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

Completed · Phase 2 · Has a placebo group

Conditions studied: Breast Cancer

In brief

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).

Key facts

Study ID

NCT02177175

Run by

Memorial Sloan Kettering Cancer Center

People needed

82

Starts

2014-06-24

Expected to finish

2021-06-24

Last updated by the study team

2022-07-12

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Memorial Sloan Kettering West Harrison — Harrison, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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