Prospective Evaluation of Carvedilol in Prevention of Cardiac Toxicity in Patients with Metastatic HER-2+ Breast Cancer, Phase III

To assess whether prophylactic beta blocker therapy with carvedilol compared with no intervention reduces the risk of subsequent cardiac dysfunction in patients with metastatic breast cancer receiving trastuzumab-based HER-2 targeted therapy.

Are you Eligible? (Inclusion Criteria)

• Patients must have metastatic breast cancer. There is no limit for number of doses of HER-2 targeted therapy prior to registration.
• Patients must be at increased risk for cardiotoxicity.
• Patients must not have taken within 21 days prior to Step 1 Registration, be currently taking at the time of Step 1 Registration, or planning to take once registered to Step 1 a beta blocker, ARB, or ACE inhibitor.
• Patients currently taking a beta blocker, ARB, or ACE inhibitor at the time of Step 1 Registration are eligible to register for the non-randomized observational cohort (Arm 3).
• Patients must be 18 years of age or older.