Cardiac Outcomes With Near-Complete Estrogen Deprivation

• Status: Not yet recruiting
• Trial end date: 2027-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Forest University Health Sciences
• Collaborator: National Cancer Institute (NCI)
• Treatments: Adenosine

Criteria

Inclusion Criteria

• Women age ≤55 who were premenopausal at the time of breast cancer diagnosis; (Premenopausal is defined as per NCCN criteria.50)

• Planned breast cancer treatment with NCED therapy that includes aromatase inhibitor therapy (or SERD, see 3.1.5) with medically or surgically induced menopause following completion of any planned chemotherapy, surgery and radiation therapy or within 3 months of initiating NCED (HR-positive tumor) or within three months of completing planned chemotherapy, surgery and radiation (HR-negative tumor)

• Women with human epidermal growth factor-2 (HER2) positive breast cancer are eligible

• Treatment with CDK-inhibitor as part of anti-neoplastic treatment plan is allowed (HR-positive tumor)

• Treatment with selective-estrogen receptor degrador (SERD) rather than aromatase inhibitor is allowed.

• Diagnosed with Stage I-III breast cancer

• ECOG performance status of 0-2

• Patients must have normal organ and marrow function as defined below: eGFR >30 ml/min/1.73 m2; Potassium 3.5-5.2 mmol/L

• Patients with concurrent malignancies are eligible as long as therapies and disease course for these are reasonably expected to not impact cardiovascular function. (Examples of eligible malignancies include: papillary/follicular thyroid cancer, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in-site and early stage cervical cancers, etc.).

• Patients with prior COVID-19 are eligible if they have recovered from the illness and are free of COVID-related symptoms other than allowable persistent symptoms: loss of taste and smell and/or grade 1 fatigue.

• Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative)

Exclusion Criteria

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

• Active asthma or chronic obstructive pulmonary disease currently requiring medications or active wheezing.

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

• 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.

• Pregnant women are excluded from this study. Because some methods of birth control are not 100% reliable, a pregnancy test is required, unless the patient has undergone either a bilateral oophorectomy, hysterectomy or both.

• Coronary revascularization in the past 6 months or known severe multi-vessel coronary artery disease previously determined to be not amendable to mechanical intervention.

• Ongoing, unrelieved symptoms thought to represent cardiac ischemia and requiring immediate cardiac catheterization

• Allergy or prior sensitivity to gadolinium or other contrasting agents or their excipients.

• Men with breast cancer