Overview

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