About this trial

The purpose of this research study is to understand what effect near complete estrogen deprivation (NCED) therapy has on the heart in breast cancer patients. Investigators want to understand if NCED changes how the heart works.

Eligibility criteria

Qualifiers

Women age ≤55 who were premenopausal at the time of breast cancer diagnosis; (Premenopausal is defined as per NCCN criteria).

Planned breast cancer treatment with NCED (near-complete estrogen deprivation) therapy that includes aromatase inhibitor therapy (or SERD) with medically or surgically induced menopause within three (3) months of initiating NCED (HR-positive tumor) or, for the cohorts not receiving NCED therapy, within three (3) months of planned chemotherapy, surgery or radiation. Index date for three months is defined as final date of treatment with chemotherapy, surgery or radiation which ever happens last (HR-negative tumor). Treatment with a Gonadotropin Releasing Hormone (GnRH) agonist for fertility preservation during chemotherapy is allowed and is not considered part of the NCED antineoplastic therapy.

Women with human epidermal growth factor-2 (HER2) negative and women with human epidermal growth factor-2 (HER2) positive breast cancer are eligible.

Treatment with CDK-inhibitor, PARP inhibitor immunotherapy or biologic (non-chemotherapy) agent as part of anti-neoplastic treatment plan is allowed. These agents are not considered chemotherapy.

Disqualifiers

History of allergic reactions attributed to compounds of similar chemical or biologic composition to adenosine

Active wheezing.

Those with contraindications for MRI such as ferromagnetic cerebral aneurysm clips or other intracranial metal, pacemakers, defibrillators, functioning neurostimulator devices or other implanted electronic devices, or some breast expanders.

Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Trial design

Treatments tested in this trial

  • Adenosine Stress Cardiac Magnetic Resonance Imaging
  • Electrocardiogram
  • Computed Tomography Angiogram
  • Laboratory Testing
  • Quality of Life Survey

Treatment groups

90 Participants
are divided into 1 treatment group

Locations

3
Duke Cancer Center27710, DurhamNorth Carolina, United States
Wake Forest Baptist Comprehensive Cancer Center27157, Winston-SalemNorth Carolina, United States
Virginia Commonwealth University Massey Cancer Center23298, RichmondVirginia, United States

Sponsors and collaborators

Duke University

Lead sponsor

National Cancer Institute (NCI)

Collaborator

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator