Patients not taking beta blocker, ARB, or ACE inhibitor at registration receive carvedilol PO BID. Courses repeat every 12 weeks for 108 weeks in the absence of disease progression or unacceptable toxicity.

Patients not taking beta blocker, ARB, or ACE inhibitor at registration receive no study intervention for up to 108 weeks.

Patients undergo observation for up to 108 weeks.

Cardiotoxicity

HER2/Neu Positive

Metastatic Malignant Neoplasm in the Brain

Recurrent Breast Carcinoma

Stage IV Breast Cancer AJCC v6 and v7

Carvedilol

Laboratory Biomarker Analysis

Patient Observation

Anchorage Associates in Radiation Medicine

Alaska Breast Care and Surgery LLC

Alaska Oncology and Hematology LLC

Alaska Women's Cancer Care

Anchorage Oncology Centre

Katmai Oncology Group

Providence Alaska Medical Center

Fairbanks Memorial Hospital

CHI Saint Vincent Cancer Center Hot Springs

Kaiser Permanente-Deer Valley Medical Center

Providence Saint Joseph Medical Center/Disney Family Cancer Center

Enloe Medical Center

City of Hope Comprehensive Cancer Center

Epic Care-Dublin

Bay Area Breast Surgeons Inc

Epic Care Partners in Cancer Care

Kaiser Permanente-Fremont

Fresno Cancer Center

Kaiser Permanente-Fresno

USC / Norris Comprehensive Cancer Center

Contra Costa Regional Medical Center

City of Hope Mission Hills

Kaiser Permanente-Modesto

Alta Bates Summit Medical Center - Summit Campus

Bay Area Tumor Institute

Kaiser Permanente Oakland-Broadway

Kaiser Permanente-Oakland

Kaiser Permanente-Rancho Cordova Cancer Center

City of Hope Rancho Cucamonga

Kaiser Permanente-Redwood City

Kaiser Permanente-Richmond

Rohnert Park Cancer Center

Kaiser Permanente-Roseville

The Permanente Medical Group-Roseville Radiation Oncology

University of California Davis Comprehensive Cancer Center

Kaiser Permanente-South Sacramento

South Sacramento Cancer Center

Kaiser Permanente - Sacramento

Kaiser Permanente-San Francisco

Kaiser Permanente-Santa Teresa-San Jose

Kaiser Permanente San Leandro

Kaiser Permanente-San Rafael

Kaiser San Rafael-Gallinas

Kaiser Permanente Medical Center - Santa Clara

Kaiser Permanente-Santa Rosa

City of Hope South Pasadena

Kaiser Permanente Cancer Treatment Center

Kaiser Permanente-South San Francisco

Kaiser Permanente-Stockton

Kaiser Permanente Medical Center-Vacaville

Kaiser Permanente-Vallejo

Kaiser Permanente-Walnut Creek

Penrose-Saint Francis Healthcare

Rocky Mountain Cancer Centers-Penrose

Kaiser Permanente-Franklin

Porter Adventist Hospital

SCL Health Saint Joseph Hospital

Mercy Medical Center

Southwest Oncology PC

Mountain Blue Cancer Care Center

Good Samaritan Medical Center

Kaiser Permanente-Rock Creek

Rocky Mountain Cancer Centers-Lakewood

Saint Anthony Hospital

Littleton Adventist Hospital

Kaiser Permanente-Lone Tree

Longmont United Hospital

Rocky Mountain Cancer Centers-Longmont

Parker Adventist Hospital

Rocky Mountain Cancer Centers-Parker

Saint Mary Corwin Medical Center

Rocky Mountain Cancer Centers - Pueblo

Rocky Mountain Cancer Centers-Thornton

Middlesex Hospital

Stamford Hospital/Bennett Cancer Center

Beebe Medical Center

Delaware Clinical and Laboratory Physicians PA

Helen F Graham Cancer Center

Medical Oncology Hematology Consultants PA

Regional Hematology and Oncology PA

Christiana Care Health System-Christiana Hospital

Beebe Health Campus

Nanticoke Memorial Hospital

Christiana Care Health System-Wilmington Hospital

Broward Health Medical Center

Moffitt Cancer Center

Cleveland Clinic-Weston

Emory University Hospital Midtown

Emory University Hospital/Winship Cancer Institute

Emory Saint Joseph's Hospital

Northside Hospital

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

Low Country Cancer Care Associates PC

Summit Cancer Care-Candler

Hawaii Oncology Inc-Pali Momi

Pali Momi Medical Center

The Cancer Center of Hawaii-Pali Momi

Hawaii Cancer Care Inc-POB II

Hawaii Oncology Inc-POB I

Island Urology

S1501 Carvedilol in Preventing Cardiac Toxicity in Patients With Metastatic HER-2-Positive Breast Cancer

Prospective Evaluation of Carvedilol in Prevention of Cardiac Toxicity in Patients With Metastatic HER-2+ Breast Cancer, Phase III

Real-time, blinded, central echocardiography (ECHO) read as a decrease in the left ventricular ejection fraction (LVEF) of >= 10 percentage points from baseline to a value of < 50% OR decrease of LVEF by >= 5 percentage points from baseline to LVEF < 50% in those baselines having a baseline LVEF of 50-54%. The distributions of time to cardiac dysfunction will be described using cumulative incidence estimates, with the statistical significance of treatment arm differences assessed by Cox and Fine-Gray regression models with adjustment for stratification factors. Gray's test will also be applied

Adverse events associated with beta blocker treatment will be assessed.

The distributions of time to interruption of trastuzumab-based therapy will be described using cumulative incidence estimates, with the statistical significance of treatment arm differences assessed by Cox and Fine-Gray regression models with adjustment for stratification factors. Gray?s test will also be applied to the primary endpoint to assess whether the results are sensitive to different model assumptions.

Will compare rate of death from competing causes between treatment arms via Cox regression to evaluate whether those rates impact the primary analysis comparison.

any of the following treating physician documented events requiring hospitalization or medical treatment, and subsequent temporary or permanent discontinuation of trastuzumab- based HER-2 targeted therapy: arrhythmia, unstable angina, non-ST segment elevated myocardial infarction, myocardial infarction, or congestive heart failure.

Patients on the active arm will be asked to record study drug consumption on a monthly intake calendar. Amount of study drug taken among patients randomized to the active arm and study drug adoption among patients randomized to the no intervention arm (i.e., contamination) will be recorded by study site staff on a case report form at each follow-up visit to assess the sensitivity of the primary treatment effect to observed conditions.

Southwest Oncology Group

National Cancer Institute (NCI)

cardiotoxicity

proline

cardiotoxicity/proline

S1501 Carvedilol in Preventing Cardiac Toxicity in Patients With Metastatic HER-2-Positive Breast Cancer

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