TrAstuzumab Cardiomyopathy Therapeutic Intervention With Carvedilol

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.

Intervention

Carvedilol

Condition

Breast Cancer

Investigators

Joerg Herrmann, Carolyn Larsen, M.D., Katherine Ruddy, MD, Joerg Herrmann, MD

See list of participating sites