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

Recruiting now · Phase 3

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

In brief

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.

Key facts

Study ID

NCT03418961

Run by

SWOG Cancer Research Network

People needed

491

Starts

2017-11-01

Expected to finish

2027-09-15

Last updated by the study team

2025-10-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• STEP 1 REGISTRATION
• Patients must:
• Have metastatic breast cancer, AND
• Be initiating within 11 calendar days of Step 1 Registration OR be continuing trastuzumab-based HER-2 targeted therapy without concurrent anthracyclines, AND
• 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
• Trastuzumab + other HER-2 targeted agent with or without chemotherapy (such as pertuzumab, lapatinib, and tucatinib)
• Ado-trastuzumab (Kadcyla®)
• Fam-trastuzumab deruxtecan (Enhertu) NOTE: Patients on lapatinib without trastuzumab are not eligible. Planned treatment with concurrent HER-2 targeted therapy and anthracyclines is not permitted.
• Patients must be at increased risk for cardiotoxicity defined by at least one of the following:
• Previous anthracycline exposure OR
• 1 or more of the following risk factors for heart disease:
• LVEF 50-54% by local ECHO read*
• Age ≥ 65
• BMI ≥ 30 kg/m2
• Current or prior anti-hypertensive therapy
• Diagnosis of coronary artery disease (CAD)
• Diagnosis of diabetes mellitus
• Diagnosis of atrial fibrillation/flutter Note: ECHO can be performed at any time prior to registration with the most recent being sent.
• Patients must not have taken within 21 days prior to Step 1 Registration, be currently taking at the time of Step 1 Registration or planning to take once registered to Step 1 a beta blocker, ARB, or ACE inhibitor, in order to be randomized (Arms 1 and 2).
• Patients enrolling in the observational cohort (Arm 3) must be currently taking a beta blocker, ARB, or ACE inhibitor at the time of Step 1 Registration.
• Patients must have a Zubrod Performance status of 0-2
• Patients must have a complete physical examination and medical history within 28 days prior to registration

Where it is running

• Lewis Cancer and Research Pavilion at Saint Joseph's/Candler — Savannah, Georgia, United States (enrolling)
• Cancer Care Center of O'Fallon — O'Fallon, Illinois, United States (enrolling)
• Moffitt Cancer Center — Tampa, Florida, United States (enrolling)
• Northeast Georgia Medical Center-Gainesville — Gainesville, Georgia, United States (enrolling)
• Saint Alphonsus Cancer Care Center-Nampa — Nampa, Idaho, United States (enrolling)
• Loyola University Medical Center — Maywood, Illinois, United States (enrolling)
• City of Hope Upland — Upland, California, United States (enrolling)
• Beebe Health Campus — Rehoboth Beach, Delaware, United States (enrolling)
• Cleveland Clinic-Weston — Weston, Florida, United States (enrolling)
• Northside Hospital — Atlanta, Georgia, United States (enrolling)
• Saint Alphonsus Cancer Care Center-Boise — Boise, Idaho, United States (enrolling)
• City of Hope Comprehensive Cancer Center — Duarte, California, United States (enrolling)
• John H Stroger Jr Hospital of Cook County — Chicago, Illinois, United States (enrolling)
• Decatur Memorial Hospital — Decatur, Illinois, United States (enrolling)
• City of Hope South Pasadena — South Pasadena, California, United States (enrolling)
• City of Hope South Bay — Torrance, California, United States (enrolling)
• Bayhealth Hospital Kent Campus — Dover, Delaware, United States (enrolling)
• Beebe South Coastal Health Campus — Frankford, Delaware, United States (enrolling)
• USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States (enrolling)
• Contra Costa Regional Medical Center — Martinez, California, United States (enrolling)
• City of Hope Mission Hills — Mission Hills, California, United States (enrolling)
• Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia, United States (enrolling)
• City of Hope Newport Beach — Newport Beach, California, United States (enrolling)
• Lewis Hall Singletary Oncology Center — Thomasville, Georgia, United States (enrolling)
• Franciscan Health Indianapolis — Indianapolis, Indiana, United States (enrolling)

Full record on ClinicalTrials.gov

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