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

Summary

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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

• Cardiotoxicity
• HER2/Neu Positive
• Metastatic Malignant Neoplasm in the Brain
• Recurrent Breast Carcinoma
• Stage IV Breast Cancer AJCC v6 and v7

Eligibility basics and study details

Study type

Interventional

Phase

Phase 3

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Sponsor

SWOG Cancer Research Network

Last updated on ClinicalTrials.gov

October 8, 2025

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites