This phase I trial studies the side effects and best dose of carvedilol in reducing the risk of cardiotoxicity in patients with stage I-III breast cancer who are being treated with doxorubicin and/or trastuzumab. Some cancer treatments can cause damage to the heart. A risk calculator has been developed to predict the likelihood that this damage (called cardiotoxicity) will be experienced. This study is being conducted to test whether this calculator can be used to identify patients who may benefit from medicines to protect the heart and to test whether a medicine, called carvedilol, can be used to protect the heart during chemotherapy for patients who are identified as being at elevated risk.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04023110.
PRIMARY OBJECTIVES:
I. To determine feasibility and safety/tolerability.
SECONDARY OBJECTIVES:
I. To prospectively validate our cardiotoxicity (CTX) risk score.
II. To explore the impact of a risk-guided cardioprotective treatment strategy with carvedilol, as compared to usual care, on measures of cardiovascular (CV) function and stress, derived from echocardiography and blood biomarkers, and on clinical heart failure.
OUTLINE: This is a dose-escalation study. Patients are randomized to 1 of 2 arms.
ARM I: Beginning day 1 of standard of care chemotherapy, patients receive carvedilol orally (PO) twice daily (BID) for 12 months in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive usual care.
After completion of study, patients are followed up at 30 days (carvedilol arm only) and 24 months.
Lead OrganizationUniversity of Pennsylvania/Abramson Cancer Center
Principal InvestigatorBonnie Ky