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Study identifier: NCT03418961 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

S1501 Dual Observational and Randomized Cohort Study of Patients With Metastatic HER-2+ Breast Cancer at Risk of Cardiac Toxicity

Condition: Cardiotoxicity · HER2/Neu Positive · Metastatic Malignant Neoplasm in the Brain  ·  Sponsor: SWOG Cancer Research Network

PhasePhase 3
Planned participants491
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

This trial has two cohorts of patients with human epidermal growth factor receptor (HER)-2-positive breast cancer that has spread to other places in the body. All patients must be receiving trastuzumab-based treatment. Both cohorts are being observed for cardiac toxicity. The largest cohort (currently open to accrual) is observational, and contains patients who are taking a beta blocker, ACE inhibitor, or ARB as well as their trastuzumab-based treatment. The goal is to understand how common cardiac problems are in this group of patients at high risk. The smaller cohort (currently closed to accrual) is randomized. Patients in this second cohort are randomized to either carvedilol or no treatment, with the goal of seeing whether carvedilol (used to treat heart failure and high blood pressure) may prevent the heart from side effects of chemotherapy.

This description comes directly from the study's public registry record.

Talk to the study team

Contact details are listed per location below or on the registry record.

Always discuss trial participation with your own doctor first.

Locations (590)

Anchorage Associates in Radiation MedicineAnchorage, Alaska, United StatesSuspended
Alaska Breast Care and Surgery LLCAnchorage, Alaska, United StatesSuspended
Alaska Oncology and Hematology LLCAnchorage, Alaska, United StatesSuspended
Alaska Women's Cancer CareAnchorage, Alaska, United StatesSuspended
Anchorage Oncology CentreAnchorage, Alaska, United StatesSuspended
Katmai Oncology GroupAnchorage, Alaska, United StatesSuspended
Providence Alaska Medical CenterAnchorage, Alaska, United StatesSuspended
Fairbanks Memorial HospitalFairbanks, Alaska, United StatesSuspended
CHI Saint Vincent Cancer Center Hot SpringsHot Springs, Arkansas, United StatesSuspended
Kaiser Permanente-Deer Valley Medical CenterAntioch, California, United StatesActive Not Recruiting
Providence Saint Joseph Medical Center/Disney Family Cancer CenterBurbank, California, United StatesSuspended
Enloe Medical CenterChico, California, United StatesActive Not Recruiting

+ 578 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT03418961