TrAstuzumab Cardiomyopathy Therapeutic Intervention With Carvedilol

Major Program
Supportive Care and Symptom Management
Research Group
Community Oncology and Prevention Trials
Mayo Clinic
Recruiting ID
For more information, see NCT03879629
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.
Breast Cancer
Joerg Herrmann, Katherine Ruddy, MD, Joerg Herrmann, MD, Joshua Mitchell, M.D., Anita Deswal, M.D., Clinical Trials Referral Office

See list of participating sites