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NCT03418961 · ClinicalTrials.gov registry record · Phase 3
S1501 Dual Observational and Randomized Cohort Study of Patients With Metastatic HER-2+ Breast Cancer at Risk of Cardiac Toxicity
A Phase 3 study of Metastatic Malignant Neoplasm in the Brain and Recurrent Breast Carcinoma, sponsored by SWOG Cancer Research Network.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 491
- Enrollment target
- 20
- Study locations
NCT03418961: Recruiting Phase 3 study of Metastatic Malignant Neoplasm in the Brain and Recurrent Breast Carcinoma, sponsored by SWOG Cancer Research Network.
NCT03418961 is a Phase 3 study of Metastatic Malignant Neoplasm in the Brain and Recurrent Breast Carcinoma that is actively recruiting participants, run by SWOG Cancer Research Network. The registered enrollment target is 491 participants, above the 77-participant average among 43 other Metastatic Malignant Neoplasm in the Brain trials with a reported enrollment target (538% higher). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03418961, a Phase 3 study of Metastatic Malignant Neoplasm in the Brain and Recurrent Breast Carcinoma, is actively recruiting participants, sponsored by SWOG Cancer Research Network.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 491 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Real-time, blinded, central echocardiography (ECHO) read as a decrease in the left ventricular ejection fraction (LVEF) of \>= 10 percentage points from baseline to a value of \< 50% OR decrease of LVEF by \>= 5 percentage points from baseline to LVEF \< 50% in those baselines having a baseline LVEF of 50-54%. The distributions of time to cardiac dysfunction will be described using cumulative incidence estimates, with the statistical significance of treatment arm differences assessed by Cox and
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 |
What NCT03418961 shows while recruiting
NCT03418961 is an interventional study that assigns participants to a tested intervention. The registered 491 participants enrollment target is mid-sized for trials with a published cap, above the 77-participant average among 43 other Metastatic Malignant Neoplasm in the Brain trials with a reported enrollment target (538% higher).
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.
NCT03418961 names 20 study sites across 3 states, led by California, Alaska, Arkansas.
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.
What interventions are being tested in trial NCT03418961?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Carvedilol (DRUG), Patient Observation (OTHER).
Who is sponsoring clinical trial NCT03418961?
This trial is sponsored by SWOG Cancer Research Network, which has 270 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT03418961's enrollment target sits among peer trials
491 1st of 43 higher than 43 of 43 other Metastatic Malignant Neoplasm in the Brain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Malignant Neoplasm in the Brain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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