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NCT03879629 · ClinicalTrials.gov registry record · Phase 2
Treating Breast Cancer Patients Undergoing Trastuzumab Treatment With Carvedilol to Reduce Incidence of Heart Failure
A Phase 2 study of Breast Cancer, sponsored by Mayo Clinic.
- Active
- Registry status
- Phase 2
- Development phase
- 184
- Enrollment target
- 5
- Study locations
NCT03879629: Active Phase 2 study of Breast Cancer, sponsored by Mayo Clinic.
NCT03879629 is a Phase 2 study of Breast Cancer that is active but no longer recruiting, run by Mayo Clinic. The registered enrollment target is 184 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (93% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03879629, a Phase 2 study of Breast Cancer, is active but no longer recruiting, sponsored by Mayo Clinic.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 184 participants
- Enrollment target
- 5
- Study locations
Study Summary
Breast cancer patients undergoing trastuzumab-based HER2-directed therapy are at risk of heart function decline or heart failure symptoms, but it is unknown if, when, and for how long cardiovascular protective strategies, e.g. with a beta-blocker, could help. This study randomly assigns those taking curative-intent trastuzumab-based HER2-directed therapy to the beta-blocker carvedilol-either when significant heart function decline or subtle early signs of heart injury (either by elevation of a cardiac blood biomarker, i.e. cardiac troponin, or by an abnormal heart ultrasound marker, i.e. global longitudinal strain) are noted, or preventatively before beginning trastuzumab-based HER2-directed therapy. This study will further randomly assign those patients on carvedilol to either discontinuation at the end of trastuzumab-based HER2-directed therapy or continuation for another year, providing much needed clinical trial data on what the best strategy ("tactic") for those at risk of cardiotoxicity with trastuzumab-based HER2-directed therapy is.
Primary Outcome
Incidence of heart failure or asymptomatic decline in left-ventricular ejection fraction (LVEF) by \>10% in patients whose LVEF is ≥50% or LVEF drop ≥5% in those with a decrease to \<50% (primary outcome measure)
Conditions Studied
Interventions
- DRUG Carvedilol
Study Locations (5)
Arizona
- Mayo Clinic - Phoenix
Florida
- Mayo Clinic in Florida - Jacksonville
Minnesota
- Mayo Clinic in Rochester - Rochester
Missouri
- Washington University in St. Louis - St Louis
Texas
- MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 184 participants |
| Start Date | 2019-08-21 |
| Est. Completion | 2027-02-28 |
| Phase | Phase 2 |
What the registry record for NCT03879629 still lists
NCT03879629 is an interventional study that assigns participants to a tested intervention. The registered 184 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which Carvedilol is the first listed.
NCT03879629 lists 5 locations in 5 states (Arizona, Florida, Minnesota).
Frequently Asked Questions
What is clinical trial NCT03879629 about?
NCT03879629 is a clinical study titled "Treating Breast Cancer Patients Undergoing Trastuzumab Treatment With Carvedilol to Reduce Incidence of Heart Failure". Breast cancer patients undergoing trastuzumab-based HER2-directed therapy are at risk of heart function decline or heart failure symptoms, but it is unknown if, when, and for how long cardiovascular protective strategies, e.g. with a beta-blocker, could help. This study randomly assigns those taking...
What is the current status of trial NCT03879629?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 184 participants. The study started on 2019-08-21. Estimated completion is 2027-02-28.
What conditions does trial NCT03879629 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT03879629?
The interventions under investigation include: Carvedilol (DRUG).
Who is sponsoring clinical trial NCT03879629?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03879629 being conducted?
This trial has 5 study locations across Arizona, Florida, Minnesota, Missouri, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03879629's enrollment target sits among peer trials
184 400th of 1224 higher than 824 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer 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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