Carvedilol for the Prevention of Anthracycline/Anti-HER2 Therapy Associated Cardiotoxicity Among Women With HER2-Positive Breast Cancer Using Myocardial Strain Imaging for Early Risk Stratification

• Status: Completed
• Trial end date: 2021-06-24
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to find out the effects, good and/or bad, of a beta blocker (carvedilol) on heart function during treatment with anti-HER2 medication(s) including trastuzumab (Herceptin).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Treatments: Carvedilol

Criteria

Inclusion Criteria:

• Female

• Age ≥ 18 years

• Non-metastatic histologically confirmed primary invasive breast carcinoma

• Pathologically confirmed HER2-positive breast cancer

• Scheduled to receive anthracycline chemotherapy followed by anti-HER2 therapy at MSKCC

• Able and willing to provide informed consent

• Willing and able to comply with the requirements of the protocol

• Able to swallow capsules

For Aim 2, all patients must meet the following criteria:

• Meet all inclusion criteria above

• LVEF > 50%

• Abnormal global longitudinal strain (<19%, or a % decrease of ≥ 11% from baseline) prior to initiation of planned anti-HER2 therapy

• Heart rate ≥ 50 beats per minute

• Sitting systolic blood pressure > 90 mmHg

Exclusion Criteria:

• Patients are to be excluded from randomization for Aim 2 of this study if they meet any of the following criteria:

• Current treatment with ACE-inhibitors or beta blockers

• Allergies or inability to tolerate beta blockers previously due to bradycardia, hypotension, or AV block.

• Known history of NCI CTCAE (Version 4.0) Grade ≥ 2 symptomatic CHF, myocardial infarction within 12 months prior to randomization, significant symptoms (Grade ≥ 3) relating to left ventricular dysfunction, significant (moderate or severe) valvular disease, or significant cardiac arrhythmia (Grade ≥ 3)

• Pre-menopausal women without a negative serum or urine pregnancy test within 4 weeks of starting treatment

• Enrollment in a therapeutic intervention trial in the Breast Medicine service