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nli4ct_semeval2024

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[ "Outcome Measurement: ", " CNS Objective Response Rate (ORR)", " The central nervous system (CNS) ORR was defined as the percentage of participants achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria in the evaluation CNS lesions on treatment: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.", " Time frame: Disease assessments occurred every 6 cycles. Patients with stable or responsive disease after completion of 6 cycles could reduce frequency of assessments to every 3 cycles. Response was evaluated up to 25 months.", "Results 1: ", " Arm/Group Title: Cohort 1 - Cabozantinib, Trastuzumab for HER2+", " Arm/Group Description: HER2-positive", " Cabozantinib- orally administered daily per treatment cycle", " Trastuzumab- IV administered once per cycle", " MRI- Baseline, Cycle 2 Day 1, and every 2 cycles", " Magnetic Resonance Angiography (MRA ), Baseline, Cycle 2 Day 1,", " Cabozantinib: One, 60 mg tablet daily of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.", " Trastuzumab: For HER2-Positive participants only. Administered by IV on day 1 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.", " Overall Number of Participants Analyzed: 21", " Measure Type: Number", " Unit of Measure: percentage of participants 5 (.2 to 24)", "Results 2: ", " Arm/Group Title: Cohort 2 - Cabozantinib for ER+ and/or PR+", " Arm/Group Description: Hormone receptor-positive (ER+ and/or PR+)", " Cabozantinib- orally administered daily per treatment cycle", " MRI- Baseline, Cycle 2 Day 1, and every 2 cycles", " Magnetic Resonance Angiography (MRA ), Baseline, Cycle 2 Day 1,", " Cabozantinib: One, 60 mg tablet daily of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.", " Overall Number of Participants Analyzed: 7", " Measure Type: Number", " Unit of Measure: percentage of participants 14 (.4 to 58)" ]

[ "Outcome Measurement: ", " Disease Free Survival (DFS): Number of Events (Disease Relapse or Death) From Baseline up to 2.75 Years", " Number of events (disease relapse or death) to time of observation for DFS. DFS defined as time from randomization to earliest documentation of disease relapse or death from any cause in postmenopausal, receptor positive, node negative or node positive breast cancer patients for adjuvant treatment with exemestane compared with adjuvant tamoxifen therapy at 2.75 years. Disease relapse: primary tumor recurrence (locoregional or distant) and ipsilateral or contralateral breast cancer (CBC). Intercurrent death: death without disease relapse.", " Time frame: Baseline (Month 0) up to 2.75 years", "Results 1: ", " Arm/Group Title: Exemestane", " Arm/Group Description: Exemestane (Aromasin ) 25 mg QD for 5 years.", " Overall Number of Participants Analyzed: 4898", " Measure Type: Number", " Unit of Measure: Events (disease relapse or death) 352", "Results 2: ", " Arm/Group Title: Tamoxifen Followed by Exemestane", " Arm/Group Description: Tamoxifen 20 mg QD; upon completing 2.5 years to 3 years of tamoxifen, participants were to be switched to exemestane 25 mg QD and then were to complete a total of 5 years endocrine therapy.", " Overall Number of Participants Analyzed: 4868", " Measure Type: Number", " Unit of Measure: Events (disease relapse or death) 388" ]

[ "Inclusion Criteria:", " unilateral breast cancer with ipsilateral lumpectomy or mastectomy and lymph node dissection (sentinel biopsy or axillary dissection)", " stage II or III unilateral secondary upper extremity lymphedema (as defined by the International Society of Lymphology)", " girth 2 cm circumferential difference and/or volume 200 mL compared to the uninvolved upper extremity at any 4 cm segment", " able to commit to a long term follow-up schedule", "Exclusion Criteria:", " active cancer/metastatic cancer", " currently receiving or have plans for adjuvant radiation or chemotherapy", " pregnant", " presence of other extremity lymphedema (primary or secondary)", " pacemaker", " artificial joints in the upper quadrants", " renal failure", " arterial insufficiency", " congestive heart failure", " chronic inflammatory conditions", " history of deep vein thrombosis (DVT) in the lymphedematous upper extremity", " previous treatment with Low Level Laser (regardless of indication)", " medication(s) known to affect body fluid balance", " body mass index (BMI) > 40 (morbid obesity)" ]

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

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

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

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

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

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

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

[ "Outcome Measurement: ", " Time to Reach Maximum Plasma Concentration (Tmax): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters", " Median Tmax = time for maximum plasma concentration (Cmax) for SU011248, SU012662, and combined SU011248 and SU012662 (total drug); collected C1D2, C2D3. Paired observation.", " Time frame: 1, 2, 4, 6, 8, 12, 24 hours postdose", "Results 1: ", " Arm/Group Title: Sunitinib in Combination With Docetaxel", " Arm/Group Description: Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.", " Overall Number of Participants Analyzed: 11", " Median (Full Range)", " Unit of Measure: hours SU011248 C1D2: 6.0 (4.0 to 24.0)", " SU011248 C2D3: 6.0 (2.0 to 8.0)", " SU012662 C1D2: 6.0 (2.0 to 24.0)", " SU012662 C2D3: 6.0 (4.0 to 24.0)", " Total drug C1D2: 6.0 (2.0 to 24.0)", " Total drug C2D3: 6.0 (2.0 to 8.0)" ]

[ "Eligibility Criteria:", " Must have invasive metastatic breast cancer", " Tumor must be Her 2/neu 3+ by IHC (must be confirmed by Ohio State University pathology)or positive FISH", " Histological confirmation of invasive breast cancer either from the original diagnosis and/or diagnosis of metastatic disease.", " Tumor must be detectable clinically or radiographically (a positive bone scan is allowed as the only site of disease). Unidimensional measurements must be obtained whenever possible). Bone marrow only disease is not eligible for enrollment on this study.", " No evidence of congestive heart failure, symptoms of coronary artery disease, serious cardiac arrhythmias, or evidence of prior myocardial infarction on EKG or ECHO. Patients must have normal LV function and LVEF(left ventricular ejection fraction)> 50% as demonstrated by either echo or muga within the proceeding 4 weeks.", " Must have adequate renal and hepatic function documented by a serum creatinine < 1.5 x the institutional upper limit of normal (ULN), serum bilirubin <1.5 x ULN and liver enzymes (AST, ALT, or alkaline phosphatase) < 2 x ULN (< 5 x ULN if hepatic metastasis) within 21 days prior to registration.", " Patients must have an ANC (absolute neutrophil count) > 1.5, platelets > 100,000, Hemoglobin >9.0 within 21 days of registration.", " If patients are on bisphosphonates at the time of registration, with a stable creatinine over the preceding 2 months, then they may continue bisphosphonates during the study.", " No more than one prior Trastuzumab/chemotherapy or Trastuzumab/biotherapy combination for metastatic disease. Additional Trastuzumab therapy may have been given in the adjuvant setting. Prior hormonal therapy is allowed for either adjuvant or metastatic disease.", " Must be >3 weeks since administration of last chemotherapy prior to initiation of treatment on this trial. Prior trastuzumab may have been administered within one week of initiation of treatment on this trial if the last dose was 2 mg/kg. Any prior trastuzumab dosing greater than 2 mg/kg requires a 3 week washout period.", " Patients may have received prior cisplatin or carboplatin for metastatic disease.", " No CNS(central nervous system)metastasis disease.", " No active infection at time of registration.", " Pregnant or nursing women may not participate in trial.", " Patients must be informed of the investigational nature of this study and sign and give written informed consent in accordance with institutional and federal guidelines.", " ECOG (Eastern Cooperative Oncology Group)performance status < 2 at the time of registration.", " Patients may participate in a non-treatment related protocol while participating in this study.", " No other active malignancy is allowed. Adequately treated basal cell, squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years is allowed." ]

[ "Inclusion Criteria:", " women >=18 years of age;", " newly diagnosed;", " infiltrating (invasive) HER2-neu-negative or HER2-neu-positive breast cancer.", "Exclusion Criteria:", " evidence of metastatic disease, except ipsilateral (same side) axillary lymph nodes;", " previous systemic or local primary treatment." ]

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

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

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

[ "INTERVENTION 1: ", " Molecular Breast Imaging", " Molecular breast imaging performed after injection of 4 mCi Tc-99m sestamibi and again after 8 mCi Tc-99m sestamibi." ]

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

[ "Outcome Measurement: ", " Investigator-evaluated Crude Progression-free Survival Rate After 12 Weeks of Study Treatment", " The PFS rate is defined as the percentage of subjects who have shown no evidence of disease progression or death from any cause following 12 weeks of treatment. Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.", " Since there is no independent reviewer, only the investigator response was reported.", " Time frame: up to week 12", "Results 1: ", " Arm/Group Title: Lapatinib + Bevacizumab", " Arm/Group Description: Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously [IV] every two weeks)", " Overall Number of Participants Analyzed: 52", " Measure Type: Count of Participants", " Unit of Measure: Participants No disease progression by Week 12: 36 69.2%", " Disease progression or death by Week 12: 16 30.8%" ]

[ "Adverse Events 1:", " Total: 5/95 (5.26%)", " Febrile neutropenia 0/95 (0.00%)", " Neutropenia 0/95 (0.00%)", " Atrial fibrillation 0/95 (0.00%)", " Pleuropericarditis 0/95 (0.00%)", " Vomiting 0/95 (0.00%)", " Pryexia 0/95 (0.00%)", " Anaphylactic shock 1/95 (1.05%)", " Gastroenteritis 0/95 (0.00%)", " Fibula fracture 1/95 (1.05%)", " Tibia fracture 1/95 (1.05%)", " Intervertebral disc protrusion 0/95 (0.00%)", "Adverse Events 2:", " Total: 3/20 (15.00%)", " Febrile neutropenia 0/20 (0.00%)", " Neutropenia 0/20 (0.00%)", " Atrial fibrillation 1/20 (5.00%)", " Pleuropericarditis 1/20 (5.00%)", " Vomiting 0/20 (0.00%)", " Pryexia 0/20 (0.00%)", " Anaphylactic shock 0/20 (0.00%)", " Gastroenteritis 1/20 (5.00%)", " Fibula fracture 0/20 (0.00%)", " Tibia fracture 0/20 (0.00%)", " Intervertebral disc protrusion 1/20 (5.00%)" ]

[ "Inclusion Criteria:", " Age > 18 years", " Women with prior histologically documented diagnosis of breast cancer", " Subjects with metastatic disease who have already received and failed at least one chemotherapy regimen for metastatic disease and, if ER/PgR +ve, have failed on at least adjuvant hormonal therapy", " Subjects for whom trastuzumab treatment is not indicated, no longer effective or refused by the subjects", " Four weeks since the last cytotoxic chemotherapy or clear evidence of progression on hormonal therapy", " Subjects who have at least one measurable lesion by CT (Computed Tomography) scan or MRI (Magnetic Resonance Imaging) according to modified WHO Tumour Response Criteria", " Subjects who have an Eastern Co-operative Oncology Group (ECOG) performance status of 0, 1 or 2", " Adequate bone marrow, liver and renal function as assessed by the following laboratory evaluations:", " Hemoglobin > 9.0 g/dl", " Absolute neutrophil count (ANC) > 1,500/mm3", " Platelet count = 100,000/µl", " Total bilirubin =1.5 x the upper limit of normal.", " Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) = 2.5 x upper limit of normal (=5 x upper limit of normal for subjects with liver involvement of their cancer)", " Amylase and lipase = 1.5 x the upper limit of normal", " Serum creatinine = 3.0 x the upper limit of normal", " Prothrombin Time (PT) or International Normalized Ratio (INR) and Partial Thromboplastin Time (PTT) < 1.5 x upper limit of normal (subjects who receive anti-coagulation treatment with an agent such as warfarin or heparin will be allowed to participate provided that no evidence of underlying abnormality in these parameters exists)", " Subjects who give written informed consent prior to any study specific screening procedures with the understanding that the subject has the right to withdraw from the study at any time, without prejudice", " Life expectancy of at least 12 weeks", " Signed informed consent must be obtained prior to any study specific procedures", "Exclusion Criteria:", " Previous malignancy (except for cervical carcinoma in situ, adequately treated basal cell carcinoma, or superficial bladder tumours [Ta, Tis and T1] or other malignancies curatively treated > 2 years prior to entry)", " Congestive heart failure > New York Heart Association (NYHA) Class II", " Cardiac arrhythmia requiring anti-arrhythmic (excluding beta blockers or digoxin)", " Active coronary artery disease or ischaemia", " Active clinically serious bacterial or fungal infections (> grade 2 National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 3)", " Known History of Human Immunodeficiency Virus (HIV) infection or chronic hepatitis B or C", " Metastatic brain or meningeal tumors unless the subject is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry. Also the patient must not be undergoing acute steroid therapy or taper (chronic steroid therapy is acceptable provided that the dose is stable for 1 month prior to and following screening radiographic study)", " Subjects with seizure disorders requiring medication (such as steroid or anti-epileptics)", " History of organ allograft", " Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results", " Known or suspected allergy to the investigational agent", " Any condition that is unstable or which could jeopardize the safety of the subject and his/her compliance in the study. Pregnant or breast-feeding subjects. Women of childbearing potential must have a negative pregnancy test performed within seven days prior to the start of study drug. Women enrolled in this trial must use adequate barrier birth control measures during the course of the trial.", " Excluded therapies include:", " Anti-cancer chemotherapy, hormonal therapy or immunotherapy during the study or within 4 weeks of study entry. Mytomicin or nitroureas should not be given within 6 weeks of study entry", " Significant surgery within 4 weeks prior to the start of study drug", " Any bone marrow transplant or stem cell rescue within 4 months of the start of study drug", " Radiotherapy during the study or within 3 weeks of the start of drug", " Use of biologic response modifiers, such as Granulocyte-Colony Stimulating Factor (G-CSF), within 3 weeks of study entry", " Investigational drug therapy outside of this trial during or within 30 days prior to start of the study drug", " Concomitant treatment with ketoconazole, itraconazole, ritonavir, or use of grapefruit juice", " Prior use of Raf-Kinase Inhibitors (RKI), Methyl Ethyl Ketone (MEK) or farnesyl transferase inhibitors", " Concomitant treatment or use of St. John's Wort", " Prior use of bevacizumab and all other drugs that target Vascular Endothelial Growth Factor (VEGF)/VEGF receptors" ]

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

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

[ "INTERVENTION 1: ", " Cholecalciferol", " Enrolled women received 50,000 IUs weekly supplementation of cholecalciferol for 8 weeks.", "INTERVENTION 2: ", " No Cholecalciferol", " Enrolled women with serum 25 (OH)D greater than or equal to 30 ng/ml received no intervention." ]

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

[ "INTERVENTION 1: ", " Low Dose Magnesium Oxide (800 mg/Day)", " Week 2:", " Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).", " Week 3:", " Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).", " Weeks 4-9:", " Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).", "INTERVENTION 2: ", " High Dose Magnesium Oxide (1200 mg/Day)", " Week 2:", " Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).", " Week 3:", " Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).", " Weeks 4-9:", " Patients take three 400 mg tablet of magnesium oxide orally (PO) daily (QD)." ]

[ "INTERVENTION 1: ", " LA-EP2006", " During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.", " LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.", "INTERVENTION 2: ", " Neulasta®", " During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.", " Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application." ]

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

[ "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%" ]

[ "Inclusion Criteria:", " Histologically or cytologically confirmed breast cancer", " Metastatic disease", " Measurable disease, defined as >=1 unidimensionally measurable lesion, including >= 1 of the following:", " Lesion >= 10 mm on CT scan (5 mm sections)", " Lesion >= 20 mm on CT scan or MRI (10 mm sections)", " Bone disease that is >= 10 mm on MRI", " Lytic bone lesions that are >= 10 mm on CT scan (with 5 mm sections) OR >= 20 mm on plain film or CT scan (with 10 mm sections)", " Lesion >= 10 mm on physical exam", " Patients must have received >= 1 prior aromatase inhibitor in either the adjuvant or metastatic setting and must have had either disease recurrence or disease progression on a prior aromatase inhibitor therapy", " No brain metastases diagnosed within the past 6 months OR previously untreated brain metastases", " Estrogen receptor-positive and/or progesterone receptor-positive, defined as > 1% staining by immunohistochemistry or > 10 fmol/mg of protein by radio-ligand dextran-coated steroid binding assay", " Postmenopausal, as defined by 1 of the following:", " Prior bilateral oophorectomy", " No menses for >= 12 months in patients with an intact uterus", " Follicle-stimulating hormone (FSH) in postmenopausal range in patients < 60 years of age who have had a prior hysterectomy or have been amenorrheic for >= 3 months", " Age >= 60 years", " Pre- or perimenopausal patients receiving monthly injections of goserelin at a dose of 3.6 mg are eligible", " ECOG 0-2", " More than 3 months", " Absolute neutrophil count >= 1,500/mm3 Platelet count >= 100,000/mm3 No bleeding diathesis", " Bilirubin =< 1.5 times upper limit of normal (ULN AST and ALT =< 2.5 times ULN", " Systolic blood pressure (BP) < 150 mm Hg and diastolic BP < 100 mm Hg on at least one reading prior to study entry No uncontrolled hypertension", " None of the following within the past 6 months:", " Symptomatic congestive heart failure", " Unstable angina pectoris", " Myocardial infarction", " Cardiac arrhythmia with hemodynamic compromise", " Not pregnant or nursing", " Able to swallow oral medication", " No known HIV positivity", " No ongoing or active infection", " No psychiatric illness or social situation that would preclude study compliance", " No other active invasive malignancy within the past 5 years except nonmelanoma skin cancer or treated carcinoma in situ of the cervix", " No other uncontrolled illness", " More than 4 weeks since prior chemotherapy", " No more than 2 prior chemotherapy regimens for metastatic disease", " At least 8 weeks since prior anastrozole therapy", " Concurrent steroids allowed if dose is stable", " More than 4 weeks since prior radiotherapy", " More than 4 weeks since prior major surgery", " Recovered from prior therapy", " No prior sorafenib", " No concurrent therapeutic anticoagulation", " Concurrent prophylactic anticoagulation (i.e., low-dose warfarin) for venous or arterial access devices allowed provided PT and PTT are =< 1.5 times ULN", " No concurrent agents that may interact with sorafenib, including any of the following:", " Hypericum perforatum (St. John's wort)", " Rifampin", " P450 CYP3A4 enzyme-inducing anticonvulsants (e.g., phenytoin, carbamazepine, or phenobarbital)", " No other concurrent investigational agents", "Exclusion Criteria:", " estrogen receptor status unknown", " history of myocardial infarction within 6 months", " performance status 3", " performance status 4", " premenopausal", " progesterone receptor status unknown", "HIV positive" ]

[ "Adverse Events 1:", " Total: 26/69 (37.68%)", " Anaemia 2/69 (2.90%)", " Febrile neutropenia 3/69 (4.35%)", " Neutropenia 4/69 (5.80%)", " Cardiac arrest 1/69 (1.45%)", " Cardiac failure congestive 1/69 (1.45%)", " Cardiac tamponade 1/69 (1.45%)", " Pericardial effusion 1/69 (1.45%)", " Abdominal pain 1/69 (1.45%)", " Ascites 2/69 (2.90%)", " Colitis 1/69 (1.45%)", " Gastritis 1/69 (1.45%)", " Gastritis erosive 1/69 (1.45%)", "Adverse Events 2:", " Total: 12/65 (18.46%)", " Anaemia 0/65 (0.00%)", " Febrile neutropenia 1/65 (1.54%)", " Neutropenia 1/65 (1.54%)", " Cardiac arrest 0/65 (0.00%)", " Cardiac failure congestive 0/65 (0.00%)", " Cardiac tamponade 0/65 (0.00%)", " Pericardial effusion 0/65 (0.00%)", " Abdominal pain 2/65 (3.08%)", " Ascites 2/65 (3.08%)", " Colitis 0/65 (0.00%)", " Gastritis 0/65 (0.00%)", " Gastritis erosive 0/65 (0.00%)" ]

[ "Adverse Events 1:", " Total: 18/115 (15.65%)", " Febrile neutropenia * 7/115 (6.09%)", " Neutropenia * 1/115 (0.87%)", " Pancytopenia * 1/115 (0.87%)", " Diarrhoea * 0/115 (0.00%)", " Nausea * 0/115 (0.00%)", " Stomatitis * 0/115 (0.00%)", " Vomiting * 1/115 (0.87%)", " Asthenia * 1/115 (0.87%)", " Mucosal inflammation * 0/115 (0.00%)", " Pyrexia * 3/115 (2.61%)", " Gastrointestinal infection * 1/115 (0.87%)", "Adverse Events 2:", " Total: 8/112 (7.14%)", " Febrile neutropenia * 3/112 (2.68%)", " Neutropenia * 2/112 (1.79%)", " Pancytopenia * 0/112 (0.00%)", " Diarrhoea * 2/112 (1.79%)", " Nausea * 2/112 (1.79%)", " Stomatitis * 1/112 (0.89%)", " Vomiting * 1/112 (0.89%)", " Asthenia * 0/112 (0.00%)", " Mucosal inflammation * 1/112 (0.89%)", " Pyrexia * 0/112 (0.00%)", " Gastrointestinal infection * 0/112 (0.00%)" ]

[ "Inclusion Criteria:", " Histologically confirmed breast cancer with evidence of metastatic disease", " HER2 3+ or FISH (fluorescent in situ hybridization)+", " Age 18 years", " No prior trastuzumab, except as given in the adjuvant or neoadjuvant setting.", " No prior chemotherapy in the metastatic setting.", "Exclusion Criteria:", " CNS (central nervous system) metastases", " Prior radiation therapy within the last 4 weeks", " Pregnant (positive pregnancy test) or lactating women", " Major surgical procedure, open biopsy, non-healing wounds, or significant traumatic injury within 28 days prior to starting study or anticipation of need for major surgical procedure during the study", " Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to start of study." ]

[ "DISEASE CHARACTERISTICS:", " Histologically confirmed invasive breast cancer meeting the following criteria:", " Primary tumor 3 cm by mammography, ultrasound, or palpation AND/OR palpable axillary lymph nodes > 1 cm", " Survivin- and/or carcinoembryonic antigen-positive by IHC", " Tumor must be localized by exam or ultrasound to allow tumor injection", " No stage IV or metastatic disease", " HER2/neu-negative tumor by IHC", " If 2+ or in the indeterminate range, further testing of HER2/neu overexpression by fluorescent in situ hybridization (FISH) is required", " Hormone receptor status known", " PATIENT CHARACTERISTICS:", " Female", " Pre-, peri-, or postmenopausal", " ECOG performance status 0-1", " Not pregnant or nursing", " Negative pregnancy test", " Fertile patients must use effective contraception during and for up to 6 months following completion of study therapy", " ANC 1,500/mm³", " Platelet count 100,000/mm³", " Alkaline phosphatase 1.5 times upper limit of normal (ULN)", " Total bilirubin 1.5 times ULN", " AST and ALT 1.5 times ULN", " Creatinine < 1.5 times ULN", " No active serious infections", " No prior malignancy except adequately treated basal cell or squamous cell skin cancer, noninvasive carcinoma, or other cancer from which the patient has been disease free for 5 years", " No comorbidity or condition that would interfere with study assessments and procedures or preclude study participation", " PRIOR CONCURRENT THERAPY:", " No prior chemotherapy or radiotherapy" ]

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

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

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

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

[ "INTERVENTION 1: ", " Group I (SparkPeople Program)", " Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device.", " Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders.", " Behavioral Dietary Intervention: Use SparkPeople web-based program", " Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program", " Activity Monitoring Device: Wear Fitbit activity monitoring device", "INTERVENTION 2: ", " Group II (Wait List)", " Participants receive the weight loss handout and a Fitbit activity monitor. After 6 months, participants receive the SparkPeople treatment.", " Exercise Intervention: Use Fitbit monitor", " Activity Monitoring Device: Wear Fitbit activity monitoring device" ]

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

[ "Outcome Measurement: ", " Central Nervous System (CNS) Objective Response Rate", " CNS objective response rate is the percentage of participants that achieve CNS complete or partial response as follows:", " CNS complete response (CR) is achieved if all of the following are satisfied:", " Complete resolution of all measurable (>= 1 cm in longest dimension [LD]) and non-measurable brain metastases", " No new CNS lesions (defined as any new lesion >= 6 mm in LD)", " Stable or decreasing steroid dose", " No new/progressive tumor-related neurologic signs or symptoms", " No progression of extra-CNS disease as assessed by RECIST", " CNS partial response (PR) is achieved if all of the following are satisfied:", " ->/= 50% reduction in the volumetric sum of all measurable (>/= 1 cm in LD) brain metastases compared to baseline", " No progression on non-measurable lesions", " No new CNS lesions (defined as any new lesion >/= 6 mm in LD)", " Stable or decreasing steroid dose", " No new/progressive tumor-related neurologic signs or symptoms", " No progression of extra-CNS disease as assessed by RECIST", " Time frame: Response was evaluated radiologically at baseline and every 2 cycles on treatment. Treatment duration for this study cohort was a median (range) of 8 cycles (1-20) which approximates months given the 4 week cycle length.", "Results 1: ", " Arm/Group Title: Carboplatin, Bevacizumab, Trastuzumab (if HER2+)", " Arm/Group Description: Participants received treatment until disease progression in either CNS or non-CNS site. Cycle duration is 28 days.", " carboplatin: AUC=5 dose given intravenously on day 8 of cycle one and Day 1 of each subsequent cycle", " bevacizumab: 15 mg/kg dose given intravenously on day 1 of each cycle", " trastuzumab*: 6 mg/kg dose given intravenously on day 8 of each cycle for patients with HER2-positive breast cancer only", " *8mg/kg loading dose in cycle 1 for some participants", " HER-2: human epidermal growth factor receptor 2", " Overall Number of Participants Analyzed: 38", " Measure Type: Number", " Unit of Measure: percentage of participants 63 (47 to 77)" ]

[ "Outcome Measurement: ", " Objective Response Rate (ORR)", " Per Response Evaluation Criteria In Solid Tumors (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), at least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", " Time frame: Up to 2 years.", "Results 1: ", " Arm/Group Title: NKTR-102 14 Day", " Arm/Group Description: NKTR-102: NKTR-102 given on a q14 day schedule", " Overall Number of Participants Analyzed: 35", " Measure Type: Number", " Unit of Measure: percentage of subjects 28.6 (14.6 to 46.3)", "Results 2: ", " Arm/Group Title: NKTR-102 21 Days", " Arm/Group Description: NKTR-102: NKTR-102 given on a q21 day schedule", " Overall Number of Participants Analyzed: 35", " Measure Type: Number", " Unit of Measure: percentage of subjects 35 (14.6 to 46.3)" ]

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

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

[ "Inclusion Criteria:", " The following criteria are to be checked at the time of study entry. The patients may only be included in the study if ALL of the following statements are FULLFILLED:", " The patient (male or female) is at least 18 years old at the time of signature of the informed consent form.", " Written informed consent has been obtained from the patient prior to the performance of any protocol-specific procedure.", " The patient is diagnosed with confirmed invasive breast cancer with stage IV disease.", " Note: If the metastatic disease is restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology or histology.", " The patient has documented disease progression or relapse following at least one prior standard therapy with trastuzumab (alone or in combination with chemotherapy).", " Patients with prior lapatinib use are eligible. Furthermore,", " The administration of the chemotherapeutic agent(s) should have been stopped for at least 28 days by the time of the first ASCI administration.", " The administration of trastuzumab alone could be maintained after chemotherapy, but the last dose of trastuzumab should not have been given less than three weeks before the first ASCI administration.", " The patient will not be given trastuzumab during the trial.", " For metastatic patients whose disease is ER+ and/or PR+ the following criteria should be met:", " Patients with visceral disease that requires chemotherapy (eg., patients with liver or lung metastases).", " Rapidly progressing or life threatening disease, as determined by the investigator.", " Patients who received hormonal therapy and are no longer benefiting from this therapy.", " A tumor lesion from the patient biopsied before or during screening shows either:", " Overexpression of the HER2 protein, as determined by immunohistochemistry (IHC, with result IHC 3+) or", " Amplification of the HER2 gene as determined by FISH (at least 4 fold i.e. at least 8 copies).", " Note: Overexpression/amplification measurements must be performed on a metastatic lesion in all cases where such a lesion is sufficiently easily accessible. If however such a biopsy is not possible, then these measurements can be performed on the primary tumor. Use of the primary tumor is to be documented and justified.", " Ten FFPE tissue sections of the tumor on which the HER2 overexpression/amplification has been done -if available-may be requested. These may be used to retrospectively carry out part of the translational research (i.e. analysis of EGF receptor activity and of the presence of immune effector cells, refer to Section 7).", " The patient has at least one measurable lesion according to RECIST criteria.", " The patient has ECOG status of 0 or 1.", " The patient has adequate bone marrow reserve as indicated by:", " White blood cell count >/= 3,000/mm3.", " Neutrophil count >/= 1,500/mm3.", " Platelet count >/= 100,000/mm3.", " Hemoglobin levels >/= 10.0 g/dl.", " The patient has adequate renal function as shown by the creatinine levels (i.e. within the normal range).", " The patient has adequate hepatic function as shown by serum bilirubin levels i.e:", " Serum bilirubin levels within the normal limits.", " Both AST and ALT levels <1.5 times the ULN. Note: However, for patients with liver metastasis, a serum bilirubin level <1.5 times the ULN and both AST and ALT levels <3 times the ULN will be accepted.", " The patient has a baseline Left Ventricular Ejection Fraction (LVEF) measured by MUGA scan equal to or greater than the LLN for the radiology facility.", " If the patient is female, she must be of non-childbearing potential, i.e. have a current tubal ligation, hysterectomy, ovariectomy or be post-menopausal, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to treatment, have a negative pregnancy test and continue such precautions for two months after completion of the study treatment.", " Adequate contraception is defined as a contraceptive method with failure rate of less than 1% per year when used consistently and correctly (when applicable, as mentioned in the product label) for example abstinence, combined or progestogen oral contraceptives, injectable progestogen, implants of levonorgestrel, oestrogenic vaginal ring, percutaneous contraceptive patches or intrauterine device (IUD) or intrauterine system (IUS), vasectomy with documented azoospermia of the sole male partner or double barrier method (condom or occlusive cap plus spermicidal agent).", " For azoospermia, \"documented\" refers to the outcome of the investigator's/ designee's medical examination of the subject or review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject's medical records.", " Post-menopause: Menopause is the age associated with complete cessation of menstrual cycles, menses, and implies the loss of reproductive potential by ovarian failure. A practical definition accepts menopause after 1 year without menses with an appropriate clinical profile at the appropriate age e.g. > 45 years.", " Able to swallow and retain oral medication.", " In the view of the investigator, the patient can and will comply with the requirements of the protocol.", "Exclusion Criteria:", " The following criteria should be checked at the time of study entry. If any apply, the patient must not be included in the study:", " The patient has received > 300 mg/m2 doxorubicin (cumulative dose) or > 600 mg/m2 epirubicin (cumulative dose).", " The patient is receiving treatment with bisphosphonate UNLESS the biphosphonate treatment was initiated more than three weeks before the first ASCI administration. (See also section 5.3.2.).", " The patient has received any investigational or non-registered product (drug or vaccine) other than the study treatment(s) within 30 days preceding the first dose of study treatment, or planned use during the study period.", " The patient is currently receiving amiodarone or has received amiodarone in the 6 months prior to screening.", " The patient requires concomitant treatment with systemic corticosteroids or any immunosuppressive agents. The use of prednisone, or equivalent, <0.5 mg/kg/day (absolute maximum 40 mg/day), or inhaled corticosteroids or topical steroids is permitted.", " The patient has a malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel.", " Patients with ulcerative colitis.", " The patient has known coronary artery disease, arrhythmia requiring treatment, clinically significant valvular disease, cardiomegaly on chest X-ray, ventricular hypertrophy (found by ECG) or previous myocardial infarction.", " The patient has any acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.", " The patient has current active hepatic or biliary's disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment).", " The patient presents with autoimmune disease (vitiligo and autoimmune thyroid disease is not an exclusion criterion).", " The patient has a known family history of congenital or hereditary immunodeficiency.", " The patient has any uncontrolled bleeding disorder or coagulation disorder or thrombocytopenia or pro-thrombotic disorder.", " The patient has a history of anaphylaxis or severe allergic reaction to vaccines or unknown allergens.", " The patient has a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to Lapatinib. These include other anilinoquinazolines, such as gefitinib (Iressa), erlotinib (Tarceva), or other chemically related compounds or excipients.", " The patient is known to be positive for the Human Immunodeficiency Virus (HIV).", " The patient has (or has had) previous or concomitant malignancies at other sites except effectively treated:", " Non-melanoma skin cancers or carcinoma in situ of the cervix", " Malignancy that has been in remission for > 2 years and is considered highly likely to have been cured.", " The patient has any psychiatric or addictive disorder that may compromise her ability to give informed consent, or to comply with the trial procedures.", " The patient has any other condition that in the opinion of the investigator might jeopardize the patient's safety or ability to comply with the requirements of the study.", " The patient is pregnant or lactating." ]

[ "Adverse Events 1:", " Total: 14/41 (34.15%)", " Cardiac ischemia/infarction 2/41 (4.88%)", " Duodenal ulcer 1/41 (2.44%)", " Vomiting 2/41 (4.88%)", " Fever 2/41 (4.88%)", " Death NOS 1/41 (2.44%)", " Liver failure 1/41 (2.44%)", " Infection - pneumonia 2/41 (4.88%)", " Infection - port site 2/41 (4.88%)", " Infection - urinary tract 1/41 (2.44%)", " Disease progression 3/41 (7.32%)", " Confusion 1/41 (2.44%)" ]

[ "INTERVENTION 1: ", " Arm I: Yoga Therapy", " Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs.", "INTERVENTION 2: ", " Arm II: Wait-List", " Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes." ]

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

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

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

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

[ "Adverse Events 1:", " Total: 39/39 (100.00%)", " Febrile Neutropenia 1/39 (2.56%)", " Heart failure 1/39 (2.56%)", " Diarrhea 3/39 (7.69%)", " Nausea/vomiting 4/39 (10.26%)", " Mucositis 3/39 (7.69%)", " Fatigue 4/39 (10.26%)", " infection 3/39 (7.69%)", " Urinary tract infection 2/39 (5.13%)", " Musculoskeletal pain 6/39 (15.38%)", " Syncope 1/39 (2.56%)", " Insomnia 3/39 (7.69%)", " Anxiety 2/39 (5.13%)" ]

[ "Adverse Events 1:", " Total: 34/214 (15.89%)", " Leukocytosis 0/214 (0.00%)", " Atrial fibrillation 0/214 (0.00%)", " Cardiac failure congestive 0/214 (0.00%)", " Pericardial effusion 1/214 (0.47%)", " Cataract 0/214 (0.00%)", " Macular fibrosis 0/214 (0.00%)", " Constipation 2/214 (0.93%)", " Diarrhoea 2/214 (0.93%)", " Enterocolitis 0/214 (0.00%)", " Ileus 1/214 (0.47%)", " Nausea 3/214 (1.40%)", "Adverse Events 2:", " Total: 27/213 (12.68%)", " Leukocytosis 1/213 (0.47%)", " Atrial fibrillation 1/213 (0.47%)", " Cardiac failure congestive 1/213 (0.47%)", " Pericardial effusion 0/213 (0.00%)", " Cataract 1/213 (0.47%)", " Macular fibrosis 1/213 (0.47%)", " Constipation 1/213 (0.47%)", " Diarrhoea 1/213 (0.47%)", " Enterocolitis 1/213 (0.47%)", " Ileus 0/213 (0.00%)", " Nausea 0/213 (0.00%)" ]

[ "Adverse Events 1:", " Total: 5/95 (5.26%)", " Febrile neutropenia 0/95 (0.00%)", " Neutropenia 0/95 (0.00%)", " Atrial fibrillation 0/95 (0.00%)", " Pleuropericarditis 0/95 (0.00%)", " Vomiting 0/95 (0.00%)", " Pryexia 0/95 (0.00%)", " Anaphylactic shock 1/95 (1.05%)", " Gastroenteritis 0/95 (0.00%)", " Fibula fracture 1/95 (1.05%)", " Tibia fracture 1/95 (1.05%)", " Intervertebral disc protrusion 0/95 (0.00%)", "Adverse Events 2:", " Total: 3/20 (15.00%)", " Febrile neutropenia 0/20 (0.00%)", " Neutropenia 0/20 (0.00%)", " Atrial fibrillation 1/20 (5.00%)", " Pleuropericarditis 1/20 (5.00%)", " Vomiting 0/20 (0.00%)", " Pryexia 0/20 (0.00%)", " Anaphylactic shock 0/20 (0.00%)", " Gastroenteritis 1/20 (5.00%)", " Fibula fracture 0/20 (0.00%)", " Tibia fracture 0/20 (0.00%)", " Intervertebral disc protrusion 1/20 (5.00%)" ]

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

[ "INTERVENTION 1: ", " Treatment (Neoadjuvant Chemotherapy Before Surgery)", " Patients receive neoadjuvant chemotherapy comprising sunitinib malate PO once daily and paclitaxel IV over 1 hour once weekly for 8-12 weeks in the absence of disease progression or unacceptable toxicity. Beginning within 3 weeks of completion of sunitinib malate and paclitaxel, patients receive doxorubicin IV once weekly for 15 weeks, cyclophosphamide PO once daily for 15 weeks, and filgrastim SC on days 2-7 for 16 weeks in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo surgery.", " sunitinib malate: Given PO", " paclitaxel: Given IV", " doxorubicin hydrochloride: Given IV", " cyclophosphamide: Given PO", " filgrastim: Given SC", " therapeutic conventional surgery: Undergo surgery", " laboratory biomarker analysis: Correlative studies", " flow cytometry: Correlative studies" ]

[ "Adverse Events 1:", " Total: 8/56 (14.29%)", " Platelets * 1/56 (1.79%)", " Heart failure * 1/56 (1.79%)", " Left ventricular systolic dysfunction * 1/56 (1.79%)", " Dehydration * 1/56 (1.79%)", " Diarrhea * 1/56 (1.79%)", " Infection with normal ANC or Grade 1 or 2 neutrophils - Bladder (urinary) * 1/56 (1.79%)", " Sodium, serum-low (hyponatremia) * 1/56 (1.79%)", " Fracture * 2/56 (3.57%)" ]

[ "Adverse Events 1:", " Total: 18/70 (25.71%)", " Cardiac arrest 1/70 (1.43%)", " Pericardial effusion 1/70 (1.43%)", " Ear pain 1/70 (1.43%)", " Blurred vision 1/70 (1.43%)", " Eye disorders - Other, specify 2/70 (2.86%)", " Abdominal Pain 5/70 (7.14%)", " Colitis 1/70 (1.43%)", " Diarrhea 2/70 (2.86%)", " Nausea 2/70 (2.86%)", " Death NOS 1/70 (1.43%)", " Edema limbs 1/70 (1.43%)", " Fatigue 3/70 (4.29%)" ]

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

[ "INTERVENTION 1: ", " FSFI Total Score (Pretest)", " Administered to participants prior to starting vaginal testosterone therapy.", "INTERVENTION 2: ", " FSFI Total Score (Postteset)", " Testosterone USP micronized powder supplied by Medisca Pharmacy was compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream was supplied in pre-filled syringes and each 0.5 mL dose delivered 300 mcg of testosterone daily. The cream was applied to the vaginal opening once daily for four weeks (28 days)." ]

[ "INTERVENTION 1: ", " FEC-75 Then Paclitaxel/Trastuzumab", " Patients receive Fluorouracil, epirubicin, and cyclophosphamide (FEC) comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies", "INTERVENTION 2: ", " Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75", " Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies" ]

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

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

[ "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%)" ]

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

[ "Adverse Events 1:", " Total: 30/98 (30.61%)", " Coagulopathy 1/98 (1.02%)", " Febrile neutropenia 7/98 (7.14%)", " Pancytopenia 2/98 (2.04%)", " Cardiac failure 0/98 (0.00%)", " Cardiac failure congestive 0/98 (0.00%)", " Pericardial effusion 0/98 (0.00%)", " Appendicitis perforated 1/98 (1.02%)", " Colitis 1/98 (1.02%)", " Ileus 1/98 (1.02%)", " Abdominal pain upper 1/98 (1.02%)", " Gastrointestinal haemorrhage 0/98 (0.00%)", "Adverse Events 2:", " Total: 21/99 (21.21%)", " Coagulopathy 0/99 (0.00%)", " Febrile neutropenia 5/99 (5.05%)", " Pancytopenia 0/99 (0.00%)", " Cardiac failure 1/99 (1.01%)", " Cardiac failure congestive 4/99 (4.04%)", " Pericardial effusion 1/99 (1.01%)", " Appendicitis perforated 0/99 (0.00%)", " Colitis 0/99 (0.00%)", " Ileus 0/99 (0.00%)", " Abdominal pain upper 0/99 (0.00%)", " Gastrointestinal haemorrhage 1/99 (1.01%)" ]

[ "Adverse Events 1:", " Total: 13/83 (15.66%)", " Cardiac failure congestive 1/83 (1.20%)", " Hypothyroidism 1/83 (1.20%)", " Nausea 2/83 (2.41%)", " Vomiting 2/83 (2.41%)", " Diarrhea 1/83 (1.20%)", " Gastrointestinal Haemorrhage 1/83 (1.20%)", " Asthenia 1/83 (1.20%)", " Hyperbilirubinaemia 1/83 (1.20%)", " Anal abscess 1/83 (1.20%)", " Dehydration 3/83 (3.61%)", " Decreased appetite 1/83 (1.20%)" ]

[ "Adverse Events 1:", " Total: 7/26 (26.92%)", " Febrile neutropenia 1/26 (3.85%)", " Neutropenia 0/26 (0.00%)", " Thrombocytopenia 0/26 (0.00%)", " Cardiac failure congestive 0/26 (0.00%)", " Extrasystoles 0/26 (0.00%)", " Nausea 1/26 (3.85%)", " Abdominal pain 0/26 (0.00%)", " Constipation 0/26 (0.00%)", " Gastrointestinal haemorrhage 0/26 (0.00%)", " Death - unknown cause 1/26 (3.85%)", " Thrombosis in device 0/26 (0.00%)", "Adverse Events 2:", " Total: 5/10 (50.00%)", " Febrile neutropenia 0/10 (0.00%)", " Neutropenia 0/10 (0.00%)", " Thrombocytopenia 1/10 (10.00%)", " Cardiac failure congestive 0/10 (0.00%)", " Extrasystoles 0/10 (0.00%)", " Nausea 0/10 (0.00%)", " Abdominal pain 0/10 (0.00%)", " Constipation 0/10 (0.00%)", " Gastrointestinal haemorrhage 0/10 (0.00%)", " Death - unknown cause 0/10 (0.00%)", " Thrombosis in device 0/10 (0.00%)" ]

[ "Adverse Events 1:", " Total: 7/26 (26.92%)", " Febrile neutropenia 1/26 (3.85%)", " Neutropenia 0/26 (0.00%)", " Thrombocytopenia 0/26 (0.00%)", " Cardiac failure congestive 0/26 (0.00%)", " Extrasystoles 0/26 (0.00%)", " Nausea 1/26 (3.85%)", " Abdominal pain 0/26 (0.00%)", " Constipation 0/26 (0.00%)", " Gastrointestinal haemorrhage 0/26 (0.00%)", " Death - unknown cause 1/26 (3.85%)", " Thrombosis in device 0/26 (0.00%)", "Adverse Events 2:", " Total: 5/10 (50.00%)", " Febrile neutropenia 0/10 (0.00%)", " Neutropenia 0/10 (0.00%)", " Thrombocytopenia 1/10 (10.00%)", " Cardiac failure congestive 0/10 (0.00%)", " Extrasystoles 0/10 (0.00%)", " Nausea 0/10 (0.00%)", " Abdominal pain 0/10 (0.00%)", " Constipation 0/10 (0.00%)", " Gastrointestinal haemorrhage 0/10 (0.00%)", " Death - unknown cause 0/10 (0.00%)", " Thrombosis in device 0/10 (0.00%)" ]

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

[ "Inclusion criteria:", " DISEASE CHARACTERISTICS:", " Scheduled to undergo screening mammogram at one of the Boston Medical Center-affiliated primary care clinics and meets 1 of the following criteria:", " Dense breast tissue", " At high-risk for breast cancer", " PATIENT CHARACTERISTICS:", " Has 1 of the following racial or ethnic backgrounds based on the patient's country of birth or the mother and father's country of birth:", " Hispanic", " Haitian Creole", " African American", " Caucasian", " PRIOR CONCURRENT THERAPY:", " None specified", "Exclusion criteria:", " No history of breast cancer, palpable breast mass, abnormal nipple discharge, or other focal complaints warranting diagnostic mammogram" ]

[ "DISEASE CHARACTERISTICS:", " Histologically proven invasive carcinoma of the breast", " No evidence of T4, N2-3, or M1 disease prior to surgery", " Node positive or high-risk node negative", " Prior breast-conserving therapy (BCT) (e.g., lumpectomy, partial mastectomy, or segmental mastectomy) and axillary node dissection or sentinel node biopsy required and must be a candidate for breast radiotherapy after BCT", " Normally patients should have microscopically clear resection margins and those with positive margins should undergo reexcision", " Patients with microscopically focally positive margins (defined as no greater than 3 times high power fields) are candidates for breast radiotherapy plus a boost to the lumpectomy site", " Patients with prior sentinel node dissection eligible if node negative, but still meet high-risk criteria", " If node positive, then a level I and II axillary dissection must be performed", " No evidence of residual disease in axilla after dissection", " Must be treated with currently accepted adjuvant systemic chemotherapy and/or hormonal therapy", " High risk of regional and systemic recurrence due to one of the following:", " Pathologically positive axillary lymph nodes", " Pathologically negative axillary lymph nodes with one of the following:", " Primary tumor greater than 5 cm", " Primary tumor greater than 2 cm and less than 10 axillary lymph nodes excised and one of the following:", " Estrogen receptor negative", " Skarf-Bloom-Richardson grade 3", " Lymphovascular invasion", " Hormone receptor status:", " Estrogen and progesterone receptor status known", " PATIENT CHARACTERISTICS:", " Age:", " 16 and over", " Sex:", " Female", " Menopausal status:", " Premenopausal or postmenopausal", "Performance status:", " ECOG 0-2", " Life expectancy:", " At least 5 years", " Hematopoietic:", " Not specified", " Hepatic:", " SGOT and/or SGPT no greater than 3 times upper limit of normal (ULN)*", " Alkaline phosphatase no greater than 3 times ULN* NOTE: * Patients with laboratory values greater than 3 times ULN may still be eligible if no metastatic disease by imaging examinations", " Renal:", " No serious nonmalignant renal disease", " Cardiovascular:", " No serious nonmalignant cardiovascular disease", " Pulmonary:", " No serious nonmalignant pulmonary disease", " Other:", " Not pregnant or nursing", " Fertile patients must use effective contraception", " No other serious nonmalignant disease (e.g., systemic lupus erythematosus or scleroderma) that would preclude definitive surgery or radiotherapy", " No other malignancy except:", " Nonmelanomatous skin cancer", " Carcinoma in situ of the cervix or endometrium", " Contralateral noninvasive breast cancer (unless prior radiotherapy to the contralateral breast)", " Invasive carcinoma of the cervix, endometrium, colon, thyroid, or melanoma that was curatively treated at least 5 years prior to study participation", " No psychiatric or addictive disorder that would preclude informed consent or study compliance", " PRIOR CONCURRENT THERAPY:", " Biologic therapy:", " Not specified", " Chemotherapy:", " See Disease Characteristics", " Concurrent standard adjuvant chemotherapy allowed", " Endocrine therapy:", " See Disease Characteristics", " Concurrent standard adjuvant hormonal therapy allowed", " Radiotherapy:", " See Disease Characteristics", " Surgery:", " See Disease Characteristics" ]

[ "Inclusion Criteria:", " The subject must be female and 18 years of age or older.", " The subject must be a preoperative clinical Tis, T1, T2, T3, T4, as well as clinical N0 and clinical M0 breast cancer", " The subject must have a diagnosis of primary breast cancer.", " The subject must be a candidate for surgical intervention, either with lumpectomy and SLNB or with mastectomy and SLNB, as the treatment of her breast cancer.", " The subject must have an Eastern Cooperative Oncology Group (ECOG) performance status of Grade 0 - 2", " The subject must provide written informed consent with Health Insurance Portability and Accountability Act (HIPAA) authorization before participating in the study", "Exclusion Criteria:", " The subject has clinical or radiological or pathologic evidence of metastatic cancer, including any abnormal or enlarged clinical palpable lymph nodes or core biopsy/surgical biopsy/fine-needle-aspiration evidence of malignant cell within any lymph nodes.", " The subject has a known hypersensitivity to vital blue dye (VBD) in a case where vital blue dye was planned for use during SLNB.", " The subject has a positive pregnancy test or is lactating.", " The subject has had prior surgery to the indicated breast or axilla." ]

[ "Outcome Measurement: ", " Safety and Tolerability in Terms of Number of Patients With Adverse Events (Serious and Non-serious)", " [Not Specified]", " Time frame: 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).", "Results 1: ", " Arm/Group Title: AZD4547 80mg bd Cont + Ex 25mg", " Arm/Group Description: 80 mg AZD4547 BD continuous + 25 mg exemestane", " Overall Number of Participants Analyzed: 5", " Measure Type: Number", " Unit of Measure: Participants 5", "Results 2: ", " Arm/Group Title: AZD4547 40mg Cont + Ex 25mg", " Arm/Group Description: 40 mg AZD4547 BD continuous + 25 mg exemestane", " Overall Number of Participants Analyzed: 5", " Measure Type: Number", " Unit of Measure: Participants 5" ]

[ "DISEASE CHARACTERISTICS:", " Histologically confirmed adenocarcinoma of the breast", " Does not overexpress HER-2/neu, defined as FISH negative or 0, 1+, or 2+ by IHC", " Stage IV disease", " Must not be eligible for therapy of known curative potential for metastatic breast cancer", " Measurable or evaluable disease", " Stable CNS disease allowed provided that it's adequately treated and not under active treatment", " Hormone receptor status not specified", " PATIENT CHARACTERISTICS:", " Menopausal status not specified", " ECOG performance status 0-1", " ANC > 1,000/mm^3", " Platelets > 100,000/mm^3", " Serum bilirubin < 2.0 mg/dL (unless due to Gilbert syndrome)", " AST and ALT < 2 times upper limit of normal (ULN)", " Alkaline phosphatase < 5 times ULN", " Serum creatinine < 2.0 mg/dL", " Ejection fraction normal by MUGA OR 50% by echocardiogram", " Not pregnant or nursing", " Fertile patients must use effective contraception", " HIV negative", " Asthma or chronic obstructive pulmonary disease that does not require daily systemic corticosteroids allowed", " No prior or concurrent autoimmune disease requiring management with systemic immunosuppression, including any of the following:", " Inflammatory bowel disease", " Systemic vasculitis", " Scleroderma", " Psoriasis", " Multiple sclerosis", " Hemolytic anemia or immune-mediated thrombocytopenia", " Rheumatoid arthritis", " Systemic lupus erythematosus", " Sjogren syndrome", " Sarcoidosis", " Other rheumatologic disease", " No other malignancies within the past 5 years, except carcinoma in situ of the cervix, superficial nonmelanoma skin cancer, superficial bladder cancer, or tamoxifen-related endometrial cancer that has been adequately treated", " No active major medical or psychosocial problems that could be complicated by study participation", " No symptomatic intrinsic lung disease or extensive tumor involvement of the lungs resulting in dyspnea at rest", " No uncontrolled medical problems", " No evidence of active acute or chronic infection", " No known severe hypersensitivity to trastuzumab, except mild to moderate infusion reactions that are easily managed and do not recur", " No allergy to corn", " PRIOR CONCURRENT THERAPY:", " See Disease Characteristics", " More than 28 days since prior and no other concurrent chemotherapy, radiation therapy, or biologic therapy (except trastuzumab)", " Concurrent endocrine therapy and supportive therapy with bisphosphonates allowed", " More than 28 days since prior and no other concurrent participation in an investigational new drug trial", " More than 28 days since prior and no other concurrent systemic oral steroids", " Topical, ocular, and nasal steroids allowed", " No prior vaccination with the allogeneic GM-CSF-secreting breast tumor vaccine" ]

[ "Inclusion Criteria:", " Female patients with histologically confirmed adenocarcinoma of the breast or inflammatory breast cancer", " Clinical stage T 1-4, N 0-3, M0", " FISH+ HER2 gene amplified breast cancer", " 18 years or older", " Normal cardiac function", " Performance status 0-2", " Cannot have received any prior chemotherapy for this disease or cannot have received chemotherapy for any other cancer in the past 5 years.", " Previous diagnosis of noninvasive breast cancer is OK.", " Must have adequate bone marrow, renal and liver function.", " Pregnant or lactating females not allowed.", " Preexisting peripheral neuropathy must be equal to or less than grade 1", " Must have archived tumor tissue for tissue testing.", "Exclusion Criteria:", " You cannot be in this study if you any of the following:", " History of cardiac disease, with New York Heart Association Class II or greater with congestive heart failure", " Any heart attack, stroke or TIAs within the last 6 months or serious arrhythmias needing medication; no bleeding diathesis or coagulopathy.", " No prior investigational drug within the last 30 days", " No prior trastuzumab or bevacizumab therapy", " 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." ]

[ "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%)" ]

[ "INTERVENTION 1: ", " Intelligent Breast Exam, iBE", " Single Arm: Additional breast exam by a FDA approved hand-held intelligent breast exam device and a clinical breast exam during their scheduled breast screening appointment. No return visit required for participation.", " intelligent Breast Exam, iBE: A bilateral iBE exam will be performed on the entire breast in addition to a clinical breast exam administered by a trained individual. If the patient is selected to participate in the inter-rater reliability portion of the study, the subject will undergo both the iBE and the clinical breast exams twice sequentially performed by two different separately trained individuals during the same visit." ]

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

[ "INTERVENTION 1: ", " Arm I: Alkaline Water", " Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks. Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.", " alkaline water: Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.", " external beam radiation therapy (EBRT): Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks.", "INTERVENTION 2: ", " Arm II: Distilled Water", " Patients undergo external beam radiation therapy as in arm I. Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy", " distilled water: Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy.", " external beam radiation therapy (EBRT): Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks." ]

[ "Adverse Events 1:", " Total: 5/26 (19.23%)", " Febrile neutropenia 1/26 (3.85%)", " Abdominal pain 0/26 (0.00%)", " Constipation 0/26 (0.00%)", " Nausea 1/26 (3.85%)", " Pancreatitis 1/26 (3.85%)", " Vomiting 2/26 (7.69%)", " Pain 0/26 (0.00%)", " Pneumonia 0/26 (0.00%)", " Urinary tract infection 1/26 (3.85%)", " Lumbar vertebral fracture 1/26 (3.85%)", " Ammonia increased 1/26 (3.85%)", " Hepatic encephalopathy 1/26 (3.85%)", "Adverse Events 2:", " Total: 4/13 (30.77%)", " Febrile neutropenia 1/13 (7.69%)", " Abdominal pain 1/13 (7.69%)", " Constipation 1/13 (7.69%)", " Nausea 0/13 (0.00%)", " Pancreatitis 0/13 (0.00%)", " Vomiting 0/13 (0.00%)", " Pain 1/13 (7.69%)", " Pneumonia 1/13 (7.69%)", " Urinary tract infection 0/13 (0.00%)", " Lumbar vertebral fracture 0/13 (0.00%)", " Ammonia increased 0/13 (0.00%)", " Hepatic encephalopathy 0/13 (0.00%)" ]

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

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

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

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

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

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

[ "Adverse Events 1:", " Total: 6/25 (24.00%)", " Supraventricular extrasystoles 1/25 (4.00%)", " Ventricular extrasystoles 1/25 (4.00%)", " Ascites 2/25 (8.00%)", " Diarrhea 1/25 (4.00%)", " Nausea 1/25 (4.00%)", " Pancreatitis 1/25 (4.00%)", " Small intestinal obstruction 1/25 (4.00%)", " Vomiting 1/25 (4.00%)", " Bile duct obstruction 1/25 (4.00%)", " Portal hypertension 1/25 (4.00%)" ]

[ "Adverse Events 1:", " Total: 6/19 (31.58%)", " Febrile neutropenia [1]1/19 (5.26%)", " Fatigue [1]1/19 (5.26%)", " Pyrexia [1]1/19 (5.26%)", " Fracture [1]1/19 (5.26%)", " Hip Fracture [1]1/19 (5.26%)", " Headache [2]1/19 (5.26%)" ]

[ "Adverse Events 1:", " Total: 1/25 (4.00%)", " Diarrhoea 0/25 (0.00%)", " Breast abscess 0/25 (0.00%)", " Breast cellulitis 0/25 (0.00%)", " Syncope 1/25 (4.00%)", "Adverse Events 2:", " Total: 1/20 (5.00%)", " Diarrhoea 1/20 (5.00%)", " Breast abscess 1/20 (5.00%)", " Breast cellulitis 1/20 (5.00%)", " Syncope 0/20 (0.00%)" ]

[ "Adverse Events 1:", " Total: 0/77 (0.00%)", " Neutropenia [1]0/77 (0.00%)", " Left ventricular dysfunction 0/77 (0.00%)", " Cardiac ischemia 0/77 (0.00%)", " Gastrointestinal pain 0/77 (0.00%)", " Colitis 0/77 (0.00%)", " Febrile neutropenia 0/77 (0.00%)", " Pulmonary/upper respiratory infection 0/77 (0.00%)", " Diverticulitis 0/77 (0.00%)", " Motor neuropathy 0/77 (0.00%)", " Endometrial mucosa thinkening 0/77 (0.00%)", "Adverse Events 2:", " Total: 12/85 (14.12%)", " Neutropenia [1]1/85 (1.18%)", " Left ventricular dysfunction 1/85 (1.18%)", " Cardiac ischemia 2/85 (2.35%)", " Gastrointestinal pain 1/85 (1.18%)", " Colitis 1/85 (1.18%)", " Febrile neutropenia 3/85 (3.53%)", " Pulmonary/upper respiratory infection 1/85 (1.18%)", " Diverticulitis 1/85 (1.18%)", " Motor neuropathy 1/85 (1.18%)", " Endometrial mucosa thinkening 1/85 (1.18%)" ]

[ "INTERVENTION 1: ", " Low Dose Magnesium Oxide (800 mg/Day)", " Week 2:", " Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).", " Week 3:", " Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).", " Weeks 4-9:", " Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).", "INTERVENTION 2: ", " High Dose Magnesium Oxide (1200 mg/Day)", " Week 2:", " Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).", " Week 3:", " Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).", " Weeks 4-9:", " Patients take three 400 mg tablet of magnesium oxide orally (PO) daily (QD)." ]

[ "Adverse Events 1:", " Total: 5/45 (11.11%)", " Neutrophils/granulocytes (ANC/AGC) * [1]0/45 (0.00%)", " Neutrophils/granulocytes (ANC/AGC) * [2]0/45 (0.00%)", " Diabetes decompensation * 0/45 (0.00%)", " Diarrhea * [2]0/45 (0.00%)", " Mucositis/stomatitis and Vomiting * [3]0/45 (0.00%)", " Pancreatitis * [4]1/45 (2.22%)", " Febrile neutropenia * [2]3/45 (6.67%)", "Adverse Events 2:", " Total: 0/46 (0.00%)", " Neutrophils/granulocytes (ANC/AGC) * [1]0/46 (0.00%)", " Neutrophils/granulocytes (ANC/AGC) * [2]0/46 (0.00%)", " Diabetes decompensation * 0/46 (0.00%)", " Diarrhea * [2]0/46 (0.00%)", " Mucositis/stomatitis and Vomiting * [3]0/46 (0.00%)", " Pancreatitis * [4]0/46 (0.00%)", " Febrile neutropenia * [2]0/46 (0.00%)", " Infection pulmonary/ Upper airway NOS * [5]0/46 (0.00%)" ]

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

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

[ "Adverse Events 1:", " Total: 8/44 (18.18%)", " Febrile neutropenia4/44 (9.09%)", " Rectal bleeding1/44 (2.27%)", " Chest pain2/44 (4.55%)", " Fever1/44 (2.27%)", " Catheter site infection1/44 (2.27%)", " Neutrophil count decreased1/44 (2.27%)", " Dizziness1/44 (2.27%)" ]

[ "Adverse Events 1:", " Total: 331/1634 (20.26%)", " Anemia 3/1634 (0.18%)", " Coagulation disorders 1/1634 (0.06%)", " Hemorrhage Vaginal 1/1634 (0.06%)", " Leukopenia 18/1634 (1.10%)", " Lymphadenopathy 0/1634 (0.00%)", " Lymphedema 0/1634 (0.00%)", " Pancytopenia 0/1634 (0.00%)", " Thrombocytopenia 0/1634 (0.00%)", " Arrhythmia 3/1634 (0.18%)", " Arrhythmia Ventricular 0/1634 (0.00%)", " Cardiomyopathy 1/1634 (0.06%)", "Adverse Events 2:", " Total: 520/1635 (31.80%)", " Anemia 5/1635 (0.31%)", " Coagulation disorders 0/1635 (0.00%)", " Hemorrhage Vaginal 0/1635 (0.00%)", " Leukopenia 56/1635 (3.43%)", " Lymphadenopathy 1/1635 (0.06%)", " Lymphedema 2/1635 (0.12%)", " Pancytopenia 1/1635 (0.06%)", " Thrombocytopenia 1/1635 (0.06%)", " Arrhythmia 3/1635 (0.18%)", " Arrhythmia Ventricular 1/1635 (0.06%)", " Cardiomyopathy 0/1635 (0.00%)" ]

[ "Inclusion Criteria:", " Histologically or cytologically confirmed invasive breast cancer, pre-operative stages II-III per AJCC 6th edition, based on baseline evaluation by clinical examination and/or breast imaging", " Cohort 1: At least 2cm of residual disease in sum of diameters by clinical or radiographic findings following their preoperative chemotherapy", " Cohort 2: Patients who have not received preoperative chemotherapy must have at least 4cm of disease in the largest diameter by clinical or radiographic findings", " Prior therapy for Cohort 1 only: Must have completed preoperative (neoadjuvant) chemotherapy with either a standard regimen (containing an anthracycline and/or a taxane) or on a clinical trial", " HER2 positive tumors must have received at least one prior trastuzumab-based therapy, and may not receive concurrent trastuzumab therapy and vaccination", " Must initiate hormonal therapy (if indicated), including ovarian suppression, at least 4 weeks prior to initiation of vaccinations", " Must have completed definitive resection of primary tumor with adequated excision of gross disease. Surgery should have occured more than 28 days but within 12 weeks prior to enrollment", " May receive concurrent hormonal therapy, such as tamoxifen, ovarian suppression, and aromatase inhibitors", " Must have had prior banked tumor of sufficient cellular yield for vaccination", " ECOG Performance Status 0 or 1", " 18 years of age or older", " Greater than 4 weeks from immunotherapy, or systemic glucocorticoid therapy", " Adequate recovery from recent surgery and radiation therapy", "Exclusion Criteria:", " Uncontrolled active infection or illness", " Other medical or psychiatric illness or social situation that would limit study compliance", " Pregnancy or nursing mothers", " Evidence of HIV infection", " Previous participation in an adenovirus-based trial", " Concurrent invasive malignancies" ]

[ "Inclusion Criteria:", " Histologically or cytologically confirmed invasive breast cancer, with stage IV disease", " Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension as greater than or equal to 20mm with conventional techniques or as greater than or equal to 10mm with spiral CT scan.", " Primary tumor or metastasis must overexpress HER2", " Patient must have received 1-2 prior chemotherapeutic regiments for metastatic breast cancer and must have been off treatment for at least three weeks.", " Patient must have received and progressed on at least 1 prior trastuzumab-containing regimen, but not more than 2, in the metastatic setting.", " Patients may have received prior radiation therapy", " Patients may have received hormonal therapy in the adjuvant or metastatic setting", " 18 years of age or older", " Life expectancy of greater than 6 months", " Normal organ and marrow function as defined in the protocol", " Left ventricular ejection fraction (LVEF) greater than or equal to the institutional lower limit of normal", "Exclusion Criteria:", " Treatment with any investigational drug within 4 weeks", " Long-term treatment, over 3 months, with a systemic steroid or another immunosuppressive agent", " Other malignancies within the past 3 years, except for adequately treated carcinoma of teh cervix or basal-or squamous-cell carcinoma of the skin", " Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001", " An active, bleeding diathesis or an oral anti-vitamin K medication", " Prior treatment with an mTOR inhibitor", " History of non-compliance with medical regimens", " Unwillingness or inability to comply with the protocol", " Major surgery within 2 weeks before study entry", " Patients with active brain metastases or leptomeningeal carcinomatosis", " Patients who have experienced grade 1 or grade 2 hypersensitivity reactions to prior trastuzumab therapy are eligible ONLY IF these reactions did not prevent further administration", " Severe and/or uncontrolled intercurrent medical condition, psychiatric illness or a social situation that could limit their ability to comply with the study requirements.", " Pregnant or breast-feeding women", " HIV positive patients", " Known hypersensitivity to RAD001 (everolimus) or other rapamycins" ]

[ "Inclusion Criteria:", " Patients must be female.", " The patient must be greater than/equal to 18 years old", " The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy or limited incisional biopsy.", " Patients must have clinical Stage IIIA, IIIB, or IIIC disease (American Joint Committee on Cancer [AJCC] staging criteria) with a primary breast tumor that is greater than/equal to 2.0 cm measured by clinical exam, unless the patient has inflammatory breast carcinoma, in which case measurable disease is not required.", " Patients must have the ability to swallow oral medication.", " The patient's Eastern Cooperative Oncology Group (ECOG) performance status must be 0 or 1.", " At the time of study entry, blood counts must meet the following criteria:", " Absolute neutrophil count (ANC) must be greater than/equal to 1200/mm3.", " Platelet count must be greater than/equal to 100,000/mm^3.", " Hemoglobin must be greater than/equal to 10 g/dL.", " The following criteria for evidence of adequate hepatic function must be met:", " total bilirubin must be less than/equal to upper limit of normal (ULN) for the lab unless the patient has a grade 1 bilirubin elevation (greater than ULN to 1.5 x ULN) due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin; and", " alkaline phosphatase must be less than 2.5 x ULN for the lab; and", " aspartate aminotransferase (AST) must be less than/equal to 1.5 x ULN for the lab.", " Alkaline phosphatase and AST may not both be greater than the ULN. For example, if the alkaline phosphatase is greater than the ULN but less than/equal to 2.5 x ULN, then the AST must be less than/equal to the ULN. If the AST is greater than the ULN but less than/equal to 1.5 x ULN, then the alkaline phosphatase must be less than/equal to ULN.", " Patients with either skeletal pain or alkaline phosphatase that is greater than ULN but less than/equal to 2.5 x ULN are eligible for inclusion in the study if a bone scan or positron emission tomography (PET) scan does not demonstrate metastatic disease. Patients with suspicious findings on bone scan or PET scan are eligible if suspicious findings are confirmed as benign by x-ray, magnetic resonance imaging (MRI), or biopsy.", " Patients with AST or alkaline phosphatase greater than ULN are eligible for inclusion in the study if liver imaging (computed tomography [CT], MRI, or PET scan) does not demonstrate metastatic disease and adequate hepatic function.", " The following criteria for evidence of adequate renal function must be met:", " Serum creatinine less than/equal to ULN for the lab.", " Calculated creatinine clearance must be greater than 50 mL/min.", " Urine protein/creatinine (UPC) ratio must be less than 1.0.", " Patients must have their left ventricular ejection fraction (LVEF) assessed by multigated acquisition (MUGA) scan or echocardiogram within 3 months prior to study entry. The LVEF must be greater than/equal to the lower limit of normal (LLN) for the cardiac imaging facility performing the MUGA scan or echocardiogram. Note: If the cardiac imaging facility cannot provide a LLN, use 50% as the LLN value.", " Note: Since the pre-entry LVEF serves as the baseline for comparing subsequent LVEF assessments to determine if bevacizumab therapy can be continued following doxorubicin and cyclophosphamide (AC) and postoperatively, it is critical that this baseline study be an accurate assessment of the patient's LVEF. If the baseline LVEF is greater than 65%, the MUGA scan or echocardiogram must be repeated prior to study entry. The lower of the two LVEF values should be used as the baseline LVEF.", " Patients must have an electrocardiogram (EKG) within 3 months prior to study entry.", "Exclusion Criteria:", " Tumor determined to be strongly HER2-positive by immunohistochemistry (3+) or by fluorescent in situ hybridization (positive for gene amplification).", " Excisional biopsy for this primary tumor.", " Synchronous bilateral invasive breast cancer.", " Surgical axillary staging procedure prior to study entry (Exceptions: 1) fine needle aspiration (FNA) of an axillary node is permitted for any patient, and 2) although not recommended, a sentinel lymph node biopsy for patients with clinically negative axillary nodes is permitted.)", " History of any of the following cancers:", " Ipsilateral breast cancer: invasive, ductal carcinoma in situ (DCIS) treated with any therapy other than excision", " Contralateral breast cancer: invasive within the past 5 years (Patients with history of DCIS or synchronous DCIS are eligible)", " History of non-breast malignancies within the 5 years prior to study entry. Patients with the following cancers are eligible if diagnosed and treated within the previous 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.", " Prior therapy with anthracyclines, taxanes, capecitabine, or bevacizumab for any malignancy.", " Treatment including radiation therapy, chemotherapy, biotherapy, and/or hormonal therapy administered for the currently diagnosed breast cancer prior to study entry. The only exception is hormonal therapy, which may have been given for up to a total of 28 days anytime after diagnosis and before study entry. In such a case, hormonal therapy must stop at or before study entry and be re-started, if indicated, following chemotherapy.", " Any of the following cardiac conditions:", " angina pectoris that requires the use of anti-anginal medication;", " history of documented congestive heart failure;", " serious cardiac arrhythmia requiring medication;", " severe conduction abnormality;", " valvular disease with documented cardiac function compromise; or", " uncontrolled hypertension defined as blood pressure greater than 150/90 on antihypertensive therapy. (Patients with hypertension that is well controlled on medication are eligible.)", " History of myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricular (LV) function.", " History of transient ischemic attack (TIA) or cerebrovascular accident (CVA).", " History of other arterial thrombotic event within 12 months before study entry.", " Symptomatic peripheral vascular disease.", " Any significant bleeding within 6 months before study entry.", " Serious or non-healing wound, skin ulcers, or bone fracture.", " Gastroduodenal ulcer(s) determined by endoscopy to be active.", " Invasive procedures defined as follows:", " Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to planned start of study therapy. (Note: Placement of a vascular access device is not considered a major surgical procedure.)", " Anticipation of need for major surgical procedures (other than the required breast surgery) during the course of the study.", " Known bleeding diathesis or coagulopathy. (Patients on warfarin with an in-range international normalized ratio [INR] [usually between 2 and 3] are eligible.)", " Other nonmalignant systemic disease (cardiovascular, renal, hepatic, diabetes, etc.) that would preclude the patient from receiving study treatment or would prevent required follow-up.", " Sensory/motor neuropathy greater than/equal to grade 2, as defined by the NCI's Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0).", " Conditions that would prohibit administration of corticosteroids.", " History of hypersensitivity reaction to drugs formulated with polysorbate 80.", " Therapy with any hormonal agent such as raloxifene, tamoxifen, or other selective estrogen receptor modulator (SERM), either for osteoporosis or breast cancer prevention. Patients are eligible only if these medications are discontinued prior to study entry.", " Any sex hormonal therapy, e.g., birth control pills, ovarian hormonal replacement therapy, etc. These patients are eligible if this therapy is discontinued prior to study entry. (Women of reproductive potential must agree to use an effective non-hormonal method of contraception during study therapy and for at least 3 months after completion of bevacizumab.)", " Pregnancy or lactation at the time of study entry.", " Use of any investigational agent within 4 weeks prior to enrollment in the study.", " Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements." ]

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

[ "INTERVENTION 1: ", " Afatinib Mono", " Afatinib monotherapy administered orally: starting dose 40 mg per day, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg.", "INTERVENTION 2: ", " Afatinib+Vino", " Afatinib 40 mg per day administered orally, continuous treatment, in combination with weekly Vinorelbine 25 mg/m² administered intravenously on days 1, 8, 15 in a 3-weekly course." ]

[ "Outcome Measurement: ", " Percentage of Participants With Overall Pathological Complete Response (pCR) After 26 Weeks of Therapy", " A pCR in the breast was defined as no pathologic evidence of invasive disease (residual ductal carcinoma in situ [DCIS] or lobular carcinoma in situ [LCIS] was allowed). A pCR in the axillary lymph node(s) was defined as no evidence of breast cancer cells in the lymph node (including subcapsular sinus). Overall pCR was defined as the sum of pCR in the breast and pCR in the lymph nodes. 26 weeks of therapy comprised the 2-week run-in phase, 12 weeks of treatment with FEC, and 12 weeks of treatment with Paclitaxel.", " Time frame: Week 26", "Results 1: ", " Arm/Group Title: Trastuzumab", " Arm/Group Description: Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.", " Overall Number of Participants Analyzed: 26", " Measure Type: Number", " Unit of Measure: percentage of participants 54.0", "Results 2: ", " Arm/Group Title: Lapatinib", " Arm/Group Description: Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.", " Overall Number of Participants Analyzed: 29", " Measure Type: Number", " Unit of Measure: percentage of participants 45.0" ]

[ "INTERVENTION 1: ", " Digital Breast Tomosynthesis", " Digital Breast Tomosynthesis + Synthetic Mammography (DBT)", " The DBT was independently read by two radiologists. A consensus meeting decided whether to recall the woman or not.", " Women selected for further assessment (positive screening exam) was recalled.", " Digital Breast Tomosynthesis + Synthetic Mammography: Two-view tomosynthesis performed with GE SenoClaire 3D Breast Tomosynthesis.", "INTERVENTION 2: ", " Digital Mammography", " The digital mammograms was independently read by two radiologists. A consensus meeting decided whether to recall the woman or not.", " Women selected for further assessment (positive screening exam) was recalled.", " Digital mammography: Two-view digital mammography performed with GE SenoClaire 3D Breast Tomosynthesis." ]

[ "INTERVENTION 1: ", " Arm I: Yoga Therapy", " Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs.", "INTERVENTION 2: ", " Arm II: Wait-List", " Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes." ]

[ "Inclusion Criteria:", " Female;", " Histologically proven stage 0-III invasive carcinoma of the breast that is ER and/or PR positive by immunohistochemical staining, who are receiving a standard dose of aromatase inhibitor (AI) therapy (letrozole 2.5mg once daily or exemestane 25mg once daily or anastrozole 1mg once daily). Women with oligometastatic disease may be included at the discretion of the principal investigator. Surgical resection, chemotherapy, and radiation therapy must have been completed at the time of study enrollment, with the exception of trastuzumab;", " AI therapy has been ongoing for 2 weeks and treatment is expected to continue;", " AI-associated musculoskeletal symptoms, defined as:", " Grade 1 or higher musculoskeletal pain that developed or worsened (6 or 7 on CGICS) during AI therapy or", " Grade 1 or higher sensory neuropathy that developed or worsened (6 or 7 on CGICS) during AI therapy;", " Average pain of 4 on the 11-point Likert scale of question #5 of the Brief Pain Inventory;", " ECOG performance status 0-2;", " Willing and able to sign an informed consent document.", "Exclusion Criteria:", " Known hypersensitivity to duloxetine or any of the inactive ingredients;", " New musculoskeletal pain that is due specifically to fracture or traumatic injury;", " Treatment with monoamine oxidase inhibitors (MAO-I) within 14 days of enrollment;", " Concurrent treatment with phenothiazines (including thioridazine), propafenone, flecainide, triptans, MAO-Is, SSRIs, SNRIs, or tricyclic antidepressants;", " Currently primary psychiatric diagnosis (schizophrenia, psychosis) or suicidal ideation, history of bipolar disorder, or seizure disorder;", " Chronic liver disease, end stage renal disease, or creatinine clearance < 30 mL/min as defined by the Cockroft-Gault equation;", " Uncontrolled narrow-angle glaucoma or clinically significant coagulation disorder;", " Pregnant or breast feeding;", " History of alcohol or other substance abuse or dependence within the year prior to enrollment;", " Serious or unstable medical condition that could likely lead to hospitalization during the course of the study or compromise study participation." ]

[ "INTERVENTION 1: ", " Radiotherapy/Supportive Care (A)", " Patients receive radiotherapy and healing touch therapy from a healing-touch therapist once a week for the duration of their radiotherapy", "INTERVENTION 2: ", " Control ARM (B)", " Patients receive radiotherapy and sham healing touch therapy from a sham healing-touch therapist once a week for the duration of their radiotherapy" ]

[ "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." ]

[ "Adverse Events 1:", " Total: 51/486 (10.49%)", " ANEMIA 1/486 (0.21%)", " NEUTROPENIA 4/486 (0.82%)", " FIBRILLATION ATRIAL 1/486 (0.21%)", " ABDOMINAL PAIN 2/486 (0.41%)", " BLOATING 1/486 (0.21%)", " BOWEL PERFORATION 1/486 (0.21%)", " COLITIS 1/486 (0.21%)", " DEHYDRATION 5/486 (1.03%)", " DIARRHEA 5/486 (1.03%)", " GASTRIC INFLAMMATION 1/486 (0.21%)", " NAUSEA 3/486 (0.62%)", " NAUSEA AND VOMITING 1/486 (0.21%)", "Adverse Events 2:", " " ]

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

[ "INTERVENTION 1: ", " Recruitment Population", " Pre-randomization recruitment and enrollment" ]

[ "Adverse Events 1:", " Total: 14/67 (20.90%)", " Febrile Neutropenia * 5/67 (7.46%)", " Anemia * 3/67 (4.48%)", " Neutropenia * 0/67 (0.00%)", " Leukopenia * 0/67 (0.00%)", " Sinus Tachycardia * 0/67 (0.00%)", " Diarrhea * 2/67 (2.99%)", " Nausea * 1/67 (1.49%)", " Vomiting * 1/67 (1.49%)", " Pancreatitis * 1/67 (1.49%)", " Pyrexia * 1/67 (1.49%)", " Bacteremia * 0/67 (0.00%)", " Breast Cellulutis * 0/67 (0.00%)", "Adverse Events 2:", " Total: 5/33 (15.15%)", " Febrile Neutropenia * 0/33 (0.00%)", " Anemia * 0/33 (0.00%)", " Neutropenia * 0/33 (0.00%)", " Leukopenia * 0/33 (0.00%)", " Sinus Tachycardia * 0/33 (0.00%)", " Diarrhea * 0/33 (0.00%)", " Nausea * 1/33 (3.03%)", " Vomiting * 1/33 (3.03%)", " Pancreatitis * 0/33 (0.00%)", " Pyrexia * 1/33 (3.03%)", " Bacteremia * 0/33 (0.00%)", " Breast Cellulutis * 0/33 (0.00%)" ]

[ "INTERVENTION 1: ", " Pertuzumab + Trastuzumab + Taxane", " Participants received pertuzumab and trastuzumab intravenously (IV) plus taxane chemotherapy once of every 3 weeks per treatment cycle until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurred first. Taxane chemotherapy was docetaxel, paclitaxel, or nab-paclitaxel, per the investigator's choice." ]

[ "INTERVENTION 1: ", " Afatinib 50 mg", " Patients received continuous daily dosing with Afatinib 50 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.", "INTERVENTION 2: ", " Lapatinib 1500 mg", " Patients received continuous daily dosing with Lapatinib 1500 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial." ]

[ "Outcome Measurement: ", " Duration in Days of Grade 4 Neutropenia in Chemotherapy Cycle 1", " Eligible subjects were randomized in a 1:1 ratio. Subjects were dosed with either the F 627 20 mg/dose PFS or Neulasta® 6 mg/dose as the study drug in each chemotherapy cycle. Subjects remained in their assigned treatment arm throughout the study. Subjects were dosed subcutaneously (SC) 24 to 28 hours after receiving TC chemotherapy (75 mg/m2 docetaxel + 600 mg/m2 cyclophosphamide) on Day 2 of each chemotherapy cycle that the subject underwent (up to 4 cycles). Grade 4 (severe) neutropenia was defined as ANC <0.5 × 109/L within the first 12 days of chemotherapy.", " Time frame: The first of 4, 21-day chemotherapy cycles (average 3 weeks)", "Results 1: ", " Arm/Group Title: F-627", " Arm/Group Description: F-627, 20 mg fixed dose pre-filled syringe, administered on Day 2 of each of 4 chemotherapy cycles.", " F-627: single dose pre-filled syringe", " Overall Number of Participants Analyzed: 197", " Mean (Standard Deviation)", " Unit of Measure: days 0.2 (0.51)", "Results 2: ", " Arm/Group Title: Neulasta", " Arm/Group Description: 6 mg fixed dose Neulasta , administered on Day 2 of each of 4 chemotherapy cycles", " Neulasta: single dose pre-filled syringe", " Overall Number of Participants Analyzed: 196", " Mean (Standard Deviation)", " Unit of Measure: days 0.2 (0.45)" ]

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

[ "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: 103/1408 (7.32%)", " Anaemia 1/1408 (0.07%)", " Angina pectoris 1/1408 (0.07%)", " Myocardial infarction 1/1408 (0.07%)", " Atrial fibrillation 0/1408 (0.00%)", " Sinus tachycardia 0/1408 (0.00%)", " Tachycardia 0/1408 (0.00%)", " Vertigo 0/1408 (0.00%)", " Diarrhoea 22/1408 (1.56%)", " Vomiting 12/1408 (0.85%)", " Nausea 4/1408 (0.28%)", " Abdominal pain 2/1408 (0.14%)", " Pancreatitis 2/1408 (0.14%)", "Adverse Events 2:", " Total: 85/1408 (6.04%)", " Anaemia 1/1408 (0.07%)", " Angina pectoris 0/1408 (0.00%)", " Myocardial infarction 1/1408 (0.07%)", " Atrial fibrillation 1/1408 (0.07%)", " Sinus tachycardia 1/1408 (0.07%)", " Tachycardia 1/1408 (0.07%)", " Vertigo 1/1408 (0.07%)", " Diarrhoea 1/1408 (0.07%)", " Vomiting 1/1408 (0.07%)", " Nausea 1/1408 (0.07%)", " Abdominal pain 0/1408 (0.00%)", " Pancreatitis 1/1408 (0.07%)" ]

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

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

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

[ "Inclusion Criteria:", " English speaking", " Diagnosis of stage 1-3 histologically confirmed first cancer of the breast", " Reside in a zip code designated as rural by the United States Department of Agriculture Economic Research Service", " Be within the initial 12 months following the end of primary treatment and meet 3 of the following 5 criteria for MetS confirmed via point-of-care testing or documentation in their medical record:", " A large waistline > 35 inches Blood pressure > 130/85; HbA1c of 5.7%-6.4%; Triglyceride levels > 150 mg/dL; HDL cholesterol levels < 50 mg/dL", "Exclusion Criteria:", " Will not exclude participants based on hormone receptivity, one exception is that we will exclude HER2 positive BCS", " Pregnant patients", " Resistant Hypertension", " Steroid-dependent asthma or Chronic obstructive pulmonary disease", " Cirrhosis or hepatic failure", " A major cardiovascular event (e.g., stroke, myocardial infarction) within the previous 90 days", " Chronic kidney disease on renal replacement therapy", " Type one or two diabetes", " Stage 4 cancer; those with a secondary cancer (except for nonmelanomatous skin cancers and carcinoma of the cervix in situ)", " Taking weight loss medications", " Current involvement in a behavioral program", " Neuropsychiatric disorder or dementia" ]

[ "Inclusion Criteria :", " women with primary breast cancer, without ongoing support for substance use.", " An AUDIT-C score >1 or more than one cigarette smoked per day.", " Individuals able to consent to benefit of intervention focused on substance use. (Karnofsky Index >70).", " Exclusion Criteria :", " Patients who currently use substances for which a second-line care is already committed.", " Patients with a Karnofsky index <70." ]

[ "Inclusion Criteria:", " Patients with biopsy-confirmed breast cancer (prior histological documentation is acceptable).", " Patients with measurable skin metastases (chest wall recurrence and/or non-chest wall skin metastases are eligible).", " Skin metastases not suitable for or patient refusing definitive surgical resection and radiation.", " (Cohort 1) Concurrent systemic cancer therapy (hormones, biologics or chemotherapy) is allowed if distant metastases have been non-progressing (stable or responding) on that regimen for > or = 12 weeks and skin metastases are non-responsive (stable or progressing) as assessed by the investigator.", " (Cohort 2) Any concurrent systemic therapy is allowed", " Age at least 18 years.", " Eastern Cooperative Oncology Group (ECOG) performance status < or = 2.", " Patients must have biopsy-accessible tumor (skin metastases) and agree to biopsies required by protocol.", " Patients must have adequate organ and bone marrow function as defined below:", " absolute neutrophil count > or = 1,500/microliter", " hemoglobin > or = 9.5 grams/deciliter", " platelets >or = 75,000/microliter", " total bilirubin < or = 1.5 X institutional upper limit of normal", " Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) < or = 2.5X institutional upper limit of normal", " creatinine < or = 1.5 X institutional upper limit of normal", " Informed consent.", "Exclusion Criteria:", " Brain metastases unless resected or irradiated and stable > or = 8 weeks.", " Treatment with other investigational agents.", " Patients who have received radiotherapy, high-potency corticosteroids, intralesional therapy, laser therapy or surgery other than biopsy to the target area within 4 weeks prior to first dosing of study agent.", " Patients who have received hyperthermia to the target area within 10 weeks prior to first dosing of study agent.", " Patients with an uncontrolled bleeding disorder.", " Patients who will be therapeutically anticoagulated with heparins or coumadin at the time of the biopsy (they are eligible if anticoagulation can be held prior to biopsy as per investigator). Patients on aspirin and other platelet agents are eligible.", " Patients with known immunodeficiency or receiving immunosuppressive therapies.", " History of allergic reactions to imiquimod or its excipients.", " Uncontrolled intercurrent medical illness or psychiatric illness/social situations that would limit compliance with study requirements.", " Pregnancy or lactation.", " Women of childbearing potential not using a medically acceptable means of contraception." ]

[ "Inclusion Criteria:", " Histologically or cytologically confirmed invasive breast carcinoma with locally recurrent or radiological evidence of metastatic disease. Locally recurrent disease must not be amenable to resection with curative intent.", " HER2+ status defined as IHC 3+ staining or in situ hybridization positive", " Patients with resistance to trastuzumab", " Prior taxane therapy", " Patients with an ECOG performance status of 0 - 2", " Patients with measurable disease as per RECIST criteria", " Documentation of negative pregnancy test for patients of child bearing potential prior to enrollment within 7 days prior to randomization. Sexually active pre-menopausal women must use adequate contraceptive measures, excluding estrogen containing contraceptives, while on study;", " Patients must meet laboratory criteria defined in the study within 21 days prior to randomization", "Exclusion Criteria:", " Prior mTOR inhibitors or vinca alkaloid agents for the treatment of cancer", " More than three prior chemotherapy lines for advanced disease.", " Symptomatic CNS metastases or evidence of leptomeningeal disease. Previously treated asymptomatic CNS metastases are allowed provided that the last treatment for CNS metastases was completed >8 weeks prior to randomization", " Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral everolimus", " Peripheral neuropathy grade 2 at randomization", " Active cardiac disease", " History of cardiac dysfunction", " Any malignancy within 5 years prior to randomization, with the exception of adequately treated in-situ carcinoma of the cervix uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer", " Known hypersensitivity to any study medication", " Breastfeeding or pregnant" ]

[ "Adverse Events 1:", " Total: 23/78 (29.49%)", " Febrile neutropenia * 4/78 (5.13%)", " Neutropenia * 1/78 (1.28%)", " Thrombocytopenia * 0/78 (0.00%)", " Acute coronary syndrome * 1/78 (1.28%)", " Cardiac failure congestive * 1/78 (1.28%)", " Myocardial infarction * 1/78 (1.28%)", " Cardiomyopathy * 0/78 (0.00%)", " Abdominal pain * 1/78 (1.28%)", " Diarrhoea * 1/78 (1.28%)", " Upper gastrointestinal haemorrhage * 1/78 (1.28%)", "Adverse Events 2:", " Total: 24/75 (32.00%)", " Febrile neutropenia * 8/75 (10.67%)", " Neutropenia * 3/75 (4.00%)", " Thrombocytopenia * 2/75 (2.67%)", " Acute coronary syndrome * 0/75 (0.00%)", " Cardiac failure congestive * 2/75 (2.67%)", " Myocardial infarction * 0/75 (0.00%)", " Cardiomyopathy * 1/75 (1.33%)", " Abdominal pain * 0/75 (0.00%)", " Diarrhoea * 1/75 (1.33%)", " Upper gastrointestinal haemorrhage * 0/75 (0.00%)" ]

[ "Adverse Events 1:", " Total: 29/30 (96.67%)", " Febrile neutropenia [1]3/30 (10.00%)", " Lymphatics 1/30 (3.33%)", " Diarrhea (without colostomy) 5/30 (16.67%)", " Abdominal pain or cramping 2/30 (6.67%)", " Colitis 1/30 (3.33%)", " Dehydration 1/30 (3.33%)", " Nausea 1/30 (3.33%)", " Stomatitis/pharyngitis (oral/pharyngeal/mucositis) 1/30 (3.33%)", " Vomiting 1/30 (3.33%)", "Adverse Events 2:", " " ]

[ "Outcome Measurement: ", " 1. Progression-free Survival (PFS) According to Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Based on Blinded Independent Central Review (BICR)", " PFS was defined as the time from randomization to progressive disease, or death, whichever occurs first. Response was assessed according to RECIST 1.1 by BICR. According to RECIST 1.1, progressive disease (PD) was defined as a 20% relative increase in the sum of diameters (SOD) of target lesions, taking as reference the nadir SOD and an absolute increase of >5 mm in the SOD, or the appearance of new lesions. PFS was analyzed using the Kaplan-Meier method and median PFS (95% confidence interval [CI]) in weeks was reported for each treatment arm. Per protocol, participants remained on assigned treatment until disease progression. Participants who discontinued study treatment for reasons other than disease progression continued to be assessed by imaging until objective documentation of progression. All participants (including participants who discontinued study treatment) were followed for survival until investigator notification to discontinue.", " Time frame: From Day 1 through last post-study efficacy follow-up (up to ~19 months)", "Results 1: ", " Arm/Group Title: Ridaforolimus + Dalotuzumab + Exemestane", " Arm/Group Description: Participants received ridaforolimus 10 mg orally (PO) every 5 days (QD x 5) plus dalotuzumab 10 mg/kg intravenously (IV) every week (QW) plus exemestane 25 mg PO every day (QD) in 28-day cycles until documented disease progression or unacceptable toxicity.", " Overall Number of Participants Analyzed: 40", " Median (95% Confidence Interval)", " Unit of Measure: Weeks 23.29 (8.71 to 38.43)", "Results 2: ", " Arm/Group Title: Ridaforolimus + Exemestane", " Arm/Group Description: Participants received ridaforolimus 30 mg PO QD x 5 plus exemestane 25 mg PO QD treatment in 28-day cycles until documented disease progression or unacceptable toxicity.", " Overall Number of Participants Analyzed: 40", " Median (95% Confidence Interval)", " Unit of Measure: Weeks 31.86 (16.00 to 39.29)" ]

[ "Adverse Events 1:", " Total: 18/70 (25.71%)", " Cardiac arrest 1/70 (1.43%)", " Pericardial effusion 1/70 (1.43%)", " Ear pain 1/70 (1.43%)", " Blurred vision 1/70 (1.43%)", " Eye disorders - Other, specify 2/70 (2.86%)", " Abdominal Pain 5/70 (7.14%)", " Colitis 1/70 (1.43%)", " Diarrhea 2/70 (2.86%)", " Nausea 2/70 (2.86%)", " Death NOS 1/70 (1.43%)", " Edema limbs 1/70 (1.43%)", " Fatigue 3/70 (4.29%)" ]

[ "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%)" ]

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

[ "DISEASE CHARACTERISTICS:", " Histologically confirmed breast cancer", " Metastatic disease amenable to biopsy", " Unresected tumor with no intention to undergo resection during study", " Archival tissue from the primary diagnosis or fresh biopsy from metastatic cancer site required", " Measurable or non-measurable disease for phase I study (The Phase I portion of this study closed and the Phase II portion of the study opened as per NCCTG Addendum 6, effective January 23, 2012.)", " Measurable disease only for phase II study", " Available tumor estrogen (ER), progesterone (PR), and HER2 status from metastatic site tested by IHC or FISH OR results from the original tumor diagnosis", " Any ER, PR, or HER2 level (positive or negative) acceptable (phase I)", " Triple-negative disease only (phase II)", " ER and PR negative defined as 1% by IHC", " HER2 negative", " Patients with triple-negative breast cancer allowed provided there is clinical or radiographic evidence of tumor progression in the adjuvant or metastatic setting", " No patients whose disease can be treated with known standard therapy that is potentially curative or definitely capable of extending life expectancy", " No known CNS metastasis", " Hormone-receptor status:", " ER and PR positive or negative (phase I)", " ER and PR negative (phase II)", " PATIENT CHARACTERISTICS:", " ECOG performance status 0-1 (phase I) or 0-2 (phase II)", " Postmenopausal defined by 1 of the following:", " 60 years of age", " 45 years of age with last menstrual period 12 months prior and estradiol and follicle-stimulating hormone levels in postmenopausal range", " Bilateral oophorectomy", " Life expectancy 12 weeks", " ANC 1,500/mm^3", " Platelet count 100,000/mm^3", " Total bilirubin normal", " ALT and AST 3 times upper limit of normal (ULN) ( 5 times ULN if due to liver metastasis)", " Serum creatinine 1.5 times ULN", " TSH normal (thyroid hormone supplements allowed for patients with hypothyroidism)", " Not pregnant or nursing", " Fertile patients must use effective contraception", " Willing to return to Mayo Clinic or NCCTG institution (phase II) for follow-up", " Willing to provide blood samples for correlative research purposes", " No uncontrolled or intercurrent illness including, but not limited to, any of the following:", " Ongoing or active infection", " Symptomatic congestive heart failure", " Unstable angina pectoris", " Cardiac arrhythmia", " Psychiatric illness and/or social situations that would limit compliance with study requirements", " No NYHA class III or IV cardiovascular disease", " No known seizure disorder", " No co-morbid systemic illnesses or other severe concurrent disease that, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens", " No immunocompromised patients, including patients known to be HIV positive", " Immunocompromised patients due to the use of corticosteroids allowed", " No malignancy within the past 5 years except for nonmelanoma skin cancer or carcinoma in situ of the cervix", " No history of myocardial infarction 6 months", " No congenital long QT syndrome or QTcF>450 msec, including:", " Complete left bundle block or use of a permanent cardiac pacemaker, history or presence of ventricular tachyarrhythmias, clinically significant resting bradycardia (<50 beats per minute)", " Right bundle branch block + left anterior hemiblock (bifascicular block)", " No congestive heart failure requiring use of maintenance therapy for life-threatening ventricular arrhythmias", " PRIOR CONCURRENT THERAPY:", " See Disease Characteristics", " More than 4 weeks since prior chemotherapy or radiotherapy and fully recovered", " No radiotherapy to > 25 % of bone marrow", " Prior treatments allowed (phase II):", " 0 or 1 prior chemotherapy regimens for breast cancer", " 2 prior aromatase-inhibitor regimens (including letrozole)", " Not currently receiving treatment in a different clinical study in which investigational procedures are performed or investigational therapies are administered", " No other concurrent investigational agent for the primary neoplasm", " No concurrent CYP3A4 inhibitors or inducers" ]

[ "Adverse Events 1:", " Total: 50/198 (25.25%)", " Anaemia 1/198 (0.51%)", " Febrile neutropenia 1/198 (0.51%)", " Leukocytosis 1/198 (0.51%)", " Leukopenia 2/198 (1.01%)", " Neutropenia 1/198 (0.51%)", " Pancytopenia 0/198 (0.00%)", " Atrial fibrillation 0/198 (0.00%)", " Cardiac failure congestive 0/198 (0.00%)", " Palpitations 0/198 (0.00%)", " Pericardial effusion 1/198 (0.51%)", " Supraventricular tachycardia 1/198 (0.51%)", "Adverse Events 2:", " Total: 51/202 (25.25%)", " Anaemia 3/202 (1.49%)", " Febrile neutropenia 2/202 (0.99%)", " Leukocytosis 0/202 (0.00%)", " Leukopenia 0/202 (0.00%)", " Neutropenia 0/202 (0.00%)", " Pancytopenia 1/202 (0.50%)", " Atrial fibrillation 1/202 (0.50%)", " Cardiac failure congestive 1/202 (0.50%)", " Palpitations 1/202 (0.50%)", " Pericardial effusion 1/202 (0.50%)", " Supraventricular tachycardia 1/202 (0.50%)" ]

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

[ "INTERVENTION 1: ", " Part 1: Dose Escalation: Cohort 1", " MM-121 - 20 mg/kg loading dose followed by 12 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV", "INTERVENTION 2: ", " Part 1: Dose Escalation: Cohort 2", " MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV", " Paclitaxel - 80mg/m2 weekly IV" ]

[ "Inclusion Criteria:", " Age > 18 years", " Women with prior histologically documented diagnosis of breast cancer", " Subjects with metastatic disease who have already received and failed at least one chemotherapy regimen for metastatic disease and, if ER/PgR +ve, have failed on at least adjuvant hormonal therapy", " Subjects for whom trastuzumab treatment is not indicated, no longer effective or refused by the subjects", " Four weeks since the last cytotoxic chemotherapy or clear evidence of progression on hormonal therapy", " Subjects who have at least one measurable lesion by CT (Computed Tomography) scan or MRI (Magnetic Resonance Imaging) according to modified WHO Tumour Response Criteria", " Subjects who have an Eastern Co-operative Oncology Group (ECOG) performance status of 0, 1 or 2", " Adequate bone marrow, liver and renal function as assessed by the following laboratory evaluations:", " Hemoglobin > 9.0 g/dl", " Absolute neutrophil count (ANC) > 1,500/mm3", " Platelet count = 100,000/µl", " Total bilirubin =1.5 x the upper limit of normal.", " Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) = 2.5 x upper limit of normal (=5 x upper limit of normal for subjects with liver involvement of their cancer)", " Amylase and lipase = 1.5 x the upper limit of normal", " Serum creatinine = 3.0 x the upper limit of normal", " Prothrombin Time (PT) or International Normalized Ratio (INR) and Partial Thromboplastin Time (PTT) < 1.5 x upper limit of normal (subjects who receive anti-coagulation treatment with an agent such as warfarin or heparin will be allowed to participate provided that no evidence of underlying abnormality in these parameters exists)", " Subjects who give written informed consent prior to any study specific screening procedures with the understanding that the subject has the right to withdraw from the study at any time, without prejudice", " Life expectancy of at least 12 weeks", " Signed informed consent must be obtained prior to any study specific procedures", "Exclusion Criteria:", " Previous malignancy (except for cervical carcinoma in situ, adequately treated basal cell carcinoma, or superficial bladder tumours [Ta, Tis and T1] or other malignancies curatively treated > 2 years prior to entry)", " Congestive heart failure > New York Heart Association (NYHA) Class II", " Cardiac arrhythmia requiring anti-arrhythmic (excluding beta blockers or digoxin)", " Active coronary artery disease or ischaemia", " Active clinically serious bacterial or fungal infections (> grade 2 National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 3)", " Known History of Human Immunodeficiency Virus (HIV) infection or chronic hepatitis B or C", " Metastatic brain or meningeal tumors unless the subject is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry. Also the patient must not be undergoing acute steroid therapy or taper (chronic steroid therapy is acceptable provided that the dose is stable for 1 month prior to and following screening radiographic study)", " Subjects with seizure disorders requiring medication (such as steroid or anti-epileptics)", " History of organ allograft", " Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results", " Known or suspected allergy to the investigational agent", " Any condition that is unstable or which could jeopardize the safety of the subject and his/her compliance in the study. Pregnant or breast-feeding subjects. Women of childbearing potential must have a negative pregnancy test performed within seven days prior to the start of study drug. Women enrolled in this trial must use adequate barrier birth control measures during the course of the trial.", " Excluded therapies include:", " Anti-cancer chemotherapy, hormonal therapy or immunotherapy during the study or within 4 weeks of study entry. Mytomicin or nitroureas should not be given within 6 weeks of study entry", " Significant surgery within 4 weeks prior to the start of study drug", " Any bone marrow transplant or stem cell rescue within 4 months of the start of study drug", " Radiotherapy during the study or within 3 weeks of the start of drug", " Use of biologic response modifiers, such as Granulocyte-Colony Stimulating Factor (G-CSF), within 3 weeks of study entry", " Investigational drug therapy outside of this trial during or within 30 days prior to start of the study drug", " Concomitant treatment with ketoconazole, itraconazole, ritonavir, or use of grapefruit juice", " Prior use of Raf-Kinase Inhibitors (RKI), Methyl Ethyl Ketone (MEK) or farnesyl transferase inhibitors", " Concomitant treatment or use of St. John's Wort", " Prior use of bevacizumab and all other drugs that target Vascular Endothelial Growth Factor (VEGF)/VEGF receptors" ]