days) for the determination of the maximum tolerated dose (MTD). Important Limitations and Caveats are provided in the respective section.", " Time frame: 28 days", "Results 1: ", " Arm/Group Title: Afatinib 20mg + Herceptin", " Arm/Group Description: Patients received continuous daily dosing with Afatinib 20mg film-coated tablets and once weekly an intravenous infusion of Herceptin until disease progression or lack of clinical benefit. This group includes patients from the dose-escalation cohort and from the expansion cohort.", " Overall Number of Participants Analyzed: 13", " Measure Type: Number", " Unit of Measure: Participants 4", "Results 2: ", " Arm/Group Title: Afatinib 30mg + Herceptin", " Arm/Group Description: Patients received continuous daily dosing with Afatinib 30mg film-coated tablets and once weekly an intravenous infusion of Herceptin until disease progression or lack of clinical benefit.", " Overall Number of Participants Analyzed: 2", " Measure Type: Number", " Unit of Measure: Participants 2" ]

[ "Adverse Events 1:", " Total: 4/95 (4.21%)", " Death not associated with CTCAE term - Death NOS 1/95 (1.05%)", " Death - Disease progression NOS 2/95 (2.11%)", " CNS cerebrovascular ischemia 1/95 (1.05%)" ]

[ "Adverse Events 1:", " Total: 3/31 (9.68%)", " Edema: limb * 2/31 (6.45%)", " Neutrophils/granulocytes (ANC/AGC) * 0/31 (0.00%)", " Cardiac General - Other (Specify, __) * [1]0/31 (0.00%)", " Cardiac General - Other (Specify, __) * [2]0/31 (0.00%)", " Left ventricular diastolic dysfunction * 0/31 (0.00%)", " Supraventricular and nodal arrhythmia - Atrial tachycardia/Paroxysmal Atrial Tachycardia * 0/31 (0.00%)", "Adverse Events 2:", " Total: 8/25 (32.00%)", " Edema: limb * 1/25 (4.00%)", " Neutrophils/granulocytes (ANC/AGC) * 0/25 (0.00%)", " Cardiac General - Other (Specify, __) * [1]1/25 (4.00%)", " Cardiac General - Other (Specify, __) * [2]0/25 (0.00%)", " Left ventricular diastolic dysfunction * 1/25 (4.00%)", " Supraventricular and nodal arrhythmia - Atrial tachycardia/Paroxysmal Atrial Tachycardia * 0/25 (0.00%)" ]

[ "INTERVENTION 1: ", " Lapatinib Plus Paclitaxel", " Participants received lapatinib 1500 mg orally OD with paclitaxel, administered as a 1-hour IV infusion at a dose of 80 mg/m^2 on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal." ]

[ "INTERVENTION 1: ", " Urea/Lactic Acid Cream", " Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily.", "INTERVENTION 2: ", " Placebo Cream", " Patients receive placebo cream applied to palms and soles twice daily." ]

[ "DISEASE CHARACTERISTICS:", " Histologically confirmed infiltrating carcinoma of the breast meeting any of the following criteria:", " T1-3, any N disease", " Proven ductal carcinoma in situ", " Unresected disease", " Planned mastectomy as definitive surgical procedure", " Known or suspected metastatic disease allowed provided mastectomy is planned", " Nonpalpable tumor allowed (e.g., initial T2-3 tumor that responded to preoperative therapy)", " No inflammatory breast cancer or other T4 features", " Successful baseline ductogram", " Baseline nipple aspiration procedure must identify a duct productive of nipple aspirate fluid", " No severe nipple retraction", " Hormone receptor status not specified", " PATIENT CHARACTERISTICS:", " Female patients", " Menopausal status not specified", " ECOG performance status 0-2", " Absolute neutrophil count 1,500/mm^3", " Platelet count 100,000/mm^3", " Hemoglobin 9.0 g/dL", " Creatinine 2 times upper limit of normal (ULN)", " Bilirubin 2 times ULN", " AST and ALT 2.5 times ULN", " Not pregnant or nursing", " Negative pregnancy test", " Fertile patients must use effective contraception", " No significant history of severe allergy to iodinated contrast material or debilitating anxiety that may not allow for a ductogram", " PRIOR CONCURRENT THERAPY:", " See Disease Characteristics", " Prior preoperative chemotherapy, trastuzumab (Herceptin®), or hormonal therapy allowed provided it was completed 7-14 days prior to study treatment", " No prior radiation therapy, excisional biopsy, breast reduction, areolar surgery, or breast implant (present or past history of implant that was removed)", " No other prior procedure that may have altered the breast ductal system in the ipsilateral breast", " No other concurrent chemotherapy, radiotherapy, endocrine therapy, or biologic agents for breast cancer", " No other concurrent investigational drugs", " Concurrent bisphosphonates allowed" ]

[ "Inclusion Criteria:", " Histologically confirmed, HER2-positive advanced and/or metastatic breast cancer not amenable to curative therapy", " At least one measurable lesion according to RECIST", " Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1", " Baseline left ventricular ejection fraction (LVEF) at least 50%", "Exclusion Criteria:", " Pregnant, lactating, or women of childbearing potential who are not surgically sterile or not willing to use adequate contraceptive methods", " Previous treatment with Herceptin or other anti-HER therapies, or any previous chemotherapy for advanced or metastatic disease", " Past medical history significant for any cardiac or central nervous system (CNS) disorders", " Poor hematologic, renal, or hepatic function", " Chronic corticosteroid therapy" ]

[ "Inclusion Criteria:", " Gail risk >= 1.7% and/or relative risk >= 3 times that for 5-year age group", " Premenopausal", " More than 6 months since initiating or discontinuing oral contraceptives", " At increased risk for breast cancer, as indicated by >= 1 of the following risk factors:", " BRCA1/2 mutation characterized as deleterious or of uncertain significance", " Prior atypical ductal hyperplasia, ductal carcinoma in situ, or lobular carcinoma in situ", " Prior random periareolar fine needle aspiration (RPFNA) showing atypical hyperplasia", " Family history consistent with hereditary breast cancer, as indicated by 1 of the following criteria:", " >= 4 relatives with breast cancer", " >= 2 relatives diagnosed with breast cancer at 50 years of age", " Breast and ovarian cancer diagnosed in same relative", " No suspicion for breast cancer on baseline mammogram performed between days 1-10 of menstrual cycle within 3 months prior to screening baseline RPFNA", " Exhibits hyperplasia with or without atypia (Masood score >= 14) with >= 500 cells AND Ki-67 positivity >= 2% by RPFNA performed within 6 months prior to initiation of study drug", " Estimated visual mammographic breast density category >= 5% on mammogram performed within 6 months prior to initiation of study drug", " Has regular menstrual cycles (between 21 and 35 days) unless using extended regimen oral contraceptives or a contraceptive device (e.g., Mirena IUD) Values for metabolic profile and blood count within normal limits", " Absolute granulocyte count > 1,000/mm^3", " Platelets > 100,000/mm^3", " Hemoglobin > 10 g/dL", " Bilirubin < 2.0 mg/dL", " AST < 2 times upper limit of normal (ULN)", " Albumin > 3.0 g/dL", " Creatinine < 1.5 mg/dL", " Alkaline phosphatase < 2 times ULN", " Concurrent hormonal contraceptives allowed provided patient remains on the same hormonal regimen from 3 months prior to baseline aspiration until the completion of study treatment", " Fertile patients must use effective contraception during and for 3 months after completion of study treatment", " Willing to ingest recommended dose of calcium and vitamin D for premenopausal bone health (1,200 mg calcium and 800 IU vitamin D daily)", " Negative pregnancy test prior to receiving study agent", " Exclusion Criteria", " pregnant or nursing", " nursing within the past 6 months", " Known osteoporosis or severe osteopenia (T-score -2 or worse by DEXA)", " History of symptomatic endometriosis with pelvic pain, poorly controlled migraines, or hot flashes", " History of deep venous thrombosis", " History of allergic reactions attributed to compounds of similar chemical or biological composition to the study agent", " Other condition or concurrent illness that, in the opinion of the investigator, would make the patient a poor candidate for RPFNA", " Less than 1 year since prior use of aromatase inhibitors (e.g., anastrozole, exemestane, or letrozole) or selective estrogen receptor modulators (e.g., tamoxifen citrate, raloxifene, or arzoxifene hydrochloride)", " Other concurrent chemopreventive agents", " Concurrent anticoagulants", " Other concurrent investigational agents", " Bilateral breast implants" ]

[ "Outcome Measurement: ", " Progression Free Survival", " [Not Specified]", " Time frame: From the date of randomization to date of first documented disease progression (i.e., the date on which a radiologic procedure or clinical evaluation was performed) or the date of death due to any cause, if before progression, assessed up to 39 months.", "Results 1: ", " Arm/Group Title: A (Sorafenib + Gemcitabine or Capecitabine)", " Arm/Group Description: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)", " Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle", " Sorafenib: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)", " Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine).", " Overall Number of Participants Analyzed: 81", " Median (95% Confidence Interval)", " Unit of Measure: Days 103 (83 to 128)", "Results 2: ", " Arm/Group Title: B (Placebo + Gemcitabine or Capecitabine)", " Arm/Group Description: Placebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)", " Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle", " Placebo: Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)", " Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine).", " Overall Number of Participants Analyzed: 79", " Median (95% Confidence Interval)", " Unit of Measure: Days 81 (48 to 95)" ]

[ "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)" ]

[ "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: 3/25 (12.00%)", " Anemia 0/25 (0.00%)", " Sinus tachycardia 0/25 (0.00%)", " Pericardial effusion 1/25 (4.00%)", " Gastrointestinal disorders - Other, specify -stomatitis) 0/25 (0.00%)", " Vomiting 1/25 (4.00%)", " Fever 0/25 (0.00%)", " Injection site reaction 1/25 (4.00%)", " Catheter related infection 0/25 (0.00%)", " Activated partial thromboplastin time prolonged 0/25 (0.00%)", "Adverse Events 2:", " Total: 2/23 (8.70%)", " Anemia 1/23 (4.35%)", " Sinus tachycardia 1/23 (4.35%)", " Pericardial effusion 0/23 (0.00%)", " Gastrointestinal disorders - Other, specify -stomatitis) 1/23 (4.35%)", " Vomiting 0/23 (0.00%)", " Fever 1/23 (4.35%)", " Injection site reaction 1/23 (4.35%)", " Catheter related infection 1/23 (4.35%)", " Activated partial thromboplastin time prolonged 1/23 (4.35%)" ]

[ "Inclusion Criteria:", " Must be female with histologically confirmed breast cancer", " Stage II-IV disease", " ER and/or PR positive", " ECOG Performance Status 0-1", " Tumor must be present following core needle biopsy as determined by physical exam or radiographic evaluation.", " Postmenopausal", " No prior treatment for current breast cancer. No other active malignancy is allowed.Adequately treated basal cell, squamous cell skin cancer, in situ cervical cancer, or any other cancer from which the patient has been disease-free for 5 years is permitted. Biphosphonates and palliative radiation for bone metastasis is permitted while on study.", " Hormone replacement therapy must be discontinued. It is not permitted during the time on study.", "Exclusion Criteria:", " Known history of aspirin or NSAID induced asthma, urticaria or allergic reactions; or allergy to sulfonamides severe enough in nature to require emergency room treatment or hospitalization.", " History of myocardial infarction or other thrombotic events.", " Inflammatory breast cancer (edema or ulceration of the skin of the breast).", " Significant renal dysfunction (serum creatinine > 1.5 x upper limit of normal).", " Significant hepatic dysfunction (serum bilirubin > 1.5 x upper limit of normal or AST, ALT > 3 x upper limit of normal)", " ANC <1.5, platelets <100,000 K/uL, and hemoglobin < 9 g/dL.", " Use of other COX-2 inhibitors such as rofecoxib (Vioxx®, aspirin, trisalicylate (Trilisate®), is not permitted during the time on study. No washout period is required. Baby aspirin, 81 mg po daily, is permitted.", " Use of NSAID's such as ibuprofen (Advil® or Motrin®), naproxyn (Aleve® Naprosyn®, or Anaprox®), etodolac (Lodine®), oxaprozin (Daypro®), difusanil (Dolobid®), nabumetone (Relafin®), or tolmetin (Tolectin®) is not permitted during the time on study." ]

[ "INTERVENTION 1: ", " Mammography Only", " For this reporting arm, the interpretation and analysis was done with mammography only.", "INTERVENTION 2: ", " Gamma Imaging", " For this reporting arm, the interpretation and analysis was done with gamma imaging only." ]

[ "Outcome Measurement: ", " Percent Change From Baseline in Lumbar Spine (L1-L4) Bone Mineral Density (BMD)", " Bone mineral density (BMD) measurements were assessed by dual energy x-ray absorptiometry (DXA). The DXA devices of participating sites were cross-calibrated and the DXA results were compiled and analyzed by a central reader. Percent change = 100*((BMD at Month 12 - Baseline BMD)/Baseline BMD)). Missing data at month 12 were imputed by using the last observation carried forward (LOCF) method. Post-baseline non-missing data from month 6 were carried forward to month 12. Data prior to month 6 were not carried forward.", " Time frame: Baseline, 12 months", "Results 1: ", " Arm/Group Title: Zoledronic Acid Upfront", " Arm/Group Description: Participants in the upfront arm received Zoledronic Acid 4 mg i.v. on Day 1 and every 6 months until disease progression (recurrence)or the end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.", " Letrozole : Participants received 2.5 mg daily.", " Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months.", " Overall Number of Participants Analyzed: 253", " Mean (Standard Deviation)", " Unit of Measure: Percentage of BMD 1.955 (3.3658)", "Results 2: ", " Arm/Group Title: Zoledronic Acid Delayed-start", " Arm/Group Description: In lieu of a placebo arm, which was considered unethical for this trial, a delayed start arm was used. Participants who met certain clinical criteria indicating risk of lumbar spine or total hip fracture, or experienced clinical fracture unrelated to trauma or any asymptomatic fracture discovered at the Month 36 scheduled visit, were started on zoledronic acid 4 mg i.v. and for every 6 months until disease progression (recurrence) or end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.", " Letrozole : Participants received 2.5 mg daily.", " Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months.", " Overall Number of Participants Analyzed: 256", " Mean (Standard Deviation)", " Unit of Measure: Percentage of BMD -2.325 (3.9542)" ]

[ "Outcome Measurement: ", " Pharmacokinetics (PK) of Oral Itraconazole", " To determine the pharmacokinetics (PK) of oral itraconazole in patients with MBC by measuring mean trough plasma levels at steady state at weeks 2 and 4.", " Time frame: pre-dose at Weeks 2 and 4", "Results 1: ", " Arm/Group Title: Itraconazole", " Arm/Group Description: oral itraconazole 200mg a day until disease progression or unacceptable toxicities.", " Overall Number of Participants Analyzed: 12", " Mean (Standard Deviation)", " Unit of Measure: ng/mL Week 2 Intraconazole Concentration: 230.7 (216.8)", " Week 4 Intraconazole Concentration: 305.8 (334.8)", " Week 2 6-OH Itraconazole Concentration: 454.8 (429.3)", " Week 4 6-OH Itraconazole Concentration: 501.6 (502.6)" ]

[ "Outcome Measurement: ", " Dose Escalation: To Evaluate the Safety and Tolerability of Escalating Doses of the MM-121 Plus Paclitaxel Combination Via Reporting of Dose-limiting Toxicity (DLT)", " To establish the safety of escalating doses of MM-121 in combination with paclitaxel in order to determine the recommended phase 2 dose. Dose-escalation conducted using standard 3+3 model to determine maximum tolerated dose. Reports of Dose-Limiting Toxicities (DLTs) were assessed to determine the MTD.", " Time frame: From date of first dose to 30 days after termination, the longest 163 weeks", "Results 1: ", " Arm/Group Title: Part 1: Dose Escalation: Cohort 1", " Arm/Group Description: MM-121 - 20 mg/kg loading dose followed by 12 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV", " Overall Number of Participants Analyzed: 7", " Measure Type: Number", " Unit of Measure: participants reporting DLTs 0", "Results 2: ", " Arm/Group Title: Part 1: Dose Escalation: Cohort 2", " Arm/Group Description: MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV", " Paclitaxel - 80mg/m2 weekly IV", " Overall Number of Participants Analyzed: 3", " Measure Type: Number", " Unit of Measure: participants reporting DLTs 1" ]

[ "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)" ]

[ "Outcome Measurement: ", " Percentage Change From Baseline in Urinary N-telopeptide of Type I Collagen (u-NTx) at Week 4", " u-NTx is a biochemical index of bone resorption. Participants provided urine specimens on Day 1 (baseline) and at Week 4 for measurement of u-NTx.", " Time frame: Baseline and Week 4", "Results 1: ", " Arm/Group Title: Single IV Infusion of ZA 4 mg", " Arm/Group Description: Participants received a single IV infusion of ZA 4 mg at the start of treatment and a once-daily odanacatib matching placebo tablet for 4 weeks.", " Overall Number of Participants Analyzed: 14", " Mean (95% Confidence Interval)", " Unit of Measure: Percentage change -73 (-80 to -62)", "Results 2: ", " Arm/Group Title: Once-daily Odanacatib 5 mg", " Arm/Group Description: Participants received a once-daily odanacatib 5 mg tablet for 4 weeks and a single IV infusion of ZA matching placebo at the start of treatment.", " Overall Number of Participants Analyzed: 27", " Mean (95% Confidence Interval)", " Unit of Measure: Percentage change -77 (-82 to -71)" ]

[ "Outcome Measurement: ", " Pathological Complete Response Rates at Surgery", " [Not Specified]", " Time frame: at surgery approximately 5 months after initial treatment", "Results 1: ", " Arm/Group Title: Cohort 1", " Arm/Group Description: Avastin 10 mg/kg IV over 90 minutes day -14 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 Avastin 10 mg/kg IV over 30-60 minutes cycles 1-3 (omit dose with cycle 4) Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles Definitive surgery Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks", " Cohort 1 and Cohort 2: Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10)", " Overall Number of Participants Analyzed: 28", " Measure Type: Number", " Unit of Measure: participants 16", "Results 2: ", " Arm/Group Title: Cohort 2", " Arm/Group Description: Abraxane 100 mg/m2 IV over 30 minutes days -14 and -7 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10) Definitive surgery Avastin 10 mg/kg IV over 30-60 minutes and Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles followed by Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks OR Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 42 weeks", " Cohort 1 and Cohort 2: Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10)", " Overall Number of Participants Analyzed: 27", " Measure Type: Number", " Unit of Measure: participants 2" ]

[ "INTERVENTION 1: ", " Experimental", " cyclophosphamide: chemotherapy", " doxorubicin hydrochloride: chemotherapy", " adjuvant therapy: chemotherapy", " radiation therapy: chemotherapy" ]

[ "INTERVENTION 1: ", " Arm A: Nab-Paclitaxel + Gemcitabine", " Participants received nab-Paclitaxel 125 mg/m^2 on Days 1 and 8 by intravenous (IV) administration followed by gemcitabine 1000 mg/m^2 on Days 1 and 8 by IV administration of each 21-day treatment cycle. Participants continued treatment until progressive disease (PD), unacceptable toxicity, required palliative radiotherapy or surgical intervention of lesion(s), withdrawal from study treatment, withdrawal of study consent, participant refusal or the investigator felt it was no longer in the best interest of the participant to continue on treatment", "INTERVENTION 2: ", " Arm B: Nab-Paclitaxel + Carboplatin", " Participants received nab-Paclitaxel 125 mg/m^2 on Days 1 and 8 by IV administration followed by carboplatin area under the curve 2 (AUC 2) on Days 1 and 8 in each 21-day treatment cycle. Participants continued treatment until progressive disease (PD), unacceptable toxicity, required palliative radiotherapy or surgical intervention of lesion(s), withdrawal from study treatment, withdrawal of study consent, participant refusal or the investigator felt it was no longer in the best interest of the participant to continue on treatment." ]

[ "INTERVENTION 1: ", " MAESTRO", "Baseline" ]

[ "INTERVENTION 1: ", " AeroForm Tissue Expansion", " AeroForm Tissue Expansion inflation with carbon dioxide by remote control", " AeroForm Tissue Expansion: The AeroForm Patient Controlled Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander.", "INTERVENTION 2: ", " Saline Tissue Expansion", " Saline Tissue Expansion inflated by needle injections of saline", " Saline Tissue Expansion: A saline tissue expander is a breast tissue expander which is implanted following mastectomy and inflated over time using needle injections to fill and inflate the expander with saline." ]

[ "Inclusion Criteria:", " Postmenopausal breast cancer (adenocarcinoma) estrogen (ER)and/or progesterone (PR) receptor positive that is locally advanced or locally recurrent and not able to be surgically removed OR with measurable and/or disease that is able to be assessed including isolated bone metastasis", " Female patients 18 years or older", " Documentation of ER+ and/or PR+", " No prior chemotherapy or hormone therapy for metastatic breast cancer or inoperable breast cancer that is locally recurrent or locally advanced", " Measurable or evaluable disease", " Radiation therapy to painful bone lesions or impending fractures is allowed as long as there is measurable or evaluable disease outside the radiated area.", " Must have adequate bone marrow, renal and liver function", " Patients receiving prior treatment with an anthracycline based chemotherapy must have a normal left ventricle ejection fraction", "Exclusion Criteria:", " No metastatic disease to the Central Nervous System", " No history of myocardial infarction (MI), stroke or transient ischemic attacks in the last 6 months", " No symptoms of peripheral vascular disease", " No history of abdominal fistula, gastrointestinal perforation or intrabdominal abscess in the past 6 months", " No known hypersensitivity to phosphate, trehalose or polysorbate", " No serious non-healing wound, ulcer or bone fracture", " No uncontrolled high blood pressure or history of hypertensive crisis", " No New York Hear Association class II congestive heart failure", " No extensive cancer involvement of the liver or lungs", " No history of significant psychiatric disorders", " No significant vascular disease", " 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. You can then decide if you wish to participate." ]

[ "Outcome Measurement: ", " The Number of Participants With Central Nervous System (CNS) Best Overall Response", " Summary of CNS Objective Response (Lapatinib Monotherapy - MITT Population)", " Response to lapatinib in patients with progressive brain metastases from ErbB2-overexpressing breast cancer.", " The primary indicator of drug efficacy was CNS objective response rate. A CNS objective response was defined as either a Complete response (CR) or Partial response (PR), as assessed by volumetric analysis of brain Magnetic resonance imaging (MRI), provided there was no progression of systemic disease outside of the CNS, increasing steroid requirements, or worsening of Neurological signs and symptoms (NSS)", " A CNS objective response rate was defined as a 50% volumetric reduction in sum of CNS target lesions, with no new or progressive CNS or non-CNS lesions, no increases in tumor-related steroid requirements and no worsening of neurological signs or symptoms", " Time frame: time from baseline to data cutoff (25 Sept 2007); approximately 2 years", "Results 1: ", " Arm/Group Title: Cohort A", " Arm/Group Description: 750mg lapatinib administered orally twice daily. Cohort A subjects had Eastern Cooperative Oncology Group (ECOG) performance status 0-1, and one or two prior trastuzumab-containing regimens, in total, for treatment of breast cancer in adjuvant and/or metastatic settings", " Overall Number of Participants Analyzed: 94", " Measure Type: Count of Participants", " Unit of Measure: Participants Complete response (CR): 0 0.0%", " Partial response (PR): 6 6.4%", " Stable disease (SD): 40 42.6%", " Progressive disease (PD): 40 42.6%", "Unknown: 8 8.5%", "Results 2: ", " Arm/Group Title: Cohort B", " Arm/Group Description: 750mg lapatinib administered orally twice daily. Cohort B subjects had ECOG performance status 2 and/or more than 2 prior trastuzumab-containing regimens for treatment of breast cancer in the adjuvant and/or metastatic settings.", " Overall Number of Participants Analyzed: 143", " Measure Type: Count of Participants", " Unit of Measure: Participants Complete response (CR): 0 0.0%", " Partial response (PR): 9 6.3%", " Stable disease (SD): 46 32.2%", " Progressive disease (PD): 70 49.0%", " Unknown: 18 12.6%" ]

[ "Adverse Events 1:", " Total: 16/30 (53.33%)", " Chest pain *1/30 (3.33%)", " Abdominal pain *1/30 (3.33%)", " Diarrhea *2/30 (6.67%)", " Edema limbs *1/30 (3.33%)", " Hypersensitivity *2/30 (6.67%)", " Autoimmune disorder *1/30 (3.33%)", " Immune system disorder *1/30 (3.33%)", " Device related infection *2/30 (6.67%)", " Upper respiratory infection *1/30 (3.33%)", " Fracture *1/30 (3.33%)" ]

[ "Adverse Events 1:", " Total: 7/52 (13.46%)", " Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe * 0/52 (0.00%)", " Atrial Fibrillation * 1/52 (1.92%)", " Sepsis * 1/52 (1.92%)", " Muscle weakness upper limb * 1/52 (1.92%)", " Dizziness * 1/52 (1.92%)", " Seizure * 1/52 (1.92%)", " Nervous system disorders - Other, specify * [1]1/52 (1.92%)", "Adverse Events 2:", " Total: 1/30 (3.33%)", " Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe * 1/30 (3.33%)", " Atrial Fibrillation * 0/30 (0.00%)", " Sepsis * 0/30 (0.00%)", " Muscle weakness upper limb * 0/30 (0.00%)", " Dizziness * 0/30 (0.00%)", " Seizure * 0/30 (0.00%)", " Nervous system disorders - Other, specify * [1]0/30 (0.00%)" ]

[ "Adverse Events 1:", " Total: 52/133 (39.10%)", " Thrombocytopenia 2/133 (1.50%)", " Anaemia 1/133 (0.75%)", " Disseminated intravascular coagulation 0/133 (0.00%)", " Atrial thrombosis 1/133 (0.75%)", " Cardiac failure 0/133 (0.00%)", " Vertigo 0/133 (0.00%)", " Vomiting 3/133 (2.26%)", " Nausea 1/133 (0.75%)", " Colitis 1/133 (0.75%)", " Constipation 1/133 (0.75%)", " Enteritis 0/133 (0.00%)", " Abdominal pain 0/133 (0.00%)", "Adverse Events 2:", " Total: 16/67 (23.88%)", " Thrombocytopenia 0/67 (0.00%)", " Anaemia 0/67 (0.00%)", " Disseminated intravascular coagulation 1/67 (1.49%)", " Atrial thrombosis 0/67 (0.00%)", " Cardiac failure 1/67 (1.49%)", " Vertigo 1/67 (1.49%)", " Vomiting 0/67 (0.00%)", " Nausea 1/67 (1.49%)", " Colitis 0/67 (0.00%)", " Constipation 0/67 (0.00%)", " Enteritis 1/67 (1.49%)", " Abdominal pain 2/67 (2.99%)" ]

[ "Inclusion Criteria:", " Adult men and women", " Patient has a confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer by local laboratory and has HER2-negative breast cancer", " Patient must have either measurable disease by RECIST 1.1 or bone lesions in absence of measurable disease.", " ECOG Performance Status 0 - 1", " Disease refractory to either, AI, tamoxifen or fulvestrant", " Previously treated on any CDK 4/6 inhibitor.", " Patient has adequate bone marrow and organ function.", "Exclusion Criteria:", " Patient with symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine therapy per the investigator's best judgment.", " Patient has received more than one line of chemotherapy for advanced disease.", " Previous treatment with mTOR inhibitors, or exemestane for advanced disease.", " Progressed on more than one CDK 4/6 inhibitor", " Patient with CNS involvement unless they are at least 4 weeks from prior therapy completion.", " Clinically significant, uncontrolled heart disease and/or recent cardiac events." ]

[ "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)." ]