Short-term effects of aromatase inhibitor endocrine therapy on heart and brain health in breast cancer
Beyond Cardiotoxicity: Characterizing the Short-term Cardiovascular Side Effects of Breast Cancer Endocrine Treatment
This project will test whether the first six months of aromatase inhibitor therapy change early heart, metabolic, and brain health measures in postmenopausal women with hormone-receptor–positive, HER2-negative breast cancer compared with age- and BMI-matched controls.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Sex | Female |
| Sponsor | University of Toronto Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06781762 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are postmenopausal biologically female patients with stage I–III, ER+/PR+, HER2-negative breast cancer who are confirmed to start aromatase inhibitor therapy within the next 2–3 months, plus matched postmenopausal control participants without recent hormone replacement.
Not a fit: Patients with prior major cardiovascular disease, diabetes, significant renal disease, prior tamoxifen use in a pre- or peri-menopausal setting, or who are not naturally postmenopausal are unlikely to benefit from this study's findings.
Why it matters
Potential benefit: If successful, the study could identify early markers of cardiovascular or brain risk that enable closer monitoring or preventative strategies for women beginning aromatase inhibitor therapy.
How similar studies have performed: Long-term observational studies have linked aromatase inhibitor duration to increased cardiovascular events, but short-term mechanistic studies like this are limited, so the approach is relatively novel for early effect characterization.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Toronto, Ontario
- University of Toronto — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Amy A. Kirkham, PhD
- Email: amy.kirkham@utoronto.ca
- Phone: 416-946-4069
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.