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S1501 Dual Observational and Randomized Cohort Study of Patients With Metastatic HER-2+ Breast Cancer at Risk of Cardiac Toxicity
NCT03418961 · View on ClinicalTrials.gov ↗
Study 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. 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.
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Carvedilol
- OTHER Patient Observation
Study Locations (20)
California
- Kaiser Permanente-Deer Valley Medical Center — Antioch
- Providence Saint Joseph Medical Center/Disney Family Cancer Center — Burbank
- Enloe Medical Center — Chico
- City of Hope Comprehensive Cancer Center — Duarte
- Epic Care-Dublin — Dublin
- Bay Area Breast Surgeons Inc — Emeryville
- Epic Care Partners in Cancer Care — Emeryville
- Kaiser Permanente-Fremont — Fremont
- Fresno Cancer Center — Fresno
- Kaiser Permanente-Fresno — Fresno
- USC / Norris Comprehensive Cancer Center — Los Angeles
Alaska
- Anchorage Associates in Radiation Medicine — Anchorage
- Alaska Breast Care and Surgery LLC — Anchorage
- Alaska Oncology and Hematology LLC — Anchorage
- Alaska Women's Cancer Care — Anchorage
- Anchorage Oncology Centre — Anchorage
- Katmai Oncology Group — Anchorage
- Providence Alaska Medical Center — Anchorage
- Fairbanks Memorial Hospital — Fairbanks
Arkansas
- CHI Saint Vincent Cancer Center Hot Springs — Hot Springs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 491 participants |
| Start Date | 2017-11-01 |
| Est. Completion | 2027-09-15 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03418961
The ClinicalTrials.gov registry entry for NCT03418961 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 491 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SWOG Cancer Research Network, which has 212 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 5 conditions, with Metastatic Malignant Neoplasm in the Brain appearing as the primary indexed condition, and to 3 interventions — of which Laboratory Biomarker Analysis is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03418961 reports 20 study locations spanning 3 distinct geographic areas — top geographies include California, Alaska, Arkansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03418961 about?
NCT03418961 is a clinical study titled "S1501 Dual Observational and Randomized Cohort Study of Patients With Metastatic HER-2+ Breast Cancer at Risk of Cardiac Toxicity". 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 (current...
What is the current status of trial NCT03418961?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 491 participants. The study started on 2017-11-01. Estimated completion is 2027-09-15.
What conditions does trial NCT03418961 study?
This clinical trial studies the following conditions: Metastatic Malignant Neoplasm in the Brain, Recurrent Breast Carcinoma, Stage IV Breast Cancer AJCC v6 and v7, Cardiotoxicity, HER2/Neu Positive. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03418961?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Carvedilol (DRUG), Patient Observation (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03418961?
This trial is sponsored by SWOG Cancer Research Network, which has 212 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03418961 being conducted?
This trial has 20 study locations across Alaska, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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