Effects of Aromatase Inhibitors on Heart and Brain Health in Breast Cancer Survivors
Beyond Cardiotoxicity: Characterizing the Long-term Cardiovascular Side Effects of Breast Cancer Endocrine Treatment
This study looks at how taking aromatase inhibitors affects heart and brain health over time in post-menopausal women who have survived hormone receptor-positive breast cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 112 (estimated) |
| Sex | Female |
| Sponsor | University of Toronto Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06776458 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the long-term cardiovascular and brain health outcomes associated with aromatase inhibitor therapy in post-menopausal women diagnosed with hormone receptor-positive breast cancer. It will compare health indices related to cardiovascular disease in breast cancer survivors at 1, 5, and 10 years post-diagnosis to a control group. The primary focus is on assessing early risk indicators for cardiovascular disease, including aortic stiffness, to better understand the implications of prolonged aromatase inhibitor use.
Who should consider this trial
Good fit: Ideal candidates include post-menopausal women with hormone receptor-positive breast cancer who have received aromatase inhibitor therapy.
Not a fit: Patients who have previously undergone treatment with tamoxifen or those with other significant cardiovascular conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the cardiovascular risks associated with aromatase inhibitors, potentially leading to improved management strategies for breast cancer survivors.
How similar studies have performed: While studies have indicated cardiovascular risks associated with aromatase inhibitors, this specific long-term observational approach is novel and has not been extensively tested.
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 * Breast cancer patients \~1 post-diagnosis who have received aromatase inhibitor therapy * Breast cancer patients \~5 and \~10 years post-diagnosis who have received aromatase inhibitor therapy for at least 2 years * 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.