Studies heart and brain effects of breast cancer hormone therapy over time
Compares heart, blood vessel and brain health in women treated with aromatase inhibitors to controls.
Key facts
- Who runs it
- University of Toronto
- Where
- Toronto, CanadaSee the site
- Trial code
- Registry title
- Chronic Impacts of Endocrine Therapy on Cardiovascular and Brain Health Outcomes in Breast Cancer
- Status
- Recruiting
- People taking part
- 112 people, planned
- Started
- 1 Feb 2025
- Planned end
- 30 Sept 2026
- Type of study
- Observational, 6 groups
- Treatments tested
- N/A - Usual Care
- Record updated
- 15 January 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for post-menopausal women who had stage I to III hormone receptor positive breast cancer and took aromatase inhibitor therapy, and post-menopausal women without breast cancer as controls.
- Sex
- Women (biologically female) only.
- Disease stage
- Stage I, II or III breast cancer, hormone receptor positive (ER+/PR+/HER-). Survivors about 1, 5 and 10 years after diagnosis.
- Earlier treatment
- Breast cancer group: aromatase inhibitor therapy (at least 2 years for those about 5 and 10 years after diagnosis), plus surgery or radiation. Hormone replacement therapy only up to 3 years in total and not in the last 6 months. No earlier tamoxifen before menopause.
- Biomarker or test result
- Hormone receptor positive and HER negative breast cancer (ER+/PR+/HER-).
Main reasons for not taking part
- Earlier tamoxifen treatment before or around menopause
- Major signs or symptoms of heart disease, diabetes or kidney disease
- Conditions that make a maximal exercise test unsafe, such as heart attack, heart failure, stroke or a cancer other than skin cancer
- Cannot give informed consent or communicate in English
- Mobility limits for exercise testing, or extreme claustrophobia
The registry criteria, word for word
Show all 19 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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 in Canada
- University of TorontoToronto, CanadaContact: Amy A. Kirkham, PhDTaking people
About the trial
What the trial wants to find out
Aromatase inhibitors are the most used endocrine therapy for hormone-positive breast cancer. Despite the evidence that aromatase inhibitor therapy is associated with increased risk of cardiovascular events, potentially related to the duration of use, no studies have been conducted to characterize the long-term effects of aromatase inhibitor therapy on the heart or vessel structure and function as underlying determinants of cardiovascular mortality. This study will characterize the long-term effects of aromatase inhibitor therapy on established and novel health indices for CVD in breast cancer patients, by examining cross-sectionally compare health indices 1-, 5- and 10-years post-diagnosis in breast cancer survivors to controls. Specifically, our objectives are as follows:
Read full original descriptionShow less
1. To examine the effects of aromatase inhibitor therapy on early risk indicators for cardiovascular disease in the peripheral vasculature and heart, including aortic stiffness (primary outcome) and secondary outcomes of peripheral and carotid artery stiffness, blood biomarkers (lipids), blood pressure, carotid intima media thickness, endothelial function, and left ventricular ejection fraction, global longitudinal strain, and left ventricular diastolic function, in breast cancer survivors compared to controls. 2. To examine the effects of aromatase inhibitor therapy on factors related to cerebrovascular health, autonomic regulation, and cognitive function, including BDNF, heart rate variability, cerebrovascular function in response to a supine-sit-stand maneuver and squatting challenge, and a core battery of cognitive function tests, in breast cancer survivors compared to controls. 3. To examine the effects of aromatase inhibitor therapy on body composition, bone mineral density, and protein metabolism, in breast cancer survivors compared to controls. 4. To examine the effects of aromatase inhibitor therapy on lifestyle factors (behavioural), including diet, physical activity (including cardiorespiratory fitness), sleep, stress, and quality of life, in breast cancer survivors compared to controls.
The investigators hypothesize that biologic and behavioural cardiovascular health indices will be deteriorated relative to controls as early as 1 year post-diagnosis and that prolonged use will further accelerate aging-related impairments.
The 6 groups in the trial
- Aromatase Inhibitors (1 year)
Breast cancer patients at 1-year post-diagnosis, who were treated with aromatase inhibitors
Treatment: N/A - Usual Care
- Aromatase Inhibitors (5 year)
Breast cancer patients at 5-year post-diagnosis, who were treated with aromatase inhibitors
Treatment: N/A - Usual Care
- Aromatase Inhibitors (10 years)
Breast cancer patients at 10-years post-diagnosis, who were treated with aromatase inhibitors
Treatment: N/A - Usual Care
- Matched Controls (1 year)
A woman without a history of cancer will be recruited to match each breast cancer patient will be matched on age and BMI (within 3 years and 3 kg/m2, whenever possible)
- Matched Controls (5 years)
A woman without a history of cancer will be recruited to match each breast cancer patient will be matched on age and BMI (within 3 years and 3 kg/m2, whenever possible)
- Matched Controls (10 years)
A woman without a history of cancer will be recruited to match each breast cancer patient will be matched on age and BMI (within 3 years and 3 kg/m2, whenever possible)
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Beyond Cardiotoxicity: Characterizing the Long-term Cardiovascular Side Effects of Breast Cancer Endocrine Treatment
- Plain-language title
- Studies heart and brain effects of breast cancer hormone therapy over timeGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 15 January 2025