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" ]

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

[ "Adverse Events 1:", " Total: 21/337 (6.23%)", " Blood/Bone Marrow-Other 0/337 (0.00%)", " Febrile neutropenia 0/337 (0.00%)", " Hemoglobin 2/337 (0.59%)", " Atrioventricular block - 2nd degree Mobitz Type II 0/337 (0.00%)", " Cardiac-ischemia/infarction 1/337 (0.30%)", " Left ventricular diastolic dysfunction 0/337 (0.00%)", " Left ventricular systolic dysfunction 1/337 (0.30%)", " Restrictive cardiomyopathy 1/337 (0.30%)", "Adverse Events 2:", " Total: 48/348 (13.79%)", " Blood/Bone Marrow-Other 1/348 (0.29%)", " Febrile neutropenia 1/348 (0.29%)", " Hemoglobin 1/348 (0.29%)", " Atrioventricular block - 2nd degree Mobitz Type II 1/348 (0.29%)", " Cardiac-ischemia/infarction 2/348 (0.57%)", " Left ventricular diastolic dysfunction 1/348 (0.29%)", " Left ventricular systolic dysfunction 0/348 (0.00%)", " Restrictive cardiomyopathy 0/348 (0.00%)" ]

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

[ "Outcome Measurement: ", " Clinical Benefit Rate (CR Plus PR Plus SD)", " Complete response (CR) + partial response (PR) + stable disease (SD) using RECIST 1.0", " CR = disappearance of all target lesions", " PR = at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter", " SD = neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for progressive disease", " SD is defined as lack of disease progression by 24 weeks.", " Time frame: 24 weeks after start of treatment", "Results 1: ", " Arm/Group Title: Arm 1 (6 mg Estradiol)", " Arm/Group Description: 6 mg of estradiol daily (2 mg tid).", " Overall Number of Participants Analyzed: 34", " Measure Type: Number", " Unit of Measure: participants Complete response (CR): 0", " Partial response (PR): 3", " Stable disease (SD): 7", "CR+PR+SD: 10", "Results 2: ", " Arm/Group Title: Arm 2 (30 mg Estradiol)", " Arm/Group Description: 30 mg of estradiol. (10 mg tid)", " Overall Number of Participants Analyzed: 32", " Measure Type: Number", " Unit of Measure: participants Complete response (CR): 0", " Partial response (PR): 1", " Stable disease (SD): 8", "CR+PR+SD: 9" ]

[ "INTERVENTION 1: ", " Treatment (Pazopanib Hydrochloride)", " Patients receive oral pazopanib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.", " pazopanib hydrochloride: Given orally", " pharmacological study: Correlative studies", " laboratory biomarker analysis: Correlative studies" ]

[ "Inclusion Criteria:", " Histologically confirmed diagnosis of primary early breast cancer, tumor size greater than or equal to 2 centimeters (cm), of Stages T2-T4/N0-2.", " Performance status 0-2 Eastern Cooperative Oncology Group (ECOG).", " Adequate organ function (bone marrow, hepatic, renal, cardiac).", "Exclusion Criteria:", " Prior anthracyclines as part of prior anticancer therapy.", " Concurrent antitumor therapy.", " Second primary malignancy.", " Serious concomitant systemic disorder.", " Pre-existing sensorial or motor neuropathy", "Grade 1." ]

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

[ "Adverse Events 1:", " Total: 8/113 (7.08%)", " Febrile neutropenia [1]0/113 (0.00%)", " Anemia with trombocytopenia 0/113 (0.00%)", " Neutropenia 1/113 (0.88%)", " Paroxism of atrial fibrillation 0/113 (0.00%)", " Ventricular extrasystolone RYAN-1 0/113 (0.00%)", " Gastrointestinal hemorrhage 1/113 (0.88%)", " Death for unknown reason 1/113 (0.88%)", " Diarrhea with vomiting and weakness 0/113 (0.00%)", "Adverse Events 2:", " Total: 13/110 (11.82%)", " Febrile neutropenia [1]1/110 (0.91%)", " Anemia with trombocytopenia 1/110 (0.91%)", " Neutropenia 1/110 (0.91%)", " Paroxism of atrial fibrillation 2/110 (1.82%)", " Ventricular extrasystolone RYAN-1 1/110 (0.91%)", " Gastrointestinal hemorrhage 0/110 (0.00%)", " Death for unknown reason 1/110 (0.91%)", " Diarrhea with vomiting and weakness 1/110 (0.91%)" ]

[ "Outcome Measurement: ", " Percentage of Participants With Feasibility", " The regimen was considered feasible if the participant was able to complete the eribulin portion without dose delay or reduction. Dose delay was defined as a delay due to eribulin-related adverse event (AE) for more than 2 days for subsequent doses (cycles after the initiation of full dose of eribulin, except holidays, scheduling difficulties and nonclinical logistical issues). If a participant had more than 1 dose omission, delay or reduction due to eribulin-related AE, these events were collectively counted as one entity in the same participant. Participants were followed for approximately 3 years after the last dose of the study treatment. Feasibility rates were calculated with or without growth factor support. In both cohorts, the percentage of participants who completed the eribulin portion of the regimen without a dose omission, delay or reduction due to eribulin-related AE was estimated via the observed completion rate and an exact 90% confidence interval (CI) was constructed.", " Time frame: From date of first dose, up to 3 years after the last dose of study treatment, or up to approximately 4 years 2 months", "Results 1: ", " Arm/Group Title: Cohort 1: Eribulin Mesylate With Filgrastim as Needed", " Arm/Group Description: Participants initially received doxorubicin (60 mg/m^2) plus cyclophosphamide (600 mg/m^2) intravenously (IV) on Day 1, of every 14-day cycle for 4 cycles. Eribulin mesylate was administered following the doxorubicin plus cyclophosphamide regimen at a dose of 1.4 mg/m^2 IV over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle for 4 cycles (Cycles 5 to 8). In this Cohort growth factors, subcutaneous pegfilgrastim (6 mg) or filgrastim, could be used with eribulin therapy at the physician's discretion if neutropenia occurred that recovered to Grade 2.", " Overall Number of Participants Analyzed: 54", " Measure Type: Number", " Unit of Measure: Percentage of participants 70.4 (58.5 to 80.4)", "Results 2: ", " Arm/Group Title: Cohort 2: Eribulin Mesylate With Prophylactic Filgrastim", " Arm/Group Description: Participants initially received doxorubicin (60 mg/m^2) plus cyclophosphamide (600 mg/m^2) IV on Day 1, of every 14-day cycle for 4 cycles. Eribulin mesylate was administered following the doxorubicin plus cyclophosphamide regimen at a dose of 1.4 mg/m^2 IV over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle for 4 cycles (Cycles 5 to 8). In this Cohort filgrastim was used with eribulin therapy at a dose of 300 micrograms for participants 60 kg or 480 micrograms for participants >60 kg, administered subcutaneously on Days 3 and 4 and Days 10 and 11 of each eribulin cycle.", " Overall Number of Participants Analyzed: 25", " Measure Type: Number", " Unit of Measure: Percentage of participants 60.0 (41.7 to 76.4)" ]

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

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

[ "Inclusion Criteria:", " Histologically confirmed stage I-III colorectal or breast cancer", " Undergone curative-intent complete surgical resection and completed all adjuvant therapy (if indicated) at least 2 months prior to enrollment", " Note: Breast cancer subjects on hormonal therapy or trastuzumab only therapy and colorectal cancer subjects on adjunctive therapies not considered cytotoxic chemotherapy (including those participating in CALGB 80702 receiving only celecoxib/placebo) are eligible.", " Participants will be allowed to receive concomitant adjuvant endocrine therapy for breast cancer; however, all endocrine agents must be initiated at least 1 month prior to enrollment in the study and continued throughout the duration of study participation.", " Less than 120 minutes of exercise per week", " Approval by oncologist or surgeon", " English speaking and able to read English", " No planned surgery anticipated in the 3 month intervention period", " At least one month from any major surgery to start of intervention including colostomy reversal", "Exclusion Criteria:", " Concurrent other malignancy or history of other malignancy treated within the past 3 years (other than non-melanoma skin cancer or in-situ cervical cancer)", " Metastatic disease", " Scheduled to receive any form of further adjuvant cancer therapy", " Currently on medication for diabetes treatment", " Pregnant or breast-feeding", " Any condition associated with increased risk of metformin-associated lactic acidosis (prior renal failure or liver failure, history of acidosis of any type; habitual intake of 3 or more alcoholic beverages per day)", " Known hypersensitivity or intolerance to metformin" ]

[ "Inclusion Criteria:", " The patient has provided written informed consent with HIPAA authorization before participating in the study, as has his/her responsible caregiver, if applicable.", " The patient is a candidate for surgical intervention, with lymph node mapping being a part of the surgical plan.", " The patient is at least 18 years of age at the time of consent.", " The patient has an ECOG performance status of Grade 0 - 2 [8].", " The patient has a clinical negative node status at the time of study entry.", " If of child bearing potential, the patient has a negative pregnancy test within 72 hours prior to administration of Lymphoseek, has been surgically sterilized, or has been postmenopausal for at least 1 year.", " The patient is currently not participating in another investigational drug study.", " Melanoma Patients", " The patient has a diagnosis of primary melanoma.", " Breast Cancer Patients", " The patient has a diagnosis of primary breast cancer.", " Patients with pure ductal carcinoma in situ (DCIS) or non-invasive carcinoma if lymph node biopsy is part of the surgical plan.", "Exclusion Criteria:", " The patient is pregnant or lactating;", " The patient has clinical or radiological evidence of metastatic cancer including palpably abnormal or enlarged lymph nodes (i.e., all patients should be any T,N0,M0);", " The patient has a known hypersensitivity to Lymphazurin or Patent Bleu V.", " Melanoma Patients", " The patient has a tumor with a Breslow depth less than 0.75mm.;", " Patients that have had preoperative chemotherapy, immunotherapy or radiation therapy;", " Patients diagnosed with a prior invasive melanoma that would occur on the same body region or potentially draining to the same nodal basin or patients with truncal or extremity primary melanoma who has had a prior breast cancer potentially draining to the same axillary nodal basin;", " Patients who have undergone node basin surgery of any type or radiation to the nodal basin(s) potentially draining the primary melanoma;", " Patients who have undergone a wide excision for their primary melanoma (>1 cm in dimension) or complex reconstruction (rotation, free flap or skin graft of any type).", " Breast Cancer Patients", " The patient has bilateral primary breast cancers or multiple tumors within their breast;", " Patients that have had prior surgical procedures such as breast implants, reduction mammoplasty or axillary surgery;", " Patients scheduled for bilateral mastectomy for any reason;", " Patients that have had preoperative radiation therapy to the affected breast or axilla" ]

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

[ "Adverse Events 1:", " Total: 10/14 (71.43%)", " Hemoglobin 2/14 (14.29%)", " Lymphopenia 1/14 (7.14%)", " Cardiac ischemia/infarction 1/14 (7.14%)", " Hypertension 2/14 (14.29%)", " Hypotension 1/14 (7.14%)", " Constipation 1/14 (7.14%)", " Diarrhea 1/14 (7.14%)", " Heartburn/dyspepsia 1/14 (7.14%)", " Fatigue (asthenia, lethargy, malaise) 2/14 (14.29%)", " Rigors/chills 1/14 (7.14%)" ]

[ "Adverse Events 1:", " Total: 96/162 (59.26%)", " Cardiac disorders - Other, specify 2/162 (1.23%)", " Diarrhea 1/162 (0.62%)", " Mucositis oral 2/162 (1.23%)", " Nausea 1/162 (0.62%)", " Fatigue 6/162 (3.70%)", " Breast infection 2/162 (1.23%)", " Soft tissue infection 1/162 (0.62%)", " Lymphocyte count decreased 2/162 (1.23%)", " Neutrophil count decreased 78/162 (48.15%)", " Hypertension 1/162 (0.62%)" ]

[ "Inclusion Criteria:", " To be included in this study, you must meet the following criteria:", " Adenocarcinoma of the breast confirmed by biopsy", " Female Patients >18 years of age", " Normal cardiac function", " Ability to perform activities of daily living with minimal assistance", " Chemotherapy naïve or have received prior chemotherapy > 5 years ago", " Adequate bone marrow, liver and kidney function", " Be informed of the investigational nature of this study", " Sign an informed consent form", " Sentinel lymph node and/or axillary dissection prior to enrollment", "Exclusion Criteria:", " You cannot participate in this study if any of the following apply to you:", " Life expectancy of < than 6 months", " History of significant heart disease", " Prior chemotherapy or hormonal therapy", " Concurrent Trastuzumab therapy", " History of significant psychiatric disorders", " History of active uncontrolled infection", " Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have." ]

[ "Adverse Events 1:", " Total: 2/2 (100.00%)", " Febrile neutropenia * 2/2 (100.00%)", " Haemorrhage NOS * 0/2 (0.00%)", " Abdominal pain * 0/2 (0.00%)", " Diarrhea * 0/2 (0.00%)", " Melaena * 0/2 (0.00%)", " Mucositis oral * 0/2 (0.00%)", " Nausea * 0/2 (0.00%)", " Vomiting * 0/2 (0.00%)", " Catheter related infection * 0/2 (0.00%)", " Infection NOS * 0/2 (0.00%)", " Leukopenia * 1/2 (50.00%)", "Adverse Events 2:", " Total: 7/29 (24.14%)", " Febrile neutropenia * 1/29 (3.45%)", " Haemorrhage NOS * 1/29 (3.45%)", " Abdominal pain * 1/29 (3.45%)", " Diarrhea * 2/29 (6.90%)", " Melaena * 1/29 (3.45%)", " Mucositis oral * 1/29 (3.45%)", " Nausea * 1/29 (3.45%)", " Vomiting * 1/29 (3.45%)", " Catheter related infection * 1/29 (3.45%)", " Infection NOS * 2/29 (6.90%)", " Leukopenia * 0/29 (0.00%)" ]

[ "Inclusion Criteria:", " Has MBC that is measurable by RECIST or has nonmeasurable disease with serum CA27.29 (or CA15.3) 50", " Has Human Epidermal Growth Factor Receptor 2 (HER2) negative breast cancer", " Prior chemotherapy is permitted with no limit on the number of prior regimens", " Two weeks or more have elapsed since last chemotherapy or radiation treatment", " Has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-2", " Is female, 18 yrs of age", " Protocol defined appropriate laboratory values", " Negative pregnancy test within 7 calendar days prior to registration", " Has signed a patient informed consent", "Exclusion Criteria:", " Had prior treatment with ixabepilone or other epothilones", " Has HER2+ disease", " Has a known, prior, severe (National Cancer Institute Common Terminology Criteria Adverse Events [NCI CTCAE] Grade 3-4) history of hypersensitivity reaction to a drug formulated in Cremophor ® EL (polyoxyethylated castor oil)", " Is receiving concurrent immunotherapy, hormonal therapy or radiation therapy", " Is receiving concurrent investigational therapy or has received such therapy within the past 30 days", " Has peripheral neuropathy > Grade 1", " Has evidence of central nervous system (CNS) involvement requiring radiation or steroid treatment. Participants with stable brain metastases who are off steroids at least 2 weeks are eligible", " Is pregnant or breast feeding" ]

[ "Inclusion Criteria:", " stage I-III breast cancer", " adjuvant or neoadjuvant anthracycline-based chemotherapy", "Exclusion Criteria:", " under age 18", " pregnancy", " metastatic or inoperable (including inflammatory) breast cancer", " confounding underlying medical illnesses", " history of mania", " history of other axis-I psychiatric disorder", " other physical or psychological impairments -" ]

[ "Adverse Events 1:", " Total: 5/14 (35.71%)", " Ileus 1/14 (7.14%)", " General disorders and administration site conditions - Other, disease progression 2/14 (14.29%)", " Infections and infestations - Other, pneumonia 1/14 (7.14%)", " Acute kidney injury 1/14 (7.14%)" ]

[ "Adverse Events 1:", " Total: 3/9 (33.33%)", " Fatigue * 1/9 (11.11%)", " Non-cardiac chest pain * 1/9 (11.11%)", " Sepsis * 1/9 (11.11%)", " Urinary tract infection * 1/9 (11.11%)", " Syncope * 1/9 (11.11%)", " Anxiety * 1/9 (11.11%)", " Thromboembolic event * 1/9 (11.11%)" ]

[ "Outcome Measurement: ", " Event-free Survival", " Event-free survival of patients treated for inflammatory (Stage IIIb) and responsive stage IV breast cancer with BUMELTT and PBSC support and low dose immunotherapy with IL2 and GM-CSF.", " Time frame: 11 years", "Results 1: ", " Arm/Group Title: TX/Maintenance Therapy for Stage IIIB/IV Breast Cancer", " Arm/Group Description: See Detailed Description.", " tamoxifen citrate: Given orally", " busulfan: Given orally", " thiotepa: Given IV", " melphalan: Given IV", " aldesleukin: Given SC", " sargramostim: Given SC", " peripheral blood stem cell transplantation: Undergo autologous peripheral blood stem cell infusion", " radiation therapy: May undergo radiotherapy after completion of IL-2/GM-CSF", " Overall Number of Participants Analyzed: 50", " Measure Type: Count of Participants", " Unit of Measure: Participants Stage IIIB Disease: 18 participants", " 11 61.1%", " Stage IV Disease: 32 participants", "9 28.1%" ]

[ "INTERVENTION 1: ", " Decongestive Physiotherapy", " This group received Complex Decongestive Physiotherapy.", " Decongestive Physiotherapy: This group received CDP, which include MLD, short-stretch bandages, lymph-reducing exercises, and skin care. MLD was applied to the anterior trunk, posterior trunk, and the base of the neck, progressing to the affected limb. Short-stretch bandages were applied in multiple layers after MLD. A low pH skin lotion was applied prior to bandaging and then stockinette was placed on the arm. The fingers and the hand were wrapped in gauze. A layer of cotton was wrapped around the arm. Bandages (6, 8 and/or 10cm) were sequentially applied in a spiral fashion around the limb with the smallest bandage starting at the hand. The most compression was at the most distal points and gradually decreased proximally. Exercises were done by patients to improve mobility and enhance lymphatic flow.", "INTERVENTION 2: ", " Decongestive Physiotherapy Plus Taping", " This group received Complex Decongestive Physiotherapy, and also applying taping to anastomosis regions.", " Decongestive Physiotherapy plus taping: This group received CDP as same protocol of active comparator. In addition, taping was applied to anterior and posterior axillo-axillary anastomosis and axillo-inguinal anastomosis. The tape was started on the unaffected side and strips of tape were applied so as to reach the affected side regarding anterior and posterior axillo-axillary anastomosis. For axillo-inguinal anastomosis, the tape was started in the inguinal region of the affected side and strips of tape were applied so that they reached the axillary region." ]

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

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

[ "Outcome Measurement: ", " Percentage Change From Baseline to Time of Surgery in Oestrogen Receptor (ER) H-score: Antitumour Effects of Fulvestrant, Anastrozole and a Combination of Both as Measured by the ER H-score.", " For each sample, the ER H-score is calculated from the percentage of cells staining very weak (+/-); weak (+); moderate (++); or strong (+++) as follows: H-score = [(0.5 x percent +/-) + (1 x percent +) + (2 x percent ++) + (3 x percent +++)]. Range 0-300. The greater the change from baseline (randomization) in ER H-score, the greater the blockage of ER expression and the greater the potential anti-tumour activity. Percentage change from baseline=[(SRG - BL)/BL]x100", " Time frame: Surgery (SRG) was to be performed between days 15 and 22 after baseline (BL)", "Results 1: ", " Arm/Group Title: Fulvestrant", " Arm/Group Description: Fulvestrant 500 mg once monthly injection", " Overall Number of Participants Analyzed: 35", " Mean (Standard Error)", " Unit of Measure: Percentage change from baseline -37 (4)", "Results 2: ", " Arm/Group Title: Fulvestrant + Anastrozole", " Arm/Group Description: Fulvestrant 500 mg once monthly injection + Anastrozole 1 mg once daily tablet", " Overall Number of Participants Analyzed: 31", " Mean (Standard Error)", " Unit of Measure: Percentage change from baseline -38 (5)" ]

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

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

[ "Inclusion Criteria:", " HER-2 overexpressing breast cancer", " Clinical stage 2-3B", " Normal ejection fraction", "Exclusion Criteria:", " Metastatic disease", " Low ejection fraction" ]

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

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

[ "INTERVENTION 1: ", " Flexitouch Device", " Lymphedema management via Flexitouch device, an intermittent pneumatic compression device (aka, lymphedema pump)", "INTERVENTION 2: ", " Manual Lymphatic Drainage (MLD)", " Lymphedema management via self-administered manual lymphatic drainage therapy" ]

[ "Outcome Measurement: ", " Number of Patients With Congestive Heart Failure (CHF) While on Active Treatment", " [Not Specified]", " Time frame: 6 months", "Results 1: ", " Arm/Group Title: AC/PTL", " Arm/Group Description: Standard doxorubicin and cyclophosphamide (AC) followed by weekly paclitaxel (80 mg/m^2) x 12 with concurrent standard dose trastuzumab (weekly x 12, then repeat 3 weeks for an additional 9 months) plus daily lapatinib (modified to 750 mg during Paclitaxel + Trastuzumab + Lapatinib (PTL) and 1000 mg during trastuzumab + lapatinib (TL)) for a total of 12 months.", " Overall Number of Participants Analyzed: 109", " Measure Type: Number", " Unit of Measure: participants 0" ]

[ "Inclusion Criteria:", " Female patients with histologically or cytologically confirmed carcinoma of the breast", " Patients with advanced/metastatic disease that is not amenable to curative therapy (either surgery or radiation therapy)", " Patients must have measurable disease by the RECIST criteria, defined as at least one lesion that can be accurately measured in at least one diameter (at least 10 mm in longest diameter (LD) by spiral computer tomography (CT) scan, or at least 20 mm by standard techniques; If the only measurable lesion is a lymph node, it must measure at least 20 mm in LD. If a single lesion is identified as the target lesion, a cytological or histological confirmation of breast carcinoma is required.", " Patients must have had prior treatment with an anthracycline and a taxane (either sequential or in combination) and may have had prior treatment with other agents as well.", " Patients must have progressed within six months of the last dose of chemotherapy, or experienced disease progression while receiving chemotherapy for advanced/metastatic disease.", " Resolution of all chemotherapy or radiation-related toxicities to less than grade 1 severity", " Age 18 years", " Eastern Cooperative Oncology Group (ECOG) Performance Status (APPENDIX 4) of 0 or 1", " Life expectancy of 3 months", " Adequate renal function as evidenced by serum creatinine 1.5 mg/dL or calculated creatinine clearance 50 mL/minute (min) per the Cockcroft and Gault formula", " Adequate bone marrow function as evidenced by absolute neutrophil count (ANC) 1.5 x 10^9/L, hemoglobin 10.0 g/dL (a hemoglobin <10.0 g/dL would be acceptable if it can be corrected by growth factor or transfusion), and platelet count 100 x 10^9/L", " Adequate liver function as evidenced by bilirubin 1.5 mg/dL and alkaline phosphatase, alanine transaminase (ALT), and aspartate transaminase (AST) 3 times the upper limits of normal (ULN) (in the case of liver metastases 5 x ULN)", " Patients willing and able to complete the FACT-B questionnaire, Analgesic Diary, Pain VAS, and the tumor-related symptomatic assessment", " Patients willing and able to comply with the study protocol for the duration of the study", " A sample from the diagnostic biopsy (paraffin block) must be available", " Written informed consent prior to any study-specific screening procedures with the understanding that the patient may withdraw consent at any time without prejudice", "Exclusion Criteria:", " Patients who have received chemotherapy, radiation, hormonal therapy, or Herceptin within 2 weeks of E7389 treatment start", " Radiation therapy encompassing > 10% of marrow", " Failure to recover from any chemotherapy related or other therapy related toxicity at study entry that is deemed to be clinically significant by the study investigator", " Prior treatment with Mitomycin C or nitrosoureas", " Prior high dose chemotherapy with hematopoietic stem cell rescue in the past two years", " Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen", " Active symptomatic brain metastasis; Patients with central Nervous System (CNS) metastasis are considered eligible if they have completed local therapy and discontinued from corticosteroids for at least two weeks before starting treatment with E7389", " Patients with meningeal carcinomatosis", " Patients who require therapeutic anti-coagulant therapy with Warfarin or related compounds; Mini dose warfarin for catheter related thrombosis prophylaxis is permitted", " Women who are pregnant or breast-feeding; Women of childbearing potential with either a positive pregnancy test at Screening or no pregnancy test. Women of childbearing potential unless (1) surgically sterile or (2) using adequate measures of contraception in the opinion of the Investigator. Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.", " Severe /uncontrolled intercurrent illness/infection", " Significant cardiovascular impairment (history of congestive heart failure > NYHA grade II, unstable angina or myocardial infarction within the past six months, or serious cardiac arrhythmia)", " Patients with organ allografts", " Patients with known positive HIV status", " Patients who have had a prior malignancy, other than carcinoma in situ of the cervix, or non-melanoma skin cancer, unless the prior malignancy was diagnosed and definitively treated 5 years previously with no subsequent evidence of recurrence", " Patients with pre-existing neuropathy > Grade 1", " Patients with a hypersensitivity to halichondrin B and/or halichondrin B chemical derivative", " Patients who participated in a prior E7389 clinical trial", " Patients with other significant disease or disorders that, in the Investigator's opinion, would exclude the patient from the study" ]

[ "Outcome Measurement: ", " Phase 1: Number of Subjects Reporting Dose-Limiting Toxicities (DLTs)", " DLTs are defined as: Any treatment-related Grade 3 non-hematologic clinical (non-laboratory) AE Any treatment-related Grade 3 or Grade 4 non-hematologic lab abnormality if: - Medical intervention is required to treat the patient, or - The abnormality leads to hospitalization, or - The abnormality persists for 7 days. Any treatment-related hematologic toxicity specifically defined as: - Thrombocytopenia Grade 4 for 7 days, or Grade 3 or 4 associated with bleeding or requiring platelet transfusion; - Neutropenia Grade 4 for 7 days, or Grade 3 or 4 associated with infection or febrile neutropenia; - Anemia Grade 4, or Grade 3 or 4 requiring blood transfusion. Any treatment-related AE leading to niraparib dose interruption per the following criteria: - A dose interruption for a non-DLT lab abnormality lasting 14 days. - A dose in interruption per dose modification rules for nonhematologic AE leading to < 80% of an intended dose being administered.", " Time frame: During Cycle 1, ie, during the first 21 days of treatment", "Results 1: ", " Arm/Group Title: Phase 1: Niraparib 200mg + Pembrolizumab", " Arm/Group Description: Niraparib 200 mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.", " Overall Number of Participants Analyzed: 6", " Measure Type: Count of Participants", " Unit of Measure: Participants 1 16.7%", "Results 2: ", " Arm/Group Title: Phase 1: Niraparib 300mg + Pembrolizumab", " Arm/Group Description: Niraparib 300 mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.", " Overall Number of Participants Analyzed: 6", " Measure Type: Count of Participants", " Unit of Measure: Participants 1 16.7%" ]

[ "Adverse Events 1:", " Total: 52/112 (46.43%)", " Febrile neutropenia * 16/112 (14.29%)", " Neutropenia * 7/112 (6.25%)", " Anaemia * 1/112 (0.89%)", " Cardiac failure * 1/112 (0.89%)", " Coronary artery disease * 1/112 (0.89%)", " Left ventricular dysfunction * 1/112 (0.89%)", " Pericardial effusion * 0/112 (0.00%)", " Hyperthyroidism * 1/112 (0.89%)", " Diarrhoea * 5/112 (4.46%)", " Vomiting * 3/112 (2.68%)", "Adverse Events 2:", " Total: 51/110 (46.36%)", " Febrile neutropenia * 26/110 (23.64%)", " Neutropenia * 7/110 (6.36%)", " Anaemia * 1/110 (0.91%)", " Cardiac failure * 0/110 (0.00%)", " Coronary artery disease * 0/110 (0.00%)", " Left ventricular dysfunction * 0/110 (0.00%)", " Pericardial effusion * 1/110 (0.91%)", " Hyperthyroidism * 0/110 (0.00%)", " Diarrhoea * 0/110 (0.00%)", " Vomiting * 1/110 (0.91%)" ]

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

[ "Adverse Events 1:", " Total: 16/48 (33.33%)", " Febrile neutropenia grade 3 3/48 (6.25%)", " Neutropenia grade 3 1/48 (2.08%)", " Holocraneal cephalea 1/48 (2.08%)", " Hypersensibility reaction grade 3 2/48 (4.17%)", " Palmoplantar erythrodysesthesia grade 3, stomatitis grade 3 1/48 (2.08%)", " Neutropenia grade 4, fever grade 1, oral mucositis grade 3 1/48 (2.08%)", " Catheter - related infection grade 3 1/48 (2.08%)" ]

[ "Adverse Events 1:", " Total: 53/218 (24.31%)", " Febrile Neutropenia 2/218 (0.92%)", " Neutropenia 2/218 (0.92%)", " Anaemia 1/218 (0.46%)", " Thrombocytopenia 1/218 (0.46%)", " Pancytopenia 0/218 (0.00%)", " Left Ventricular Dysfunction 4/218 (1.83%)", " Atrial Fibrillation 0/218 (0.00%)", " Angina Unstable 0/218 (0.00%)", " Arteriospasm Coronary 1/218 (0.46%)", " Cardiac Arrest 1/218 (0.46%)", "Adverse Events 2:", " Total: 58/228 (25.44%)", " Febrile Neutropenia 1/228 (0.44%)", " Neutropenia 1/228 (0.44%)", " Anaemia 0/228 (0.00%)", " Thrombocytopenia 1/228 (0.44%)", " Pancytopenia 1/228 (0.44%)", " Left Ventricular Dysfunction 13/228 (5.70%)", " Atrial Fibrillation 2/228 (0.88%)", " Angina Unstable 1/228 (0.44%)", " Arteriospasm Coronary 0/228 (0.00%)", " Cardiac Arrest 0/228 (0.00%)" ]

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

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

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

[ "Adverse Events 1:", " Total: 52/112 (46.43%)", " Febrile neutropenia * 16/112 (14.29%)", " Neutropenia * 7/112 (6.25%)", " Anaemia * 1/112 (0.89%)", " Cardiac failure * 1/112 (0.89%)", " Coronary artery disease * 1/112 (0.89%)", " Left ventricular dysfunction * 1/112 (0.89%)", " Pericardial effusion * 0/112 (0.00%)", " Hyperthyroidism * 1/112 (0.89%)", " Diarrhoea * 5/112 (4.46%)", " Vomiting * 3/112 (2.68%)", "Adverse Events 2:", " Total: 51/110 (46.36%)", " Febrile neutropenia * 26/110 (23.64%)", " Neutropenia * 7/110 (6.36%)", " Anaemia * 1/110 (0.91%)", " Cardiac failure * 0/110 (0.00%)", " Coronary artery disease * 0/110 (0.00%)", " Left ventricular dysfunction * 0/110 (0.00%)", " Pericardial effusion * 1/110 (0.91%)", " Hyperthyroidism * 0/110 (0.00%)", " Diarrhoea * 0/110 (0.00%)", " Vomiting * 1/110 (0.91%)" ]

[ "Adverse Events 1:", " Total: 5/19 (26.32%)", " Pain 3/19 (15.79%)", " White blood cells (WBC) 5/19 (26.32%)", " Hemoglobin (Hgb) 1/19 (5.26%)", " Absolute neutrophil count (ANC) 5/19 (26.32%)", " Platelets 3/19 (15.79%)", " Elevated Aspartate Aminotransferase (AST) 1/19 (5.26%)", " Elevated Alanine Aminotransferase (ALT) 1/19 (5.26%)", " Dyspnea 3/19 (15.79%)" ]

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

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

[ "Inclusion Criteria:", " Diagnosis of breast cancer", " Part 1 only: Surgery for breast cancer within the past eight weeks (mastectomy or lumpectomy with either sentinel or axillar dissection), including those women with a history of previous surgery for breast cancer, radiation therapy or chemotherapy", " Part 2 only: Completion of surgery and radiation therapy for breast cancer within the past six weeks.", " Home access to internet from stationary computer, lab top or tablet", " Ability to use internet", " Ability to read and understand Danish", "Exclusion Criteria:", " Surgery for breast cancer with immediate breast reconstruction", " Diagnosis of primary lymphedema", " Metastatic or inflammatory breast cancer", " Planned use of chemotherapy within the next 6 weeks", " Surgical complications: infection, drainage issues, seroma, hematoma", " Severe physical, cognitive, or psychiatric illness causing inability to follow the study protocol: i.e. severe depression, anxiety, dementia, poor physical health with likely possibility of hospitalization within the next twelve weeks.", " Planned hospitalization or surgery within the next twelve weeks", " Participation in another clinical trial with a rehabilitation or exercise intervention" ]

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

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

[ "Inclusion Criteria:", " Show evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the trial.", " Females 18 years of age and < 75 years of age.", " Diagnosed with Stage II-IV breast cancer.", " Subject is scheduled to undergo 4 cycles of TA chemotherapy (docetaxel, doxorubicin, 75, and 60 mg/m2, respectively).", " ECOG Performance status of 2.", " White Blood Cell count (WBC) 4.0 109/L, hemoglobin 11.5 g/dL and a platelet count 150 109/L.", " Demonstrate adequate renal, hepatic function (Liver function tests (ALT, AST, alkaline phosphatase and total bilirubin)) should be less than 2.5x upper limits of normal (ULN). Serum creatinine should be less than 1.7x ULN.", " All subjects must agree to use at least one of the following types of contraception: intrauterine device, implantable progesterone device, progesterone intramuscular injection, or oral contraceptive, which has been started at least one month prior to visit one and will continue for the duration of the trial. The contraceptive patch or condom use with spermicide is also acceptable forms of contraception as long as they will be used continually throughout the duration of the trial.", "Exclusion Criteria:", " Subject is <18 or 75 years of age.", " Disease progression has occurred while receiving a taxane regimen.", " Subject has undergone radiation therapy within 4 weeks of enrollment.", " Subject has undergone bone marrow or stem-cell transplantation.", " Subject has a history of prior malignancy other than breast cancer that is NOT in remission.", " Subjects that have used G-CSF or any other drug that may potentiate the release of neutrophils (i.e. lithium) within 6 weeks of the screening period are excluded.", " Subject has had chemotherapy within 365 days of screening.", " Subject has documented congestive heart failure, cardiomyopathy or myocardial infarction by clinical diagnosis, ECG test, or any other relevant test.", " History of alcohol or drug abuse that would interfere with the ability to be compliant with the study procedure.", " Unwillingness to participate in the study.", " Any underlying medical condition that, in the Investigator's opinion, would make the administration of study drug hazardous to the patient or that would obscure the interpretation of adverse events.", " Receiving other investigational drugs or biologics within 1 month or five half lives of enrollment.", " Any condition, which can cause splenomegaly.", " Chronic constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease.", " ALT, AST, alkaline phosphatase, total bilirubin 2.5 upper limit of normal.", " Subject with active infection, or known to be infected with chronic active Hepatitis B within the last 1 year (unless shown at the time of study entry to be Hepatitis B antigen negative), or having any history of Hepatitis C.", " Women who are pregnant or breast-feeding.", " Subject known to be seropositive for HIV, or who have had an AIDS defining illness or a known immunodeficiency disorder.", " Subject with a history of tuberculosis or exposure to tuberculosis. Patients that have received a prior chest X-ray for suspicion of tuberculosis are also excluded unless they have been confirmed to be PPD negative or they had latent tuberculosis that has been previously treated.", " Subjects with Sickle Cell disease", " Subjects with known hypersensitivity to E.coli derived proteins' pegfilgrastim' filgrastim, or any other component of the study drug." ]

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

[ "INTERVENTION 1: ", " Arm I (Lymphedema Education)", " Six weeks after surgery, patients receive a brief initial post-operative care session describing lymphedema risk and prevention through oral instruction and written materials. Patients complete physical assessments and questionnaires at 6 weeks and at 6, 12, and 18 months. Patients are also contacted by telephone at 9 and 15 months.", "INTERVENTION 2: ", " Arm II (Lymphedema Education, Physical Therapy)", " Patients receive lymphedema education and complete physical assessments and questionnaires as in Arm I. Patients also complete a personalized physical therapy intervention, receive a refrigerator magnet, and a 15-minute video that reinforces information and exercises." ]

[ "Inclusion Criteria:", " Age 18 years.", " Histologically or cytologically confirmed breast cancer diagnosis", " with metastatic disease. Patients without pathologic or cytologic", " confirmation of metastatic disease should have unequivocal", " evidence of metastasis.", " 3. Measurable disease, as per RECIST criteria (Therasse et al.", " 2000). Measurable disease cannot be previously irradiated", " unless progression was documented. Measurable disease is", " defined as: at least one lesion that can be accurately measured in", " at least one dimension [longest diameter to be recorded] as", " >20 mm with conventional techniques, or as >10 mm with spiral", " computed tomography (CT) scan. Disease must be measurable,", " i.e., bone-only disease or evaluable-only disease is not eligible.", " 4. Patients with brain metastasis may participate if they:", " have undergone appropriate treatment,", " are at least 1 month post-treatment,", " have no neurologic symptoms,", " are not on steroids,", " have a follow-up magnetic resonance imaging (MRI) scan that", " demonstrates no residual active lesions, and", " have no new untreated lesions.", " 5 The following prior therapies are allowed:", " No prior chemotherapy in the metastatic setting. However,", " patients must have received prior adjuvant or neo-adjuvant", " chemotherapy.", " Prior radiation therapy in either the metastatic or early-stage", " setting, as long as <25% of the bone marrow has been", " treated. Radiation therapy must be completed at least", " 14 days prior to study registration, and all radiation-related", " toxicities must be resolved to grade 1 before the patient is", " eligible for study inclusion.", " Any number of hormonal therapies in the neo-adjuvant,", " adjuvant, or metastatic setting is allowed. Patients must", " discontinue hormonal therapy at least 1 week prior to starting", " study treatment.", "Prior bevacizumab administered >4 weeks before initiation of", " study treatment is allowed.", " 6 HER2-negative status. Documentation of HER2 results must be", " available at the time of study enrollment. HER2-negative is", " defined as:", " Immunohistochemical (IHC) 0 or IHC 1+ OR", " Fluorescence in situ hybridization (FISH) negative (defined by", " FISH ratio <2.2) OR", " Silver in-situ hybridization (SISH) negative (defined by SISH", " ratio <2.2).", " Patients with an IHC 2+ will need to be validated as HER2-negative", " by FISH.", " 7 An Eastern Cooperative Oncology Group (ECOG) performance", " status of < or = to 2.", " 8. Normal bone marrow function as defined by:", " absolute neutrophil count (ANC) >1,500/μL;", " platelets >100,000/μL;", " hemoglobin >9 g/dL.", " 9 Normal hepatic function as defined by:", " total bilirubin within normal institutional limits;", " aspartate aminotransferase (AST) and alanine", " aminotransferase (ALT) <2.5 × the institutional upper limit of", " normal (ULN) for patients without liver metastasis; <5.0 × ULN", " for patients with liver metastasis.", " 10. Normal renal function as defined by creatinine <1.5 × ULN.", " 11. Left ventricular ejection fraction (LVEF) within institutional limits of", " normal.", " 12. International normalized ratio (INR) <1.5 or a prothrombin", " time/partial thromboplastin time (PT/PTT) within normal limits.", " Patients receiving anti-coagulation treatment with an agent such", " as warfarin or heparin may be allowed to participate. The INR", " should be measured prior to initiation of sorafenib, and for", " patients on warfarin, INR should be monitored at least weekly", " following initiation of protocol treatment, until the INR is stable and", " therapeutic.", " 13. Life expectancy of >6 months.", " 14. For women of childbearing potential, negative serum pregnancy", " test within 7 days prior to starting treatment.", " 15. For women of childbearing potential and men, agreement to use a", " method of contraception that is acceptable to their physician from", " time of first signing the informed consent and for the study", " duration. Men should use adequate birth control for at least three", " months after the last administration of sorafenib. If a woman", " becomes pregnant or suspects she is pregnant while participating", " in this study, she must agree to inform her treating physician", " immediately. As applicable, patients must agree to discontinue", " breast-feeding until at least 3 weeks after their last dose of study", " drug.", " 16. Recovery to < grade 1 toxicity due to prior therapy.", " 17. Ability to understand and willingness to sign a written informed", " consent document.", " Exclusion Criteria", " More than one (>1) prior chemotherapy regimen.", " Treatment with chemotherapy, biologic agents, or targeted agents", " within the previous 4 weeks.", " Previous treatment with sorafenib or ixabepilone.", " Women who are pregnant or breastfeeding.", " Neuropathy (motor or sensory) greater than grade 1.", " Uncontrolled intercurrent illness including (but not limited to)", " ongoing or active infection >grade 2.", " Known history of human immunodeficiency virus (HIV), Hepatitis", " B, or Hepatitis C infection.", " History of other non-breast cancer malignancy treated with", " curative intent within the 5 years preceding study enrollment with", " the exception of carcinoma in situ of the cervix, non-melanoma", " skin cancer, or follicular thyroid cancer.", " Concurrent hormonal therapy, chemotherapy other than", " ixabepilone, or radiation treatments while on study as well as", " treatment with other investigational agents while on study.", " Cardiac disease:", "Congestive heart failure (CHF) greater than New York Heart Association", " (NYHA) Class II (see Appendix B).", " Unstable angina (anginal symptoms at rest) or new onset angina", " (i.e., began within the last 3 months).", " Myocardial infarction within the past 6 months.", " Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.", " Uncontrolled hypertension (systolic blood pressure >150 mmHg", " or diastolic pressure >100 mmHg despite optimal medical", " management).", " Thrombolic or embolic events such as cerebrovascular accident,", " including transient ischemic attacks, within the past 6 months.", " Pulmonary hemorrhage or bleeding event grade 2 within", " 4 weeks of the first dose of study treatment, or any other", " hemorrhage or bleeding event grade 3 within 4 weeks of the", " first dose of study treatment.", " 14. Serious non-healing wound, ulcer, or bone fracture.", " 15. Evidence or history of bleeding diathesis or coagulopathy.", " 16. Major surgery, open biopsy or significant traumatic injury within", " 4 weeks of the first dose of study drugs or anticipation of the need", " for major surgical procedure.", " 17. Chronic use of CYP3A4 inducers and use of the following strong", " CYP3A4 inhibitors: ketoconazole, itraconazole, clarithromycin,", " atazanavir, nefazodone, saquinavir, telithromycin, ritonavir,", " amprenavir, indinavir, nelfinavir, delavirdine, and voriconazole.", " Use of these agents should be discontinued at least 72 hours", " prior to initiation of study treatment.", " 18. Use of St. John's Wort or rifampin (rifampicin).", " 19. Any condition that impairs patient's ability to swallow whole pills or", " gastrointestinal (GI) tract disease that involves an inability to take", " oral medication, malabsorption syndrome, a requirement for", " intravenous (IV) alimentation, prior surgical procedures affecting", " absorption, or uncontrolled inflammatory GI disease (e.g., Crohn's", " disease or ulcerative colitis).", " 20. Psychiatric illness/social situations that would limit compliance", " with study requirements.", " 21. Known or suspected allergy to sorafenib, Cremophor EL", " (polyoxyethylated castor oil) or a drug formulated in", " Cremophor EL such as paclitaxel or any other agent given in the", " course of this trial.", "Exclusion Criteria:" ]

[ "INTERVENTION 1: ", " Treatment (Biological Therapy, Chemo)", " Patients receive Abraxane IV over 30 minutes on days 1, 8, and 15 and apply topical imiquimod to cutaneous lesions QD on days 1-4, 8-11, 15-18, and 22-25. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.", " imiquimod: Given topically", " Abraxane: Given IV", " laboratory biomarker analysis: Correlative studies", " RNA analysis: Correlative studies", " immunoenzyme technique: Correlative studies" ]

[ "Adverse Events 1:", " Total: 5/32 (15.63%)", " Febrile neutropenia 1/32 (3.13%)", " Supraventricular tachycardia 1/32 (3.13%)", " Hypersensitivity 2/32 (6.25%)", " Catheter site infection 1/32 (3.13%)", " Confusional state 1/32 (3.13%)" ]

[ "Adverse Events 1:", " Total: 285/752 (37.90%)", " Anaemia 2/752 (0.27%)", " Disseminated intravascular coagulation 2/752 (0.27%)", " Febrile neutropenia 51/752 (6.78%)", " Neutropenia 47/752 (6.25%)", " Thrombocytopenia 2/752 (0.27%)", " Atrial fibrillation 1/752 (0.13%)", " Atrial flutter 0/752 (0.00%)", " Cardiac failure congestive 1/752 (0.13%)", " Left ventricular dysfunction 0/752 (0.00%)", "Adverse Events 2:", " Total: 117/382 (30.63%)", " Anaemia 3/382 (0.79%)", " Disseminated intravascular coagulation 0/382 (0.00%)", " Febrile neutropenia 11/382 (2.88%)", " Neutropenia 20/382 (5.24%)", " Thrombocytopenia 0/382 (0.00%)", " Atrial fibrillation 1/382 (0.26%)", " Atrial flutter 1/382 (0.26%)", " Cardiac failure congestive 0/382 (0.00%)", " Left ventricular dysfunction 1/382 (0.26%)" ]

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

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

[ "Adverse Events 1:", " Total: 24/32 (75.00%)", " Disseminated intravascular coagulation * 1/32 (3.13%)", " Febrile neutropenia * 1/32 (3.13%)", " Adrenal insufficiency * 1/32 (3.13%)", " Endocrine disorder * 1/32 (3.13%)", " Chills * 1/32 (3.13%)", " Fatigue * 1/32 (3.13%)", " Fever * 1/32 (3.13%)", " Multi-organ failure * 1/32 (3.13%)", " Hepatic failure * 1/32 (3.13%)", " Infection * 1/32 (3.13%)", " Sepsis * 1/32 (3.13%)" ]

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

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

[ "INTERVENTION 1: ", " Triptorelin Plus Tamoxifen", " Determination of estrogen levels in blood samples from patients being treated with triptorelin plus tamoxifen for 5 years.", "INTERVENTION 2: ", " Triptorelin Plus Exemestane", " Determination of estrogen levels in blood samples from patients being treated with triptorelin plus exemestane for 5 years." ]

[ "INTERVENTION 1: ", " LBH589 With Capecitabine", " MTD, LBH589 with Capecitabine", " LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.", " Capecitabine: Capecitabine will be administered orally twice daily for 14 days out of every 21 days.", "INTERVENTION 2: ", " LBH589 and Lapatinib", " LBH589 and Lapatinib", " LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.", " Lapatinib: Lapatinib, 1000 mg PO daily will be added to this combination." ]

[ "INTERVENTION 1: ", " Participants With Stage 0-III Breast Cancer", " Women with Stage 0-III breast cancer, treated with breast conserving surgery or mastectomy and clear margins, will receive 15 doses of radiation over three weeks.", " Hypofractionated Simultaneous Integrated Boost Radiotherapy: Participants will receive radiotherapy treatments to the whole breast or chest wall to a dose of 2.66 Gy per day x 15 fractions simultaneously with a boost treatment. The boost treatment will be given on the same days as the whole breast treatment. The lumpectomy cavity + scar (in lumpectomy patients) or chest wall scar (mastectomy patients) will receive 0.54 Gy per day x 15 fractions." ]

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

[ "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: 10/30 (33.33%)", " Hemoglobin decreased 2/30 (6.67%)", " Abdominal pain 1/30 (3.33%)", " Colitis 1/30 (3.33%)", " Diarrhea 7/30 (23.33%)", " Nausea 2/30 (6.67%)", " Rectal hemorrhage 1/30 (3.33%)", " Fatigue 1/30 (3.33%)", " Skin infection 1/30 (3.33%)", " Neutrophil count decreased 1/30 (3.33%)", " Platelet count decreased 3/30 (10.00%)", " Dehydration 1/30 (3.33%)" ]

[ "Inclusion Criteria:", " Biopsy-proven breast cancer, metastatic (persistent or recurrent).", " Failed 1 line of therapy (endocrine or chemotherapy) for metastatic disease.", " Min. 3 distinct metastatic sites, at least one measurable lesion which is at least 1 cm or larger in largest diameter.", " Must be 4 weeks since all of the following treatments (recovered from toxicity of prior treatment to Grade 1, excluding alopecia):", " major surgery;", " radiotherapy;", " chemotherapy ( 6 weeks since therapy if a nitrosourea, mitomycin, or monoclonal antibodies such as bevacizumab);", " immunotherapy;", " biotherapy/targeted therapies.", " >18 years of age.", " Life expectancy >6 months.", " Eastern Cooperative Oncology Group (ECOG) status 0 or 1.", " Adequate organ function including:", " Hemoglobin 10.0g/dL, absolute neutrophil count (ANC) 1,500/mm3, and platelets 100,000/mm3.", " Hepatic: Serum total bilirubin 1.5x upper limit of normal (ULN) (Patients with Gilbert's Disease may be included if total bilirubin is 3.0mg/dL), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) 2.5xULN. If patient has known liver metastases, ALT and/or AST 5xULN are allowed.", " Renal: creatinine clearance 60mL/min.", " Prothrombin (PT) and partial thromboplastin times (PTT) <ULN.", " Negative for hepatitis viruses B and C unless consistent with prior vaccination or prior infection with full recovery.", " Patients of childbearing potential must agree to use effective contraception while on study, and for 3 months after last treatment.", " Understand and sign written informed consent document. No consent by durable power of attorney.", "Exclusion Criteria:", " Second malignancy - unless following curative intent therapy, has been disease free for 2 years with probability of recurrence <5%. Curatively treated early-stage squamous cell carcinoma of the skin, basal cell carcinoma of the skin, or cervical intraepithelial neoplasia (CIN) are allowed.", " Concurrent cancer therapy.", " Uncontrolled central nervous system (CNS) metastases, meningeal carcinomatosis, malignant seizures, or disease that causes or threatens neurologic compromise (e.g. unstable vertebral metastases).", " History of ascites or pleural effusions, unless successfully treated.", " Organ transplant, including allogeneic bone marrow transplant.", " Immunosuppressive therapy including:", " Systemic corticosteroid therapy, including replacement therapy for hypoadrenalism. Inhaled or topical corticosteroids are allowed (if therapy is <5 days and is limited to systemic steroids as antiemetics);", " Cyclosporine A, tacrolimus, or sirolimus.", " Investigational agents within 4 weeks prior to study enrollment ( 6 weeks if treatment was long-acting agent such as monoclonal antibody).", " Significant or uncontrolled medical illness, e.g. congestive heart failure (CHF), myocardial infarction, symptomatic coronary artery disease, significant ventricular arrhythmias within the last 6 months, or significant pulmonary dysfunction. Patients with remote history of asthma or active mild asthma may participate.", " Active infection, including unexplained fever (>38.5°C).", " Systemic autoimmune disease (e.g. systemic lupus erythematosus, active rheumatoid arthritis).", " Known allergy to any component of GC1008.", " Active thrombophlebitis, thromboembolism, hypercoagulability states, bleeding, or anti-coagulation therapy (including anti platelet agents i.e. aspirin, clopidogrel, ticlopidine, dipyridamole, other agents inducing long-acting platelet dysfunction). Patients with history of deep venous thrombosis are allowed if treated, completely resolved, and no treatment for >4months.", " Calcium >11.0mg/dL (2.75mmol/L) unresponsive or uncontrolled in response to standard therapy (e.g. bisphosphonates).", " Patients who, in the opinion of the Investigator, have significant medical or psychosocial problems, including, but not limited to:", " Other serious non-malignancy-associated conditions that may be expected to limit life expectancy or significantly increase the risk of SAEs;", " Conditions, psychiatric, substance abuse, or other, that, in the opinion of the Investigator, would preclude informed consent, consistent follow-up, or compliance with any aspect of the study;", " Pregnant or nursing women." ]

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

[ "INTERVENTION 1: ", " 6-Mercaptopurine and Methotrexate (6MP/MTX)", " 6-Mercaptopurine: 6MP 75mg/m2 body surface area, administered orally (PO) once a day (od) in the morning 1 hour after eating, on a continuous schedule. One cycle is 28 days. Treatment is given continuously until disease progression.", " Methotrexate: Methotrexate 20mg/m2 will be taken orally, once a week, in the morning. One cycle is 28 days. Treatment is given continuously until disease progression.", " Update: These original doses were reduced following an Urgent Safety Measure in August 2012 due to a large proportion of patients requiring a dose reduction or treatment delay due to incidences of myelo-suppression.", " The reduced doses were 55mg/m2 of 6MP orally once a day, and 15mg/m2 of Methotrexate orally once a week." ]

[ "INTERVENTION 1: ", " Samarium 153-EDTMP + Stem Cell Transplant", " Samarium 153-EDTMP tracer dose = 30 millicurie (mCi) intravenous Day 1; or with study drug to bones, receive higher therapy dose of 153 Sm-EDTMP 7-14 days after tracer dose. Stem Cell Transplant Day 0, about 14-21 days after Samarium 153-EDTMP." ]

[ "INTERVENTION 1: ", " Exemestane", " Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.", "INTERVENTION 2: ", " Tamoxifen", " Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period." ]

[ "Inclusion Criteria:", " Show evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the trial.", " Females 18 years of age and < 75 years of age.", " Diagnosed with Stage II-IV breast cancer.", " Subject is scheduled to undergo 4 cycles of TA chemotherapy (docetaxel, doxorubicin, 75, and 60 mg/m2, respectively).", " ECOG Performance status of 2.", " White Blood Cell count (WBC) 4.0 109/L, hemoglobin 11.5 g/dL and a platelet count 150 109/L.", " Demonstrate adequate renal, hepatic function (Liver function tests (ALT, AST, alkaline phosphatase and total bilirubin)) should be less than 2.5x upper limits of normal (ULN). Serum creatinine should be less than 1.7x ULN.", " All subjects must agree to use at least one of the following types of contraception: intrauterine device, implantable progesterone device, progesterone intramuscular injection, or oral contraceptive, which has been started at least one month prior to visit one and will continue for the duration of the trial. The contraceptive patch or condom use with spermicide is also acceptable forms of contraception as long as they will be used continually throughout the duration of the trial.", "Exclusion Criteria:", " Subject is <18 or 75 years of age.", " Disease progression has occurred while receiving a taxane regimen.", " Subject has undergone radiation therapy within 4 weeks of enrollment.", " Subject has undergone bone marrow or stem-cell transplantation.", " Subject has a history of prior malignancy other than breast cancer that is NOT in remission.", " Subjects that have used G-CSF or any other drug that may potentiate the release of neutrophils (i.e. lithium) within 6 weeks of the screening period are excluded.", " Subject has had chemotherapy within 365 days of screening.", " Subject has documented congestive heart failure, cardiomyopathy or myocardial infarction by clinical diagnosis, ECG test, or any other relevant test.", " History of alcohol or drug abuse that would interfere with the ability to be compliant with the study procedure.", " Unwillingness to participate in the study.", " Any underlying medical condition that, in the Investigator's opinion, would make the administration of study drug hazardous to the patient or that would obscure the interpretation of adverse events.", " Receiving other investigational drugs or biologics within 1 month or five half lives of enrollment.", " Any condition, which can cause splenomegaly.", " Chronic constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease.", " ALT, AST, alkaline phosphatase, total bilirubin 2.5 upper limit of normal.", " Subject with active infection, or known to be infected with chronic active Hepatitis B within the last 1 year (unless shown at the time of study entry to be Hepatitis B antigen negative), or having any history of Hepatitis C.", " Women who are pregnant or breast-feeding.", " Subject known to be seropositive for HIV, or who have had an AIDS defining illness or a known immunodeficiency disorder.", " Subject with a history of tuberculosis or exposure to tuberculosis. Patients that have received a prior chest X-ray for suspicion of tuberculosis are also excluded unless they have been confirmed to be PPD negative or they had latent tuberculosis that has been previously treated.", " Subjects with Sickle Cell disease", " Subjects with known hypersensitivity to E.coli derived proteins' pegfilgrastim' filgrastim, or any other component of the study drug." ]

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

[ "Inclusion Criteria:", " English or Spanish speaking women age 18", " Heart Rate > 60 bpm", " Systolic Blood Pressure > 100 mm/Hg", " Deemed eligible to receive neoadjuvant chemotherapy with 12 cycles of weekly taxane therapy (paclitaxel 80mg/m2 or Abraxane 100 mg/m2 if there is a shortage of paclitaxel) followed by 4 cycles of Adriamycin (60mg/m2) and cyclophosphamide (600 mg/m2) given every 2 weeks with growth-factor support.", " Echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA) with ejection fraction > 50%.", " Patients with hormone receptor +/- and human epidermal growth factor receptor 2 protein (HER2) +/- breast cancer are eligible", " If a patient has HER2-positive breast cancer, Herceptin and Perjeta will be given along with taxane therapy", " Any stage invasive breast cancer provided the primary breast tumor size is 1 cm", " Agree to participate in research blood collection at 4 different time periods (20 ml = 4 teaspoons)", " Agree to the evaluation of already collected core biopsy, as well as surgical resection tissue, for predictive biomarkers. The biopsy prior to Taxol #1 is optional.", "Exclusion Criteria:", " Patients failing to meet the inclusion criteria", " Corrected QT interval (QTc) prolongation as defined by > 470 milliseconds on electrocardiogram (ECG)", " First-degree Atrioventricular (AV) block on ECG in which P-R interval lengthened > 200 milliseconds; Second Degree; or Third Degree", " On beta-blocker treatment. If discontinued, patients must have been off beta-blockers for at least 3 months.", " History of asthma, given concern for β-blockade in this population" ]

[ "INTERVENTION 1: ", " Arm I (Minocycline Hydrochloride)", " Patients receive minocycline hydrochloride PO BID on days 1-7. Treatment repeats every 7 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.", "INTERVENTION 2: ", " Arm II (Placebo)", " Patients receive a placebo PO BID on days 1-7. Treatment repeats every 7 days for up to 12 courses in the absence of disease progression or unacceptable toxicity." ]

[ "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" ]

[ "INTERVENTION 1: ", " Arm I", " Patients receive dose-intensive chemotherapy comprising doxorubicin hydrochloride IV over 10-15 minutes on day 1, oral cyclophosphamide once daily on days 1-7, and filgrastim subcutaneously on days 2-7. Courses repeat every 7 days for up to 12 weeks in the absence of disease progression or unacceptable toxicity. Beginning 1 week later, patients then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes once a week for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients with HER-2/neu positive disease also receive trastuzumab IV over 30-90 minutes once a week for 1 year in the absence of disease progression or unacceptable toxicity.", " doxorubicin hydrochloride: Given IV", " cyclophosphamide: Given orally", " filgrastim: Given SC", " paclitaxel albumin-stabilized nanoparticle formulation: Given IV", " trastuzumab: Given IV", " laboratory biomarker analysis: Correlative studies", " quality-of-life assessment: Ancillary studies" ]

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

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

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

[ "Adverse Events 1:", " Total: 6/62 (9.68%)", " Musculoskeletal * 1/62 (1.61%)", " Mood Alteration: Depression * 1/62 (1.61%)", " renal - Other * 1/62 (1.61%)", " Obstruction, GU: Uterus * 1/62 (1.61%)", " Sexual * 0/62 (0.00%)", " Pulmonary/Upper Respiratory: Dyspnea * 1/62 (1.61%)", " Ulceration * 1/62 (1.61%)", "Adverse Events 2:", " Total: 1/64 (1.56%)", " Musculoskeletal * 0/64 (0.00%)", " Mood Alteration: Depression * 0/64 (0.00%)", " renal - Other * 0/64 (0.00%)", " Obstruction, GU: Uterus * 0/64 (0.00%)", " Sexual * 1/64 (1.56%)", " Pulmonary/Upper Respiratory: Dyspnea * 0/64 (0.00%)", " Ulceration * 0/64 (0.00%)" ]

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

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

[ "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)" ]

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

[ "Adverse Events 1:", " Total: 6/110 (5.45%)", " Sudden death unexplained 1/110 (0.91%)", " General body pain 1/110 (0.91%)", " Lymphangitis 1/110 (0.91%)", " Femur fracture 1/110 (0.91%)", " Parathyroid adenoma 1/110 (0.91%)", " Depression worsened 1/110 (0.91%)", " Calculus urinary bladder 1/110 (0.91%)", " Pneumopathy 1/110 (0.91%)" ]

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

[ "Outcome Measurement: ", " Phase 1 - Maximum Tolerated Dose (MTD) in Milligrams (mg)", " MTD of 1-methyl-d-tryptophan (indoximod) given by mouth (PO), twice a day (BID), with up to 6 fixed doses Ad.p53 DC vaccinations every 2 weeks (q2wks). This phase 1 study used a 3+3 design with 7 indoximod dose levels (DL) (100 mg, 200 mg, 400 mg, 800 mg daily (QD) then 800 mg, 1,200 mg, and 1,600 mg PO BID +up to 6 fixed dose Ad.p53 DC vaccinations q2wks. Toxicity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0. The MTD is the highest dose level below the maximally administered dose (MAD) that is safely tolerated among 6 treated patients, that is, 0 or 1 out of 6 patients experiences a dose limiting toxicity (DLT).", " Time frame: Up to 4 weeks", "Results 1: ", " Arm/Group Title: Treatment (Vaccine Therapy, 1-methyl-d-tryptophan)", " Arm/Group Description: Participants receive adenovirus-p53 transduced dendritic cell (Ad.p53-DC) vaccine ID in weeks 1, 3, 5, and 10, and then every 3 weeks for 6 total doses. Participants also receive 1-methyl-d-tryptophan (indoximod) orally (PO) daily (QD) on days 1-21. Treatment with 1-methyl-d-tryptophan repeats every 28 days (patients with stable disease) for up to 12 courses in the absence of disease progression or unacceptable toxicity.", " adenovirus-p53 transduced dendritic cell (DC) vaccine: Given intradermally (ID)", " 1-methyl-d-tryptophan: Given orally (PO)", " Laboratory biomarker analysis: Correlative studies", " Overall Number of Participants Analyzed: 30", " Measure Type: Number", " Unit of Measure: indoximod dose in mg 1600" ]

[ "INTERVENTION 1: ", " Collective Placebo", " Patients receive 1 capsule of placebo 2 times per day for 6 weeks and; patients receive 1 capsule of placebo 4 times per day for 6 weeks.", "INTERVENTION 2: ", " Pilocarpine 2 Times Per Day", " Patients receive 5mg of Pilocarpine 2 times per day for 6 weeks." ]

[ "INTERVENTION 1: ", " Itraconazole", " oral itraconazole 200mg a day until disease progression or unacceptable toxicities." ]

[ "Adverse Events 1:", " Total: 13/50 (26.00%)", " Febrile neutropenia 3/50 (6.00%)", " Neutropenia 1/50 (2.00%)", " Pancreatitis 1/50 (2.00%)", " Cholangitis 1/50 (2.00%)", " Cholelithiasis 1/50 (2.00%)", " Anaphylactic reaction [1]1/50 (2.00%)", " Pneumonia 1/50 (2.00%)", " Pneumonitis chemical 1/50 (2.00%)", " Spinal compression fracture 1/50 (2.00%)", " Dehydration 1/50 (2.00%)", " Electrolyte imbalance 1/50 (2.00%)" ]

[ "Adverse Events 1:", " Total: 1/3 (33.33%)", " FEBRILE NEUTROPENIA 0/3 (0.00%)", " LYMPH NODE PAIN 0/3 (0.00%)", " NEUTROPHIL COUNT DECREASED 0/3 (0.00%)", " THROMBOCYTOPENIA 0/3 (0.00%)", " CHEST PAIN 0/3 (0.00%)", " DEHYDRATION 0/3 (0.00%)", " PLEURAL EFFUSION 1/3 (33.33%)", " PNEUMONITIS 0/3 (0.00%)", " PULMONARY INFILTERATES 0/3 (0.00%)", " ALOPECIA 0/3 (0.00%)" ]

[ "Inclusion Criteria:", " Histologically confirmed diagnosis of primary early breast cancer, tumor size greater than or equal to 2 centimeters (cm), of Stages T2-T4/N0-2.", " Performance status 0-2 Eastern Cooperative Oncology Group (ECOG).", " Adequate organ function (bone marrow, hepatic, renal, cardiac).", "Exclusion Criteria:", " Prior anthracyclines as part of prior anticancer therapy.", " Concurrent antitumor therapy.", " Second primary malignancy.", " Serious concomitant systemic disorder.", " Pre-existing sensorial or motor neuropathy", "Grade 1." ]

[ "Inclusion Criteria:", " Histologically and/or cytologically confirmed breast cancer", " Received adjuvant/neo-adjuvant chemotherapy for breast cancer with anthracycline regimen", " To have at least one measurable region", " Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1", " To have adequate organ function (bone marrow, liver and renal function)", "Exclusion Criteria:", " To have interstitial pneumonia or pulmonary fibrosis", " To have inflammatory breast cancer", " Within 28 days after the latest chemotherapy or radiotherapy, 14 days after the latest hormonal/immunotherapy or 7 days after surgery", " To have brain metastases with symptoms", " To have severe complication (cardiac infarction, infection, drug hypersensitivity or diabetes)" ]

[ "Inclusion Criteria:", " Age: no limit", " Karnofsky performance status (KPS) 70", " No more than 5 metastatic sites involving one or more different organs (liver, lung or bone).", " The size of the lesion must be such that it can be safely treated to sterilizing radiation doses according to the rules in the protocol.", " Previously treated lesions are not eligible unless the prescribed dose can be safely delivered.", " Concurrent therapy is allowed and recommended. The chemotherapy protocol type and schedule are at the discretion of the medical oncologist.", " Informed consent must be obtained.", " Pregnancy test must be negative for women of child bearing potential", "Exclusion Criteria:", " Inability of patient to be followed longitudinally as specified by protocol.", " Technical inability to achieve required dose based on safe dose constraints required for radiosurgery.", " Women who are pregnant or nursing.", " Failure to meet requirements in Inclusion Criteria", " Contraindications to radiation." ]

[ "Adverse Events 1:", " Total: 14/58 (24.14%)", " Constipation 1/58 (1.72%)", " Vomiting 1/58 (1.72%)", " Upper gastrointestinal haemorrhage 1/58 (1.72%)", " Asthenia 1/58 (1.72%)", " Chest pain 1/58 (1.72%)", " Pain 1/58 (1.72%)", " Sepsis 2/58 (3.45%)", " Fall 1/58 (1.72%)", " Spinal compression fracture 1/58 (1.72%)", " Neutrophil count decreased 1/58 (1.72%)", " Dehydration 1/58 (1.72%)", " Hypovolaemia 1/58 (1.72%)" ]

[ "Outcome Measurement: ", " The Percentage of Patients Achieving Pathological Complete Response Defined as the Absence of Invasion Tumor Cells in the Breast and in Axillary Lymph Nodes, Regardless of Ductal Carcinoma in Situ (DCIS)", " Subject who went through Neoadjuvant period completely (24 weeks), will receive surgery within 3-6 weeks after last treatment of neoadjuvant period.", " The primary endpoint, Pathological complete response, will be assessed using resected bio-specimens collected in breast and axilla during a surgery.", " Time frame: After Neo-adjuvant therapy and Surgery (up to 30 weeks)", "Results 1: ", " Arm/Group Title: CT-P6", " Arm/Group Description: Patient received CT-P6 at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m^2, epirubicin 75mg/m^2, and cyclophosphamide 500mg/m^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study.", " Overall Number of Participants Analyzed: 248", " Measure Type: Number", " Unit of Measure: percentage of responders 46.77 (40.43 to 53.19)", "Results 2: ", " Arm/Group Title: Herceptin", " Arm/Group Description: Patient received Herceptin at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m^2, epirubicin 75mg/m^2, and cyclophosphamide 500mg/m^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study.", " Overall Number of Participants Analyzed: 256", " Measure Type: Number", " Unit of Measure: percentage of responders 50.39 (44.10 to 56.68)" ]

[ "Eligibility Criteria:", " Patients must be women with a histologically confirmed diagnosis of locally advanced or inflammatory breast carcinoma. 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):", " a .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.", " b. 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.", " Patients with the clinical diagnosis of congestive heart failure or angina pectoris are NOT eligible. Patients with hypertension or age > 60 years must have a Multiple Gated Acquisition (MUGA) or echocardiogram scan performed within 90 days prior to registration (indicate not applicable (NA) if no MUGA required) and Left Ventricular Ejection Fraction (LVEF) % 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 glutamic oxaloacetic transaminase (SGOT) or Serum glutamic pyruvic 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", " 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.", " 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." ]

[ "Inclusion Criteria:", " Patients with a diagnosis of invasive adenocarcinoma of the breast confirmed by histology or cytology at MSKCC.", " Clinical evidence of metastatic breast cancer.", " HER2 overexpression and/or amplification as determined by immunohistochemistry (3+) or FISH ( 2.0).", " Progressive disease following treatment with trastuzumab for metastatic breast cancer or as adjuvant therapy (either single-agent or combination therapy)", " Prior therapy inclusion:", " No more than two prior chemotherapy regimens allowed for advanced stage disease", " No prior fluoropyrimidine in the metastatic setting. Adjuvant fluoropyrimidine is permitted if >6 months prior to treatment on study.", " No restriction for prior hormonal therapy. No concurrent use of endocrine therapy is permitted.", " No more than 450mg/m2 cumulative dose of prior doxorubicin", " At least 3 weeks since prior chemotherapy or radiation therapy", " Age or = to 18. Because no dosing or adverse event data are currently available on the use of lapatinib in patients <18 years of age, children are excluded from this study.", " 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.", " Negative HCG pregnancy test for premenopausal women of reproductive capacity and for women less than 12 months after the menopause.", " Asymptomatic, central nervous system metastases are permitted if patients remain clinically stable after discontinuation of corticosteroids and anticonvulsants.", " ECOG performance status < or = to 2", " Life expectancy of greater than 12 weeks", " Patients must have normal organ and marrow function as defined below:", " leukocytes or = to 3,000/μL", " absolute neutrophil count or = 1,500/μL", " platelets or = 100,000/μL", " total bilirubin within normal institutional limits AST (SGOT)/ALT(SGPT) or = 2.5x institutional upper limit of normal serum creatinine within normal institutional limits", " Cardiac ejection fraction at or above the lower limit of normal of 50% as measured by multigated radionuclide angiography (MUGA) scan. If LVEF is greater than 70%, and ECHO should be performed as well. Baseline and on treatment scans should be performed using the same modality and preferably at the same institution.", " Ability to understand and the willingness to sign a written informed. consent document.", " Able to swallow and retain oral medication.", "Exclusion Criteria:", " Patients may not be receiving any concurrent anticancer therapy or investigational agents with the intention of treating breast cancer.", " History of allergic reactions attributed to compounds of similar chemical or biologic composition to lapatinib or capecitabine.", " Known DPD deficiency.", " Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within 6 months of study entry, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.", " Pregnant women are excluded from this study because lapatinib is member of the 4- anilinoquinazoline class of kinase inhibitors with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with lapatinib, breastfeeding should be discontinued if the mother is treated with lapatinib.", " HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with lapatinib. Appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated.", " Patients with GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption,uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis).", " Concomitant requirement for medication classified as CYP3A4 inducers or inhibitors:", " Medications that inhibit or induce CYP3A4 are prohibited. Eligibility of patients receiving medications or substances known to affect, or with the potential to affect the activity or pharmacokinetics of lapatinib will be determined following review of their use by the Principal Investigator.", " Renal function as measured by creatinine clearance < 30ml/min", " Patients are permitted to participate in other non-therapeutic clinical trials while receiving treatment on this study (ie, experimental imaging, minor procedures necessary for tissue acquisition on study)" ]

[ "INTERVENTION 1: ", " Ginkgo Biloba", " Ginkgo Biloba: Patients will take 120 mg per day (60 mg BID)", "INTERVENTION 2: ", " Placebo", " Placebo: Patients will take 1 tablet BID" ]

[ "INTERVENTION 1: ", " Alpelisib + Letrozole", " Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.", "INTERVENTION 2: ", " Placebo + Letrozole", " Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily." ]

[ "Outcome Measurement: ", " Percentage of Participants With Progressive Disease at Week 12 in Cohort 1", " The percentage of participants with progressive disease (PD) 12 weeks after randomization was measured. Per Response Evaluation Criteria In Solid Tumors (RECIST), a response of PD is defined as a >=20% increase in target lesions. Participants were also classified as having PD if their response at Week 12 was unknown or missing. Response was determined by an independent radiologist and by an investigator.", " Time frame: Week 12", "Results 1: ", " Arm/Group Title: Cohort 1: Lapatinib 1500 mg", " Arm/Group Description: Lapatinib 1500 milligrams (mg) administered orally once a day", " Overall Number of Participants Analyzed: 72", " Measure Type: Number", " Unit of Measure: percentage of participants Independently Evaluated: 38.9", " Investigator Evaluated: 43.1", "Results 2: ", " Arm/Group Title: Cohort 1: Lapatinib 1000 mg/Pazopanib 400 mg", " Arm/Group Description: Lapatinib 1000 mg and Pazopanib 400 mg administered orally once a day", " Overall Number of Participants Analyzed: 69", " Measure Type: Number", " Unit of Measure: percentage of participants Independently Evaluated: 36.2", " Investigator Evaluated: 37.7" ]

[ "INTERVENTION 1: ", " Exemestane", " Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.", "INTERVENTION 2: ", " Tamoxifen", " Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period." ]

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

[ "INTERVENTION 1: ", " Accelerated Intensity Modulated Radiation Therapy (AIMRT)", " All patients shall receive a total of 40.5 Gy to the entire breast in 2.7 Gy/fraction x 15 fractions, Monday to Friday for 3 weeks delivered prone in uniform daily doses through IMRT tangent fields. A concurrent boost to the original tumor bed of 0.50 Gy will be delivered.", " Accelerated intensity modulated radiation therapy (AIMRT)" ]

[ "INTERVENTION 1: ", " Vorinostat", " Women in the vorinostat group were scheduled to receive 6 doses of oral vorinostat at 300 mg twice daily (bid), with the last dose administered by study personnel approximately 2 hours before the scheduled breast surgery (or biopsy)." ]

[ "INTERVENTION 1: ", " Treatment (Chemotherapy With or Without Maintenance Therapy)", " SYSTEMIC CHEMOTHERAPY: Patients receive cyclophosphamide IV over 1 hour and paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.", " MAINTENANCE THERAPY (Her-2 neu positive patients): Patients receive trastuzumab IV over 30 minutes on day 1. Treatment repeats every 14 days for 5 courses and then every 21 days for 14 courses in the absence of disease progression or unacceptable toxicity.", " cyclophosphamide, paclitaxel, trastuzumab: Given IV" ]

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

[ "DISEASE CHARACTERISTICS:", " Histologically confirmed stage IV or recurrent adenocarcinoma of the breast", " Measurable disease", " Disease recurrence must not be within 1 year of receiving prior adjuvant docetaxel", " Stable brain metastases allowed", " Hormone receptor status:", " Not specified", " PATIENT CHARACTERISTICS:", " Age", " 18 and over", " Sex", " Male or female", " Menopausal status", " Not specified", " Performance status", " ECOG (Eastern Cooperative Oncology Group) 0-2 OR", " Karnofsky 60-100%", " Life expectancy", " More than 6 months", " Hematopoietic", " WBC(White Blood Count) at least 3,000/mm^3", " Platelet count at least 100,000/mm^3", " Absolute neutrophil count at least 1,500/mm^3", " Hemoglobin at least 8 g/dL", " Hepatic", " Bilirubin normal", " AST(aspartate aminotransferase)/ALT(alanine aminotransferase) no greater than 2.5 times upper limit of normal", " Renal", " Creatinine normal OR", " Creatinine clearance at least 60 mL/min", " No clinically significant proteinuria", " No significant impairment of renal function", " Cardiovascular", " No New York Heart Association class III or IV heart disease", " No symptomatic congestive heart failure", " No unstable angina pectoris", " No cardiac arrhythmia", " No inadequately controlled hypertension", " Other", " Not pregnant or nursing", " Negative pregnancy test", " Fertile patients must use effective barrier contraception", " No prior severe hypersensitivity reaction to docetaxel or drugs formulated with polysorbate 80", " No other malignancy within the past 10 years except inactive nonmelanoma skin cancer, carcinoma in situ of the cervix, carcinoma in situ of the breast, or bilateral breast cancer", " No ongoing or active infection", " No peripheral neuropathy greater than grade 1", " No other concurrent uncontrolled medical condition that would preclude study participation", " No psychiatric illness or social situation that would preclude study compliance", " PRIOR CONCURRENT THERAPY:", " Biologic therapy", " Prior trastuzumab (Herceptin) allowed", " Chemotherapy", " See Disease Characteristics", " No prior chemotherapy for recurrent or metastatic disease", " Prior adjuvant chemotherapy allowed", " Endocrine therapy", " Prior hormonal therapy allowed", " Radiotherapy", " Not specified", " Surgery", " Not specified", " Other", " No other concurrent investigational agents" ]

[ "INTERVENTION 1: ", " Lapatinib Monotherapy", " Lapatinib: 1500 mg (six 250 mg tablets) orally once daily" ]

[ "Adverse Events 1:", " Total: 2/17 (11.76%)", " Nausea * 1/17 (5.88%)", " Pain - Abdomen NOS * 1/17 (5.88%)", " Constipation * 1/17 (5.88%)" ]

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

[ "Adverse Events 1:", " Total: 29/110 (26.36%)", " Atrial fibrillation 1/110 (0.91%)", " Nausea 2/110 (1.82%)", " Abdominal pain 1/110 (0.91%)", " Abdominal pain upper 1/110 (0.91%)", " Constipation 1/110 (0.91%)", " Pancreatitis 1/110 (0.91%)", " Vomiting 1/110 (0.91%)", " Pyrexia 3/110 (2.73%)", " Axillary pain 2/110 (1.82%)", " Chest pain 1/110 (0.91%)", " Influenza like illness 1/110 (0.91%)", "Adverse Events 2:", " " ]

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

[ "INTERVENTION 1: ", " 6-Mercaptopurine and Methotrexate (6MP/MTX)", " 6-Mercaptopurine: 6MP 75mg/m2 body surface area, administered orally (PO) once a day (od) in the morning 1 hour after eating, on a continuous schedule. One cycle is 28 days. Treatment is given continuously until disease progression.", " Methotrexate: Methotrexate 20mg/m2 will be taken orally, once a week, in the morning. One cycle is 28 days. Treatment is given continuously until disease progression.", " Update: These original doses were reduced following an Urgent Safety Measure in August 2012 due to a large proportion of patients requiring a dose reduction or treatment delay due to incidences of myelo-suppression.", " The reduced doses were 55mg/m2 of 6MP orally once a day, and 15mg/m2 of Methotrexate orally once a week." ]

[ "INTERVENTION 1: ", " Zr89-trastuzumab PET/CT", " Zr89-trastuzumab (trastuzumab labelled with zirconium 89) for PET/CT single arm" ]

[ "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: ", " Definity Infusion", " Infusion of Definity (Perflutren Lipid Microspheres)", " Definity infusion: 3 ml of Perflutren Lipid Microspheres (Definity) mixed in 50 ml of saline is infused at a rate of approximately 4ml/min" ]

[ "INTERVENTION 1: ", " Meso BioMatrix Acellular Peritoneum Matrix", " All subjects had the Meso BioMatrix Acellular Peritoneum Matrix implanted along with a tissue expander during the first stage of breast reconstruction. After tissue expansion, the tissue expander was replaced with a breast implant during the second stage of reconstruction." ]

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

[ "INTERVENTION 1: ", " Intervention", " Text message management prompts: YBCS will receive text message prompts on how to manage hot flashes and vaginal dryness", " Text message management prompts", "INTERVENTION 2: ", " Control", " Control YBCS will not receive text message prompts on managing hot flashes and vaginal dryness" ]

[ "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" ]

[ "Adverse Events 1:", " Total: 4/109 (3.67%)", " Anaemia * 0/109 (0.00%)", " Haemolytic uraemic syndrome * 0/109 (0.00%)", " Leukopenia * 0/109 (0.00%)", " Cardiac failure * 0/109 (0.00%)", " Pyrexia * 1/109 (0.92%)", " Hepatic function abnormal * 1/109 (0.92%)", " Arthritis bacterial * 0/109 (0.00%)", " Lung infection * 0/109 (0.00%)", " Haemoglobin decreased * 1/109 (0.92%)", " Neutrophil count decreased * 0/109 (0.00%)", "Adverse Events 2:", " Total: 9/110 (8.18%)", " Anaemia * 1/110 (0.91%)", " Haemolytic uraemic syndrome * 0/110 (0.00%)", " Leukopenia * 0/110 (0.00%)", " Cardiac failure * 1/110 (0.91%)", " Pyrexia * 2/110 (1.82%)", " Hepatic function abnormal * 0/110 (0.00%)", " Arthritis bacterial * 2/110 (1.82%)", " Lung infection * 0/110 (0.00%)", " Haemoglobin decreased * 1/110 (0.91%)", " Neutrophil count decreased * 0/110 (0.00%)" ]

[ "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: ", " Exercise", " an acute bout of exercise performed 24 hours prior to each cycle of anthracyclines and no exercise for 48 hours post exercise", "INTERVENTION 2: ", " Usual Care", " no exercise for 72 hours prior or 48 hours post each cycle of anthracyclines" ]

[ "Adverse Events 1:", " Total: 81/353 (22.95%)", " Febrile neutropenia * 13/353 (3.68%)", " Anaemia * 21/353 (0.28%)", " Neutropenia * 25/353 (1.42%)", " Thrombocytopenia * 20/353 (0.00%)", " Hypercoagulation * 21/353 (0.28%)", " Leukopenia * 21/353 (0.28%)", " Atrial fibrillation * 1/353 (0.28%)", " Cardiac failure * 0/353 (0.00%)", " Cardiac failure congestive * 0/353 (0.00%)", " Myocardial infarction * 1/353 (0.28%)", "Adverse Events 2:", " Total: 86/361 (23.82%)", " Febrile neutropenia * 0/361 (0.00%)", " Anaemia * 25/361 (1.39%)", " Neutropenia * 20/361 (0.00%)", " Thrombocytopenia * 22/361 (0.55%)", " Hypercoagulation * 20/361 (0.00%)", " Leukopenia * 20/361 (0.00%)", " Atrial fibrillation * 0/361 (0.00%)", " Cardiac failure * 0/361 (0.00%)", " Cardiac failure congestive * 0/361 (0.00%)", " Myocardial infarction * 0/361 (0.00%)" ]

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

[ "Inclusion Criteria:", " To be included in this study, you must meet the following criteria:", " Locally advanced/inflammatory adenocarcinoma of the breast", " 18 years of age or older", " Normal heart function", " Able to perform activities of daily living with minimal assistance", " No prior chemotherapy for breast cancer", " Adequate bone marrow, liver and kidney function", " No evidence or history of significant cardiovascular abnormalities", " Sentinel node or axillary dissection", " Sign an informed consent form", "Exclusion Criteria:", " You cannot participate in this study if any of the following apply to you:", " Pregnant or breast feeding", " History of heart disease with congestive heart failure", " Heart attack within the previous 6 months", " Prior chemotherapy or hormone therapy for breast cancer", " History of active uncontrolled infection", " Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have." ]

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

[ "Adverse Events 1:", " Total: 19/70 (27.14%)", " Febrile Neutropenia 24/70 (5.71%)", " Pericarditis 21/70 (1.43%)", " Sinus bradycardia 21/70 (1.43%)", " Abdominal Pain 2/70 (2.86%)", " Diarrhea 21/70 (1.43%)", " Lower gastrointestinal hemorrhage 21/70 (1.43%)", " Nausea 21/70 (1.43%)", " Non Cardiac-Chest pain 22/70 (2.86%)", " Fever 24/70 (5.71%)", " Skin infection 41/70 (1.43%)", " Neutrophil count decreased 31/70 (1.43%)" ]