RecruitingCardiotoxicityHER2/Neu PositiveMetastatic Malignant Neoplasm in the Brain

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

Eligible age

18+ yrs

Accepts

All genders

Locations

42 states

Healthy volunteers

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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.

Sponsor: SWOG Cancer Research Network

You may qualify if…

✓ STEP 1 REGISTRATION
✓ Patients must:
✓ 1. Have metastatic breast cancer, AND
✓ 2. Be initiating within 11 calendar days of Step 1 Registration OR be continuing trastuzumab-based HER-2 targeted therapy without concurrent anthracyclines, AND
✓ 3. Be receiving the trastuzumab-based HER-2 targeted therapy for metastatic disease in first, second, third-, or fourth-line setting. Patients may have brain metastasis. There is no limit for number of doses of HER-2 targeted therapy prior to registration.
✓ Examples of eligible HER-2 targeted therapy:
✓ Trastuzumab or a trastuzumab biosimilar
✓ Trastuzumab + chemotherapy or hormonal therapy