OncoMatch/Clinical Trials/NCT03418961
S1501 Dual Observational and Randomized Cohort Study of Patients With Metastatic HER-2+ Breast Cancer at Risk of Cardiac Toxicity
Is NCT03418961 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Carvedilol for cardiotoxicity.
Treatment: Carvedilol — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) overexpression
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ZUBROD 0–2
Prior therapy
Must have received: HER2-targeted therapy (trastuzumab, trastuzumab biosimilar, pertuzumab, lapatinib, tucatinib, ado-trastuzumab, fam-trastuzumab deruxtecan) — metastatic
Be initiating within 11 calendar days of Step 1 Registration OR be continuing trastuzumab-based HER-2 targeted therapy without concurrent anthracyclines
Cannot have received: HER2-targeted therapy without trastuzumab (lapatinib)
Patients on lapatinib without trastuzumab are not eligible
Cannot have received: HER2-targeted therapy with concurrent anthracyclines
Planned treatment with concurrent HER-2 targeted therapy and anthracyclines is not permitted
Lab requirements
Kidney function
Patients must not be dialysis dependent
Liver function
Serum bilirubin < 3.0 x institutional upper limit of normal (IULN); AST and ALT < 5.0 x IULN
Cardiac function
LVEF >= 50% by echocardiogram (2D or 3D) within 28 days prior to registration; central review required
Patients must have LVEF >= 50% echocardiogram (2D or 3D) within 28 days prior to registration. The echocardiogram must be obtained from a S1501 validated ECHO laboratory (lab) and submitted for central review by the S1501 ECHO core lab.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Anchorage Associates in Radiation Medicine · Anchorage, Alaska
- Alaska Breast Care and Surgery LLC · Anchorage, Alaska
- Alaska Oncology and Hematology LLC · Anchorage, Alaska
- Alaska Women's Cancer Care · Anchorage, Alaska
- Anchorage Oncology Centre · Anchorage, Alaska
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify