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

NCT03879629 PHASE2 ACTIVE_NOT_RECRUITING

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.

Details

Lead sponsor	Mayo Clinic
Phase	PHASE2
Status	ACTIVE_NOT_RECRUITING
Enrolment	184
Start date	Wed Aug 21 2019 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Sun Feb 28 2027 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Breast Cancer

Interventions

• Carvedilol

Countries

United States