A Phase II Study to See if Carvedilol Can Help Prevent Heart Function Problems in Women Receiving Anthracyclines or Anti-HER2 Therapies for Breast Cancer

Protocol
14-099
Full Title
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
Phase
II
Purpose

Anthracycline drugs (such as doxorubicin) and anti-HER2 therapies (such as trastuzumab) are commonly used to treat women with breast cancer. However, these medications can cause abnormal heart function. Strain imaging is a new method of monitoring heart function in cancer patients and uses ultrasound. In this study, researchers want to see if strain imaging is useful for monitoring heart function during breast cancer treatment.

Researchers also want to see if the drug carvedilol can protect heart function in women receiving anthracycline and anti-HER2 therapies for breast cancer. Carvedilol is a drug called a beta blocker and is already used to treat heart failure and high blood pressure. The patients in this study who show decreased “strain” on an ultrasound of the heart, which may indicate an increased risk of cardiac side effects from cancer treatment, will be randomly assigned to receive carvedilol or a placebo. The investigators will see if carvedilol can protect heart function and prevent interruption of breast cancer treatment. They’ll also do blood tests to see if they can identify markers that will indicate which patients are most likely to benefit from carvedilol.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must be women with stage I-III breast cancer who are receiving an anthracycline drug followed by anti-HER2 therapy as part of their treatment.
  • Patients may not already be taking a beta blocker before entering the study.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Anthony Yu at 212-639-7932.

Disease(s)
Breast Cancer
Locations
Related Diseases