Effects of Aromatase Inhibitors on Heart and Brain Health in Breast Cancer Survivors

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 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.

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
* 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 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.