Myocardial Structural, Functional, and Metabolic Changes in Women Undergoing Breast Cancer Chemotherapy

Condition/Intervention:

  • Myocardial structural, functional, and metabolic changes

Study Name:

Myocardial Structural, Functional, and Metabolic Changes in Women Undergoing Breast Cancer Chemotherapy

Phase:

Pilot

Summary:  

The purpose of this study is to examine the early effects of chemotherapy on the heart in women who are undergoing treatment for breast cancer. Women who are treated for breast cancer are at risk of heart problems for various reasons. One reason is that chemotherapy and radiation therapy aimed to kill breast cancer cells can cause changes in the heart. The ultimate goal is to develop preventive and therapeutic strategies that will protect the myocardium (muscular tissue of the heart) from injury during breast cancer treatment.

The study will utilize a gadolinium-based contrast agent which has been approved by the Food and Drug Administration (FDA) but is considered experimental for use in this study due to the higher dose.

Key Inclusion Criteria:

  • Women from diverse racial/ethnic groups
  • Competent to give informed consent
  • Diagnosed with Stage I, II, or III (left or right) sided breast cancer
  • Systemic therapy recommended, with or without therapeutic irradiation

Key Exclusion Criteria:

  • Known cardiomyopathy prior to chemotherapy
  • Left ventricular dysfunction, acute coronary syndrome, cardiogenic shock or requiring inotropic or intra-aortic balloon support
  • Planned percutaneous coronary intervention or coronary artery bypass graft surgery or established obstructive coronary artery disease with ischemia eligible for revascularization, acute myocardial infarction

Please see complete list of inclusion and exclusion criteria.

Principal Investigator:

Puja Mehta, MD

Co-Investigators Include:

Dr. William Audeh, MD
C. Noel Bairey Merz, MD
Daniel Berman, MD
Debiao Li, MD

Study Coordinator and Contact:

Warren Youssefian
Phone: 310-248-6947
Email: warren.youssefian@cshs.org

Status:

Active

IRB No.:

33425

Date Last Updated:

06/15