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ACTIVE NOT RECRUITING
NCT03879629
PHASE2

Treating Breast Cancer Patients Undergoing Trastuzumab Treatment With Carvedilol to Reduce Incidence of Heart Failure

Sponsor: Mayo Clinic

View on ClinicalTrials.gov

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.

Official title: TrAstuzumab Cardiomyopathy Therapeutic Intervention With Carvedilol (TACTIC) Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

184

Start Date

2019-08-21

Completion Date

2027-02-28

Last Updated

2025-11-20

Healthy Volunteers

No

Conditions

Interventions

DRUG

Carvedilol

oral Carvedilol maximally tolerated doses 3.125 mg to 25 mg twice a day

Locations (5)

Mayo Clinic

Phoenix, Arizona, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Washington University in St. Louis

St Louis, Missouri, United States

MD Anderson Cancer Center

Houston, Texas, United States