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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.

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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.

Conditions Studied

Breast Cancer

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

FieldValue
Enrollment Target 184 participants
Start Date 2019-08-21
Est. Completion 2027-02-28
Phase Phase 2

Sponsor

Mayo Clinic

2,844 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03879629

The ClinicalTrials.gov registry entry for NCT03879629 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 184 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (93% lower). The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.

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 reports 5 study locations spanning 5 distinct geographic areas - top geographies include 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.

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Read our methodology - how this data is sourced, computed, and verified.
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.