Short-term effects of aromatase inhibitor endocrine therapy on heart and brain health in breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational longitudinal case-control study follows postmenopausal biologically female patients with stage I–III, hormone receptor–positive, HER2-negative breast cancer who are starting aromatase inhibitor therapy and compares them with age- and BMI-matched postmenopausal control participants. The study focuses on the first six months of endocrine treatment and measures established and novel cardiovascular, metabolic, and behavioral health indices, plus select brain-health markers. Participants receive usual care while the study collects serial measurements to characterize short-term changes linked to aromatase inhibitor exposure. The goal is to identify early signals and potential mechanisms that could explain the known longer-term rise in cardiovascular events with aromatase inhibitor duration.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Case group:

* Biologically female
* Post-menopausal with natural (no bilateral oophorectomy) amenorrhea for at least 1 year
* If using hormone replacement therapy, limit of a maximum of 3 years of treatment but not within the last 6 months.
* Diagnosis of stage I, II, or III breast cancer
* Hormone receptor positive breast cancer
* HER negative (ER+/PR+/HER-) breast cancer
* Confirmed to start aromatase inhibitor therapy for the first time in next 2-3 months
* Received surgery/radiation therapies

Control group:

* Biologically female
* Post-menopausal with natural (no bilateral oophorectomy) amenorrhea for at least 1 year
* If using hormone replacement therapy, limit of a maximum of 3 years of treatment but not within the last 6 months.

Exclusion Criteria:

* Previous treatment using tamoxifen endocrine therapy in a pre-or peri-menopausal setting
* Major signs or symptoms of cardiovascular diseases, diabetes, or renal disease (taken from the American College of Sports Medicine's Guidelines for Exercise Testing and Prescription 11th edition Table 2.1: pain or discomfort in the chest, neck, jaw, arms with rest or exercise, shortness of breath at rest or with mild exertion, dizziness or syncope, loss of balance or passing out, ankle edema, palpitations or tachycardia, intermittent claudication, known heart murmur, unusual fatigue with usual activities.)
* American Heart Association's absolute or relative contraindications for symptom-limited maximal exercise testing (myocardial infarction, aortic or coronary artery stenosis, heart failure, pulmonary embolism or deep vein thrombosis, inflammation of the heart (myocarditis, pericarditis, and/or endocarditis), uncontrolled cardiac arrythmia, advanced or complete electrical heart block, stroke or transient ischemia attack, blood pressure \>200mmHg/100mmHg, a cancer diagnosis other than skin cancer)
* Unable to provide informed consent or communicate in English
* Mobility limitations to exercise testing (i.e., wheelchair, walker use, limp impeding walking)
* Extreme claustrophobia

Where it's running

• University of Toronto
  Toronto, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Amy A. Kirkham, PhD
• Email: amy.kirkham@utoronto.ca
• Phone: 416-946-4069

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.