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Treating Breast Cancer Patients Undergoing Trastuzumab Treatment With Carvedilol to Reduce Incidence of Heart Failure
Sponsor: Mayo Clinic
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
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