Datasets:

AshtonIsNotHere

/

nli4ct_semeval2024

like 0

[ "Outcome Measurement: ", " Recommended Phase II Dose as Assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (Phase I)", " Dose-limiting toxcities (DLT) were defined as grade 3-4 febrile neutropenia, thrombocytopenia and non-hemtological toxicity attributed to therapy (nausea, vomiting and diarrhea would be considered dose limiting only if not adequately controlled with therapy). Any toxicity occurring during cycle 1 that resulted in dose reduction of vorinostat or paclitaxel or failure to complete all protocol specificed doses in the first cycle was also considered a DLT", " Time frame: 28 days", "Results 1: ", " Arm/Group Title: Phase I", " Arm/Group Description: Vorinostat dose (200 or 300 mg BID) was assigned at the time of registration. Vorinostat was administered orally twice daily on days 1-3, 8-10, and 15-17 of each 28-day cycle.", " All patients also received paclitaxel at 90 mg/m2 as 1-hour infusion on days 2, 9, and 16 of every 28-day cycle. Bevacizumab was administered on day 2 and day 16 of the 28 day cycle at 10 mg/kg dose. Vorinostat dose escalation was carried out in the standard 3 + 3 phase I trial design based upon toxicity observed during the first cycle of therapy.", " Overall Number of Participants Analyzed: 6", " Measure Type: Number", " Unit of Measure: mg 300" ]

[ "Inclusion Criteria:", " Age greater than or equal to 18 years", " Histologic diagnosis of palpable invasive breast cancer or ductal carcinoma in situ", " Patient desire to undergo breast surgery", " Ability to voluntarily provide informed consent to participate prior to any study-related assessments/procedures being conducted", " The cancer enhances on breast MRI imaging.", "Exclusion Criteria:", " Absolute contraindication to MRI, including presence of implanted electrical device (pacemaker or neurostimulator), aneurysm clip, or metallic foreign body in or near eyes", " Severe claustrophobia", " Contraindication to use of gadolinium-based intravenous contrast, including life-threatening allergy or compromised renal function (creatinine > 2.0)", " History of median sternotomy", " Pregnancy. Patient attestation that they are not pregnant will be acceptable as per standard policy for MRIs at DHMC." ]

[ "Outcome Measurement: ", " Progression Free Survival (PFS)", " PFS is defined as the time from randomization to the earlier of disease progression or death due to any cause. Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or progression in a non-target lesion, or the appearance of new lesions. The primary analysis of PFS was based on PFS events determined retrospectively by the central independent review committee, blinded to treatment assignment and investigator assessments according to RECIST 1.1 criteria.", " Time frame: Evaluated every 6 - 9 weeks following treatment initiation", "Results 1: ", " Arm/Group Title: Capecitabine", " Arm/Group Description: Capecitabine administered on Days 1 through 14 of each 21 day cycle until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study.", " Overall Number of Participants Analyzed: 109", " Median (95% Confidence Interval)", " Unit of Measure: months 2.8 (1.6 to 3.2)", "Results 2: ", " Arm/Group Title: CDX-011", " Arm/Group Description: CDX-011 administered on Day 1 of each 21 day cycle until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study.", " Overall Number of Participants Analyzed: 218", " Median (95% Confidence Interval)", " Unit of Measure: months 2.9 (2.8 to 3.5)" ]

[ "Adverse Events 1:", " Total: 10/71 (14.08%)", " ATRIAL FIBRILLATION 1/71 (1.41%)", " CARDIAC TAMPONADE 1/71 (1.41%)", " PERICARDIAL EFFUSION 1/71 (1.41%)", " SUPRAVENTRICULAR TACHYCARDIA 1/71 (1.41%)", " DIARRHOEA 1/71 (1.41%)", " NAUSEA 1/71 (1.41%)", " VOMITING 1/71 (1.41%)", " CHEST PAIN 1/71 (1.41%)", " PNEUMONIA 1/71 (1.41%)", " MALIGNANT PLEURAL EFFUSION 1/71 (1.41%)", " HEPATIC ENCEPHALOPATHY 1/71 (1.41%)" ]

[ "- Inclusion Criteria:", " A patient will be considered for enrollment in this study if all of the following criteria are met:", " Female patients 18 years of age.", " Have either:", " locally advanced TNBC defined as invasive ductal cancer; ER- tumors with <10% of tumor nuclei immunoreactive; PR- tumors with <10% of tumor nuclei immunoreactive; T3 or T4 disease, regardless of nodal status (T2 disease is eligible if there are positive lymph nodes present by physical exam or imaging evaluation or histological evaluation, OR", " High-risk ER+ breast cancer defined as grade 3 invasive ductal or mixed ductal/lobular cancers, or grade 2 with Ki67 20%; node positive as evidenced by physical exam or imaging evaluation or histological evaluation.", " HER2- negative breast cancer. If HER2-, it is defined as follows:", " FISH-negative (FISH ratio <2.0), or", " IHC 0-1+, or", " IHC 2+ AND FISH-negative (FISH ratio<2.0)", " Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1", " Adequate hematologic function, defined by:", " Absolute neutrophil count (ANC) >1500/mm3", " Platelet count 100,000/mm3", " Hemoglobin >9 g/dL (in the absence of red blood cell transfusion)", " Adequate liver function, defined by:", " AST and ALT 2.5 x the upper limit of normal (ULN)", " Total bilirubin 1.5 x ULN", " Adequate renal function, defined by:", " a. Serum creatinine 1.5 x ULN or calculated creatinine clearance of 60 ml/min", " Patients with previous history of invasive cancers (including breast cancer) are eligible if definitive treatment was completed more than 5 years prior to initiating current study treatment, and there is no evidence of recurrent disease.", " Eligible for treatment with paclitaxel, doxorubicin, cyclophosphamide and carboplatine.", " Patient must be accessible for treatment and follow-up.", " Patients must be willing to undergo research biopsies to obtain breast cancer tissue for whole exome sequencing and evaluation of tumor immune microenvironment.", " All patients must be able to understand the investigational nature of the study and give written informed consent prior to study entry.", "Exclusion Criteria:", " A patient will be ineligible for inclusion in this study any of the following criteria are met:", " Evidence of metastatic disease on bone scan and CT scan of chest/abdomen (or PET CT scan). Patients with intrathoracic metastatic adenopathy are eligible.", " Active infection or unexplained fever >38.5°C during screening.", " Active infections including viral hepatitis and HIV.", " Active asthma or other condition requiring steroid therapy.", " Autoimmune disease including lupus erythematosus or rheumatoid arthritis. Topical or inhaled corticosteroids are allowed.", " Patients who are currently receiving or who have received previous systemic therapy for breast cancer (eg, chemotherapy, antibody therapy, targeted agents).The use of an LHRH agonist during chemotherapy in premenopausal women who wish to preserve ovarian function is allowed, but is not required.", " Women who are pregnant or lactating. All patients with reproductive potential must agree to use effective contraception from time of study entry until at least 3 months after the last administration of study drug.", " Have a NYHA Class III or IV CHF or LVEF <55%. Patients with significant cardiac disease history within 1 year or ventricular arrhythmias requiring medication are also excluded.", " Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation such as:", " severe impaired lung functions as defined as spirometry and DLCO that is 50% of the normal predicted value and/or O2 saturation that is 88% or less at rest on room air", " uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN", " liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh class C).", " History of any other disease, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug, or that might affect interpretation of the results of this study, or render the patient at high risk for treatment complications.", " Any other investigational or anti-cancer treatments while participating in this study.", "Any other cancer" ]

[ "Inclusion Criteria:", " Tissue diagnosis of a breast carcinoma", " The oncologist must have prescribed doxorubicin as part of the planned chemotherapy regimen", " Have acceptable organ function within 14 days of enrollment defined as:", " liver function: total bilirubin, AST and ALT within normal institutional limits", " kidney function: estimated Creatinine Clearance > 60 ml/min calculated creatinine clearance (for females) - formula: (140 - age) x weight x .85 divided by (sCr x 72)", " At least 18 years old", " Patient must have given written informed consent indicating an understanding of the investigational nature of the study", " Agrees not to consume grapefruit juice while on the study", "Exclusion Criteria:", " Known allergy to enalapril", " Taking any known P450 cytochrome inducers or inhibitors", " Taking any herbal supplements while on the study or the week prior to receiving doxorubicin", " Taking an ace-inhibitor or angiotensin receptor blocker", " Pregnant or lactating. Enalapril is Pregnancy Categories C (first trimester) and D (second and third trimesters)" ]

[ "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:", " Histologically confirmed triple-negative (estrogen, progesterone, and HER-2 receptor negative) adenocarcinoma of the breast in pre- or post-menopausal women with measurable or non-measurable metastatic disease", " Participant who in the Investigator's opinion requires combination therapy for their disease", " Life expectancy of greater than or equal to (>/=)12 weeks", "Exclusion Criteria:", " Previous chemotherapy for metastatic breast cancer", " Participants currently undergoing radiation therapy for the treatment of metastatic disease (apart from the relief of metastatic bone pain)", " Major surgery or significant traumatic injury within 28 days prior to enrollment or anticipation of the need for major surgery during study treatment" ]

[ "INTERVENTION 1: ", " Dexamethasone + Ondansetron IV", " All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.", " Patients receive dexamethasone IV or orally and ondansetron IV on day 1 (prior to each dose of doxorubicin hydrochloride).", "INTERVENTION 2: ", " Dexamethasone + Palonosetron IV", " All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.", " Patients receive dexamethasone IV or orally and palonosetron IV on day 1 (prior to each dose of doxorubicin hydrochloride)." ]

[ "INTERVENTION 1: ", " Arm A: Triptorelin + Letrozol", " Arm A: Triptorelin 3.75 mg i.m. on day 1 every 28 days for 6 cycles + letrozole 2.5 mg/day orally for 6 cycles", " Triptorelin: Triptorelin 3.75 mg injected into the muscle on day 1 every 28 days for 6 cycles (1 cycle= 28 days)", " Letrozole: Letrozole 2.5 mg orally every day for 6 cycles", "INTERVENTION 2: ", " Arm B: Degarelix + Letrozol", " Arm B: Degarelix 240 mg s.c. on day 1 of cycle 1, followed by 80 mg s.c. on day 1 of cycles 2 to 6 + letrozole 2.5 mg every day orally for 6 cycles", " Degarelix: Degarelix 240 mg injected under the skin given as two injections of 120 mg on the first day of treatment, followed by injection of 80 mg on day 1 of cycles 2 to 6 (1 cycle=28 days)", " Letrozole: Letrozole 2.5 mg orally every day for 6 cycles" ]

[ "INTERVENTION 1: ", " Zoledronic Acid Upfront", " Participants in the upfront arm received Zoledronic Acid 4 mg i.v. on Day 1 and every 6 months until disease progression (recurrence)or the end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.", " Letrozole : Participants received 2.5 mg daily.", " Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months.", "INTERVENTION 2: ", " Zoledronic Acid Delayed-start", " In lieu of a placebo arm, which was considered unethical for this trial, a delayed start arm was used. Participants who met certain clinical criteria indicating risk of lumbar spine or total hip fracture, or experienced clinical fracture unrelated to trauma or any asymptomatic fracture discovered at the Month 36 scheduled visit, were started on zoledronic acid 4 mg i.v. and for every 6 months until disease progression (recurrence) or end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.", " Letrozole : Participants received 2.5 mg daily.", " Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months." ]

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

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

[ "Adverse Events 1:", " Total: 33/132 (25.00%)", " Febrile neutropenia 1/132 (0.76%)", " Haematotoxicity 1/132 (0.76%)", " Neutropenia 1/132 (0.76%)", " Sinus bradycardia 1/132 (0.76%)", " Tachycardia 1/132 (0.76%)", " Abdominal pain 2/132 (1.52%)", " Abdominal pain upper 1/132 (0.76%)", " Constipation 1/132 (0.76%)", " Large intestinal obstruction 1/132 (0.76%)", " Nausea 3/132 (2.27%)" ]

[ "Adverse Events 1:", " Total: 3/50 (6.00%)", " Skin lymphangitis 1/50 (2.00%)", " Bone marrow suppression 0/50 (0.00%)", " Allergic shock 1/50 (2.00%)", " Deep incisional SSI 1/50 (2.00%)", "Adverse Events 2:", " Total: 1/51 (1.96%)", " Skin lymphangitis 0/51 (0.00%)", " Bone marrow suppression 1/51 (1.96%)", " Allergic shock 0/51 (0.00%)", " Deep incisional SSI 0/51 (0.00%)" ]

[ "Adverse Events 1:", " Total: 30/112 (26.79%)", " Thrombocytopenia 1/112 (0.89%)", " Dysphagia 1/112 (0.89%)", " Haemorrhoidal haemorrhage 1/112 (0.89%)", " Oesophageal stenosis 1/112 (0.89%)", " Upper gastrointestinal haemorrhage 1/112 (0.89%)", " Asthenia 1/112 (0.89%)", " Disease progression 1/112 (0.89%)", " Hepatotoxicity 1/112 (0.89%)", " Cellulitis 3/112 (2.68%)", " Pneumonia 2/112 (1.79%)", " Osteomyelitis 1/112 (0.89%)" ]

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

[ "Outcome Measurement: ", " Phase 1: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) for Alisertib in Combination With Paclitaxel", " The MTD is defined as the dose range at which 1 of 6 evaluable participants experience dose limiting toxicities (DLT). DLT was evaluated according to National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.02 and was defined as any of the following events: 1. Grade 4 neutropenia and thrombocytopenia lasting 7 consecutive days; 2. Grade 4 neutropenia with fever and/or infection; 3. Platelet count <10,000/mm^3; 4. Grade 3 thrombocytopenia with bleeding; 5. Any other Grade 3 nonhematologic toxicity, with following exceptions: Grade 3 nausea/emesis, Grade 3 diarrhoea, Grade 3 fatigue, Grade 3 nonhematological toxicity that could be controlled to Grade 2 with appropriate treatment; 6. Other alisertib-related nonhematologic toxicities Grade 2 that, in opinion of investigator, required a dose reduction or discontinuation of therapy with alisertib.", " Time frame: Cycle 1 (Up to 28 days)", "Results 1: ", " Arm/Group Title: Alisertib + Paclitaxel (Phase 1)", " Arm/Group Description: Participants with ovarian cancer received alisertib (MLN8237) 10, 20, 30 or 40 mg, orally, twice daily (BID) on Days 1-3, 8-10 and 15-17, combined with weekly paclitaxel 60 or 80 mg/m^2, intravenous infusion, weekly (Days 1, 8, 15) in 28-day cycles in Phase 1 (Up to 37 cycles).", " Overall Number of Participants Analyzed: 49", " Measure Type: Number", " Unit of Measure: mg 40" ]

[ "Outcome Measurement: ", " Progression-Free Survival (PFS)", " Time in months from start of study treatment to first documentation of objective tumor progression (per RECIST) or death due to any cause. PFS was calculated as (first event date minus first randomization date plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was \"Death\").", " Time frame: Baseline, every 6 weeks until disease progression or death (up to 3 years from first dose)", "Results 1: ", " Arm/Group Title: Sunitinib", " Arm/Group Description: SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.", " Overall Number of Participants Analyzed: 113", " Median (95% Confidence Interval)", " Unit of Measure: Months Core radiology laboratory assessment: 2.0 (1.5 to 2.8)", " Investigator's assessment: 1.7 (1.5 to 2.6)", "Results 2: ", " Arm/Group Title: Standard of Care", " Arm/Group Description: One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.", " Overall Number of Participants Analyzed: 104", " Median (95% Confidence Interval)", " Unit of Measure: Months Core radiology laboratory assessment: 2.7 (1.7 to 2.8)", " Investigator's assessment: 2.5 (1.4 to 2.9)" ]

[ "INTERVENTION 1: ", " Control Arm", " Mail", " Standard Reminder Postcard", "INTERVENTION 2: ", " Family Physician Reminder Letter Arm", " Mail", " Standard Reminder Postcard", " Family Physician Reminder Letter" ]

[ "INTERVENTION 1: ", " 3D HI and SHI of UCA", " Perflutren injection, suspension (IV)0.25 ml followed by 3D Harmonic imaging (HI) then (IV) 20 micro-l/kg followed by 3D subharmonic imaging (SHI)", " 3D HI and SHI of UCA: Perflutren injection, suspension (IV)0.25 ml followed by 3D Harmonic imaging (HI) then (IV) 20 micro-l/kg followed by 3D subharmonic imaging (SHI)" ]

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

[ "Inclusion Criteria:", " All subjects must be female.", " Postmenopausal status, defined as any one of the following criteria:", " Documented history of bilateral oophorectomy.", " Age 60 years or more.", " Age 45 to 59 and satisfying one or more of the following criteria:", " Amenorrhea for at least 12 months and intact uterus.", " Amenorrhea for less than 12 months and a follicle stimulating hormone (FSH) and estradiol concentration within postmenopausal range including: patients who have had a hysterectomy and patients who have received hormone replacement.", " Patients must have histologically confirmed invasive breast cancer with a primary tumor of 3 cm or more in greatest dimension as measured by clinical examination.", " Estrogen receptor and/or progesterone receptor positive disease.", " Patients must not have received any prior treatment for current or newly diagnosed breast cancer.", " Patients must have not received previous treatment with any of the study medications or similar drugs.", " No use of selective estrogen receptor modulators (SERM) such as raloxifene or similar agents in the past 2 years.", " WHO performance status of 0, 1, or 2.", " Adequate organ function defined as follows:", " Adequate renal function, defined by a serum creatinine within 3 times the upper limits of normal.", " Adequate liver function, defined by total bilirubin, AST, ALT, and alkaline phosphatase within 3 times the upper limits of normal.", " Adequate bone marrow function, defined as a WBC greater than 3.0 ml, PLT greater than 75,000/ul, Hb greater than 9 gm/l.", " Willing to undergo breast core biopsies as required by the study protocol. - Ability to understand and sign a written informed consent for participation in the trial.", " Life expectancy of at least 1 year.", "Exclusion Criteria:", " Premenopausal status.", " Other coexisting malignancies with the exception of basal cell carcinoma or cervical cancer in situ.", " Patients with brain metastasis.", " WHO performance status of 3 or 4.", " Is judged by the investigator, uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.", " Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the clinical trial. - Concurrent treatment with estrogens or progestins. Patients must stop these drugs at least two weeks prior to study entry.", " Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment.", " Platelet count less than 75,000.", " In the opinion of the investigator, bleeding diathesis or anticoagulation therapy that would preclude intramuscular injections.", " History of hypersensitivity to castor oil.", " Any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded) - Patients with recurrent breast cancer.", " Patients with contralateral second primary breast cancers are eligible." ]

[ "Inclusion Criteria:", " To be included in this study, you must meet the following criteria:", " Metastatic breast cancer confirmed by biopsy", " No more than one prior chemotherapy regimen for metastatic breast cancer", " Able to perform activities of daily living with minimal assistance", " Adequate bone marrow, liver and kidney function", " Age 18 years or older", " Give written informed consent", "Exclusion Criteria:", " You cannot participate in this study if any of the following apply to you:", " Moderate to severe peripheral neuropathy", " Uncontrolled blood pressure or uncontrolled heart beat irregularities", " Diabetes Mellitus with fasting blood sugar greater than 200 mg %", " Significant heart disease within the prior 6 months", " Severe or uncontrolled medical disease", " Active uncontrolled infection", " Known chronic liver disease", " Known diagnosis of HIV infection", " Pregnant or breast feeding females", " Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have." ]

[ "Inclusion Criteria:", " Histologically or cytologically confirmed, HER2-negative adenocarcinoma of the breast, with measurable or non-measurable locally recurrent or metastatic disease. Locally recurrent disease must not be amenable to resection with curative intent.", " ECOG performance status of 0 or 1", " For women of childbearing potential, use of an acceptable and effective method of non-hormonal contraception", " For patients who have received recent radiotherapy, recovery prior to randomization from any significant acute toxicity, and radiation treatments have to be completed more than 3 weeks from randomization", "Exclusion Criteria:", " Disease-Specific Exclusions:", " HER2-positive status", " Prior chemotherapy for locally recurrent or metastatic disease", " Prior hormonal therapy < 2 weeks prior to randomization", " Prior adjuvant or neo-adjuvant chemotherapy is allowed, provided its conclusion has been for at least 12 months prior to randomization", " Investigational therapy within 28 days of randomization", " General Medical Exclusions:", " Life expectancy of < 12 weeks", " Inadequate organ function", " Uncontrolled serious medical or psychiatric illness", " Active infection requiring intravenous (IV) antibiotics at screening", " Pregnancy or lactation", " History of other malignancies within 5 years prior to screening, except for tumors with a negligible risk for metastasis or death" ]

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

[ "Outcome Measurement: ", " Progression-Free Survival (PFS)", " Time in months from start of study treatment to first documentation of objective tumor progression (per RECIST) or death due to any cause. PFS was calculated as (first event date minus first randomization date plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was \"Death\").", " Time frame: Baseline, every 6 weeks until disease progression or death (up to 3 years from first dose)", "Results 1: ", " Arm/Group Title: Sunitinib", " Arm/Group Description: SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.", " Overall Number of Participants Analyzed: 113", " Median (95% Confidence Interval)", " Unit of Measure: Months Core radiology laboratory assessment: 2.0 (1.5 to 2.8)", " Investigator's assessment: 1.7 (1.5 to 2.6)", "Results 2: ", " Arm/Group Title: Standard of Care", " Arm/Group Description: One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.", " Overall Number of Participants Analyzed: 104", " Median (95% Confidence Interval)", " Unit of Measure: Months Core radiology laboratory assessment: 2.7 (1.7 to 2.8)", " Investigator's assessment: 2.5 (1.4 to 2.9)" ]

[ "INTERVENTION 1: ", " Phase 1: Addition of Supine MRI to Conventional Imaging", " Pre-operative supine MRI with intraoperative optical scanning and tracking (group MRI)" ]

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

[ "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: 0/3 (0.00%)", " Pericardial effusion 0/3 (0.00%)", " Tachycardia 0/3 (0.00%)", " Nausea 0/3 (0.00%)", " Vomiting 0/3 (0.00%)", " Abdominal pain 0/3 (0.00%)", " Colitis 0/3 (0.00%)", " Diarrhoea 0/3 (0.00%)", " Gastritis 0/3 (0.00%)", " Ileus 0/3 (0.00%)", " Fatigue 0/3 (0.00%)", " Pyrexia 0/3 (0.00%)", " Pain 0/3 (0.00%)", " Hepatic cirrhosis 0/3 (0.00%)", " Cellulitis 0/3 (0.00%)", "Adverse Events 2:", " Total: 22/64 (34.38%)", " Pericardial effusion 1/64 (1.56%)", " Tachycardia 1/64 (1.56%)", " Nausea 2/64 (3.13%)", " Vomiting 2/64 (3.13%)", " Abdominal pain 2/64 (3.13%)", " Colitis 1/64 (1.56%)", " Diarrhoea 1/64 (1.56%)", " Gastritis 1/64 (1.56%)", " Ileus 1/64 (1.56%)", " Fatigue 1/64 (1.56%)", " Pyrexia 1/64 (1.56%)", " Pain 1/64 (1.56%)", " Hepatic cirrhosis 1/64 (1.56%)", " Cellulitis 3/64 (4.69%)" ]

[ "Adverse Events 1:", " Total: 20/88 (22.73%)", " Cardiac Failure * 2/88 (2.27%)", " Intracardiac thrombus * 1/88 (1.14%)", " Abdominal pain * 1/88 (1.14%)", " Diarrhoea * 2/88 (2.27%)", " Enteritis * 1/88 (1.14%)", " Intestinal perforation * 1/88 (1.14%)", " Chest pain * 1/88 (1.14%)", " Death * 1/88 (1.14%)", " Erysipelas * 1/88 (1.14%)", " Pneumonia * 1/88 (1.14%)", " Abdominal wound dehiscence * 1/88 (1.14%)" ]

[ "Adverse Events 1:", " Total: 0/0", " Leukopenia 0/0", " Neutropenia 0/0", " Ocular-other 0/0", " Elevated SGPT 0/0", " Arthralgia 0/0", " CNS hemorrhage 0/0", " Neurologic-other 0/0", " Radiation dermatitis 0/0", "Adverse Events 2:", " Total: 11/473 (2.33%)", " Leukopenia 2/473 (0.42%)", " Neutropenia 5/473 (1.06%)", " Ocular-other 1/473 (0.21%)", " Elevated SGPT 1/473 (0.21%)", " Arthralgia 1/473 (0.21%)", " CNS hemorrhage 1/473 (0.21%)", " Neurologic-other 1/473 (0.21%)", " Radiation dermatitis 1/473 (0.21%)" ]

[ "Outcome Measurement: ", " Fraction of Patients With Increased Levels of Circulating Endothelial Cells", " An exact 95% confidence interval (CI) will be calculated for the CEC response rate. With 26 patients, this CI will be no wider than 40% (e.g., if 13 of 26 patients respond, the CI is 30% to 70%).", " Time frame: After 3 weeks of treatment", "Results 1: ", " Arm/Group Title: Treatment (Cediranib Maleate)", " Arm/Group Description: Patients receive oral AZD2171 once daily for 42 days. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.", " Overall Number of Participants Analyzed: 26", " Measure Type: Number", " Unit of Measure: percentage of participants 30" ]

[ "Outcome Measurement: ", " Mean Duration of Grade 4 Neutropenia During Cycle 1 of Chemotherapy", " Mean duration of severe neutropenia, defined as the mean number of consecutive days with Grade 4 neutropenia (ANC less than 0.5*10^9 cells/L)", " Time frame: 21 days (Cycle 1 of chemotherapy treatment)", "Results 1: ", " Arm/Group Title: EP2006 + EP2006 & Neupogen", " Arm/Group Description: All subjects randomized to receive either EP2006 in Cycle 1", " Overall Number of Participants Analyzed: 101", " Mean (Standard Deviation)", " Unit of Measure: Days 1.17 (1.11)", "Results 2: ", " Arm/Group Title: Neupogen + Neupogen & EP2006", " Arm/Group Description: All subjects randomized to receive Neupogen in Cycle 1", " Overall Number of Participants Analyzed: 103", " Mean (Standard Deviation)", " Unit of Measure: Days 1.2 (1.02)" ]

[ "Inclusion Criteria:", " Patients must have histologically confirmed adenocarcinoma with HER2/neu immunohistochemistry 3+ or FISH-amplified breast cancer with a ratio of 2.0", " Tumor size of 3 cm and node-negative disease. Nodes with single cells or tumor clusters < 0.2 mm by H&E or IHC are considered node-negative. Patients with micrometastasis (nodes with tumor clusters between 0.02 and 0.2 cm) are allowed. Further axillary dissection will be determined by the patient's surgeon as per standard of care.", " Patients must be 18 years of age.", " Patients must have an ECOG performance status of 0 or 1.", " Treatment should be started within 90 days of the final surgical procedure for breast cancer.", " Patients may have bilateral synchronous breast tumors. Patients may have received hormonal therapy for the purpose of chemoprevention but must be willing to discontinue prior to enrollment and while participating in this trial.", " If patients have peripheral neuropathy, it must be grade 1.", " Patients must be willing to discontinue sex hormonal therapy e.g., birth control pills, ovarian hormonal replacement therapy, etc., prior to enrollment. Women of childbearing potential must be willing to consent to using effective contraception while on treatment and for a reasonable period thereafter.", " Hematologic parameters: absolute neutrophil count (ANC) 1500/μL and platelet count 100,000/μL.", " Non-hematologic parameters: total bilirubin must be 1.5 X institutional upper limit of normal (ULN), transaminases (SGOT or SGPT) 3.0 x ULN.", " Negative HCG pregnancy test for premenopausal women of reproductive capacity and for women less than 12 months after the menopause. LVEF by ECHO (with strain if possible) with LVEF of 50%. If an ECHO cannot be done, a MUGA may be performed.", " Patients must give written, informed consent indicating their understanding of and willingness to participate in the study.", "Exclusion Criteria:", " Patients with stage IV breast cancer or undergoing chemotherapy, radiation therapy, immunotherapy, or biotherapy for current breast cancer.", " Pregnant or breastfeeding patients.", " Patients with a concurrently active second malignancy, other than adequately treated non-melanoma skin cancers or in situ cervical cancer.", " Patients with unstable angina, congestive heart failure, or with a history of a myocardial infarction within 12 months. Patients with high-risk uncontrolled arrhythmias (ventricular tachycardia, high-grade AV block, supraventricular arrhythmias which are not adequately rate-controlled). Patients are excluded if they have grade 3 QT prolongation (Appendix F) (>500 ms) or require drugs that may prolong the QT.", " Subjects who have current active hepatic (including hepatitis B or C) or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones).", " Patients with active, unresolved infections.", " Patients with a sensitivity to E. coli derived proteins." ]

[ "Adverse Events 1:", " Total: 7/45 (15.56%)", " Febrile neutropenia 1/45 (2.22%)", " Cardiac ischemia/infarction 1/45 (2.22%)", " Ventricular arrhythmia - left ventricular systolic dysfunction 1/45 (2.22%)", " Hemmorhage - GI 1/45 (2.22%)", " Pancreatitis 1/45 (2.22%)", " Infection - pneumonia 1/45 (2.22%)", " Infection - Streptococcus 1/45 (2.22%)", " Abcess of Bartholin's cyst 1/45 (2.22%)" ]

[ "Adverse Events 1:", " Total: 7/37 (18.92%)", " gr 3port infection, 1/37 (2.70%)", " flu 1/37 (2.70%)", " Febrile Neutropenia 1/37 (2.70%)", " gr 4 sepsis, intubated [1]1/37 (2.70%)", " Diarrhea gr 2, Nausea gr 3, infection gr 3 1/37 (2.70%)", " infection normal ANC/viral grade 1 1/37 (2.70%)", " Dehydration 3, Diarrhea 3, Vomit 3, HGB3, Nausea 3, K 3, Dyspnea 2 1/37 (2.70%)", " gr 3cellulitis - breast 1/37 (2.70%)", "Adverse Events 2:", " Total: 8/23 (34.78%)", " gr 3port infection, 0/23 (0.00%)", " flu 0/23 (0.00%)", " Febrile Neutropenia 0/23 (0.00%)", " gr 4 sepsis, intubated [1]0/23 (0.00%)", " Diarrhea gr 2, Nausea gr 3, infection gr 3 0/23 (0.00%)", " infection normal ANC/viral grade 1 0/23 (0.00%)", " Dehydration 3, Diarrhea 3, Vomit 3, HGB3, Nausea 3, K 3, Dyspnea 2 0/23 (0.00%)", " gr 3cellulitis - breast 0/23 (0.00%)" ]

[ "Adverse Events 1:", " Total: 130/503 (25.84%)", " Febrile Neutropenia21/503 (4.17%)", " Neutropenia9/503 (1.79%)", " Anaemia1/503 (0.20%)", " Pancytopenia1/503 (0.20%)", " Pericardial Effusion2/503 (0.40%)", " Cardiac Failure1/503 (0.20%)", " Extrasystoles0/503 (0.00%)", " Vertigo1/503 (0.20%)", " Nausea7/503 (1.39%)", " Vomiting5/503 (0.99%)", " Diarrhoea1/503 (0.20%)", " Abdominal Pain1/503 (0.20%)", " Ascites1/503 (0.20%)", "Adverse Events 2:", " Total: 64/247 (25.91%)", " Febrile Neutropenia3/247 (1.21%)", " Neutropenia0/247 (0.00%)", " Anaemia2/247 (0.81%)", " Pancytopenia0/247 (0.00%)", " Pericardial Effusion0/247 (0.00%)", " Cardiac Failure0/247 (0.00%)", " Extrasystoles1/247 (0.40%)", " Vertigo0/247 (0.00%)", " Nausea2/247 (0.81%)", " Vomiting1/247 (0.40%)", " Diarrhoea4/247 (1.62%)", " Abdominal Pain3/247 (1.21%)", " Ascites2/247 (0.81%)" ]

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

[ "Inclusion Criteria:", " Female patients with histological or cytological proven diagnosis of breast cancer", " Stage IV disease", " Performance Status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Scale", " Patients had to have previously received anthracycline based regimens as a adjuvant therapy or neo-adjuvant chemotherapy and then progressed and developed metastatic disease", " Adequate organ function", "Exclusion Criteria:", " Prior chemotherapy for metastatic disease", " Previous radiation therapy is allowed but must not have included whole pelvis radiation", " Known or suspected brain metastasis. Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator", " Concurrent administration of any other tumor therapy, including cytotoxic chemotherapy, hormonal therapy and immunotherapy (including trastuzumab (Herceptin))", " Peripheral neuropathy of Common Toxicity Criteria (CTC) Grade greater than 1. History of significant neurological or mental disorder, including seizures or dementia" ]

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

[ "Inclusion Criteria:", " Patients must have cytologically/histologically documented locally advanced or metastatic breast cancer with either:", " Progression on treatment with any aromatase inhibitor for metastatic disease;", " Recurrence while on adjuvant aromatase inhibitors or within 12 months of completion;", " Recurrence after having completed adjuvant tamoxifen for at least 12 months;", " Patient who are not candidates for or are intolerant of aromatase inhibitor treatment;", " Patients are allowed (but not required) to have one prior chemotherapy regimen for metastatic disease.", " Tumors must express estrogen or progesterone receptor.", " Patients are eligible regardless of the menopausal status.", " Age > 18 years old", " Patients must have Eastern Cooperative Oncology Group (ECOG) performance status 0-2.", " Patients must be able to give informed consent and able to follow guidelines given in the study.", " Patients must have acceptable organ function, as defined by the following laboratory parameters: white blood count (WBC) >3.0 x 10^9/L; absolute neutrophil count (ANC) >1.5 x 10^9/L; hemoglobin (Hgb) >10.0g/dL; platelets (PLT) >100 x 10^9/L, Bilirubin < 2.0 mg/dl, aspartate aminotransferase/alanine aminotransferase (AST/ALT) < 2.5 X upper limit of normal (ULN), Creatinine <1.8 mg/dl (Creatinine clearance >60 ml/min).", " Women of childbearing age must have a negative pregnancy test. All patients of reproductive potential must use an effective method of contraception during the study and 6 months following termination of treatment. (Not applicable to patients with bilateral oophorectomy and/or hysterectomy or to female patients who are older than 50 years and have not had a menstrual cycle in more than one year.", " Patients must have measurable disease by RECIST criteria by staging studies performed within 30 days of enrollment. For patients with bone only disease: For this protocol isolated bone lesions can be classified as target lesions if they are measurable by MRI at screening and must be followed by MRI.", " Both men and women of all races and ethnic groups are eligible for this trial.", "Exclusion Criteria:", " Patients must not have received tamoxifen for metastatic disease.", " Patients must not have evidence of significant active infection (e.g., pneumonia, cellulitis, wound abscess, etc.) at time of study entry.", " Patients must be disease-free of prior invasive malignancies for > 5 years with the exception of: curatively-treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix.", " Pregnant and breast-feeding women are excluded from the study because effects on the fetus are unknown and there may be a risk of increased fetal wastage.", " Patients with uncontrolled central nervous system (CNS) metastasis or a history of seizures are excluded. Patients with stable CNS metastasis (either surgically resected, treated with gamma knife or stable for 3 months following whole brain radiation therapy [WBRT] are eligible). Patients with stable brain metastases will need an MRI within 4 weeks prior to start of therapy.", " Patients may not be receiving any other investigational agents and must have stopped all other histone deacetylase inhibitors (including Valproic acid) or other hormonal therapies.", " Patients must have discontinued their prior therapies for breast cancer and radiation therapy for a minimum of 3 weeks, patient is excluded if radiation therapy was given to a single measurable lesion and the disease is otherwise not measurable.", " Patients are excluded if they have any known hypersensitivity reaction to tamoxifen.", " Patient with a history of blood clots are not eligible.", " Women who have abnormal vaginal bleeding and/or endometrial hyperplasia or cancer are not eligible.", " Patients with evidence of visceral crisis are not eligible for this study." ]

[ "Inclusion Criteria:", " Ability to understand and the willingness to sign a written informed consent document.", " Signed written informed consent.", " Women undergoing sentinel lymph node biopsy.", " Women with breast cancer with known or suspected lymph node involvement.", " Women undergoing sentinel node identification and completion axillary lymph node dissection.", " Women of 18 years of age or older.", " Eastern Cooperative Oncology Group (ECOG) or Karnofsky Performance Status 0,1,2.", " Complete Blood Count (CBC) and basic Metabolic Panel within 6 months", "Exclusion Criteria:", " History of liver or kidney failure will not be eligible.", " Allergies to iodine containing products will not be eligible.", " Women who are pregnant will not be eligible.", " Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements." ]

[ "INTERVENTION 1: ", " SCPR Intervention", " Young breast cancer participants will receive their SCPR and access to additional web-based educational reproductive health information, including resource lists of helpful websites, followed by regular reproductive health prompts and study adherence reminders for 24 weeks.", " Reproductive Health Survivorship Care Plan (SCPR): The reproductive health survivorship care plan (SCPR) is a web-based educational tool that will include information on how to manage various reproductive health issues such as hot flashes, fertility concerns, contraception practices, and sexual function. The intervention also includes additional web-based information and resource lists, text-based reproductive health and study adherence", "INTERVENTION 2: ", " Control", " Young breast cancer participants randomized to the waitlist control arm will receive access to the web-based resources and study adherence reminders. At completion of the 24 weeks of follow up, they will have access to their SCPR.", " Control: Web-based resource lists and text-based study adherence reminders" ]

[ "Outcome Measurement: ", " Objective Response Rate (ORR)", " An objective response (OR) is defined as a patient having a best overall response of either complete response (CR) or partial response (PR). A patient has best overall response of CR if she had overall response of CR or PR on one visit and met the confirmation criteria per RECIST. ORR is defined as percentage of patients with objective response.", " Each patient with measurable disease at baseline was assessed for OR from the sequence of Response Evaluation Criteria in Solid Tumors (RECIST) scan data up to data cut-off. RECIST scans were performed every 12 weeks (+/- 2weeks) from randomization", " Time frame: baseline and every 12 weeks (+/- 2weeks) from randomization data up to data cut-off (19th march 2008)", "Results 1: ", " Arm/Group Title: Fulvestrant 250 mg", " Arm/Group Description: Fulvestrant 250 mg", " Overall Number of Participants Analyzed: 45", " Measure Type: Number", " Unit of Measure: percentage of participants 11.1", "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 participants 17.6" ]

[ "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: ", " 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%" ]

[ "DISEASE CHARACTERISTICS:", " Histologically confirmed breast cancer", " Stage I or II disease (T1-T2, N0, M0/MX disease)", " No chest wall invasion by tumor (T3 disease)", " Medially or centrally located lesion", " No multicentric disease", " Multifocal disease allowed", " No clinically positive axillary nodes", " No enlarged internal mammary nodes by CT scan", " Hormone receptor status not specified", " PATIENT CHARACTERISTICS:", " Male or female", " Menopausal status not specified", " American Society of Anesthesiologists (ASA) physical status classification 1-2", " Not pregnant or nursing", " Negative pregnancy test", " No other concurrent known, invasive malignancy", " No known chronic pulmonary disease", " No known allergy to methylene blue or isosulfan blue", " PRIOR CONCURRENT THERAPY:", " No prior thoracic or cardiac surgery", " No prior ipsilateral chest tube placement", " Contralateral chest tube placement allowed", " No prior neoadjuvant chemotherapy", " No prior radiotherapy to the mediastinum" ]

[ "Adverse Events 1:", " Total: 8/86 (9.30%)", " Hypersensitivity reaction to Cisplatin 1/86 (1.16%)", " Infection with normal ANC 4/86 (4.65%)", " Neutrophil Count 1/86 (1.16%)", " Hyperglycemia 1/86 (1.16%)", " Hypertension 1/86 (1.16%)" ]

[ "Adverse Events 1:", " Total: 20/88 (22.73%)", " Cardiac Failure * 2/88 (2.27%)", " Intracardiac thrombus * 1/88 (1.14%)", " Abdominal pain * 1/88 (1.14%)", " Diarrhoea * 2/88 (2.27%)", " Enteritis * 1/88 (1.14%)", " Intestinal perforation * 1/88 (1.14%)", " Chest pain * 1/88 (1.14%)", " Death * 1/88 (1.14%)", " Erysipelas * 1/88 (1.14%)", " Pneumonia * 1/88 (1.14%)", " Abdominal wound dehiscence * 1/88 (1.14%)" ]

[ "Inclusion Criteria:", " Patient must be postmenopausal defined as meeting one or more of the following:", " Age 60 years", " Amenorrheic for at least 12 months", " Surgically sterile- having undergone bilateral oophorectomy,", " FSH level in postmenopausal range according to institutional standards (note follicle-stimulating hormone (FSH) laboratory testing must be ordered as standard of care to determine optimal treatment and should not be ordered simply to confirm eligibility to this study)", " OR Pre-menopausal for whom standard estradiol treatment (ET) is planned with ovarian suppression (imaging on study should be completed prior to start of ovarian suppression)", " Patient must have histological or cytological confirmed breast cancer and fall into one of the following categories:", " New diagnosis with plans for at least 6 months of neoadjuvant ET or any amount of neoadjuvant ET if surgery is planned as this will be used for response assessment .", " Patients with newly diagnosed metastatic breast cancer or patient with known metastatic disease who has progressed while on therapy (no washout period is needed if the patient was treated with AIs or chemotherapy, but 2 months washout period is needed if the patient was treated with tamoxifen) who are going to be treated with ET.", " Patient must have any one of the following types of breast cancer (primary or metastatic): ER+/PgR+/HER2- or ER+/PgR-/HER2-.", " ER+ is defined as Allred score of at least 4 and greater.", " PgR+ is defined as Allred score of at least 4 and greater.", " Immunohistochemistry (IHC) is the primary assay methodology for HER2. HER2- refers to HER2 of 0, 1+ by IHC or negative by fluorescence in situ hybridization (FISH)", " Patient must have at least one measurable lesion according to RECIST 1.1 by radiological evaluation (ultrasound, mammography, MRI, CT, PET) or physical examination.", " Patients with evaluable osseous metastasis that are lytic or mixed lytic-sclerotic are eligible.", " Patients with hepatic lesions may be eligible provided the location of the lesion is peripheral or not too close to hepatic ducts. Decision on hepatic lesion eligibility will be made by the principal investigator or sub-investigator after careful review of all available imaging to ensure evaluation of the lesion will not be obscured by normal hepatobiliary excretion of 18F-FFNP.", " Patient must be able to understand and willing to sign a written informed consent document.", " Prior chemotherapy or endocrine therapy is allowed", " The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 or, based on the judgment of the treating medical oncologist, can tolerate imaging and at least 6 months of ET", " The patient should have a life expectancy of > 6 months.", "Exclusion Criteria:", " Patient with other invasive malignancies, with the exception of non-melanoma skin cancer or cervical carcinoma in-situ, who had (or have) any evidence of the other cancer present within the last 5 years", " Unable to tolerate up to 60 min of PET imaging per imaging session.", " Patients with non-measurable non-evaluable lesions such as pleural effusion are not eligible to participate.", " Patients with vertebral lesions that, in the opinion of the Principal Investigator and the treating medical oncologist, pose an imminent risk for cord compression." ]

[ "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." ]

[ "Adverse Events 1:", " Total: 3/10 (30.00%)", " Sinus tachycardia * 1/10 (10.00%)", " Blurred vision * 1/10 (10.00%)", " Memory impairment * 1/10 (10.00%)", " Dyspnea * 2/10 (20.00%)" ]

[ "Adverse Events 1:", " Total: 13/24 (54.17%)", " FEBRILE NEUTROPENIA 5/24 (20.83%)", " HAEMATOTOXICITY 0/24 (0.00%)", " NEUTROPENIA 3/24 (12.50%)", " LYMPHADENOPATHY 0/24 (0.00%)", " PERICARDIAL EFFUSION 1/24 (4.17%)", " ATRIAL FIBRILLATION 1/24 (4.17%)", " APLASIA 0/24 (0.00%)", " NAUSEA 0/24 (0.00%)", " PYREXIA 1/24 (4.17%)", " EXTRAVASATION 0/24 (0.00%)", " CHOLECYSTITIS 1/24 (4.17%)", " PATHOLOGICAL FRACTURE 1/24 (4.17%)", "Adverse Events 2:", " Total: 6/24 (25.00%)", " FEBRILE NEUTROPENIA 0/24 (0.00%)", " HAEMATOTOXICITY 1/24 (4.17%)", " NEUTROPENIA 0/24 (0.00%)", " LYMPHADENOPATHY 1/24 (4.17%)", " PERICARDIAL EFFUSION 0/24 (0.00%)", " ATRIAL FIBRILLATION 0/24 (0.00%)", " APLASIA 1/24 (4.17%)", " NAUSEA 1/24 (4.17%)", " PYREXIA 0/24 (0.00%)", " EXTRAVASATION 1/24 (4.17%)", " CHOLECYSTITIS 0/24 (0.00%)", " PATHOLOGICAL FRACTURE 0/24 (0.00%)" ]

[ "Inclusion Criteria:", " Invasive breast cancer verified in a histological biopsy", " Age 65 or younger", " Estrogen receptor (ER), PgR and HER2 expression have been determined", " No distant metastases present (M0)", " The patient provides a written informed consent for study participation", " The estimated risk of breast cancer recurrence is high (25% or higher within the first 5 years from the date of the diagnosis, over >35% within the first 10 years from the diagnosis)", "Exclusion Criteria:", " Patients with breast cancer with \"a special histological type\" (mucinous, papillary, medullary, or tubular type of breast cancer) when no metastases are present in the ipsilateral axillary lymph nodes", " The WHO performance status is moderate/poor, Z >1", " The peripheral blood leukocyte count is less than 3.0 x 109/L, the blood granulocyte count is less than 1.5 x 109/L, or the blood thrombocyte count is less than 120 x 109/L", " Any physical or mental disorder that is considered to prohibit administration of chemotherapy", " Cardiac failure; severe cardiac arrythmia requiring regular medication" ]

[ "Inclusion Criteria:", " Females 18 years of age", " Histologically confirmed invasive breast cancer", " Planning for surgical resection of breast tumor and sentinel node or axillary lymph node resection", " Planning neoadjuvant chemotherapy", " HER2 positive disease", " Measurable disease in the breast after diagnostic biopsy, defined as longest diameter 2.0 cm", " Known estrogen receptor (ER) and progesterone receptor (PR) hormone receptor status at study entry", " Normal bone marrow function", " Normal hepatic function", " Normal renal function", " Subjects must sign an Institutional Review Board/Ethics Committee (IRB/EC)-approved informed consent form before any study specific procedures", " Inclusion Criteria for Randomization:", " Left ventricular ejection fraction (LVEF) of 55% by 2D echocardiogram", " Complete all 4 cycles of run-in chemotherapy", "Exclusion Criteria:", " Bilateral breast cancer", " Presence of known metastases", " Received prior treatment, including chemotherapy, biologic therapy, radiation or surgery with the exception of diagnostic biopsy for primary breast cancer", " Other concomitant active malignancy or history of malignancy in the past 5 years except treated basal cell carcinoma of the skin or carcinoma in situ of the cervix", " Pre-existing clinically significant ( grade 2) peripheral neuropathy", " Any history of documented or current congestive heart failure, current high-risk uncontrolled arrhythmias, current angina pectoris requiring a medicinal product, current clinically significant valvular disease, current evidence of transmural infarction on electrocardiogram (ECG), or current poorly controlled hypertension", " Severe dyspnea at rest requiring supplementary oxygen therapy", " History of positivity for hepatitis B surface antigen, hepatitis C virus, or human immunodeficiency virus (HIV)", " Recent infection requiring a course of systemic anti-infectives that were completed 14 days before enrollment (with the exception of uncomplicated urinary tract infection)", " Woman of childbearing potential who is pregnant or is breast feeding", " Woman of childbearing potential who is not consenting to use highly effective methods of birth control (eg, true abstinence [periodic abstinence (eg calendar ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception], sterilization, or other non-hormonal forms of contraception) during treatment and for at least 7 months after the last administration of the protocol specified treatment", " Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study", " Other investigational procedures while participating in this study are excluded", " Subject has known sensitivity to any of the products to be administered during the study, including mammalian cell derived drug products, trastuzumab, murine proteins, or to any of the excipients", " Subject previously has enrolled and/or has been randomized in this study", " Subject likely to not be available to complete all protocol required study visits or procedures", " History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the Investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion" ]

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

[ "Adverse Events 1:", " Total: 17/50 (34.00%)", " Fatigue 4/50 (8.00%)", " Papulopustular rash 1/50 (2.00%)", " Alanine aminotransferase increased 5/50 (10.00%)", " Aspartate aminotransferase increased 4/50 (8.00%)", " Alkalosis 1/50 (2.00%)", " Anorexia 1/50 (2.00%)", " Hyperglycemia 2/50 (4.00%)", " Nervous system disorders - Other 1/50 (2.00%)", " Dry skin 1/50 (2.00%)", " Rash acneiform 1/50 (2.00%)" ]

[ "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%)" ]

[ "Adverse Events 1:", " Total: 13/72 (18.06%)", " Neutrophils/granulocytes * 24/72 (5.56%)", " Mucositis/stomatitis * 22/72 (2.78%)", " Vomiting * 21/72 (1.39%)", " Febrile neutropaenia * 6/72 (8.33%)", " Infection with normal absolute neutrophil count (ANC) or grade 1 or 2 neutrophils * 21/72 (1.39%)" ]

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

[ "Outcome Measurement: ", " Progression Free Survival (PFS)", " Defined as the time from the date of randomization to the date of the first documentation of objective tumor progression or death due to any cause, whichever occurs first. If tumor progression data include more than 1 date, the first date will be used. PFS (in months) will be calculated as (first event date minus randomization date plus 1) divided by 30.4.", " Time frame: Baseline until disease progression (up to 3 years from first dose)", "Results 1: ", " Arm/Group Title: Sunitinib + Capecitabine", " Arm/Group Description: Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.", " Overall Number of Participants Analyzed: 221", " Median (95% Confidence Interval)", " Unit of Measure: months Independent radiology assessment: 5.5 (4.5 to 6.0)", " Investigator's assessment: 5.4 (4.4 to 5.8)", "Results 2: ", " Arm/Group Title: Capecitabine", " Arm/Group Description: Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.", " Overall Number of Participants Analyzed: 221", " Median (95% Confidence Interval)", " Unit of Measure: months Independent radiology assessment: 5.9 (5.4 to 7.6)", " Investigator's assessment: 5.5 (4.3 to 6.8)" ]

[ "Outcome Measurement: ", " Progression-Free Survival (PFS) Rate", " PFS was based on Kaplan-Meier estimates. PFS was defined as time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from death case report forms (CRFs). Percentage of participants who had not experienced progression or death by Week 16 is reported.", " Time frame: Baseline up to Week 16", "Results 1: ", " Arm/Group Title: Bosutinib", " Arm/Group Description: Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.", " Overall Number of Participants Analyzed: 73", " Measure Type: Number", " Unit of Measure: percentage of participants 39.6 (28.1 to 50.8)" ]

[ "Inclusion Criteria:", " Clinical stage I or II (T1 or T2, N0 or N1) invasive mammary carcinoma", " Diagnosis may be made by fine needle aspiration cytology or core biopsy", " A repeat core biopsy is not required for patients who have a paraffin embedded diagnostic core biopsy specimen available for immunohistochemical staining", "Exclusion Criteria:", " Patients with locally advanced disease who are planning to undergo preoperative neoadjuvant therapy are not eligible*", " Locally advanced disease includes any of the following:", " Primary tumor 5 cm (T3)", " Tumor of any size with direct extension to the chest wall or skin (T4a-c)", " Inflammatory breast cancer (T4d)", " Fixed axillary lymph node metastases (N2)", " Metastasis to ipsilateral internal mammary node (N3) NOTE: *Patients with primary tumors 5 cm (T3) or tumors involving the chest wall or skin who are not candidates for preoperative chemotherapy or who decline preoperative chemotherapy are eligible", " Measurable residual tumor at the primary site", " Measurable disease is defined as any mass that can be reproducibly measured by physical examination", " Planning to undergo surgical treatment with either segmental resection or total mastectomy", " Patients with a prior history of contralateral breast cancer are eligible if they have no evidence of recurrence of their initial primary breast cancer", " No locally recurrent breast cancer", " No evidence of distant metastatic disease (i.e., lung, liver, bone, or brain metastases)", " Hormone receptor status not specified", " PATIENT CHARACTERISTICS:", " Menopausal status not specified", " Eastern Cooperative Oncology Group (ECOG) performance status 0-1", " ANC 1,000/mm^3", " Creatinine 1.5 times upper limit of normal (ULN)", " Total bilirubin 1.5 times ULN", " Serum glutamic oxaloacetic transminase (SGOT) and serum glutamic pyruvic transminase (SGPT) 1.5 times ULN", " Must be at least 18 years old", " Not pregnant or nursing", " Negative pregnancy test", " Fertile patients must use effective contraception", " No serious medical illness that, in the judgement of the treating physician, places the patient at high risk of operative mortality", " PRIOR CONCURRENT THERAPY:", " See Disease Characteristics", " No prior chemotherapy for this primary breast cancer", " At least 7 days since prior tamoxifen or raloxifene as a preventive agent" ]

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

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

[ "Outcome Measurement: ", " Tumor Response Rate (Complete and Partial) Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)", " [Not Specified]", " Time frame: 4 weeks", "Results 1: ", " Arm/Group Title: Arm 1", " Arm/Group Description: Patients receive oral lapatinib and oral tamoxifen once daily on days 1-28.", " lapatinib ditosylate: Given orally", " tamoxifen citrate: Given orally", " Overall Number of Participants Analyzed: 17", " Measure Type: Number", " Unit of Measure: participants 1 (1 to 27)" ]

[ "Adverse Events 1:", " Total: 5/25 (20.00%)", " Hypertension 1/25 (4.00%)", " Dehydration 1/25 (4.00%)", " Infection With Normal Anc Or Grade 1 Or 2 Neutrophils 2/25 (8.00%)", " Pain 1/25 (4.00%)", " Dyspnea (Shortness Of Breath) 2/25 (8.00%)" ]

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

[ "Outcome Measurement: ", " Phase 1: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) for Alisertib in Combination With Paclitaxel", " The MTD is defined as the dose range at which 1 of 6 evaluable participants experience dose limiting toxicities (DLT). DLT was evaluated according to National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.02 and was defined as any of the following events: 1. Grade 4 neutropenia and thrombocytopenia lasting 7 consecutive days; 2. Grade 4 neutropenia with fever and/or infection; 3. Platelet count <10,000/mm^3; 4. Grade 3 thrombocytopenia with bleeding; 5. Any other Grade 3 nonhematologic toxicity, with following exceptions: Grade 3 nausea/emesis, Grade 3 diarrhoea, Grade 3 fatigue, Grade 3 nonhematological toxicity that could be controlled to Grade 2 with appropriate treatment; 6. Other alisertib-related nonhematologic toxicities Grade 2 that, in opinion of investigator, required a dose reduction or discontinuation of therapy with alisertib.", " Time frame: Cycle 1 (Up to 28 days)", "Results 1: ", " Arm/Group Title: Alisertib + Paclitaxel (Phase 1)", " Arm/Group Description: Participants with ovarian cancer received alisertib (MLN8237) 10, 20, 30 or 40 mg, orally, twice daily (BID) on Days 1-3, 8-10 and 15-17, combined with weekly paclitaxel 60 or 80 mg/m^2, intravenous infusion, weekly (Days 1, 8, 15) in 28-day cycles in Phase 1 (Up to 37 cycles).", " Overall Number of Participants Analyzed: 49", " Measure Type: Number", " Unit of Measure: mg 40" ]

[ "DISEASE CHARACTERISTICS:", " Confirmed diagnosis of prior operable, noninflammatory breast cancer meeting the following criteria:", " Steroid hormone receptor-positive tumors (estrogen receptor and/or progesterone receptor), determined by immunohistochemistry, after primary surgery and before commencement of prior endocrine therapy", " Prior local treatment including surgery with or without radiotherapy for primary breast cancer with no known clinical residual loco-regional disease", " Following primary surgery, eligible patients must have had evidence of lymph node involvement either in the axillary or internal mammary nodes, but not supraclavicular nodes", " Clinically disease-free", " Must have completed 4-6 years of prior adjuvant selective estrogen receptor modulators (SERMs), aromatase inhibitors (AIs), or a sequential combination of both", " When calculating 4-6 years, neoadjuvant endocrine therapy should not be included", " No evidence of recurrent disease or distant metastatic disease", " No prior bilateral breast cancer", " PATIENT CHARACTERISTICS:", " Female", " Must be postmenopausal by any of the following criteria:", " Patients of any age who have had a bilateral oophorectomy (including radiation castration AND amenorrheic for > 3 months)", " Patients 56 years old or older with any evidence of ovarian function must have biochemical evidence of definite postmenopausal status (defined as estradiol, luteinizing hormone [LH], and follicle-stimulating hormone [FSH] in the postmenopausal range)", " Patients 55 years old or younger must have biochemical evidence of definite postmenopausal status (defined as estradiol, LH, and FSH in the postmenopausal range)", " Patients who have received prior luteinizing-hormone releasing-hormone (LHRH) analogues within the last year are eligible if they have definite evidence of postmenopausal status as defined above", " Clinically adequate hepatic function", " No bone fracture due to osteoporosis at any time during the 4-6 years of prior therapy", " No prior or current malignancy except adequately treated basal cell or squamous cell carcinoma of the skin, in situ carcinoma of the cervix or bladder, or contra- or ipsilateral in situ breast carcinoma", " No other nonmalignant systemic diseases (cardiovascular, renal, lung, etc.) that would prevent prolonged follow-up", " No psychiatric, addictive, or any other disorder that compromises compliance with protocol requirements", " PRIOR CONCURRENT THERAPY:", " See Disease Characteristics", " More than 12 months since prior and no other concurrent endocrine SERM/AI therapy", " Any type of prior adjuvant therapy allowed including, but not limited to, any of the following:", " Neoadjuvant chemotherapy", " Neoadjuvant endocrine therapy", " Adjuvant chemotherapy", " Trastuzumab (Herceptin®)", " Ovarian ablation", " Gonadotropin releasing hormone analogues", " Lapatinib ditosylate", " No concurrent hormone-replacement therapy, bisphosphonates (except for treatment of bone loss), or any other investigational agent" ]

[ "Adverse Events 1:", " Total: 6/18 (33.33%)", " Skin infection [1]2/18 (11.11%)", " Radiation dermatitis 2 [1]4/18 (22.22%)", "Adverse Events 2:", " " ]

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

[ "Outcome Measurement: ", " Mean Duration of Severe Neutropenia (DSN) During Cycle 1 of Chemotherapy", " Mean duration of severe neutropenia, defined as number of consecutive days with ANC <0.5 × 10^9/l (grade 4 neutropenia).", " Time frame: 21 days (Cycle 1 of chemotherapy treatment)", "Results 1: ", " Arm/Group Title: LA-EP2006", " Arm/Group Description: During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.", " LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application.", " Overall Number of Participants Analyzed: 155", " Mean (Standard Deviation)", " Unit of Measure: days FAS: 151 participants", " 1.36 (1.133)", " PP: 148 participants", " 1.34 (1.141)", "Results 2: ", " Arm/Group Title: Neulasta ", " Arm/Group Description: During each chemotherapy cycle eligible patients receive Neulasta s.c. post chemotherapy application.", " Neulasta : Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.", " Overall Number of Participants Analyzed: 153", " Mean (Standard Deviation)", " Unit of Measure: days FAS: 149 participants", " 1.19 (0.984)", " PP: 144 participants", " 1.19 (0.991)" ]

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

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

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

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

[ "The following information on clinical trials is provided for information purposes only to allow participants and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.", "INCLUSION CRITERIA:", " Histologically or cytologically proven adenocarcinoma of the breast at first diagnosis", " Stage IV disease with at least one measurable lesion according to the RECIST criteria", " HER2/neu positive as determined by 3+ immunohistochemistry (IHC) staining or fluorescence in situ hybridization (FISH) positivity or negative tumors", " Life expectancy of >/= 24 weeks", " No prior chemotherapy for metastatic breast cancer. (Prior endocrine therapy is permitted).", " Prior neoadjuvant or adjuvant chemotherapy is permitted, or at least 12 months must have elapsed since the neoadjuvant or adjuvant therapy. Subjects may have received prior adjuvant anthracyclines (maximum cumulative dose, 360 mg/m^2 doxorubicin or 750 mg/m^2 epirubicin)", " At least 4 weeks since prior surgery, radiotherapy, endocrine therapy, or experimental drug therapy with complete recovery from the effects of these interventions", " It is recommended that all baseline staging should be completed within 35 days prior to study entry. All subjects will have the following workup as applicable; CT scan of brain, CT scan or MRI of chest and abdomen, and bone scan or PET scan. In cases of positive bone or PET scans, bone X-ray evaluation and/or MRI is required to confirm or exclude metastatic bone disease. Subjects with metastatic disease limited to bone are ineligible unless at least one lytic lesion is measurable and can be followed by RECIST criteria. Other tests may be performed as clinically indicated", " Normal cardiac function must be confirmed by left ventricular ejection fraction (LVEF) of >/= 50% or shortening fraction (multiple-gated acquisition [MUGA] scan or echocardiography respectively). The result must be greater than the lower limit of normal (LLN) for the institution.", " Subjects receiving bisphosphonate therapy; however, if bisphosphonates were started within <2 months prior to treatment the bone lesions will not be evaluated for response, and the subjects must have another site of metastatic disease that is either measurable or evaluable for response", "EXCLUSION CRITERIA:", " Prior chemotherapy for metastatic breast cancer", " Prior treatment with bevacizumab or other anti-VEGF therapy", " Concurrent treatment with any other non-protocol anticancer therapy with the exception of radiation therapy as long as all target lesions being followed are not in the radiation field and if HER2/neu positive, HER2/neu-directed therapy", " Current or prior history of brain or leptomeningeal metastases", " Presence of neuropathy >/= 2", " Presence of any non-healing wound, fracture, or ulcer, or the presence of clinically significant (>/= Grade 2) peripheral vascular disease", " 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", " Active peptic ulcer disease, inflammatory bowel disease, or other gastrointestinal condition increasing the risk of perforation; history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to beginning therapy", " History of bleeding diathesis or coagulopathy" ]

[ "Outcome Measurement: ", " Number of Participants Who Experienced Cardiac Events (Level 1 or 2), or Inability to Administer Trastuzumab Either During the 8 Cycles of Chemotherapy or According to Package Insert for a Total Duration of 1 Year", " Cardiac events defined as:", " Level 1: Cardiac death due to heart failure (HF), myocardial infarction or arrhythmia, or probable cardiac death defined as sudden, unexpected death within 24 hours of a definite or probable cardiac event, or severe symptomatic HF, concomitant with a left ventricular ejection fraction (LVEF) drop of >10 percentage points from baseline and to 50% LVEF", " Level 2: Asymptomatic systolic dysfunction or mildly symptomatic HF concomitant with an LVEF drop of >10 percentage points from baseline and to <50% LVEF; the LVEF drop was to have been confirmed within 3-4 weeks.", " Time frame: 8 cycles of chemotherapy and subsequently one year of planned trastuzumab treatment", "Results 1: ", " Arm/Group Title: Pegylated Liposomal Doxorubicin (PLD) Based Regimen", " Arm/Group Description: PLD 35 mg/m^2 IV over 60 minutes + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days + trastuzumab 2 mg/kg IV over 30 minutes (first dose 4 mg/kg IV over 90 minutes) given once weekly for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes given weekly for 12 weeks (4 courses)", " Overall Number of Participants Analyzed: 120", " Measure Type: Number", " Unit of Measure: Participants 5", "Results 2: ", " Arm/Group Title: Doxorubicin Based Regimen", " Arm/Group Description: doxorubicin 60 mg/m^2 intravenous (IV) push + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes (first administration 4 mg/kg IV over 90 minutes) given weekly for 12 weeks (4 courses)", " Overall Number of Participants Analyzed: 59", " Measure Type: Number", " Unit of Measure: Participants 11" ]

[ "Outcome Measurement: ", " Time to Progression (TTP) - Expert Evaluation Committee Assessment", " Time in months from randomization to first documentation of objective tumor progression or death due to breast cancer, whichever comes first. Tumor progression was determined by the expert evaluation committee using RECIST version 1.0 as an at least a 20% increase in the sum of the longest diameters (SLD) of the target lesions compared to the smallest SLD since the study treatment started. For participants with bone metastasis only, at least 25% increase in the measurable lesion according to General Rules for Clinical and Pathological Study of Breast Cancer (The 14th edition).", " Time frame: Up to 2008 days of the treatment", "Results 1: ", " Arm/Group Title: Exemestane", " Arm/Group Description: One tablet each of exemestane 25 mg and anastrozole placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.", " Overall Number of Participants Analyzed: 147", " Median (95% Confidence Interval)", " Unit of Measure: months 13.8 (10.8 to 16.5)", "Results 2: ", " Arm/Group Title: Anastrozole", " Arm/Group Description: One tablet each of anastrozole 1 mg and exemestane placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.", " Overall Number of Participants Analyzed: 145", " Median (95% Confidence Interval)", " Unit of Measure: months 11.1 (10.8 to 16.6)" ]

[ "Adverse Events 1:", " Total: 19/3761 (0.51%)", " Cardiac ischemia/infarction 3/3761 (0.08%)", " Left ventricular systolic dysfunction 1/3761 (0.03%)", " Restrictive cardiomyopathy 1/3761 (0.03%)", " Supraven.arrhyth. Atrial flutter 1/3761 (0.03%)", " Ventric.arrhyth. Trigeminy 1/3761 (0.03%)", " Hypothyroidism 0/3761 (0.00%)", " Blurred vision 1/3761 (0.03%)", " Nyctalopia 0/3761 (0.00%)", " Ocular - Other 1/3761 (0.03%)", "Adverse Events 2:", " Total: 7/3759 (0.19%)", " Cardiac ischemia/infarction 0/3759 (0.00%)", " Left ventricular systolic dysfunction 0/3759 (0.00%)", " Restrictive cardiomyopathy 0/3759 (0.00%)", " Supraven.arrhyth. Atrial flutter 0/3759 (0.00%)", " Ventric.arrhyth. Trigeminy 0/3759 (0.00%)", " Hypothyroidism 1/3759 (0.03%)", " Blurred vision 0/3759 (0.00%)", " Nyctalopia 1/3759 (0.03%)", " Ocular - Other 0/3759 (0.00%)" ]

[ "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%)" ]

[ "INCLUSION CRITERIA", " Histologically-confirmed, bi-dimensionally measurable, recurrent or metastatic carcinoma of the breast that is progressive", " Premenopausal, defined as any of:", " Last menstrual period within 3 months, or", " Post-hysterectomy without bilateral oophorectomy and with follicle-stimulating hormone (FSH) in the premenopausal range, or,", " If tamoxifen administered within the past 3 months, plasma estradiol must be in the premenopausal range", " Either positive estrogen and/or progesterone receptor determination by Immunohistochemistry (IHC) or competitive binding assay on metastatic disease, or if not performed on their metastatic disease a positive result on their primary breast cancer specimen.", " Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2", " Granulocytes > 1500/mm^3", " Platelets > 100,000/mm^3", " Serum glutamic oxaloacetic transaminase (SGOT) < 2.5 x upper limit of normal", " Total bilirubin < 1.5 mg/dL", " May have received irradiation to bony sites of disease for pain control or for prevention of fracture. The irradiated site(s) will NOT be evaluable for disease response.", " Must be using effective contraception or not be of childbearing potential", " Signed written informed consent", " INCLUSION CRITERIA", " Active, unresolved infection", " Active malignancy other than breast cancer, in situ carcinoma of the cervix, or non-melanomatous skin cancers in the past 5 years", " Prior treatment with an aromatase inhibitor or inactivator", " Prior treatment with an luteinizing hormone-releasing hormone (LH/RH) agonist/antagonist", " Adjuvant chemotherapy within 6 months of study entry.", " Received chemotherapy or hormonal therapy in the 3 weeks prior to enrollment", " Central nervous system metastasis", " Lymphangitic pulmonary metastasis", " Pregnant or lactating" ]

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

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

[ "Adverse Events 1:", " Total: 2/4 (50.00%)", " Abdominal pain 0/4 (0.00%)", " Disease progression 0/4 (0.00%)", " Dehydration 2/4 (50.00%)", " Hyponatraemia 1/4 (25.00%)", " Metastasis to central nervous system 1/4 (25.00%)", " Oesophageal adenocarcinoma 0/4 (0.00%)", " Intracranial hypotension 0/4 (0.00%)", " Pneumothorax 0/4 (0.00%)", " Dyspnoea 0/4 (0.00%)", " Hypoxia 0/4 (0.00%)", "Adverse Events 2:", " Total: 1/3 (33.33%)", " Abdominal pain 0/3 (0.00%)", " Disease progression 0/3 (0.00%)", " Dehydration 0/3 (0.00%)", " Hyponatraemia 0/3 (0.00%)", " Metastasis to central nervous system 0/3 (0.00%)", " Oesophageal adenocarcinoma 0/3 (0.00%)", " Intracranial hypotension 0/3 (0.00%)", " Pneumothorax 1/3 (33.33%)", " Dyspnoea 0/3 (0.00%)", " Hypoxia 0/3 (0.00%)" ]

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

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

[ "INTERVENTION 1: ", " Control Arm", " Mail", " Standard Reminder Postcard", "INTERVENTION 2: ", " Family Physician Reminder Letter Arm", " Mail", " Standard Reminder Postcard", " Family Physician Reminder Letter" ]

[ "INTERVENTION 1: ", " 3D HI and SHI of UCA", " Perflutren injection, suspension (IV)0.25 ml followed by 3D Harmonic imaging (HI) then (IV) 20 micro-l/kg followed by 3D subharmonic imaging (SHI)", " 3D HI and SHI of UCA: Perflutren injection, suspension (IV)0.25 ml followed by 3D Harmonic imaging (HI) then (IV) 20 micro-l/kg followed by 3D subharmonic imaging (SHI)" ]

[ "Inclusion Criteria:", " Women aged 45-69, according to the target age of the screening centres involved;", " New invited women in mammography screening programme.", "Exclusion Criteria:", "None" ]

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

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

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

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

[ "Outcome Measurement: ", " 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)" ]

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

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

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

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

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

[ "Outcome Measurement: ", " Best Overall Response (BOR)", " Percentage of participants with best overall (objective) response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST).", " Time frame: Evaluations were performed every 6 weeks until progression reported between day of first participant randomized, 20 June 2007, until cut-off date, 31 July 2009", "Results 1: ", " Arm/Group Title: Cisplatin and Cetuximab", " Arm/Group Description: Cisplatin 75 milligram per square meter (mg/m^2) intravenous (IV) infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles and cetuximab initially 400 mg/m^2 followed by 250 mg/m^2 IV infusion weekly. Participants who demonstrated at least stable disease (SD) up to 6 cycles of cisplatin continued treatment with cetuximab only until progressive disease (PD) or occurrence of unacceptable toxicity.", " Overall Number of Participants Analyzed: 115", " Measure Type: Number", " Unit of Measure: percentage of participants 20.0 (13.1 to 28.5)", "Results 2: ", " Arm/Group Title: Cisplatin", " Arm/Group Description: Cisplatin 75 mg/m^2 IV infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles until the first occurrence of PD, unacceptable toxicity or withdrawal of consent.", " Overall Number of Participants Analyzed: 58", " Measure Type: Number", " Unit of Measure: percentage of participants 10.3 (3.9 to 21.2)" ]

[ "Adverse Events 1:", " Total: 17/50 (34.00%)", " Fatigue 4/50 (8.00%)", " Papulopustular rash 1/50 (2.00%)", " Alanine aminotransferase increased 5/50 (10.00%)", " Aspartate aminotransferase increased 4/50 (8.00%)", " Alkalosis 1/50 (2.00%)", " Anorexia 1/50 (2.00%)", " Hyperglycemia 2/50 (4.00%)", " Nervous system disorders - Other 1/50 (2.00%)", " Dry skin 1/50 (2.00%)", " Rash acneiform 1/50 (2.00%)" ]

[ "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%)" ]

[ "Adverse Events 1:", " Total: 9/157 (5.73%)", " Blood disorder 1/157 (0.64%)", " Hemoglobin decreased 1/157 (0.64%)", " Hemolysis 0/157 (0.00%)", " Arrhythmia 0/157 (0.00%)", " Cardiac disorder 0/157 (0.00%)", " Myocardial ischemia 1/157 (0.64%)", " Hearing impaired 0/157 (0.00%)", " Tinnitus 0/157 (0.00%)", " Cataract 0/157 (0.00%)", " Diplopia 0/157 (0.00%)", " Glaucoma 0/157 (0.00%)", " Vision blurred 0/157 (0.00%)", "Adverse Events 2:", " Total: 14/157 (8.92%)", " Blood disorder 0/157 (0.00%)", " Hemoglobin decreased 2/157 (1.27%)", " Hemolysis 1/157 (0.64%)", " Arrhythmia 0/157 (0.00%)", " Cardiac disorder 0/157 (0.00%)", " Myocardial ischemia 0/157 (0.00%)", " Hearing impaired 2/157 (1.27%)", " Tinnitus 1/157 (0.64%)", " Cataract 1/157 (0.64%)", " Diplopia 0/157 (0.00%)", " Glaucoma 1/157 (0.64%)", " Vision blurred 1/157 (0.64%)" ]

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

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

[ "INTERVENTION 1: ", " Cohort -1 (250mg BYL719, 3.6mg/kg T-DM1)", " Patients receive 250 mg PO daily PI3K inhibitor BYL719 on days 1-21 and 3.6mg/kg IV over 30-90 minutes on day 1 ado-trastuzumab emtansine (T-DM1). Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.", " PI3K inhibitor BYL719: Given PO", " Ado-trastuzumab emtansine: Given IV", " Pharmacological study: Correlative studies", " Laboratory biomarker analysis: Optional correlative studies", "INTERVENTION 2: ", " Cohort 1 (300mg BYL719, 3.6mg/kg T-DM1)", " Patients receive 300 mg PO daily PI3K inhibitor BYL719 on days 1-21 and 3.6mg/kg IV over 30-90 minutes on day 1 ado-trastuzumab emtansine (T-DM1). Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.", " PI3K inhibitor BYL719: Given PO", " Ado-trastuzumab emtansine: Given IV", " Pharmacological study: Correlative studies", " Laboratory biomarker analysis: Optional correlative studies" ]

[ "Inclusion Criteria:", " The patient must consent to be in the study and must have signed an approved consent form conforming to institutional guidelines", " The patient must be 18 years or older.", " Core biopsy should definitively demonstrate invasive carcinoma.", " Invasive carcinoma should be ER-apha receptor positive", " The tumor should be approximately at least 1 cm, to account for variability in imaging and imaging occult disease (physical exam, mammography, ultrasound). We recognize that from time to time because of this variation, there might not be enough tissue available for analysis after surgical excision but this will allow the greatest opportunity to capture as many eligible patients as possible.", " Patients in whom surgical excision of the tumor is part of standard of care management", " ECOG score of 0 or 1", " Negative serum or urine beta-hCG pregnancy test at screening for patients of child-bearing potential (this is routinely done if the patient is premenopausal and having surgery)", " Consent to participate in DBBR (RPCI only)", "Exclusion Criteria:", " Male patients are not eligible for this study", " Female patients with inoperable tumors or women with stage 4 disease diagnosed on CT, PET, PET/CT or bone scan.", " Patients with diagnosis by FNA cytology only", " Pregnant or lactating women", " Prior therapy for breast cancer, including irradiation, chemo- immuno- and/or hormonal therapy", " Patients receiving any hormonal therapy, e.g. ovarian hormonal replacement therapy, infertility medications etc., are not eligible", " Nonmalignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude the patient from being subjected to surgical excision", " Psychiatric or addictive disorders that would preclude obtaining informed consent", " Patients known or suspected to have hypercoagulable syndrome or with history of venous or arterial thrombosis, stroke, TIA, or pulmonary embolism", " Women with non-invasive disease or microinvasion are not eligible.", " Women undergoing neoadjuvant chemotherapy are not eligible", " women currently on tamoxifen and raloxifene for prevention are not eligible", " Patients shall not receive any herbal/alternative therapies such as flaxseed or soy products or black cohosh.", " Patients with a known mutation in p53 (Li Fraumeni Syndrome)" ]

[ "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" ]

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

[ "Outcome Measurement: ", " Progression Free Survival (PFS)", " Progression free survival is defined as time from date of registration until the date of first documented disease progression or date of death from any cause, whichever occurs first.", " Time frame: From date of registration until disease progression or death, whichever occurs first", "Results 1: ", " Arm/Group Title: Avastin (Bevacizumab) Plus Hormone", " Arm/Group Description: All patients received Avastin (Bevacizumab) 15 mg/kg IV every three weeks as well as continuing with hormonal therapy they previously were taking.", " Overall Number of Participants Analyzed: 30", " Median (95% Confidence Interval)", " Unit of Measure: days 125.5 (90 to 256)" ]

[ "Adverse Events 1:", " Total: 14/67 (20.90%)", " Febrile neutropenia 21/67 (1.49%)", " Leukopenia 21/67 (1.49%)", " Neutropenia 21/67 (1.49%)", " Macular hole 21/67 (1.49%)", " Diarrhoea 22/67 (2.99%)", " Abdominal pain 21/67 (1.49%)", " Abdominal pain upper 21/67 (1.49%)", " Enteritis 21/67 (1.49%)", " Gastritis 21/67 (1.49%)", " Nausea 21/67 (1.49%)", " Vomiting 21/67 (1.49%)", " Pneumonia 21/67 (1.49%)", "Adverse Events 2:", " Total: 1/10 (10.00%)", " Febrile neutropenia 20/10 (0.00%)", " Leukopenia 20/10 (0.00%)", " Neutropenia 20/10 (0.00%)", " Macular hole 20/10 (0.00%)", " Diarrhoea 20/10 (0.00%)", " Abdominal pain 20/10 (0.00%)", " Abdominal pain upper 20/10 (0.00%)", " Enteritis 20/10 (0.00%)", " Gastritis 20/10 (0.00%)", " Nausea 20/10 (0.00%)", " Vomiting 20/10 (0.00%)", " Pneumonia 20/10 (0.00%)" ]

[ "Inclusion Criteria:", " All subjects must be female.", " Postmenopausal status, defined as any one of the following criteria:", " Documented history of bilateral oophorectomy.", " Age 60 years or more.", " Age 45 to 59 and satisfying one or more of the following criteria:", " Amenorrhea for at least 12 months and intact uterus.", " Amenorrhea for less than 12 months and a follicle stimulating hormone (FSH) and estradiol concentration within postmenopausal range including: patients who have had a hysterectomy and patients who have received hormone replacement.", " Patients must have histologically confirmed invasive breast cancer with a primary tumor of 3 cm or more in greatest dimension as measured by clinical examination.", " Estrogen receptor and/or progesterone receptor positive disease.", " Patients must not have received any prior treatment for current or newly diagnosed breast cancer.", " Patients must have not received previous treatment with any of the study medications or similar drugs.", " No use of selective estrogen receptor modulators (SERM) such as raloxifene or similar agents in the past 2 years.", " WHO performance status of 0, 1, or 2.", " Adequate organ function defined as follows:", " Adequate renal function, defined by a serum creatinine within 3 times the upper limits of normal.", " Adequate liver function, defined by total bilirubin, AST, ALT, and alkaline phosphatase within 3 times the upper limits of normal.", " Adequate bone marrow function, defined as a WBC greater than 3.0 ml, PLT greater than 75,000/ul, Hb greater than 9 gm/l.", " Willing to undergo breast core biopsies as required by the study protocol. - Ability to understand and sign a written informed consent for participation in the trial.", " Life expectancy of at least 1 year.", "Exclusion Criteria:", " Premenopausal status.", " Other coexisting malignancies with the exception of basal cell carcinoma or cervical cancer in situ.", " Patients with brain metastasis.", " WHO performance status of 3 or 4.", " Is judged by the investigator, uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.", " Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the clinical trial. - Concurrent treatment with estrogens or progestins. Patients must stop these drugs at least two weeks prior to study entry.", " Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment.", " Platelet count less than 75,000.", " In the opinion of the investigator, bleeding diathesis or anticoagulation therapy that would preclude intramuscular injections.", " History of hypersensitivity to castor oil.", " Any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded) - Patients with recurrent breast cancer.", " Patients with contralateral second primary breast cancers are eligible." ]

[ "Inclusion Criteria:", " To be included in this study, you must meet the following criteria:", " Metastatic breast cancer confirmed by biopsy", " No more than one prior chemotherapy regimen for metastatic breast cancer", " Able to perform activities of daily living with minimal assistance", " Adequate bone marrow, liver and kidney function", " Age 18 years or older", " Give written informed consent", "Exclusion Criteria:", " You cannot participate in this study if any of the following apply to you:", " Moderate to severe peripheral neuropathy", " Uncontrolled blood pressure or uncontrolled heart beat irregularities", " Diabetes Mellitus with fasting blood sugar greater than 200 mg %", " Significant heart disease within the prior 6 months", " Severe or uncontrolled medical disease", " Active uncontrolled infection", " Known chronic liver disease", " Known diagnosis of HIV infection", " Pregnant or breast feeding females", " Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have." ]

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

[ "INTERVENTION 1: ", " Neratinib 40 mg", "Neratinb 40 mg qd", "INTERVENTION 2: ", " Neratinib 80 mg", "Neratinib 80 mg qd" ]

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

[ "INTERVENTION 1: ", " Sole Method", " patients will be treated with HDR brachytherapy using Mammosite ML as the sole method for radiation delivery after lumpectomy for breast cancer or DCIS", " Mammosite ML: 34 Gy / 10 fractions (3.4 Gy per fraction) 2 fractions / day (separated by at least 6 hours) Delivered in 5 consecutive working days", "INTERVENTION 2: ", " Boost", " patients will be treated with HDR brachytherapy using Mammosite ML as a boost technique prior to standard external beam radiation after lumpectomy for breast cancer or DCIS", " Mammosite ML: 5-10.2 Gy / 2-3 fractions (3.4 Gy per fraction) 2 fractions / day (separated by at least 6 hours) Delivered in 1-2 days Followed by whole breast radiation (25-28 daily tx)" ]

[ "INTERVENTION 1: ", " Manual Lymph Drainage", " Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb", " Manual Lymph Drainage (MLD): MLD is a practitioner-applied manual massage technique designed to decrease limb volume in patients with lymphedema by enhancing movement of lymph fluid, resulting in reductions in interstitial fluid.", "INTERVENTION 2: ", " Negative Pressure", " PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb", " PhysioTouch: The PhysioTouch is a hand-held device that administers negative pressure under the treatment head, and gently pulls the underlying skin and subcutaneous tissue into the suction cup. This suction produces a stretch to the skin and in the subcutaneous tissue space. This action is thought to facilitate lymphatic flow from the interstitium into the lymphatic vessels, and mobilizes the superficial fascia." ]

[ "INTERVENTION 1: ", " Cohort A: Advanced Triple-Negative Breast Cancer (TNBC)", " 6 mg/kg IMGN853 IV Q3W" ]

[ "Adverse Events 1:", " Total: 39/2240 (1.74%)", " Supraven.arrhyth. Atrial fibrillation 1/2240 (0.04%)", " Cardiac ischemia/infarction 2/2240 (0.09%)", " Valvular heart disease 1/2240 (0.04%)", " Cardiac General - Other 2/2240 (0.09%)", " Endocrine - Other 1/2240 (0.04%)", " Ocular - Other 1/2240 (0.04%)", " Colitis 2/2240 (0.09%)", " Diarrhea 1/2240 (0.04%)", " Dysphagia 1/2240 (0.04%)", " Gastritis 1/2240 (0.04%)" ]

[ "Adverse Events 1:", " Total: 6", " Agranulocytosis 0/42 (0.00%)", " Anaemia 2/42 (4.76%)", " Febrile neutropenia 1/42 (2.38%)", " Leukopenia 0/42 (0.00%)", " Neutropenia 1/42 (2.38%)", " Thrombocytopenia 1/42 (2.38%)", " Cardio-respiratory arrest 0/42 (0.00%)", " Pericardial effusion 1/42 (2.38%)", " Gastric ulcer haemorrhage 0/42 (0.00%)", " Melaena 0/42 (0.00%)", " Fatigue 1/42 (2.38%)", " Multi-organ failure 0/42 (0.00%)", "Adverse Events 2:", " Total: 13", " Agranulocytosis 1/61 (1.64%)", " Anaemia 1/61 (1.64%)", " Febrile neutropenia 0/61 (0.00%)", " Leukopenia 2/61 (3.28%)", " Neutropenia 2/61 (3.28%)", " Thrombocytopenia 1/61 (1.64%)", " Cardio-respiratory arrest 1/61 (1.64%)", " Pericardial effusion 0/61 (0.00%)", " Gastric ulcer haemorrhage 1/61 (1.64%)", " Melaena 1/61 (1.64%)", " Fatigue 1/61 (1.64%)", " Multi-organ failure 1/61 (1.64%)" ]

[ "Adverse Events 1:", " Total: 67/240 (27.92%)", " Anaemia 0/240 (0.00%)", " Febrile neutropenia 1/240 (0.42%)", " Leukopenia 2/240 (0.83%)", " Neutropenia 1/240 (0.42%)", " Thrombocytopenia 0/240 (0.00%)", " Atrial fibrillation 0/240 (0.00%)", " Cardiac failure congestive 2/240 (0.83%)", " Cardiac tamponade 1/240 (0.42%)", " Cardio-respiratory arrest 1/240 (0.42%)", " Left ventricular dysfunction 0/240 (0.00%)", "Adverse Events 2:", " Total: 56/234 (23.93%)", " Anaemia 1/234 (0.43%)", " Febrile neutropenia 0/234 (0.00%)", " Leukopenia 0/234 (0.00%)", " Neutropenia 0/234 (0.00%)", " Thrombocytopenia 1/234 (0.43%)", " Atrial fibrillation 1/234 (0.43%)", " Cardiac failure congestive 0/234 (0.00%)", " Cardiac tamponade 0/234 (0.00%)", " Cardio-respiratory arrest 0/234 (0.00%)", " Left ventricular dysfunction 1/234 (0.43%)" ]

[ "Inclusion Criteria:", " Female patients of Chinese origin with histologically or cytologically proven diagnosis of breast cancer.", " Unresectable, locally recurrent breast cancer or stage IV disease.", " Have at least one measurable lesion as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria.", " Performance Status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Scale", " Treatment with an anthracycline-based chemotherapy regimen in the adjuvant/neoadjuvant setting with subsequent disease relapse.", "Exclusion Criteria:", " Prior chemotherapy for unresectable, locally advanced breast cancer or metastatic disease.", " Concurrent administration of any other tumor therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy.", " Known or suspected brain metastasis or second primary malignancy that is clinically detectable at the time of consideration for study enrollment.", " Active infection or other serious condition.", " Pregnant or breastfeeding." ]

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

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

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

[ "Outcome Measurement: ", " Change in Bone Mineral Density (BMD) Measured by Dual (Energy) X-ray Absorptiometry (DXA) at Lumbar Spine (L2-L4) From Baseline to Month 24", " Bone mineral density (BMD) by DXA at lumbar spine (L2-L4); DXA assessments of the BMD at dual hips. (BMD). Two X-ray beams with different energy levels are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone.", " Time frame: baseline, month 24", "Results 1: ", " Arm/Group Title: Placebo", " Arm/Group Description: Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).", " Overall Number of Participants Analyzed: 36", " Mean (Standard Deviation)", " Unit of Measure: Z-score -0.075 (0.041)", "Results 2: ", " Arm/Group Title: Zometa", " Arm/Group Description: Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).", " Overall Number of Participants Analyzed: 34", " Mean (Standard Deviation)", " Unit of Measure: Z-score 0.037 (0.042)" ]

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

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