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, Carolyn Larsen, M.D., Katherine Ruddy, MD, Joerg Herrmann, MD, Joshua Mitchell, M.D., Anita Deswal, M.D.

See list of participating sites