S1501 Dual Observational and Randomized Cohort Study of Patients With Metastatic HER-2+ Breast Cancer at Risk of Cardiac Toxicity (NCT03418961)
Prospective Observational Cohort Study of Patients With Metastatic HER-2+ Breast Cancer at Risk of Cardiac Toxicity
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Anchorage Associates in Radiation Medicine — Anchorage, Alaska
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (590 Sites)
Showing the first 25 of 590 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
- Katmai Oncology Group — Anchorage, Alaska
- Providence Alaska Medical Center — Anchorage, Alaska
- Fairbanks Memorial Hospital — Fairbanks, Alaska
- CHI Saint Vincent Cancer Center Hot Springs — Hot Springs, Arkansas
- Kaiser Permanente-Deer Valley Medical Center — Antioch, California
- Providence Saint Joseph Medical Center/Disney Family Cancer Center — Burbank, California
- Enloe Medical Center — Chico, California
- City of Hope Comprehensive Cancer Center — Duarte, California
- Epic Care-Dublin — Dublin, California
- Bay Area Breast Surgeons Inc — Emeryville, California
- Epic Care Partners in Cancer Care — Emeryville, California
- Kaiser Permanente-Fremont — Fremont, California
- Fresno Cancer Center — Fresno, California
- Kaiser Permanente-Fresno — Fresno, California
- USC / Norris Comprehensive Cancer Center — Los Angeles, California
- Contra Costa Regional Medical Center — Martinez, California
- City of Hope Mission Hills — Mission Hills, California
- Kaiser Permanente-Modesto — Modesto, California
- City of Hope Newport Beach — Newport Beach, California
- Alta Bates Summit Medical Center - Summit Campus — Oakland, California
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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- Cardiotoxicity Assessment Through Comprehensive Heart Imaging to Predict Heart Failure — San Diego, California
Explore by condition: All Cardiotoxicity clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.