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nli4ct_semeval2024

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[ "Adverse Events 1:", " Total: 9/29 (31.03%)", " Neutropenia 5/29 (17.24%)", " Cataracts 1/29 (3.45%)", " Abdominal Pain 1/29 (3.45%)", " Perforated Appendix 1/29 (3.45%)", " Surgical Intervention 1/29 (3.45%)", " Deep Vein Thrombosis 1/29 (3.45%)", " Cerebrovascular Ischemia 1/29 (3.45%)", "Adverse Events 2:", " " ]

[ "INTERVENTION 1: ", " Fulvestrant + Anastrozole", " Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg", "INTERVENTION 2: ", " Anastrozole", "Anastrozole 1 mg" ]

[ "INTERVENTION 1: ", " Prone to Supine MRI Evaluated by Radiologist A", " Radiologist A, number of participants successfully segmented", "INTERVENTION 2: ", " Prone to Supine MRI Evaluated by Radiologist B", " Radiologist B, number of participants successfully segmented" ]

[ "Outcome Measurement: ", " Time to Progression (TTP)", " Time to progression is defined as the time from treatment start until objective tumor progression. Progression is defined per Response Evaluation Criteria in Solid Tumors (RECIST)v1.0 guidelines as a measurable increase in the smallest diameter of any target lesion, progression of existing non-target lesions, or the appearance of 1 or more new lesions. The median time to progression is the parameter used to describe TTP.", " Time frame: TTP was measured from day 1 of treatment until time of progression (assessed every 8 weeks), up to 29 months.", "Results 1: ", " Arm/Group Title: Capecitabine and Fulvestrant", " Arm/Group Description: Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight < 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of 80 kg.", " Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days.", " Overall Number of Participants Analyzed: 41", " Median (95% Confidence Interval)", " Unit of Measure: Months 26.94 [1] (7.26 to NA)" ]

[ "Outcome Measurement: ", " Percentage of Participants With Feasibility", " The regimen was considered feasible if the participant was able to complete the eribulin portion without dose delay or reduction. Dose delay was defined as a delay due to eribulin-related adverse event (AE) for more than 2 days for subsequent doses (cycles after the initiation of full dose of eribulin, except holidays, scheduling difficulties and nonclinical logistical issues). If a participant had more than 1 dose omission, delay or reduction due to eribulin-related AE, these events were collectively counted as one entity in the same participant. Participants were followed for approximately 3 years after the last dose of the study treatment. Feasibility rates were calculated with or without growth factor support. In both cohorts, the percentage of participants who completed the eribulin portion of the regimen without a dose omission, delay or reduction due to eribulin-related AE was estimated via the observed completion rate and an exact 90% confidence interval (CI) was constructed.", " Time frame: From date of first dose, up to 3 years after the last dose of study treatment, or up to approximately 4 years 2 months", "Results 1: ", " Arm/Group Title: Cohort 1: Eribulin Mesylate With Filgrastim as Needed", " Arm/Group Description: 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.", " Overall Number of Participants Analyzed: 54", " Measure Type: Number", " Unit of Measure: Percentage of participants 70.4 (58.5 to 80.4)", "Results 2: ", " Arm/Group Title: Cohort 2: Eribulin Mesylate With Prophylactic Filgrastim", " Arm/Group Description: 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.", " Overall Number of Participants Analyzed: 25", " Measure Type: Number", " Unit of Measure: Percentage of participants 60.0 (41.7 to 76.4)" ]

[ "Outcome Measurement: ", " Recommended Dose Level for Phase II Testing (RPTD) (Phase I)", " The RPTD is defined as the highest dose level at which at most one of 6 patients develops a dose limiting toxicity (DLT) during the first course of treatment and the next highest dose level has 2 or more DLTs. The number of patients in each cohort reporting a DLT is reported.", " Dose-limiting toxicities (DLTs) are defined as any of the following adverse events (AEs) that are related to study agent with an attribution of possible, probably, or definite and fulfilling one of the following criteria:", " Any grade 4 hematologic toxicity", " Hyperglycemia that cannot be stably controlled with diabetic medication", " Any grade 3 or 4 non-hematologic toxicity (except asymptomatic medically manageable laboratory abnormalities such as hyperlipidemia, hypophosphatemia, and hypokalemia)", " Time frame: During first course", "Results 1: ", " Arm/Group Title: Dose Level 1", " Arm/Group Description: 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22", " 3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.", " Overall Number of Participants Analyzed: 3", " Measure Type: Number", " Unit of Measure: DLTs 2", "Results 2: ", " Arm/Group Title: Dose Level -1", " Arm/Group Description: 20 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22", " 3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22", " Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.", " Overall Number of Participants Analyzed: 1", " Measure Type: Number", " Unit of Measure: DLTs 1" ]

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

[ "Inclusion Criteria:", " Patients must have histologically or cytologically confirmed primary invasive breast cancer", " Primary tumor is larger than 2 cm in diameter (T2) as measured by caliper or ultrasound", " Overexpression and/or amplification of HER2 is confirmed by immunohistochemistry (IHC) 3+ or fluorescence in situ hybridization (FISH) + when IHC 2+", " Patients have not received prior therapies for breast cancer", " Patients have Karnofsky >= 70%", " Leukocytes >= 3,000/mcL", " Absolute neutrophil count >= 1,500/mcL", " Hemoglobin >= 9.0 g/dL", " Platelets >= 75,000/mcL", " Total bilirubin =< 1.5 times institutional upper limit of normal", " Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamic pyruvate transaminase[SGPT]) =< 2.5 times institutional ULN", " Creatinine =< 1.5 times institutional upper limit of normal (ULN)", " Patients must have left ventricular ejection fraction (LVEF) >= 50% by multi-gated acquisition (MUGA) or echocardiography", " Patients must be able to take oral medications (i.e., no uncontrolled vomiting, inability to swallow, or diagnosis of chronic malabsorption)", " Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation as well as for at least 6 months after the last dose of trastuzumab", " Ability to understand and willingness not only for treatment but also for undergoing serial biopsies and sign a written informed consent document", " Only Japanese women are eligible for the trial", "Exclusion Criteria:", " Patients who have had chemotherapy or radiotherapy", " Patients who are receiving any other investigational agents", " Patients have distal metastasis (stage IV disease)", " Patients with previous (within 10 years) or current history of malignant neoplasm except for curatively treated basal and squamous cell carcinoma of the skin or carcinoma in situ of the cervix", " Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to lapatinib or other agents used in study", " Patients receiving any medications or substances that are inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) are ineligible", " Patients who have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements", " Pregnant women", " Patients who have family or personal history of congenital long or short QT syndrome, Brugada syndrome, QT/QTc prolongation, or torsade de pointes", " Patients who have chronic gastrointestinal disease presenting with diarrhea (inflammatory bowel disease, malabsorption, or >= grade 2 diarrhea of any etiology at baseline)", " Patients who have neuropathy >= grade 2 of any cause", " Patients are diagnosed with inflammatory breast cancer or bilateral breast cancer" ]

[ "Inclusion Criteria:", " Postmenopausal status defined as history of at least 12 months without spontaneous menstrual bleeding or a documented hysterectomy and bilateral salpingo oophorectomy", " Breast density greater than 25%", " No hormone replacement therapy for at least six months prior to entry into this study", " Non-smokers.", "Exclusion Criteria:", " History of stroke, pulmonary embolism or deep vein thrombosis", " History of atherosclerotic heart disease", " Presence of any known hypercoagulable state either congenital (e.g., protein S deficiency) or acquired (e.g., corticosteroid treatment)", " Diabetes mellitus", " Uncontrolled hypertension (BP 140/90)", " Presence of a psychiatric condition that would interfere with adherence to the protocol." ]

[ "INTERVENTION 1: ", " Health Tracking (Control)", " Participants assigned to the health-tracking condition received usual care and did not attend any meetings.", "INTERVENTION 2: ", " Peer Support", " The peer support group meetings focused on fostering purpose in life by providing participants with opportunities to support and care for one another. Patients completed a weekly diary of critical experiences or current life problems as homework, and were then encouraged to share these experiences in the group meetings. The group facilitator encouraged participants to help one another with these issues, and share how they had dealt with similar problems." ]

[ "INTERVENTION 1: ", " Exemestane (Exemestane Alone)", " oral dose exemestane taken with food (25 mg tablet once daily)", "INTERVENTION 2: ", " Combination (Exemestane + Celecoxib)", " oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)" ]

[ "Inclusion Criteria:", " Recent primary surgery for breast cancer", " Early stage breast cancer", " Postmenopausal", " Hormone receptor positive", " Positive lymph node involvement", "Exclusion Criteria:", " Metastatic disease", " Presence of contralateral breast cancer including DCIS", " Progression", " Other protocol-defined inclusion/exclusion criteria may apply." ]

[ "Inclusion Criteria:", " Metastatic adenocarcinoma of the breast (Stage IV)", " Actively receiving endocrine therapy for at least 6 weeks (with or without HER2 therapy)", " Minimum age 18 years", " ECOG Performance status of 0, 1 or 2", " Normal organ and marrow function as defined in the protocol", "Exclusion Criteria:", " Participants may not be receiving any other study agents", " Actively receiving chemotherapy (exclusive of hormonal or HER2 therapy ) within last 5 weeks", " Any statin therapy within the last 3 weeks", " Asian decent (including Filipino, Chinese, Japanese, Korean, Vietnamese or Asian-Indian origin)", " Concomitant use of the following drugs: cyclosporine, fibrates, niacin, gemfibrozil, ketaconazole, spironolactone, cimetidine, warfarin, erythromycin, or protease inhibitors", " Conditions predisposing to renal failure secondary to rhabdomyolysis", " Recent history of heavy alcohol use as judged by the treating physician", " Known to be pregnant (testing not required) or nursing", " History of rhabdomyolysis on statin therapy", " Known history of Hepatitis C or active hepatitis B infection (baseline testing not required)", " Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, hepatitis, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements" ]

[ "Outcome Measurement: ", " Objective Response (ORR)", " Objective response rate was defined as percentage of patients with either complete response (CR - disappearance of all target lesions) or partial response (PR - at least 30% decrease in the sum of diameters of target lesions). All patients were to be followed up every 12 weeks for progression, defined by response evaluation criteria in solid tumors (RECIST v1.1).", " Time frame: The planned data cut-off for this study was when all patients, except withdrawals, had been followed up for at least 24 weeks. Patients received treatment up to approximately 2 years.", "Results 1: ", " Arm/Group Title: Fulvestrant 250 mg", " Arm/Group Description: Fulvestrant 250 mg", " Overall Number of Participants Analyzed: 47", " Measure Type: Number", " Unit of Measure: Percentage of patients 8.5 (2.4 to 20.4)", "Results 2: ", " Arm/Group Title: Fulvestrant 250 mg + Loading Dose", " Arm/Group Description: Fulvestrant 250 mg + Loading Dose", " Overall Number of Participants Analyzed: 51", " Measure Type: Number", " Unit of Measure: Percentage of patients 5.9 (1.2 to 16.2)" ]

[ "INTERVENTION 1: ", " Group 2 (RS 11-25)", " Patients with an intermediate RS (11-25) were assigned to Group 2. The subject was then randomized to treatment Arm 1, neoadjuvant hormonal therapy, or treatment Arm 2, neoadjuvant chemotherapy." ]

[ "INTERVENTION 1: ", " AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib", " Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared [mg/m^2]) and cyclophosphamide (AC) (600 mg/m^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months." ]

[ "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%)" ]

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

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

[ "Adverse Events 1:", " Total: 29/48 (60.42%)", " Anemia 4/48 (8.33%)", " Febrile neutropenia 7/48 (14.58%)", " Atrial fibrillation 1/48 (2.08%)", " Pericardial effusion 1/48 (2.08%)", " Sinus bradycardia 1/48 (2.08%)", " Nausea 2/48 (4.17%)", " Vomiting 2/48 (4.17%)", " Death NOS 1/48 (2.08%)", " Fatigue 3/48 (6.25%)", " Allergic reaction 1/48 (2.08%)", " Lung infection 1/48 (2.08%)", " Mucosal infection 1/48 (2.08%)" ]

[ "Adverse Events 1:", " Total: 28/39 (71.79%)", " Anemia 1/39 (2.56%)", " Leukopenia 4/39 (10.26%)", " Neutropenia 4/39 (10.26%)", " Chest Pain 1/39 (2.56%)", " Pericarditis 1/39 (2.56%)", " Sinus Tach. 1/39 (2.56%)", " Sinus Tachycardia 1/39 (2.56%)", " Eye tearing 1/39 (2.56%)", " Diarrhea 7/39 (17.95%)", " Mucositis 3/39 (7.69%)", " Nausea 2/39 (5.13%)", " Vomiting [1]1/39 (2.56%)", " Fatigue 6/39 (15.38%)" ]

[ "Adverse Events 1:", " Total: 2/3 (66.67%)", " Febrile neutropenia 1/3 (33.33%)", " Atrial flutter 0/3 (0.00%)", " Atrial fibrillation 0/3 (0.00%)", " Cardiac failure 0/3 (0.00%)", " Sinus bradycardia 1/3 (33.33%)", " Supraventricular tachycardia 0/3 (0.00%)", " Abdominal pain upper 0/3 (0.00%)", " Dysphagia 0/3 (0.00%)", " Intestinal mass 0/3 (0.00%)", " Pancreatitis acute 0/3 (0.00%)", " Small intestinal obstruction 0/3 (0.00%)", "Adverse Events 2:", " Total: 0/3 (0.00%)", " Febrile neutropenia 0/3 (0.00%)", " Atrial flutter 0/3 (0.00%)", " Atrial fibrillation 0/3 (0.00%)", " Cardiac failure 0/3 (0.00%)", " Sinus bradycardia 0/3 (0.00%)", " Supraventricular tachycardia 0/3 (0.00%)", " Abdominal pain upper 0/3 (0.00%)", " Dysphagia 0/3 (0.00%)", " Intestinal mass 0/3 (0.00%)", " Pancreatitis acute 0/3 (0.00%)", " Small intestinal obstruction 0/3 (0.00%)" ]

[ "Adverse Events 1:", " Total: 112/458 (24.45%)", " Febrile neutropenia 8/458 (1.75%)", " Neutropenia 6/458 (1.31%)", " Anaemia 3/458 (0.66%)", " Thrombocytopenia 3/458 (0.66%)", " Pancytopenia 2/458 (0.44%)", " Myocardial infarction 0/458 (0.00%)", " Pericardial effusion 0/458 (0.00%)", " Tachycardia 0/458 (0.00%)", " Acute myocardial infarction 1/458 (0.22%)", " Atrial fibrillation 0/458 (0.00%)", "Adverse Events 2:", " Total: 39/221 (17.65%)", " Febrile neutropenia 5/221 (2.26%)", " Neutropenia 1/221 (0.45%)", " Anaemia 2/221 (0.90%)", " Thrombocytopenia 0/221 (0.00%)", " Pancytopenia 0/221 (0.00%)", " Myocardial infarction 2/221 (0.90%)", " Pericardial effusion 2/221 (0.90%)", " Tachycardia 2/221 (0.90%)", " Acute myocardial infarction 0/221 (0.00%)", " Atrial fibrillation 1/221 (0.45%)" ]

[ "Outcome Measurement: ", " Percent Change From Baseline to 2 Weeks in Ki67 Expression", " Tumor tissue collected through a core biopsy at baseline and at the end of cycle 1 was used to determine Ki67 expression. Ki67 expression is defined as the percent of cells staining positive by validated central assay.", " Time frame: Baseline, 2 Weeks", "Results 1: ", " Arm/Group Title: Abemaciclib + Anastrozole", " Arm/Group Description: Participants were given 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for 2 weeks.", " All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for an additional 14 weeks.", " Total treatment duration was 16 weeks.", " Overall Number of Participants Analyzed: 59", " Geometric Mean (90% Confidence Interval)", " Unit of Measure: Percent Change -92.86 (-94.82 to -90.16)", "Results 2: ", " Arm/Group Title: Abemaciclib", " Arm/Group Description: Participants received 150 mg of abemaciclib orally Q12H for 2 weeks.", " All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole QD for an additional 14 weeks.", " Total treatment duration was 16 weeks.", " Overall Number of Participants Analyzed: 52", " Geometric Mean (90% Confidence Interval)", " Unit of Measure: Percent Change -90.52 (-93.12 to -86.93)" ]

[ "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" ]

[ "Adverse Events 1:", " Total: 6/40 (15.00%)", " Nausea 1/40 (2.50%)", " Vomiting 1/40 (2.50%)", " Chest pain 1/40 (2.50%)", " Hypercalcemia 1/40 (2.50%)", " Thromboembolism 2/40 (5.00%)" ]

[ "Adverse Events 1:", " Total: 46/170 (27.06%)", " Anaemia 1/170 (0.59%)", " Febrile neutropenia 1/170 (0.59%)", " Cardiac tamponade 1/170 (0.59%)", " Myocarditis 1/170 (0.59%)", " Pericardial effusion 2/170 (1.18%)", " Pericarditis 1/170 (0.59%)", " Colitis 1/170 (0.59%)", " Constipation 1/170 (0.59%)", " Diarrhoea 0/170 (0.00%)", " Gastroenteritis eosinophilic 0/170 (0.00%)", " Intestinal obstruction 0/170 (0.00%)", "Adverse Events 2:", " Total: 0/1 (0.00%)", " Anaemia 0/1 (0.00%)", " Febrile neutropenia 0/1 (0.00%)", " Cardiac tamponade 0/1 (0.00%)", " Myocarditis 0/1 (0.00%)", " Pericardial effusion 0/1 (0.00%)", " Pericarditis 0/1 (0.00%)", " Colitis 0/1 (0.00%)", " Constipation 0/1 (0.00%)", " Diarrhoea 0/1 (0.00%)", " Gastroenteritis eosinophilic 0/1 (0.00%)", " Intestinal obstruction 0/1 (0.00%)", " Nausea 0/1 (0.00%)" ]

[ "Adverse Events 1:", " Total: 12/538 (2.23%)", " Hypertension 0/538 (0.00%)", " Acoustic Neuroma 1/538 (0.19%)", " Diarrhea 0/538 (0.00%)", " Colitis 1/538 (0.19%)", " Elevated ALT or AST enzyme 7/538 (1.30%)", " Diagnosis of Uterine Cancer 0/538 (0.00%)", " Motorcycle accident 0/538 (0.00%)", " Fall 0/538 (0.00%)", " Surgery 3/538 (0.56%)", "Adverse Events 2:", " Total: 8/537 (1.49%)", " Hypertension 1/537 (0.19%)", " Acoustic Neuroma 0/537 (0.00%)", " Diarrhea 1/537 (0.19%)", " Colitis 0/537 (0.00%)", " Elevated ALT or AST enzyme 0/537 (0.00%)", " Diagnosis of Uterine Cancer 2/537 (0.37%)", " Motorcycle accident 1/537 (0.19%)", " Fall 1/537 (0.19%)", " Surgery 2/537 (0.37%)" ]

[ "Adverse Events 1:", " Total: 46/170 (27.06%)", " Anaemia 1/170 (0.59%)", " Febrile neutropenia 1/170 (0.59%)", " Cardiac tamponade 1/170 (0.59%)", " Myocarditis 1/170 (0.59%)", " Pericardial effusion 2/170 (1.18%)", " Pericarditis 1/170 (0.59%)", " Colitis 1/170 (0.59%)", " Constipation 1/170 (0.59%)", " Diarrhoea 0/170 (0.00%)", " Gastroenteritis eosinophilic 0/170 (0.00%)", " Intestinal obstruction 0/170 (0.00%)", "Adverse Events 2:", " Total: 0/1 (0.00%)", " Anaemia 0/1 (0.00%)", " Febrile neutropenia 0/1 (0.00%)", " Cardiac tamponade 0/1 (0.00%)", " Myocarditis 0/1 (0.00%)", " Pericardial effusion 0/1 (0.00%)", " Pericarditis 0/1 (0.00%)", " Colitis 0/1 (0.00%)", " Constipation 0/1 (0.00%)", " Diarrhoea 0/1 (0.00%)", " Gastroenteritis eosinophilic 0/1 (0.00%)", " Intestinal obstruction 0/1 (0.00%)", " Nausea 0/1 (0.00%)" ]

[ "Adverse Events 1:", " Total: 12/538 (2.23%)", " Hypertension 0/538 (0.00%)", " Acoustic Neuroma 1/538 (0.19%)", " Diarrhea 0/538 (0.00%)", " Colitis 1/538 (0.19%)", " Elevated ALT or AST enzyme 7/538 (1.30%)", " Diagnosis of Uterine Cancer 0/538 (0.00%)", " Motorcycle accident 0/538 (0.00%)", " Fall 0/538 (0.00%)", " Surgery 3/538 (0.56%)", "Adverse Events 2:", " Total: 8/537 (1.49%)", " Hypertension 1/537 (0.19%)", " Acoustic Neuroma 0/537 (0.00%)", " Diarrhea 1/537 (0.19%)", " Colitis 0/537 (0.00%)", " Elevated ALT or AST enzyme 0/537 (0.00%)", " Diagnosis of Uterine Cancer 2/537 (0.37%)", " Motorcycle accident 1/537 (0.19%)", " Fall 1/537 (0.19%)", " Surgery 2/537 (0.37%)" ]

[ "Adverse Events 1:", " Total: 6/22 (27.27%)", " Cardiac General, other1/22 (4.55%)", " Pain - Abdomen NOS1/22 (4.55%)", " Death not assoc w CTCAE term- Death NOS1/22 (4.55%)", " Death not assoc w CTCAE term-Disease prog NOS1/22 (4.55%)", " Liver dysfunction/failure1/22 (4.55%)", " Sodium, low (hyponatremia)1/22 (4.55%)", " Dyspnea (shortness of breath)2/22 (9.09%)" ]

[ "Adverse Events 1:", " Total: 20/52 (38.46%)", " Anaemia 0/52 (0.00%)", " Pancytopenia 1/52 (1.92%)", " Acute myocardial infarction 0/52 (0.00%)", " Atrial fibrillation 0/52 (0.00%)", " Cardiac failure 1/52 (1.92%)", " Cardiogenic shock 1/52 (1.92%)", " Palpitations 0/52 (0.00%)", " Pericardial effusion 0/52 (0.00%)", " Right ventricular failure 1/52 (1.92%)", " Abdominal pain 0/52 (0.00%)", " Ascites 3/52 (5.77%)", "Adverse Events 2:", " Total: 25/49 (51.02%)", " Anaemia 2/49 (4.08%)", " Pancytopenia 0/49 (0.00%)", " Acute myocardial infarction 1/49 (2.04%)", " Atrial fibrillation 1/49 (2.04%)", " Cardiac failure 0/49 (0.00%)", " Cardiogenic shock 0/49 (0.00%)", " Palpitations 1/49 (2.04%)", " Pericardial effusion 4/49 (8.16%)", " Right ventricular failure 0/49 (0.00%)", " Abdominal pain 1/49 (2.04%)", " Ascites 0/49 (0.00%)" ]

[ "Adverse Events 1:", " Total: 10/31 (32.26%)", " Edema, limb 1/31 (3.23%)", " Thrombosis1/31 (3.23%)", " diarrhea1/31 (3.23%)", " Pain 2/31 (6.45%)", " Pain, back1/31 (3.23%)", " Pain, extrimity limb 1/31 (3.23%)", " Syncope 1/31 (3.23%)", " Pain, chest/thorax1/31 (3.23%)", " hyponatremia 1/31 (3.23%)", " fever1/31 (3.23%)", " AST 1/31 (3.23%)", " infection1/31 (3.23%)", " Anorexia 1/31 (3.23%)", " Dyspnea 2/31 (6.45%)" ]

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

[ "INTERVENTION 1: ", " 100 mg Q-122", " Dosage was 100 mg Q-122 administered orally as two 50 mg capsules once daily for 28 days.", "INTERVENTION 2: ", " 200 mg Q-122", " Dosage was 200 mg Q-122 administered orally as four 50 mg capsules once daily for 28 days." ]

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

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

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

[ "Inclusion Criteria:", " Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1", " Histologically confirmed estrogen receptor (ER)-negative, progesterone receptor (PR)-negative, and human epidermal growth factor 2 (HER2)-negative adenocarcinoma of the breast with measurable metastatic or locally advanced disease", " Locally advanced disease must not be amenable to resection with curative intent", " Measurable disease, according to RECIST, v1.1", " Adequate hematologic and end organ function", " Agreement to use highly effective contraceptive methods as stated in protocol", "Exclusion Criteria:", " Disease-Specific Exclusion Criteria", " Known HER2-, ER-positive, or PR-positive breast cancer by local laboratory assessment", " Any prior chemotherapy, hormonal, or targeted therapy, for inoperable locally advanced or metastatic triple-negative breast cancer (mTNBC)", " Any systemic anticancer therapy within 3 weeks prior to Cycle 1, Day 1", " Any radiation treatment to metastatic site within 28 days of Cycle 1, Day 1", " Major surgical procedure, open biopsy, or significant traumatic injury within 30 days prior to Cycle 1, Day 1 or anticipation of need for major surgical procedure during the course of the study", " Prior exposure to experimental treatment targeting rapidly accelerated fibrosarcoma (Raf), MAP kinase/ERK kinase (MEK), or the mitogen-activated protein kinase (MAPK) pathway", " Brain metastases (symptomatic or nonsymptomatic) that have not been treated previously, are progressive, or require any type of therapy (e.g., radiation, surgery, or steroids) to control symptoms from brain metastases within 30 days prior to first study treatment dose", " Cobimetinib-Specific Exclusion Criteria", " History of or evidence of retinal pathology on ophthalmologic examination that is considered a risk factor for neurosensory retinal detachment/central serous chorioretinopathy (CSCR), retinal vein occlusion (RVO), or neovascular macular degeneration", " Cobimetinib is metabolized by the hepatic cytochrome P3A4 (CYP3A4) enzyme. Drugs CYP3A4/5 inhibitors and inducers should be avoided", " Atezolizumab-Specific Exclusion Criteria (Cohorts II and III Only)", " History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins", " Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation", " History of autoimmune disease", " Prior allogenic stem cell or solid organ transplantation", " History of idiopathic pulmonary fibrosis (including pneumonitis), drug induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest computed tomography (CT) scan", " Positive test for Human Immunodeficiency Virus (HIV)", " Active hepatitis B (defined as having a positive hepatitis B surface antigen [HBsAg] or positive hepatitis B virus [HBV] deoxyribonucleic acid [DNA] test at screening) or hepatitis C", " Active tuberculosis", " Receipt of a live, attenuated vaccine within 4 weeks prior to randomization or anticipation that such a live, attenuated vaccine will be required during the study", " Prior treatment with cluster of differentiation (CD) 137 (CD137) agonists or immune checkpoint blockade therapies, including anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4), anti-programmed death-1 (anti-PD-1), or anti-programmed death ligand-1 (anti-PD-L1) therapeutic antibodies", " Treatment with systemic immunostimulatory agents (including but not limited to interferons or Interlukin-2 [IL-2]) within 4 weeks or five half-lives of the drug (whichever is shorter) prior to randomization", " Treatment with systemic corticosteroids or other systemic immunosuppressive medications within 2 weeks prior to randomization, or anticipated requirement for systemic immunosuppressive medications during the trial", " Cardiac Exclusion Criteria", " History of clinically significant cardiac dysfunction", " Corrected QT interval at screening greater than (>) 480 milliseconds (ms) (average of triplicate screening measurements)", " Left ventricular ejection fraction (LVEF) below the institutional lower limit of normal or below 50 percent (%), whichever is lower", " General Exclusion Criteria", " No other history of or ongoing malignancy that would potentially interfere with the interpretation of the pharmacodynamic or efficacy assay", " Pregnancy (positive serum pregnancy test) or lactation", " Uncontrolled serious medical or psychiatric illness", " Active infection requiring IV antibiotics on Cycle 1, Day 1", " Participants who have a history of hypersensitivity reactions to paclitaxel or other drugs formulated in Cremophor® EL (polyoxyethylated castor oil) or to nab-paclitaxel and any of the excipients" ]

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

[ "Inclusion Criteria:", " 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: ", " Recommended Dose Level for Phase II Testing (RPTD) (Phase I)", " The RPTD is defined as the highest dose level at which at most one of 6 patients develops a dose limiting toxicity (DLT) during the first course of treatment and the next highest dose level has 2 or more DLTs. The number of patients in each cohort reporting a DLT is reported.", " Dose-limiting toxicities (DLTs) are defined as any of the following adverse events (AEs) that are related to study agent with an attribution of possible, probably, or definite and fulfilling one of the following criteria:", " Any grade 4 hematologic toxicity", " Hyperglycemia that cannot be stably controlled with diabetic medication", " Any grade 3 or 4 non-hematologic toxicity (except asymptomatic medically manageable laboratory abnormalities such as hyperlipidemia, hypophosphatemia, and hypokalemia)", " Time frame: During first course", "Results 1: ", " Arm/Group Title: Dose Level 1", " Arm/Group Description: 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22", " 3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.", " Overall Number of Participants Analyzed: 3", " Measure Type: Number", " Unit of Measure: DLTs 2", "Results 2: ", " Arm/Group Title: Dose Level -1", " Arm/Group Description: 20 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22", " 3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22", " Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.", " Overall Number of Participants Analyzed: 1", " Measure Type: Number", " Unit of Measure: DLTs 1" ]

[ "Outcome Measurement: ", " pCR Within the Breast, Defined as no Evidence of Invasive Tumor Remaining in the Breast at Surgery Following Completion of Chemotherapy", " Pathological complete response (pCR) rates will be based on institutional pathology reports. In the final analysis for publication, rates will be based on blinded central review of these institutional pathology reports. The Chi-squared test will be conducted at the two-sided 0.05 level. A 95% confidence interval will be computed for the difference in pCR rates.", " Time frame: Up to 5 years", "Results 1: ", " Arm/Group Title: FEC-75 Then Paclitaxel/Trastuzumab", " Arm/Group Description: Patients receive Fluorouracil, epirubicin, and cyclophosphamide (FEC) comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies", " Overall Number of Participants Analyzed: 138", " Measure Type: Number", " Unit of Measure: percentage of participants 56.5 (47.8 to 64.9)", "Results 2: ", " Arm/Group Title: Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75", " Arm/Group Description: Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies", " Overall Number of Participants Analyzed: 142", " Measure Type: Number", " Unit of Measure: percentage of participants 54.2 (45.7 to 62.6)" ]

[ "Adverse Events 1:", " Total: 21/2125 (0.99%)", " Febrile neutropenia 0/2125 (0.00%)", " Hemoglobin 0/2125 (0.00%)", " Cardiac General-Other 0/2125 (0.00%)", " Cardiac-ischemia/infarction 1/2125 (0.05%)", " Conduction abnorm/AV block - Sick sinus syndrome 0/2125 (0.00%)", " Left ventricular diastolic dysfunction 0/2125 (0.00%)", " Left ventricular systolic dysfunction 0/2125 (0.00%)", " Pain - Cardiac/heart 0/2125 (0.00%)", "Adverse Events 2:", " Total: 190/2186 (8.69%)", " Febrile neutropenia 3/2186 (0.14%)", " Hemoglobin 3/2186 (0.14%)", " Cardiac General-Other 2/2186 (0.09%)", " Cardiac-ischemia/infarction 1/2186 (0.05%)", " Conduction abnorm/AV block - Sick sinus syndrome 1/2186 (0.05%)", " Left ventricular diastolic dysfunction 3/2186 (0.14%)", " Left ventricular systolic dysfunction 1/2186 (0.05%)", " Pain - Cardiac/heart 3/2186 (0.14%)" ]

[ "Adverse Events 1:", " Total: 10/33 (30.30%)", " Constipation 1/33 (3.03%)", " Dysphagia 1/33 (3.03%)", " Ileus 1/33 (3.03%)", " Nausea 1/33 (3.03%)", " Vomiting 1/33 (3.03%)", " Fatigue 1/33 (3.03%)", " Pain 1/33 (3.03%)", " Sepsis 2/33 (6.06%)", " Urinary tract infection 1/33 (3.03%)", " Alanine aminotransferase increased 1/33 (3.03%)", " Aspartate aminotransferase increased 1/33 (3.03%)", " Dehydration 2/33 (6.06%)" ]

[ "Adverse Events 1:", " Total: 6/21 (28.57%)", " Hypertension 3/21 (14.29%)", " Edema 3/21 (14.29%)", " Nausea 2/21 (9.52%)", " Fracture 1/21 (4.76%)", " Dizziness 3/21 (14.29%)", " Syncope 2/21 (9.52%)", " Headache 2/21 (9.52%)", " Dyspnea 2/21 (9.52%)", " Hypoxia 3/21 (14.29%)" ]

[ "Adverse Events 1:", " Total: 1/40 (2.50%)", " Hypertension 0/40 (0.00%)", " Lower GI bleed 1/40 (2.50%)", " Death 0/40 (0.00%)", " Headache 0/40 (0.00%)", " Dyspnea 0/40 (0.00%)", " Sinusitis 0/40 (0.00%)", " Wound Dehiscence 0/40 (0.00%)", "Adverse Events 2:", " Total: 3/41 (7.32%)", " Hypertension 1/41 (2.44%)", " Lower GI bleed 0/41 (0.00%)", " Death 0/41 (0.00%)", " Headache 0/41 (0.00%)", " Dyspnea 0/41 (0.00%)", " Sinusitis 1/41 (2.44%)", " Wound Dehiscence 1/41 (2.44%)" ]

[ "INTERVENTION 1: ", " Fulvestrant With Enzalutamide", " 500mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) and 160mg of Enzalutamide will be given, in conjunction with Fulvestrant, PO daily.", " Fulvestrant with Enzalutamide: 500mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) and 160mg of Enzalutamide will be given PO daily. Patients will receive a tumor biopsy at the start of treatment and 4 weeks after the start of treatment, with an optional 3rd biopsy at the end treatment." ]

[ "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%" ]

[ "Outcome Measurement: ", " Number of Participants With Clinical Benefit (CBR) and Number of Participants With CBR Having a Disease Free Interval (DFI) Greater Than 2 Years - Evaluable Population", " CBR=participants with complete response (CR) + participants with partial response (PR) + participants with stable disease (SD) for a length of time greater than, equal to 6 months. CR= Disappearance of all target lesions. No new lesions. PR= At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. SD= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference the smallest sum LD since the treatment started. Physical examination,radiological assessment, and bone scans (if applicable) were used to assess outcome.", " Time frame: First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years)", "Results 1: ", " Arm/Group Title: Dasatinib Plus Letrozole", " Arm/Group Description: Dasatinib + Letrozole: Tablets, Oral, once daily, up to 2 years", " Dasatinib 100 mg + Letrozole 2.5 mg", " Patients on letrozole plus dasatinib received both drugs until progressive disease (PD) or intolerable toxicity. If the intolerable toxicity was determined to be related to dasatinib, dasatinib was discontinued and the patient continued on single-agent letrozole. Although drugs were taken daily, cycle length was 28-days", " Overall Number of Participants Analyzed: 56", " Measure Type: Number", " Unit of Measure: participants CBR (CR+PR+SD): 40", " CBR, DFI <= 2 Years: 20", "CBR, DFI > 2 Years: 20", "Results 2: ", " Arm/Group Title: Letrozole", " Arm/Group Description: Letrozole: Tablets, Oral, 2.5 mg, once daily, up to 2 years", " Patients on letrozole who developed progressive disease continued letrozole, and dasatinib was added to their treatment regimen. Although drugs were taken daily, cycle length was 28-days", " Overall Number of Participants Analyzed: 61", " Measure Type: Number", " Unit of Measure: participants CBR (CR+PR+SD): 40", " CBR, DFI <= 2 Years: 20", "CBR, DFI > 2 Years: 20" ]

[ "Adverse Events 1:", " Total: 8/30 (26.67%)", " Heart Failure 1/30 (3.33%)", " Vertigo 1/30 (3.33%)", " Small intestinal obstruction 1/30 (3.33%)", " Fever 1/30 (3.33%)", " Aspartate aminotransferase increased 1/30 (3.33%)", " Alanine aminotransferase increased 1/30 (3.33%)", " Back Pain 1/30 (3.33%)", " Pleural effusion 1/30 (3.33%)", " Rash maculo-papular 1/30 (3.33%)", " Hypotension 1/30 (3.33%)" ]

[ "Adverse Events 1:", " Total: 2/3 (66.67%)", " Febrile neutropenia 1/3 (33.33%)", " Atrial flutter 0/3 (0.00%)", " Atrial fibrillation 0/3 (0.00%)", " Cardiac failure 0/3 (0.00%)", " Sinus bradycardia 1/3 (33.33%)", " Supraventricular tachycardia 0/3 (0.00%)", " Abdominal pain upper 0/3 (0.00%)", " Dysphagia 0/3 (0.00%)", " Intestinal mass 0/3 (0.00%)", " Pancreatitis acute 0/3 (0.00%)", " Small intestinal obstruction 0/3 (0.00%)", "Adverse Events 2:", " Total: 0/3 (0.00%)", " Febrile neutropenia 0/3 (0.00%)", " Atrial flutter 0/3 (0.00%)", " Atrial fibrillation 0/3 (0.00%)", " Cardiac failure 0/3 (0.00%)", " Sinus bradycardia 0/3 (0.00%)", " Supraventricular tachycardia 0/3 (0.00%)", " Abdominal pain upper 0/3 (0.00%)", " Dysphagia 0/3 (0.00%)", " Intestinal mass 0/3 (0.00%)", " Pancreatitis acute 0/3 (0.00%)", " Small intestinal obstruction 0/3 (0.00%)" ]

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

[ "Adverse Events 1:", " Total: 57/57 (100.00%)", " Dry eyes 13/33 (39.39%)", " Heartburn 9/33 (27.27%)", " Nausea after the CT (before day 7) 57/57 (100.00%)", " Herpetic eruption 0/33 (0.00%)", " Dry skin 15/33 (45.45%)", " Alopecia 57/57 (100.00%)", "Adverse Events 2:", " Total: 23/23 (100.00%)", " Dry eyes 2/11 (18.18%)", " Heartburn 2/11 (18.18%)", " Nausea after the CT (before day 7) 23/23 (100.00%)", " Herpetic eruption 3/11 (27.27%)", " Dry skin 9/11 (81.82%)", " Alopecia 23/23 (100.00%)" ]

[ "Outcome Measurement: ", " Number of Participants With Progression Free Survival (PFS)", " Complete Response (CR): disappearance of all target lesions. Any pathological lymph nodes (target or non-target) must have exhibited a reduction in short axis to < 10 mm. Partial Response (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum of diameters. Progressive Disease (PD): at least 20% increase in sum of diameters of target lesions taking as reference the smallest sum on study accompanied by an absolute increase of at least 5 mm or appearance of one or more new lesions. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference smallest sum diameters. PFS is time from enrollment to date of first documented disease progression or death due to any cause. A participant is considered to be censored when data on time to event is missing due to a subject being lost to follow-up or non-occurrence of the outcome event before the completion of the trial.", " Time frame: up to 18 months", "Results 1: ", " Arm/Group Title: Patients Without Bone Metastases", " Arm/Group Description: Patients with no bone metastasis were randomized into a 1:1 ratio to standard therapy plus zoledronic acid 4mg IV Zoledronic acid administration monthly during Months 1-18.", " Overall Number of Participants Analyzed: 15", " Measure Type: Number", " Unit of Measure: Participants Event: 9", "Censor: 6", "Results 2: ", " Arm/Group Title: Patients With Bone Metastases", " Arm/Group Description: Patients with bone metastasis received standard therapy + zoledronic acid for 18 months (discontinued upon disease progression/secondary malignancy)", " Overall Number of Participants Analyzed: 29", " Measure Type: Number", " Unit of Measure: Participants Event: 19", "Censor: 10" ]

[ "Outcome Measurement: ", " Progression-Free Survival (PFS): Independent Radiological Facility (IRF) Assessment", " IRF assessed PFS was defined as time (in months) from randomization until the date of first documented radiologic progressive disease per response evaluation criteria in solid tumors (RECIST) version 1.1 or death from any cause, whichever occurs first. As per RECIST v1.1, progression defined as 1) for target lesions: at least a 20% increase in the sum of target lesion measurements, compared to the smallest sum on study (including baseline), the absolute increase in the sum has to be at least 5 millimeter (mm); 2) for non-target lesions: unequivocal progression of non-target lesions, evaluated as a whole, such that it is clear that treatment has failed and disease is progressing, regardless of the status of the target lesions; 3) and/or appearance of one or more new lesions. The analysis was performed by Kaplan-Meier method.", " Time frame: Baseline until radiologic progressive disease or death due to any cause (up to maximum duration of 36.9 months)", "Results 1: ", " Arm/Group Title: Talazoparib", " Arm/Group Description: Participants received talazoparib 1 mg, orally, once daily until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or sponsor's decision to terminate the trial (up to a maximum of 70.2 months). One cycle was of 21 days.", " Overall Number of Participants Analyzed: 287", " Median (95% Confidence Interval)", " Unit of Measure: months 8.6 (7.2 to 9.3)", "Results 2: ", " Arm/Group Title: Physician's Choice Treatment", " Arm/Group Description: Participants received 1 of the following drugs in specified regimens, as per the physician's choice: 1) capecitabine 1250 mg/m^2 orally twice daily on Day 1 to 14 in each cycle; 2) eribulin mesylate 1.4 mg/m^2 (equivalent to eribulin 1.23 mg/ m^2), as 2 to 5 minute IV infusion on Day 1 and 8 in each cycle; 3) gemcitabine 1250 mg/m^2 as 30-minute IV infusion on Day 1 and 8 in each cycle; 4) vinorelbine 30 mg/m^2 as 6 to 10 minute IV infusion on Day 1, 8, and 15 in each cycle; until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or Sponsor's decision to terminate the trial (up to a maximum of 45.3 months). One cycle was of 21 days.", " Overall Number of Participants Analyzed: 144", " Median (95% Confidence Interval)", " Unit of Measure: months 5.6 (4.2 to 6.7)" ]

[ "INTERVENTION 1: ", " Lapatinib,Whole Brain Radiation,Herceptin", " Lapatinib before and during Whole Brain Radiation Therapy (WBRT), then Herceptin 4mg/kg IV weekly" ]

[ "Inclusion Criteria:", " Subjects who were confirmed to have a response after receiving at least two courses of weekly paclitaxel therapy and considered to need to continue the therapy by the investigator/subinvestigator among the patients with advanced or recurrent breast cancer who had met the selection criteria and participated in the preceding phase II clinical study" ]

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

[ "INTERVENTION 1: ", " Single Drain", " Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group.", " Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.", " Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla.", " Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.", "INTERVENTION 2: ", " Double Drain", " Insertion of double drains: Two negative pressure drains will be inserted into the axilla and below the lower flap in the double drains group.", " Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.", " Insertion of double drains: Two drains will be inserted into the axilla and below the lower flap in the double drains group.", " Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography." ]

[ "Adverse Events 1:", " Total: 2/6 (33.33%)", " Febrile neutropenia * 1/6 (16.67%)", " Neutropenia * 0/6 (0.00%)", " Thrombocytopenia * 1/6 (16.67%)", " Diarrhoea * 0/6 (0.00%)", " Pyrexia * 0/6 (0.00%)", " Thrombosis in device * 1/6 (16.67%)", " Fatigue * 0/6 (0.00%)", " Mucosal inflammation * 0/6 (0.00%)", " Device deployment issue * 0/6 (0.00%)", " Hepatocellular injury * 1/6 (16.67%)", " Cholecystitis * 1/6 (16.67%)", "Adverse Events 2:", " Total: 2/6 (33.33%)", " Febrile neutropenia * 1/6 (16.67%)", " Neutropenia * 1/6 (16.67%)", " Thrombocytopenia * 0/6 (0.00%)", " Diarrhoea * 0/6 (0.00%)", " Pyrexia * 0/6 (0.00%)", " Thrombosis in device * 1/6 (16.67%)", " Fatigue * 0/6 (0.00%)", " Mucosal inflammation * 0/6 (0.00%)", " Device deployment issue * 0/6 (0.00%)", " Hepatocellular injury * 0/6 (0.00%)", " Cholecystitis * 0/6 (0.00%)" ]

[ "Inclusion Criteria:", " Unicentric Stage I invasive ductal breast cancer or Grade I or II DCIS measuring less than or equal to 2cm on pathology and/or mammography", " Histologically negative tumor margin 2 mm or more from any inked edges, or no tumor in a re-excision specimen or final shaved specimen", " Clips must be placed in the lumpectomy cavity at the time of final excision in order to aid in the delineation of the tumor cavity at the time of simulation and radiation delivery", "Exclusion Criteria:", " No distant metastasis", " Not pregnant or breastfeeding", " No diffuse suspicious microcalcifications", " No prior radiation therapy to the ipsilateral or contralateral breast or thorax", " No histologic evidence of lymphovascular invasion (LVI)", " No histologic evidence of EIC", " No history of cosmetic or reconstructive breast surgery", " No psychiatric illness that would prevent the patient from giving informed consent", " No medical conditions that, in the opinion of the treating physician would make this protocol unreasonably hazardous for the patient", " No other currently active second malignancy other than non-melanoma skin cancers" ]

[ "Inclusion Criteria:", " Patients should have a life expectancy of at least 10 years, excluding their diagnosis of breast cancer.", " Submission of a block from the diagnostic biopsy sample and from the surgical sample, if gross residual disease greater than or equal to 1.0 cm was removed at the time of surgery, is required for all patients", " Patients of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy and for at least 6 months after the last dose of study therapy.", " The Eastern Cooperative Oncology Group (ECOG) performance status must be 0 or 1.", " Patients must have the ability to swallow oral medication.", " The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy or by limited incisional biopsy.", " Patients must have ER analysis performed on the primary tumor prior to randomization. If ER analysis is negative, then progesterone receptor (PgR) analysis must also be performed. (Patients are eligible with either hormone receptor-positive or hormone receptor-negative tumors.)", " Breast cancer must be determined to be HER2-positive prior to randomization. Assays using FISH or CISH require gene amplification. Assays using IHC require a strongly positive (3+) staining score.", " Clinical staging, based on the assessment by physical exam, must be American Joint Committee on Cancer (AJCC) stage IIB, IIIA, IIIB, or IIIC: cT2 and cN1; cT3 and cN0 or cN1; Any cT and cN2 or cN3; or cT4", " The patient must have a mass in the breast or axilla measuring greater than or equal to 2.0 cm by physical exam, unless the patient has inflammatory breast cancer, in which case measurable disease by physical exam is not required.", " At the time of randomization, blood counts performed within 4 weeks prior to randomization must meet the following criteria: absolute neutrophil count (ANC) must be greater than or equal to 1200/mm3; Platelet count must be greater than or equal to 100,000/mm3; Hemoglobin must be greater than or equal to 10 g/dL", " The following criteria for evidence of adequate hepatic function performed within 4 weeks prior to randomization must be met: total bilirubin must be less than or equal to upper limit of normal (ULN) for the lab unless the patient has a bilirubin elevation greater than ULN to 1.5 x ULN due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin; and alkaline phosphatase must be less than or equal to 2.5 x ULN for the lab; and aspartate aminotransferase (AST) and ALT must be less than or equal to 1.5 x ULN for the lab.", " Patients with alkaline phosphatase greater than ULN but less than or equal to 2.5 x ULN are eligible for inclusion in the study if liver imaging (CT, MRI, PET, or PET-CT scan) performed within 4 weeks prior to randomization does not demonstrate metastatic disease and the requirements for adequate hepatic function are met.", " Patients with either unexplained 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 a bone scan, PET-CT scan, or PET scan performed within 4 weeks prior to randomization does not demonstrate metastatic disease. Patients with suspicious findings on bone scan or PET scan are eligible if suspicious findings are determined to be benign by x-ray, MRI, or biopsy.", " Serum creatinine performed within 4 weeks prior to randomization must be less than or equal to 1.5 x ULN for the lab.", " The left ventricular ejection fraction (LVEF) assessment by 2-D echocardiogram or multiple gated acquisition(MUGA) scan performed within 90 days prior to randomization must be greater than or equal to 50% regardless of the facility's LLN.", "Exclusion Criteria:", " fine-needle aspiration (FNA) alone to diagnose the primary breast cancer.", " Excisional biopsy or lumpectomy performed prior to randomization.", " Surgical axillary staging procedure prior to randomization. (Procedures that are permitted prior to study entry include: 1) FNA or core biopsy of an axillary node for any patient, and 2) although not recommended, a pre-neoadjuvant therapy SN biopsy for patients with clinically negative axillary nodes.)", " Definitive clinical or radiologic evidence of metastatic disease. (Note: Chest imaging [mandatory for all patients] and other imaging [if required] must have been performed within 90 days prior to randomization.)", " History of ipsilateral invasive breast cancer regardless of treatment or ipsilateral ductal carcinoma in situ (DCIS) treated with radiation therapy (RT). (Patients with a history of LCIS are eligible.)", " Contralateral invasive breast cancer at any time. (Patients with contralateral DCIS or lobular carcinoma in situ (LCIS) are eligible.)", " History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to randomization.", " Known metastatic disease from any malignancy (solid tumor or hematologic).", " Previous therapy with anthracyclines, taxanes, cyclophosphamide, trastuzumab, or neratinib for any malignancy.", " Treatment including RT, chemotherapy, and/or targeted therapy, administered for the currently diagnosed breast cancer prior to randomization.", " Continued endocrine therapy such as raloxifene or tamoxifen (or other SERM) or an aromatase inhibitor. (Patients are eligible if these medications are discontinued prior to randomization.)", " Any continued sex hormonal therapy, e.g., birth control pills and ovarian hormone replacement therapy. Patients are eligible if these medications are discontinued prior to randomization.", " Active hepatitis B or hepatitis C with abnormal liver function tests.", " Intrinsic lung disease resulting in dyspnea.", " Active infection or chronic infection requiring chronic suppressive antibiotics.", " Malabsorption syndrome, ulcerative colitis, inflammatory bowel disease, resection of the stomach or small bowel, or other disease or condition significantly affecting gastrointestinal function.", " Persistent greater than or equal to grade 2 diarrhea regardless of etiology.", " Sensory or motor neuropathy greater than or equal to grade 2, as defined by the NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0.", " Conditions that would prohibit intermittent administration of corticosteroids for paclitaxel premedication.", " Chronic daily treatment with corticosteroids with a dose of greater than or equal to 10 mg/day methylprednisolone equivalent (excluding inhaled steroids).", " Uncontrolled hypertension defined as a systolic BP greater than 150 mmHg or diastolic BP greater than 90 mmHg, with or without anti-hypertensive medications. (Patients with hypertension that is well-controlled on medication are eligible.)", " Cardiac disease (history of and/or active disease) that would preclude the use of any of the drugs included in the treatment regimen. This includes but is not confined to: Active cardiac disease: symptomatic angina pectoris within the past 180 days that required the initiation of or increase in anti-anginal medication or other intervention; ventricular arrhythmias except for benign premature ventricular contractions; supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication; conduction abnormality requiring a pacemaker; valvular disease with documented compromise in cardiac function; and symptomatic pericarditis. History of cardiac disease: myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LV function; history of documented congestive heart failure (CHF); and documented cardiomyopathy.", " Other nonmalignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up.", " Pregnancy or lactation at the time of randomization.", " The investigator should assess the patient to determine if she has any psychiatric or addictive disorder or other condition that, in the opinion of the investigator, would preclude her from meeting the study requirements.", " Use of any investigational agent within 4 weeks prior to randomization." ]

[ "INTERVENTION 1: ", " Diagnostic (18F-FLT)", " Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.", " Fluorothymidine F-18: Undergo 18F-FLT PET/CT", " Positron Emission Tomography: Undergo 18F-FLT PET/CT", " Computed Tomography: Undergo 18F-FLT PET/CT", " Laboratory Biomarker Analysis: Correlative studies" ]

[ "INTERVENTION 1: ", " Herceptin© + Taxane", " 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 .", "INTERVENTION 2: ", " MYL-1401O Trastuzumab + Taxane", " 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." ]

[ "INCLUSION CRITERIA:", " Patient must be 18 years of age or older", " Patients must have histologically confirmed (by routine H&E staining) adenocarcinoma of the breast any T, any N, M0 disease", " Patients must have undergone a segmental mastectomy (SM) with a level I and ll axillary dissection or sentinel lymph node biopsy. Surgical margins at time of local surgery must be negative greater or equal to 2mm for both invasive carcinoma and for non-invasive ductal carcinoma Patients who have post-operative margins which are negative but less than 2mm will be considered eligible if the surgeon states that the margin in question cannot be improved.", " Patients must be registered such that radiation therapy begins within 10 weeks of last surgery", " Patients must have a performance status 0 or 1 by Eastern Cooperative Oncology Group (ECOG) criteria or a 80-100 Karnofsky Performance Scale at time of consult", " Women of all races and ethnic groups are eligible for this trial", "EXCLUSION CRITERIA:", " Patients must not have received prior radiation therapy to the breast at any time for any reason", " Patients with squamous carcinomas or sarcomas of the breast cancer are not eligible", " Patients treated with a mastectomy are NOT eligible", " Any patient with active local-regional disease prior to registration is not eligible", " No other prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or any other cancer from which the patient has been disease-free for at least 5 years", " Patients must not be pregnant due to the potential for fetal harm as a result of this treatment regimen. Women of child-bearing potential must use effective non hormonal contraception while undergoing radiation therapy", " Patients must not have a serious medical or psychiatric illness which prevents informed consent or compliance with treatment" ]

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

[ "Inclusion Criteria:", " Histologically or cytologically confirmed adenocarcinoma of the breast.", " Measurable or evaluable locally advanced or metastatic disease.", " Age 18 years.", " Disease progression during or after treatment with a bevacizumab-containing regimen in the adjuvant or first-line metastatic setting.", " Patients must have discontinued chemotherapy at least 3 weeks prior to randomization.", " No more than one prior chemotherapy regimen for locally advanced or metastatic disease.", " Prior hormonal therapy allowed provided it has been discontinued prior to randomization.", " Prior radiation therapy is allowed but must be completed at least 3 weeks prior to randomization. Previously radiated area(s) must not be the only site of disease.", " ECOG Performance Status of 0 or 1.", " Adequate bone marrow, liver, and renal function", " Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to randomization, and must agree to use adequate contraception prior to study entry, for the duration of study participation and 28 days after the last study drug dosing.", " Patients must be able and willing to sign a written informed consent.", " Patients must be able to swallow and retain oral medication.", "Exclusion Criteria:", " Patients with breast cancer over-expressing human epidermal growth factor receptor 2 (HER-2) (gene amplification by FISH or 3+ over-expression by immunohistochemistry). Patients with unknown HER-2 status are not eligible.", " Patients with active brain metastases.", " Major surgery, open biopsy, or significant traumatic injury within 4 weeks of randomization.", " Prior use of gemcitabine/capecitabine or sorafenib.", " Evidence or history of bleeding diathesis or coagulopathy.", " Serious, non-healing wound, ulcer, or bone fracture.", " Substance abuse, or medical, psychological, or social condition that may interfere with the patient's participation in the study or evaluation of the study results.", " Use of cytochrome P450 enzyme-inducing anti-epileptic drugs is not allowed.", " Clinically significant cardiac disease", " Uncontrolled hypertension", " Thrombolic, embolic, venous, or arterial events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.", " Pulmonary hemorrhage/bleeding event > NCI-CTCAE Grade 2 within 4 weeks of randomization.", " Any other hemorrhage/bleeding event NCI-CTCAE Grade 3 within 4 weeks of randomization.", " Active clinically serious infection > NCI-CTCAE Grade 2.", " Known HIV infection or chronic hepatitis B or C (the safety and effectiveness of sorafenib in this patient population have not been studied).", " Previous or concurrent cancer that is distinct in primary site or histology from breast cancer EXCEPT cervical cancer in-situ, treated basal cell carcinoma, superficial bladder tumors [Ta and Tis] or any cancer curatively treated > 5 years prior to randomization.", " Known or suspected allergy to sorafenib or gemcitabine/capecitabine.", " Prior or concurrent use of St. John's Wort or rifampin (rifampicin) within 3 weeks of randomization.", " Concurrent anti-cancer therapy other than gemcitabine/capecitabine and sorafenib/placebo.", " Prior treatment with any agent that targets VEGF or VEGFR (licensed or investigational), except bevacizumab.", " Women who are pregnant or breast-feeding.", " Use of any investigational drug within 30 days or 5 half-lives, whichever is longer, preceding randomization.", " Inability to comply with protocol and/or not willing or not available for follow-up assessments.", " Any condition which in the investigator's opinion makes the patient unsuitable for the study participation." ]

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

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

[ "INTERVENTION 1: ", " Pecs Group", " Ultrasound guided pectoral nerve block is performed right after induction, before surgery. The needle is advanced to the tissue plane between the pectoralis major and pectoralis minor muscle at the vicinity of the pectoral branch of the acromiothoracic artery, and 10 mL of 0.5% ropivacaine deposited. In a similar manner, 20 mL is deposited at the level of the third rib between the pectoralis minor muscle and the serratus anterior muscle .", "INTERVENTION 2: ", " Control Group", "There is no block." ]

[ "INTERVENTION 1: ", " Tamoxifen or Letrozole", " tamoxifen or letrozole work in treating women with ductal carcinoma in situ", " letrozole", " tamoxifen citrate", " conventional surgery", " neoadjuvant therapy" ]

[ "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." ]

[ "INTERVENTION 1: ", " Patients Undergoing Mastectomy Surgery", " Number of individuals having mastectomy surgery who were approached for participation in the trial" ]

[ "INTERVENTION 1: ", " Treatment (Tivantinib)", " Patients receive tivantinib PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection at baseline and periodically during study for c-Met expression, relevant markers (HGF and VEGF), PTEN loss, and PI3K mutation analysis by FISH and IHC. Archived tumor tissue samples are also analyzed.", " Laboratory Biomarker Analysis: Correlative studies", " Tivantinib: Given PO" ]

[ "Adverse Events 1:", " Total: 4/31 (12.90%)", " Bleeding 1/31 (3.23%)", " Pain 2/31 (6.45%)", " Dehydration 1/31 (3.23%)", " Dyspnea 1/31 (3.23%)" ]

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

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

[ "INTERVENTION 1: ", " Niraparib 200 mg", " Participants received niraparib 200 milligrams (mg) orally once daily in 28-day treatment cycles. After 2 cycles, participants either underwent surgery, received additional cycles of niraparib (maximum of 6 cycles total), or received neoadjuvant chemotherapy, at physician's discretion. A breast magnetic resonance imaging (MRI) was performed at the end of cycle 2 and breast ultrasounds were performed at the end of each cycle, including any additional cycles beyond cycle 2. After completion of all neoadjuvant therapy participants proceeded to surgery, at which time pathological complete response (pCR) was assessed." ]

[ "INTERVENTION 1: ", " Topical Saline", " Topical liquid lidocaine: active intervention drug numbs the hypersensitive mucosa of the vulvar vestibule", " Topical saline: saline applied to the vestibule mucosa will not reverse the local tenderness", "INTERVENTION 2: ", " Topical Liquid Lidocaine", " Topical liquid lidocaine: active intervention drug numbs the hypersensitive mucosa of the vulvar vestibule", " Topical saline: saline applied to the vestibule mucosa will not reverse the local tenderness" ]

[ "INTERVENTION 1: ", " Phase 1b (Schedule 1): Eribulin Mesilate (1.2 mg/m^2)", " Participants received eribulin mesilate 1.2 mg/m^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).", "INTERVENTION 2: ", " Phase 1b (Schedule 1): Eribulin Mesilate (1.6 mg/m^2)", " Participants received eribulin mesilate 1.6 mg/m^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1)." ]

[ "Outcome Measurement: ", " Percentage of Participants With Best Tumor Response of Partial Response (PR) or Complete Response (CR) While On-study", " CR=Disappearance of all clinical and radiologic evidence of target lesions; PR=At least 30% reduction in the sum of the longest diameter of all target lesions.", " Time frame: Baseline visit and then every 8 weeks to 12 months, then every 3 months until disease progression", "Results 1: ", " Arm/Group Title: Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg", " Arm/Group Description: Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.", " Overall Number of Participants Analyzed: 46", " Measure Type: Number", " Unit of Measure: Percentage of participants 47.8 (32.9 to 63.1)", "Results 2: ", " Arm/Group Title: Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg", " Arm/Group Description: Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.", " Overall Number of Participants Analyzed: 45", " Measure Type: Number", " Unit of Measure: Percentage of participants 71.1 (55.7 to 83.6)" ]

[ "Adverse Events 1:", " Total: 30/98 (30.61%)", " NEUTROPENIA 1/98 (1.02%)", " ATRIAL FIBRILLATION 1/98 (1.02%)", " CARDIAC FAILURE 1/98 (1.02%)", " TACHYCARDIA 0/98 (0.00%)", " ACUTE VESTIBULAR SYNDROME 1/98 (1.02%)", " VERTIGO 0/98 (0.00%)", " ABDOMINAL PAIN 0/98 (0.00%)", " COLITIS 0/98 (0.00%)", " DIARRHOEA 2/98 (2.04%)", " FEMORAL HERNIA 0/98 (0.00%)", " HAEMATEMESIS 0/98 (0.00%)", " ILEUS 0/98 (0.00%)", " NAUSEA 0/98 (0.00%)", "Adverse Events 2:", " Total: 46/102 (45.10%)", " NEUTROPENIA 0/102 (0.00%)", " ATRIAL FIBRILLATION 0/102 (0.00%)", " CARDIAC FAILURE 0/102 (0.00%)", " TACHYCARDIA 2/102 (1.96%)", " ACUTE VESTIBULAR SYNDROME 0/102 (0.00%)", " VERTIGO 1/102 (0.98%)", " ABDOMINAL PAIN 2/102 (1.96%)", " COLITIS 1/102 (0.98%)", " DIARRHOEA 8/102 (7.84%)", " FEMORAL HERNIA 1/102 (0.98%)", " HAEMATEMESIS 1/102 (0.98%)", " ILEUS 1/102 (0.98%)" ]

[ "Inclusion Criteria:", " Signed informed consent", " At least 19 years old", " Glomerular filtration rate> 60", " Heterogeneously or extremely dense breasts (BI-RADS category c or d).", "Exclusion Criteria:", " History of iodinated contrast allergy", " Pregnant or lactating as determined by routine standard practice", " Personal history of breast cancer", " History of prior breast excisional biopsy (Patients with a history of core needle biopsy will not be excluded)", " History of prior breast reduction mammoplasty surgery", " History of prior breast augmentation surgery", " Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study." ]

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

[ "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%)" ]

[ "Adverse Events 1:", " Total: 14/76 (18.42%)", " Neutropenia 10/76 (13.16%)", " Febrile neutropenia 1/76 (1.32%)", " Anaemia 0/76 (0.00%)", " Thrombocytopenia 0/76 (0.00%)", " Cardiopulmonary failure 0/76 (0.00%)", " Optic ischaemic neuropathy 0/76 (0.00%)", " Bowel peristalsis increased 1/76 (1.32%)", " Colitis 0/76 (0.00%)", " Diarrhoea 0/76 (0.00%)", " Gastritis 0/76 (0.00%)", " Nausea 0/76 (0.00%)", "Adverse Events 2:", " Total: 12/76 (15.79%)", " Neutropenia 2/76 (2.63%)", " Febrile neutropenia 1/76 (1.32%)", " Anaemia 0/76 (0.00%)", " Thrombocytopenia 0/76 (0.00%)", " Cardiopulmonary failure 1/76 (1.32%)", " Optic ischaemic neuropathy 1/76 (1.32%)", " Bowel peristalsis increased 0/76 (0.00%)", " Colitis 1/76 (1.32%)", " Diarrhoea 0/76 (0.00%)", " Gastritis 0/76 (0.00%)", " Nausea 1/76 (1.32%)" ]

[ "Adverse Events 1:", " Total: 0/244 (0.00%)", " Pregnancy *0/244 (0.00%)", " Endocervical cancer *0/244 (0.00%)", " Nosocomial pneumonia *0/244 (0.00%)", " Venous thrombosis *0/244 (0.00%)", "Adverse Events 2:", " Total: 5/255 (1.96%)", " Pregnancy *1/255 (0.39%)", " Endocervical cancer *1/255 (0.39%)", " Nosocomial pneumonia *2/255 (0.78%)", " Venous thrombosis *1/255 (0.39%)" ]

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

[ "Adverse Events 1:", " Total: 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%)" ]

[ "DISEASE CHARACTERISTICS:", " Histologically or cytologically confirmed breast cancer with radiographically confirmed metastases to the brain", " Extracranial metastases allowed", " Must have demonstrated progression of brain metastases after prior treatment for brain metastases, including any of the following:", " External beam radiotherapy", " Brachytherapy", " Stereotactic radiosurgery", " Surgery", " Chemotherapy", " Treatments with investigational drugs, biologics, or devices", " Disease progression in the CNS must meet 1 of the following criteria:", " New lesions in the CNS on an imaging study (contrast-enhanced CT scan or MRI)", " Progressive lesions on an imaging study (contrast-enhanced CT scan or MRI)", " New or progressive lesions that do not meet measurable disease definition allowed", " Leptomeningeal disease allowed if concurrent progression or parenchymal brain metastases", " Not a candidate for surgical resection and/or further stereotactic radiosurgery", " Hormone receptor status not specified", " PATIENT CHARACTERISTICS:", " Menopausal status not specified", " ECOG performance status 0-2", " Life expectancy 1 month", " Hemoglobin 10 g/dL (transfusion allowed)", " ANC 1,500/mm³", " Granulocyte count 1,500/mm³", " Platelet count 100,000/mm³", " Creatinine 1.5 mg/dL", " Total bilirubin 1.5 times upper limit of normal (ULN)", " AST and ALT 3 times ULN", " Must be able to swallow and retain oral medications", " No other active malignancy except for any of the following:", " Curatively treated basal or squamous cell carcinoma of the skin", " Carcinoma in situ of the cervix", " Other malignancies considered disease-free", " Not pregnant or nursing", " Negative pregnancy test", " Fertile patients must use effective contraception", " No history of immediate or delayed-type hypersensitivity reaction to gadolinium contrast agents or other contraindication to gadolinium contrast", " No other known contraindication to MRI including, but not limited to, any of the following:", " Cardiac pacemaker", " Implanted cardiac defibrillator", " Brain aneurysm clips", " Cochlear implant", " Ocular foreign body", " Shrapnel", " No active or uncontrolled infection", " PRIOR CONCURRENT THERAPY:", " See Disease Characteristics", " Recovered from the side effects of prior chemotherapy, surgery, or radiotherapy for extracranial disease or brain metastases", " Concurrent trastuzumab, bisphosphonate, and/or corticosteroid therapy allowed", " At least 1 week since prior or on current stable dose of corticosteroid therapy", " Patients on an enzyme-inducing anti-epileptic agent (EIAE) or valproic acid are eligible if they are switched to an alternate non-EIAE medication", " Concurrent coumadin allowed", " No prophylactic use of filgrastim (G-CSF) during first course of treatment" ]

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

[ "Inclusion Criteria:", " Female patients with histologically or cytologically confirmed carcinoma of the breast.", " Every effort should be made to make paraffin embedded tissue or slides from the diagnostic biopsy or surgical specimen available for confirmation of diagnosis.", " Patients with locally recurrent or metastatic disease who have received at least two (and not more than five) prior chemotherapeutic regimens for breast cancer, at least two of which were administered for treatment of locally recurrent and/or metastatic disease.", " Prior therapy must be documented by the following criteria prior to entry onto study:", " Regimens must have included an anthracycline (e.g., doxorubicin, epirubicin) and a taxane (e.g., paclitaxel, docetaxel) in any combination or order. Treatment with any of these agents is not required if they are contraindicated for a certain patient.", " One or two of these regimens may have been administered as adjuvant and/or neoadjuvant therapy, but at least 2 must have been given for relapsed or metastatic disease.", " Patients must have proved refractory to the most recent chemotherapy, documented by progression on or within six (6) months of therapy.", " Patients with Human Epidermal Growth Factor 2 (HER2/neu) positive tumors may additionally have been treated with trastuzumab.", " Patients may have additionally been treated with anti-hormonal therapy.", " Resolution of all chemotherapy or radiation-related toxicities to Grade 1 severity or lower, except for stable sensory neuropathy <= Grade 2 and alopecia.", " Age >= 18 years.", " Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.", " Life expectancy of >= 3 months.", " Adequate renal function as evidenced by serum creatinine <= 2.0 mg/dL or calculated creatinine clearance >= 40 mL/min per the Cockcroft and Gault formula.", " Adequate bone marrow function as evidenced by absolute neutrophil count (ANC) >= 1.5 x 10^9/L, hemoglobin >= 10.0 g/dL (a hemoglobin <10.0 g/dL is acceptable if it is corrected by growth factor or transfusion), and platelet count >= 100 x 10^9/L.", " Adequate liver function as evidenced by bilirubin <= 1.5 times the upper limits of normal (ULN) and alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) <= 3 x ULN (in the case of liver metastases <= 5 x ULN), unless there are bone metastases, in which case liver specific alkaline phosphatase must be separated from the total and used to assess the liver function instead of the total alkaline phosphatase. In case alkaline phosphatase is >3 x ULN (in absence of liver metastases) or > 5 x ULN (in presence of liver metastases) AND patient is known to have bone metastases, the liver specific alkaline phosphatase must be separated from the total and used to assess the liver function instead of the total alkaline phosphatase.", " Patients willing and able to comply with the study protocol for the duration of the study.", " Written informed consent prior to any study-specific screening procedures with the understanding that the patient may withdraw consent at any time without prejudice.", " EXCLUSION CRITERIA", " Patients who have received any of the following treatments within the specified period before E7389 or TPC treatment start:", " chemotherapy, radiation, trastuzumab or hormonal therapy within three weeks.", " any investigational drug within four weeks.", " Radiation therapy encompassing > 30% of marrow.", " Prior treatment with mitomycin C or nitrosourea.", " Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen.", " Patients with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study. Any signs (e.g., radiologic) and/or symptoms of brain metastases must be stable for at least 4 weeks before starting study treatment; radiographic stability should be determined by comparing a contrast-enhanced computed tomography or magnetic resonance imaging brain scan performed during screening to a prior scan performed at least 4 weeks earlier.", " Patients with meningeal carcinomatosis.", " Patients who are receiving anti-coagulant therapy with warfarin or related compounds, other than for line patency, and cannot be changed to heparin-based therapy if randomized to E7389 are not eligible. If a patient is to continue on mini-dose warfarin, then the prothrombin time (PT) or international normalized ratio (INR) must be closely monitored.", " Women who are pregnant or breast-feeding; women of childbearing potential with either a positive pregnancy test at screening or no pregnancy test; women of childbearing potential unless (1) surgically sterile or (2) using adequate measures of contraception in the opinion of the Investigator. Perimenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.", " Severe/uncontrolled intercurrent illness/infection.", " Significant cardiovascular impairment (history of congestive heart failure > New York Heart Association grade II, unstable angina or myocardial infarction within the past six months, or serious cardiac arrhythmia).", " Patients with organ allografts requiring immunosuppression.", " Patients with known positive HIV status.", " Patients who have had a prior malignancy, other than previous breast cancer, carcinoma in situ of the cervix, or non-melanoma skin cancer, unless the prior malignancy was diagnosed and definitively treated >= 5 years previously with no subsequent evidence of recurrence.", " Patients with pre-existing neuropathy > Grade 2.", " Patients with a hypersensitivity to halichondrin B and/or halichondrin B chemical derivative.", " Patients who participated in a prior E7389 clinical trial whether or not E7389 was received.", " Patients with other significant disease or disorders that, in the Investigator's opinion, would exclude the patient from the study." ]

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

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

[ "INTERVENTION 1: ", " Initial Cohort", " Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG Subcutaneous administration 5 doses of 300 micrograms", " Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG: All research participants will receive the Mimotope P10s-PADRE/MONTANIDE ISA 51 VG vaccine via subcutaneous (SC) injection following the schedule", "INTERVENTION 2: ", " Escalation Cohort", " Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG Subcutaneous administration of 5 doses of 500 micrograms", " Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG: All research participants will receive the Mimotope P10s-PADRE/MONTANIDE ISA 51 VG vaccine via subcutaneous (SC) injection following the schedule" ]

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

[ "Adverse Events 1:", " Total: 19/51 (37.25%)", " Febrile neutropenia 6/51 (11.76%)", " Anaemia 1/51 (1.96%)", " Leukopenia 1/51 (1.96%)", " Neutropenia 1/51 (1.96%)", " Thrombocytopenia 0/51 (0.00%)", " Pericarditis 1/51 (1.96%)", " Atrial flutter 0/51 (0.00%)", " Cardiac failure congestive 0/51 (0.00%)", " Visual impairment 0/51 (0.00%)", " Dysphagia 1/51 (1.96%)", " Abdominal pain 0/51 (0.00%)", " Chills 1/51 (1.96%)", "Adverse Events 2:", " Total: 17/50 (34.00%)", " Febrile neutropenia 0/50 (0.00%)", " Anaemia 1/50 (2.00%)", " Leukopenia 0/50 (0.00%)", " Neutropenia 1/50 (2.00%)", " Thrombocytopenia 1/50 (2.00%)", " Pericarditis 0/50 (0.00%)", " Atrial flutter 1/50 (2.00%)", " Cardiac failure congestive 1/50 (2.00%)", " Visual impairment 1/50 (2.00%)", " Dysphagia 0/50 (0.00%)", " Abdominal pain 1/50 (2.00%)", " Chills 0/50 (0.00%)" ]

[ "Outcome Measurement: ", " Complete Pathological Response (pCR) Rate in Breast and Axilla According to the Miller&Payne Criteria (G5-A and G5-D).", " Within 3-4 weeks after last docetaxel dose the surgery was performed to evaluate pathological response. According to the Miller&Payne Criteria, pCR in node-negative patients is a grade 5-A and in node-positive patients is a grade 5-D.", " Time frame: Up to 16 weeks", "Results 1: ", " Arm/Group Title: Arm 1: EC -> D + Lapatinib", " Arm/Group Description: EC -> D + Lapatinib", " Drugs plus Biological", " Epirubicin + Cyclophosphamide (EC) each 21 days for 4 cycles -> Docetaxel (D) + lapatinib each 21 days for 4 cycles)", " Overall Number of Participants Analyzed: 51", " Measure Type: Number", " Unit of Measure: percentage of participants with pCR 23.5 (11.9 to 35.1)", "Results 2: ", " Arm/Group Title: Arm 2: EC -> D + Trastuzumab", " Arm/Group Description: EC -> D + Trastuzumab", " Drug plus Biological", " Epirubicin + Cyclophosphamide (EC) each 21 days for 4 cycles -> Docetaxel (D) + Trastuzumab each 21 days for 4 cycles", " Overall Number of Participants Analyzed: 48", " Measure Type: Number", " Unit of Measure: percentage of participants with pCR 47.9 (33.8 to 62.0)" ]

[ "Outcome Measurement: ", " Number of Patients With a Pathological Complete Response (pCR) Who Received Targeted Therapy With Trastuzumab and Pertuzumab or Bevacizumab Predicted by Genomically-derived Molecular Subtypes.", " Number of patients with a pathological complete response (pCR) who received targeted therapy with trastuzumab and pertuzumab or bevacizumab predicted by genomically-derived molecular subtypes (HER2 positive or HER2 negative. pCR is defined as absence of invasive cancer in breast or lymph nodes after neoadjuvant chemotherapy.", " Time frame: Up to 30 days after last cycle of treatment", "Results 1: ", " Arm/Group Title: Cohort 1P (HER2 Positive)", " Arm/Group Description: Patients receive a run-in Pertuzumab treatment of 840 mg IV over 60 minutes on day -14 followed by Trastuzumab IV over 30-60 minutes and Pertuzumab IV over 30-60 minutes, docetaxel IV, and carboplatin IV on day 1. Treatment repeats very 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.", " Overall Number of Participants Analyzed: 5", " Measure Type: Count of Participants", " Unit of Measure: Participants 4 80.0%", "Results 2: ", " Arm/Group Title: Cohort 1T (HER2 Positive)", " Arm/Group Description: Patients receive a run-in Trastuzumab treatment of 8 mg/kg IV over 90 minutes on day -14 followed by Trastuzumab IV over 30-60 minutes and Pertuzumab IV over 30-60 minutes, Docetaxel IV, and Carboplatin IV on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.", " Overall Number of Participants Analyzed: 6", " Measure Type: Count of Participants", " Unit of Measure: Participants 6 100.0%" ]

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

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

[ "Inclusion Criteria:", " Women 18 and 75 years of age.", " Voluntary signed informed consent form (ICF).", " Proven diagnosis of metastatic breast cancer (MBC).", " At least one, but no more than three, prior chemotherapy regimens for MBC.", " Patients with known HER-2 overexpressing MBC must have failed at least one prior trastuzumab-containing regimen for metastatic disease.", " Disease evaluable for response by specific appropriate criteria.", " No or minimal disease-related symptoms not affecting patient daily activities.", " Adequate major organ function (normal or minimal alteration in liver, kidney, hematological, metabolic and cardiac function)", " Wash out periods prior to Day 1 of Cycle 1:", " At least three weeks since the last chemotherapy (six weeks in some particular cases) and At least four weeks since the last radiotherapy (RT) > 30 Gy) and At least one week since the last hormonal therapy and At least two weeks since the last biological/investigational therapy", " Minimal or no ongoing toxicity from immediately prior therapy according to specific appropriate criteria. Mild ongoing toxicity is allowed in case of alopecia, skin toxicity, fatigue and/or finger numbness or tumbling.", " Patients of child-bearing potential must agree to use a medically approved contraception method until at least six weeks after the last study drug administration.", " Known deleterious germline mutation of BRCA1/2 (Patients in Cohorts A and A1)", " Prior treatment with PARP inhibitors (Patients in Cohort A1)", "Exclusion Criteria:", " Prior treatment with PM01183 or trabectedin.", " Extensive prior RT.", " Prior or concurrent malignant disease unless cured for more than five years.", " Exceptions are breast cancer in the other breast.", " Uncommon or rare subtypes of breast cancer.", " Symptomatic or progressive brain metastases.", " Bone-limited and exclusively metastases.", " Relevant diseases or clinical situations which may increase patient's risk:", " History of cardiac disease. Moderate breathing difficulties or oxygen requirement Active uncontrolled infection. Unhealed wound or presence of any external drainage. Chronically active viral hepatitis. Immunocompromised patients, including those known to be infected by human immunodeficiency virus (HIV).", " Known muscular disease or functional alteration", " Pregnant or breastfeeding women.", " Impending need for immediate RT for symptomatic relief.", " Limitation of the patient's ability to comply with the treatment or to follow-up the protocol." ]

[ "Adverse Events 1:", " Total: 6/81 (7.41%)", " Colitis [1]1/81 (1.23%)", " Multiple Sclerosis Relapse 1/81 (1.23%)", " Neurotoxicity [2]2/81 (2.47%)", " Community-acquired pneumonia 1/81 (1.23%)", " Local Infection Reservoir Area 1/81 (1.23%)" ]

[ "Adverse Events 1:", " Total: 20/52 (38.46%)", " Anaemia 0/52 (0.00%)", " Pancytopenia 1/52 (1.92%)", " Acute myocardial infarction 0/52 (0.00%)", " Atrial fibrillation 0/52 (0.00%)", " Cardiac failure 1/52 (1.92%)", " Cardiogenic shock 1/52 (1.92%)", " Palpitations 0/52 (0.00%)", " Pericardial effusion 0/52 (0.00%)", " Right ventricular failure 1/52 (1.92%)", " Abdominal pain 0/52 (0.00%)", " Ascites 3/52 (5.77%)", "Adverse Events 2:", " Total: 25/49 (51.02%)", " Anaemia 2/49 (4.08%)", " Pancytopenia 0/49 (0.00%)", " Acute myocardial infarction 1/49 (2.04%)", " Atrial fibrillation 1/49 (2.04%)", " Cardiac failure 0/49 (0.00%)", " Cardiogenic shock 0/49 (0.00%)", " Palpitations 1/49 (2.04%)", " Pericardial effusion 4/49 (8.16%)", " Right ventricular failure 0/49 (0.00%)", " Abdominal pain 1/49 (2.04%)", " Ascites 0/49 (0.00%)" ]

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

[ "INTERVENTION 1: ", " Fulvestrant 250 mg + Tipifarnib 300 mg", " Patients receive fulvestrant 250 mg intramuscularly on day 1 and oral tipifarnib 300 mg twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity" ]

[ "Adverse Events 1:", " Total: 111/669 (16.59%)", " Leukocytes * [1]1/669 (0.15%)", " Hemoglobin * [1]1/669 (0.15%)", " Hemoglobin * [2]0/669 (0.00%)", " CNS cerebrovascular ischemia * [1]0/669 (0.00%)", " CNS cerebrovascular ischemia * [3]0/669 (0.00%)", " Heart Failure * [1]3/669 (0.45%)", " Thrombosis/embolism * [1]1/669 (0.15%)", " Thrombosis/embolism * [3]0/669 (0.00%)", "Adverse Events 2:", " Total: 138/715 (19.30%)", " Leukocytes * [1]0/715 (0.00%)", " Hemoglobin * [1]0/715 (0.00%)", " Hemoglobin * [2]1/715 (0.14%)", " CNS cerebrovascular ischemia * [1]1/715 (0.14%)", " CNS cerebrovascular ischemia * [3]1/715 (0.14%)", " Heart Failure * [1]1/715 (0.14%)", " Thrombosis/embolism * [1]3/715 (0.42%)", " Thrombosis/embolism * [3]2/715 (0.28%)" ]

[ "Adverse Events 1:", " Total: 3/5 (60.00%)", " Febrile neutropenia 3/5 (60.00%)", " Atrial fibrillation 0/5 (0.00%)", " Myocardial Infarction 0/5 (0.00%)", " Blurred Vision 0/5 (0.00%)", " Dysphagia 0/5 (0.00%)", " Fever 0/5 (0.00%)", " General disorders and administration site conditions - Other 0/5 (0.00%)", " Localized edema 0/5 (0.00%)", " Non-cardiac chest pain 0/5 (0.00%)", " Pain 0/5 (0.00%)", " Sepsis 0/5 (0.00%)" ]

[ "Adverse Events 1:", " Total: 17/110 (15.45%)", " Hemoglobin [1]1/110 (0.91%)", " Esophagitis 1/110 (0.91%)", " Dysphagia 1/110 (0.91%)", " Nausea/Vomiting 1/110 (0.91%)", " Nausea 1/110 (0.91%)", " Fever 1/110 (0.91%)", " Febrile Neutropenia 11/110 (10.00%)", " Infection - Other [2]1/110 (0.91%)", " Infection - Pneumonia 1/110 (0.91%)", " Dyspnea 2/110 (1.82%)", " Hypoxia 1/110 (0.91%)" ]

[ "Adverse Events 1:", " Total: 27/94 (28.72%)", " Anaemia 2/94 (2.13%)", " Febrile neutropenia 2/94 (2.13%)", " Leukopenia 1/94 (1.06%)", " Neutropenia 0/94 (0.00%)", " Thrombocytopenia 1/94 (1.06%)", " Arrhythmia 0/94 (0.00%)", " Atrial fibrillation 0/94 (0.00%)", " Cardiac failure congestive 0/94 (0.00%)", " Cardiomyopathy 0/94 (0.00%)", " Pericardial effusion 0/94 (0.00%)", " Tachycardia 0/94 (0.00%)", "Adverse Events 2:", " Total: 36/93 (38.71%)", " Anaemia 2/93 (2.15%)", " Febrile neutropenia 9/93 (9.68%)", " Leukopenia 3/93 (3.23%)", " Neutropenia 4/93 (4.30%)", " Thrombocytopenia 1/93 (1.08%)", " Arrhythmia 1/93 (1.08%)", " Atrial fibrillation 1/93 (1.08%)", " Cardiac failure congestive 3/93 (3.23%)", " Cardiomyopathy 2/93 (2.15%)", " Pericardial effusion 1/93 (1.08%)", " Tachycardia 1/93 (1.08%)" ]

[ "Outcome Measurement: ", " Clinical Benefit Rate", " Clinical benefit = complete response (CR), partial response (PR), or stable disease (SD) lasting for at least 6 months, assessed per Response Evaluation Criteria of Solid Tumor (RECIST).CR=disappearance of all target and non-target lesions. PR= disappearance of or at least 30% decrease in the sum of the longest diameters of target lesions, with non-progressive disease in non-target lesions. SD= sum of the longest diameters of target lesions decrease <30% or increase <20%, with non-progressive disease in non-target lesions. 141 eligible, treated patients were included.", " Time frame: assessed every 3 cycles while on treatment, assessed every 3 months when follow up <2 years, every 6 months between 2-3 years,no specific requirements after 3 years", "Results 1: ", " Arm/Group Title: Anastrozole and ZD1839", " Arm/Group Description: [Not Specified]", " Overall Number of Participants Analyzed: 72", " Measure Type: Number", " Unit of Measure: percentage of participants 44 (33 to 57)", "Results 2: ", " Arm/Group Title: Fulvestrant and ZD1839", " Arm/Group Description: [Not Specified]", " Overall Number of Participants Analyzed: 69", " Measure Type: Number", " Unit of Measure: percentage of participants 41 (29 to 53)" ]

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

[ "Outcome Measurement: ", " Disease-free Survival After Prolonged Endocrine Treatment", " To determine whether 5 years of additional Anastrozole was more effective than 2 years of additional Anastrozole after 5 years of adjuvant endocrine therapy in terms of disease-free survival.", " Time frame: DFS was defined as the time from two years after randomization to the earliest occurrence of loco-regional recurrence, distant recurrence, contralateral new breast cancer, second cancer or death from any cause, assessed up to a maximum of 8.5 years", "Results 1: ", " Arm/Group Title: Arm A: Anastrozol", " Arm/Group Description: 1 mg per day for 2 years", " Overall Number of Participants Analyzed: 1281", " Median (Inter-Quartile Range)", " Unit of Measure: Years NA [1] (7.7 to NA)", "Results 2: ", " Arm/Group Title: Arm B: Anastrozol", " Arm/Group Description: 1 mg per day for 5 years", " Overall Number of Participants Analyzed: 1323", " Median (Inter-Quartile Range)", " Unit of Measure: Years NA [1] (8.1 to NA)" ]

[ "Outcome Measurement: ", " Changes in QTcF After Treatment With DS-8201a in Participants With HER2-expressing Metastatic and/or Unresectable Breast Cancer", " The number of participants with notable electrocardiogram changes meeting predefined criteria is being reported.", " Time frame: Screening (within 7 days before enrollment) up to Cycle 3 Day 15 (each cycle is 21 days)", "Results 1: ", " Arm/Group Title: DS-8201a", " Arm/Group Description: Participants who received 6.4 mg/kg of DS-8201a as an intravenous (IV) infusion once every 3 weeks on Day 1 of each 21-day cycle.", " Overall Number of Participants Analyzed: 49", " Measure Type: Count of Participants", " Unit of Measure: Participants Maximum change from baseline in QTcF: >30 ms: 3 6.1%", " Maximum change from baseline in QTcF: >60 ms: 0 0.0%" ]

[ "Inclusion Criteria:", " women >=18 years of age;", " >=1 target lesion;", " locally advanced or metastatic breast cancer;", " demonstrated resistance to anthracycline;", " >=2 regimens of chemotherapy for advanced/metastatic disease.", "Exclusion Criteria:", " previous treatment with Xeloda, continuous 5-fluorouracil infusion, or other oral fluoropyrimidines;", " previous treatment with paclitaxel or docetaxel for advanced/metastatic disease." ]

[ "Outcome Measurement: ", " Objective Response Rate (ORR)", " Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective response (OR) = CR + PR.", " Time frame: From date of randomization until the date of first documented progression or date of intolerable toxicity, whichever came first, assessed up to 54 months.", "Results 1: ", " Arm/Group Title: D+C and Taxane Naive", " Arm/Group Description: Doxil, Carboplatin and Taxane naive", " Overall Number of Participants Analyzed: 39", " Measure Type: Number", " Unit of Measure: percentage of participants 30.8 (17.0 to 47.6)", "Results 2: ", " Arm/Group Title: D+C and Taxane Pretreated", " Arm/Group Description: Doxil, Carboplatin and Taxane pretreated", " Overall Number of Participants Analyzed: 42", " Measure Type: Number", " Unit of Measure: percentage of participants 31.0 (17.6 to 47.1)" ]

[ "INTERVENTION 1: ", " Physical Activity Intervention", " Participants will participate in a multi-component physical activity intervention for 12 weeks with a 6 month follow up.", " Print-based education: Subjects were given a copy of Exercise for Health: An Exercise Guide for Breast Cancer Survivors. Topics covered within the book include benefits of exercise; recommendations on type, duration, frequency and intensity of exercise; goal-setting; and advice on overcoming barriers.", " Fitbit: Subjects were provided with a Fitbit and instructed to wear the device daily.", " Active Living counseling: The Active Living counseling program consists of 12 weekly group educational sessions. These sessions involved discussion of topics related to increasing physical activity, including: identifying and overcoming barriers, setting goals, and time management.", " Facility Access: Subjects will have access to the exercise lab in the UT Southwestern Depression Center consisting of equipment for aerobic exercise (treadmills, stationary bikes, etc.)." ]

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

[ "Outcome Measurement: ", " Insulin", " Insulin measured as percent change from baseline", " Time frame: change from baseline to 6 months", "Results 1: ", " Arm/Group Title: Metformin + Lifestyle Intervention", " Arm/Group Description: Metformin: Week 1: 500 mg at dinner time Weeks 2-4: 1000 mg at dinner time Weeks 5+: 500 mg in morning; 1000 mg at dinner time", " Lifestyle intervention: Telephone-based lifestyle intervention (dietary change and physical activity) for weight loss.", " Overall Number of Participants Analyzed: 83", " Least Squares Mean (95% Confidence Interval)", " Unit of Measure: percent change from baseline -21.8 (-29.7 to -13.0)", "Results 2: ", " Arm/Group Title: Placebo + Lifestyle Intervention", " Arm/Group Description: Placebo: Week 1: 1 pill at dinner time Weeks 2-4: 2 pills at dinner time Weeks 5+: 1 pill in morning; 2 pills at dinner time", " Lifestyle intervention: Telephone-based lifestyle intervention (dietary change and physical activity) for weight loss.", " Overall Number of Participants Analyzed: 83", " Least Squares Mean (95% Confidence Interval)", " Unit of Measure: percent change from baseline -17.7 (-25.9 to -8.6)" ]

[ "Outcome Measurement: ", " Overall Survival (OS)", " Overall survival was defined as the time in months from randomization until the date of death. For those patients who had not died, survival duration was censored at the last date the patient was known to be alive. Median OS with 95% CI estimated using the Kaplan-Meier Product Limit Method.", " Time frame: from date of randomization until death", "Results 1: ", " Arm/Group Title: Ixabepilone + Capecitabine", " Arm/Group Description: Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.", " Overall Number of Participants Analyzed: 609", " Median (95% Confidence Interval)", " Unit of Measure: months 16.39 (14.95 to 17.91)", "Results 2: ", " Arm/Group Title: Capecitabine", " Arm/Group Description: Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.", " Overall Number of Participants Analyzed: 612", " Median (95% Confidence Interval)", " Unit of Measure: months 15.64 (13.86 to 17.02)" ]

[ "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%)" ]

[ "Adverse Events 1:", " Total: 14/76 (18.42%)", " Neutropenia 10/76 (13.16%)", " Febrile neutropenia 1/76 (1.32%)", " Anaemia 0/76 (0.00%)", " Thrombocytopenia 0/76 (0.00%)", " Cardiopulmonary failure 0/76 (0.00%)", " Optic ischaemic neuropathy 0/76 (0.00%)", " Bowel peristalsis increased 1/76 (1.32%)", " Colitis 0/76 (0.00%)", " Diarrhoea 0/76 (0.00%)", " Gastritis 0/76 (0.00%)", " Nausea 0/76 (0.00%)", "Adverse Events 2:", " Total: 12/76 (15.79%)", " Neutropenia 2/76 (2.63%)", " Febrile neutropenia 1/76 (1.32%)", " Anaemia 0/76 (0.00%)", " Thrombocytopenia 0/76 (0.00%)", " Cardiopulmonary failure 1/76 (1.32%)", " Optic ischaemic neuropathy 1/76 (1.32%)", " Bowel peristalsis increased 0/76 (0.00%)", " Colitis 1/76 (1.32%)", " Diarrhoea 0/76 (0.00%)", " Gastritis 0/76 (0.00%)", " Nausea 1/76 (1.32%)" ]

[ "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%)" ]

[ "Adverse Events 1:", " Total: 13/61 (21.31%)", " Anaemia 1/61 (1.64%)", " Febrile neutropenia 1/61 (1.64%)", " Cardiac failure congestive 0/61 (0.00%)", " Pericardial effusion 0/61 (0.00%)", " Constipation 1/61 (1.64%)", " Intestinal perforation 1/61 (1.64%)", " Stomatitis 0/61 (0.00%)", " Non-cardiac chest pain 2/61 (3.28%)", " Condition aggravated 1/61 (1.64%)", " General physical health deterioration 1/61 (1.64%)", "Adverse Events 2:", " Total: 12/60 (20.00%)", " Anaemia 1/60 (1.67%)", " Febrile neutropenia 0/60 (0.00%)", " Cardiac failure congestive 1/60 (1.67%)", " Pericardial effusion 1/60 (1.67%)", " Constipation 0/60 (0.00%)", " Intestinal perforation 0/60 (0.00%)", " Stomatitis 1/60 (1.67%)", " Non-cardiac chest pain 0/60 (0.00%)", " Condition aggravated 0/60 (0.00%)", " General physical health deterioration 1/60 (1.67%)" ]

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

[ "Outcome Measurement: ", " Clinical Benefit Defined as Complete Response (CR), Partial Response (PR) or Stable Disease (SD) Lasting >= 24 Weeks, as Determined by the Investigator According to RECIST v1.1", " Clinical Benefit was defined as CR, PR, or SD lasting more than equal to 24 weeks from randomization in participants with measurable disease at baseline, as determined by the investigator according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1. Per RECIST v1.1 for target lesions assessed by CT or MRI: CR, Disappearance of all target lesions; PR, PR >= 30% decrease in the sum of diameters of target lesions (TL) taking as reference the baseline sum of diameters; SD, neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Disease Progression (PD), PD>= 20% increase in the sum of diameters of TL taking as reference the smallest sum on study(Nadir). In addition to the relative increase of 20% sum must have demonstrate an absolute increase of at least 5mm.", " Time frame: Randomization through till 6 months after the last participant is enrolled into the study (up to approximately 23 months)", "Results 1: ", " Arm/Group Title: Venetoclax + Fulvestrant", " Arm/Group Description: Participants were administered Venetoclax 800mg orally QD and Fulvestrant 500mg IM on Day 1 and 15 of Cycle 1 and Day 1 of subsequent cycles (Cycle length = 28 days).", " Overall Number of Participants Analyzed: 51", " Measure Type: Number", " Unit of Measure: Percentage of Participants 11.8 (4.44 to 23.87)", "Results 2: ", " Arm/Group Title: Fulvestrant", " Arm/Group Description: Participants were administered Fulvestrant 500mg only IM on Day 1 and 15 of Cycle 1 and Day 1 of subsequent cycles (Cycle length = 28 days).", " Overall Number of Participants Analyzed: 51", " Measure Type: Number", " Unit of Measure: Percentage of Participants 13.7 (5.70 to 26.26)" ]

[ "INTERVENTION 1: ", " Tamoxifen", " Tamoxifen 20mg orally daily for 5 years", "INTERVENTION 2: ", " Ovarian Function Suppression", " Tamoxifen 20mg orally daily or Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)", " Note: Data were collected separately for the T+OFS and E+OFS participants in the parent study, IBCSG 24-02 (SOFT). The sample size for this Co-SOFT substudy was small, so the analysis plan was revised to pre-specify collective analysis for all patients receiving OFS." ]

[ "INTERVENTION 1: ", " Single Drain", " Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group.", " Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.", " Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla.", " Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.", "INTERVENTION 2: ", " Double Drain", " Insertion of double drains: Two negative pressure drains will be inserted into the axilla and below the lower flap in the double drains group.", " Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.", " Insertion of double drains: Two drains will be inserted into the axilla and below the lower flap in the double drains group.", " Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography." ]

[ "Inclusion Criteria:", " Females with Stage II invasive breast cancer and documented axillary metastases by core biopsy, clinical examination, or fine-needle aspiration who are scheduled to undergo an ALND.", " Females > 21 years of age", "Exclusion Criteria:", " Prior ipsilateral axillary surgery", " Prior ipsilateral axillary radiation", " Prior ipsilateral breast cancer", " Prior ipsilateral breast radiation", " Allergy to isosulfan blue dye", " History of ipsilateral upper extremity lymphedema", " Prior history of surgical excision of the upper outer quadrant of the ipsilateral breast", " Prior history of neoadjuvant chemotherapy for current breast cancer", " Bulky axillary disease at presentation (N2)" ]

[ "Inclusion Criteria:", " Patients with histologic confirmation of invasive, but non-inflammatory carcinoma of the breast.", " Stage I (T1N0) are not eligible for the neo-adjuvant portion of the protocol.", " High-risk patients (patients with any of the following: high proliferation rate - Ki67 >35% or poorly differentiated tumors (black's modified grade 3); ER/PR negative; lymphovascular invasion) with stage I disease are eligible for adjuvant therapy.", " Patients with pure mucinous carcinomas, tubular carcinomas or pure medullary carcinomas are eligible if the patient's tumor is larger than 3 cm in size or if the patient has tumor involvement of the lymph nodes (>2mm).", " Patients with bilateral breast cancers are eligible.", " Patients with pN2a (metastasis in four to nine axillary lymph nodes) are eligible as are patients with pN3a (ten or more axillary lymph nodes). Patients with infraclavicular lymph node involvement are NOT eligible.", " Patients must have clinically measurable disease to be treated in the neoadjuvant setting. This includes patients with a non-palpable primary who have histologically proven lymph node (LN) involvement that is clinically palpable and measurable by ultrasound", " Histologic confirmation of invasive tumor will be done by core needle biopsy for patients with intact primary tumors. If patients have undergone adequate core biopsy prior to evaluation at MDACC, repeat core biopsy is optional.", " Patients must sign an informed consent indicating that they are aware of the investigational nature of the study, in keeping with institutional policy.", " Patients with a prior history of breast cancer are eligible if the current primary breast cancer is of a higher stage than the original breast cancer and the patient has not received any of the current study medications including past doxorubicin.", " Patients should have adequate bone marrow function, as defined by peripheral granulocyte count of > 1,500/mm3, and platelet count > 100,000/mm3. Patients must have adequate liver function with a bilirubin within normal laboratory values. Transaminases (SGPT) may be up to 2.5x upper limit of normal (ULN) if alkaline phosphatase is < ULN or alkaline phosphatase may be up to 4 x ULN if transaminases are < ULN.", " In addition, patients should have adequate renal function, defined as a serum creatinine < 2.5 mg% and/or creatinine clearance greater than 51 ml/min as calculated by Cockcroft and Gault Equation: Cockcroft and Gault Equation: Creatinine clearance for males = {(140 - age [yrs])(body weight [kg])}/{(72) (serum creatinine [mg/dL])}. Creatinine clearance for females = 0.85 x male value", " Patients who had surgical therapy prior to referral will be eligible for randomization to systemic chemotherapy administered in the adjuvant setting.", " Patients who have overexpression of the her-2/neu oncogene are eligible for the study.", "Exclusion Criteria:", " Patients with N2 (clinical staging) or N3 (clinical staging) nodal disease, inflammatory breast cancer, or metastatic disease are not eligible. This includes patients with infraclavicular and/or supraclavicular lymph node involvement. Patients with pN2a (metastasis in four to nine axillary lymph nodes) are eligible.", " Patients with pN2b (metastasis in clinically apparent internal mammary lymph nodes in the absence of axillary lymph node metastasis) are not eligible. Patients with T4 lesions in the neoadjuvant setting are not eligible. Patients with limited T4 lesions in the adjuvant setting (for example, focal extension into the skin with negative margins) are eligible.", " Severe hypersensitivity reactions to agents formulated in either cremophor or polysorbate 80 must be excluded. Patients with hypersensitivity reactions to any of the study medications must be excluded.", " Those patients with history of other malignancies will be excluded, except non-melanoma skin cancer and non-invasive cervical cancer.", " Patients with uncompensated congestive heart failure are not eligible. Patients with myocardial infarction within the past 12 months are ineligible.", " Patients who are pregnant or lactating are not eligible. Women of childbearing potential must have a negative pregnancy test prior to initiation of chemotherapy. Women of childbearing potential who will not use a reliable and appropriate contraceptive method during the study are not eligible.", " Patients who have had an organ allograft are ineligible.", " Patients with serious concurrent infections are ineligible.", " Sexually active male patients unwilling to practice contraception during the study are ineligible.", " Patients with pre-existing peripheral neuropathy > grade 1." ]

[ "Adverse Events 1:", " Total: 1/6 (16.67%)", " Angina pectoris 0/6 (0.00%)", " Pericardial effusion 0/6 (0.00%)", " Diplopia 0/6 (0.00%)", " Abdominal pain 0/6 (0.00%)", " Colitis 0/6 (0.00%)", " Gastritis 0/6 (0.00%)", " Nausea 0/6 (0.00%)", " Vomiting 0/6 (0.00%)", " Fatigue 0/6 (0.00%)", " General physical health deterioration 0/6 (0.00%)", " Generalised oedema 0/6 (0.00%)", " Hepatic failure [1]0/6 (0.00%)", "Adverse Events 2:", " Total: 2/6 (33.33%)", " Angina pectoris 0/6 (0.00%)", " Pericardial effusion 0/6 (0.00%)", " Diplopia 0/6 (0.00%)", " Abdominal pain 0/6 (0.00%)", " Colitis 0/6 (0.00%)", " Gastritis 0/6 (0.00%)", " Nausea 0/6 (0.00%)", " Vomiting 0/6 (0.00%)", " Fatigue 0/6 (0.00%)", " General physical health deterioration 0/6 (0.00%)", " Generalised oedema 0/6 (0.00%)", " Hepatic failure [1]0/6 (0.00%)" ]

[ "Adverse Events 1:", " Total: 0/2 (0.00%)", " ANAEMIA 0/2 (0.00%)", " FEBRILE NEUTROPENIA 0/2 (0.00%)", " LYMPHADENOPATHY 0/2 (0.00%)", " NEUTROPENIA 0/2 (0.00%)", " PANCYTOPENIA 0/2 (0.00%)", " THROMBOCYTOPENIA 0/2 (0.00%)", " ATRIAL FIBRILLATION 0/2 (0.00%)", " CARDIAC TAMPONADE 0/2 (0.00%)", " PERICARDIAL EFFUSION 0/2 (0.00%)", " TACHYCARDIA 0/2 (0.00%)", " ABDOMINAL PAIN 0/2 (0.00%)", " ABDOMINAL PAIN UPPER 0/2 (0.00%)", "Adverse Events 2:", " Total: 0/1 (0.00%)", " ANAEMIA 0/1 (0.00%)", " FEBRILE NEUTROPENIA 0/1 (0.00%)", " LYMPHADENOPATHY 0/1 (0.00%)", " NEUTROPENIA 0/1 (0.00%)", " PANCYTOPENIA 0/1 (0.00%)", " THROMBOCYTOPENIA 0/1 (0.00%)", " ATRIAL FIBRILLATION 0/1 (0.00%)", " CARDIAC TAMPONADE 0/1 (0.00%)", " PERICARDIAL EFFUSION 0/1 (0.00%)", " TACHYCARDIA 0/1 (0.00%)", " ABDOMINAL PAIN 0/1 (0.00%)", " ABDOMINAL PAIN UPPER 0/1 (0.00%)" ]

[ "Adverse Events 1:", " Total: 5/11 (45.45%)", " Hemorrhage, GI-abdomen NOS 21/11 (9.09%)", " Pain-liver 21/11 (9.09%)", " Infection-ulcer 20/11 (0.00%)", " Hemoglobin 20/11 (0.00%)", " Hypoglycemia 20/11 (0.00%)", " Pain-rib cage due to vomiting 20/11 (0.00%)", " Obstruction-gu ureter 1/11 (9.09%)", " Hemorrhage gu-bladder 21/11 (9.09%)", " Pain-breast 21/11 (9.09%)", " Pleural effusion 22/11 (18.18%)", "Adverse Events 2:", " Total: 0/6 (0.00%)", " Hemorrhage, GI-abdomen NOS 20/6 (0.00%)", " Pain-liver 20/6 (0.00%)", " Infection-ulcer 20/6 (0.00%)", " Hemoglobin 20/6 (0.00%)", " Hypoglycemia 20/6 (0.00%)", " Pain-rib cage due to vomiting 20/6 (0.00%)", " Obstruction-gu ureter 0/6 (0.00%)", " Hemorrhage gu-bladder 20/6 (0.00%)", " Pain-breast 20/6 (0.00%)", " Pleural effusion 20/6 (0.00%)" ]

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

[ "INTERVENTION 1: ", " Monotherapy: Alobresib 0.6 mg", " Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 0.6 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.", "INTERVENTION 2: ", " Monotherapy: Alobresib 1.4 mg", " Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 1.4 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD." ]

[ "Outcome Measurement: ", " Clinical Benefit Rate (Complete Response, Partial Response, or Stable Disease)", " Response evaluation criteria in solid tumors (RECIST) criteria version 1.0 was used for response evaluation. Clinical benefit rate is defined as the proportion of subjects experiencing a complete response (CR), partial response (PR), or stable disease (SD) for at least 24 weeks.", " Evaluation of target lesions: Complete Response (CR)-- Disappearance of all target lesions; Partial Response (PR)-- At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Stable Disease (SD)-- Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started;", " Evaluation of non-target lesions: Complete Response (CR)-- Disappearance of all non-target lesions and normalization of tumor marker level; Incomplete Response/ Stable Disease (SD)-- Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits", " Time frame: Up to 24 months", "Results 1: ", " Arm/Group Title: Treatment (Temsirolimus)", " Arm/Group Description: Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.", " Temsirolimus: Given IV", " Overall Number of Participants Analyzed: 31", " Measure Type: Number", " Unit of Measure: percentage of participants 9.7" ]

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

[ "Inclusion Criteria:", " Adult Women ( 18 years old).", " Histologically or cytologically confirmed invasive breast carcinoma with local recurrence or radiological evidence of metastatic disease.", " Must have at least one lesion that can be accurately measured or bone lesions in the absence of measurable disease.", " HER2+ patients by local laboratory testing (IHC 3+ staining or in situ hybridization positive).", " Prior trastuzumab and/or chemotherapy (taxanes included) as neo-adjuvant or adjuvant treatment is allowed but should be discontinued > 12 months prior to randomization.", " Prior treatment for breast cancer with endocrine therapy (adjuvant or metastatic settings) is allowed but should be discontinued at randomization. Patients treated with bisphosphonates at entry or who start bisphosphonates during study may continue this therapy during protocol treatment.", " Documentation of negative pregnancy test.", " Organ functions at time of inclusion.", "Exclusion Criteria:", " Prior mTOR inhibitors for the treatment of cancer.", " Other anticancer therapy for locally advanced or metastatic breast cancer except for prior hormonal therapy.", " Patients with only non-measurable lesions other than bone metastasis (e.g. pleural effusion, ascites, etc).", " Radiotherapy to 25% of the bone marrow within 4 weeks prior to randomization", " History of central nervous system metastasis.", " Impairment of gastrointestinal (GI) function or GI disease or active ulceration of the upper gastrointestinal tract.", " Serious peripheral neuropathy.", " Cardiac disease or dysfunction.", " Uncontrolled hypertension.", "HIV.", "Pregnant," ]

[ "Outcome Measurement: ", " Percentage of Participants With Objective Response (OR; Using Response Evaluation Criteria in Solid Tumors [RECIST])", " The participant had an OR if her best overall response (BOR) during the study was either a complete response (CR) or a partial response (PR) according to the RECIST as determined by the investigator. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (LD) of all target lesions. Confidence interval (CI) was Computed using Clopper-Pearson method.", " Time frame: Assessed every 6 weeks for first 12 months from randomization thereafter every 3 months until disease progression (maximum participant objective response of 18.3 weeks)", "Results 1: ", " Arm/Group Title: Ixabepilone 40 mg/m^2", " Arm/Group Description: ixabepilone 40 mg/m^2 every 3 weeks", " Overall Number of Participants Analyzed: 40", " Measure Type: Number", " Unit of Measure: percentage of participants 30.0 (16.6 to 46.5)", "Results 2: ", " Arm/Group Title: Cetuximab 250 mg/m^2 + Ixabepilone 40 mg/m^2", " Arm/Group Description: cetuximab 400 mg/m^2 loading dose then 250 mg/m^2 weekly + ixabepilone 40 mg/m^2 every 3 weeks", " Overall Number of Participants Analyzed: 39", " Measure Type: Number", " Unit of Measure: percentage of participants 35.9 (21.2 to 52.8)" ]