Prospective Evaluation of Carvedilol in Prevention of Cardiac Toxicity in Patients with Metastatic HER-2+ Breast Cancer, Phase III
Objective
Primary Objective
To assess whether prophylactic beta blocker therapy with carvedilol compared with no prophylaxis reduces the risk of subsequent cardiac dysfunction in patients with metastatic breast cancer receiving trastuzumab based HER-2 targeted therapy.
Secondary Objectives
To assess whether prophylactic beta blocker therapy with carvedilol compared with no prophylaxis reduces the risk of predefined subsequent cardiac events in patients with metastatic breast cancer receiving trastuzumab based HER-2 targeted therapy.
To evaluate if prophylactic carvedilol compared with no prophylaxis results in a longer time to first interruption of trastuzumab based HER-2 targeted therapy due to either cardiac dysfunction or events.
To assess whether prophylactic beta blocker therapy with carvedilol compared with no prophylaxis reduces the risk of subsequent cardiac dysfunction OR events in this population.
To establish and prospectively collect a predefined panel of baseline core cardiovascular measures and develop a predictive model of cardiac dysfunction (see Section 11.2).
To evaluate the rate of cardiac dysfunction in an observational arm consisting of individuals otherwise eligible for the study except for use of beta blockers, angiotensin receptor blocker (ARB), or angiotensin converting enzyme (ACE) inhibitors for other medical reasons.
To compare the local and central reads of left ventricular ejection fraction (LVEF) and strain and assess if strain changes can predict drop in ejection fraction.
Assess if strain can be used in the community as a marker of cardiotoxicity.
