Actively Recruiting
Chronic Impacts of Endocrine Therapy on Cardiovascular and Brain Health Outcomes in Breast Cancer
Led by University of Toronto · Updated on 2025-01-15
112
Participants Needed
1
Research Sites
86 weeks
Total Duration
On this page
Sponsors
U
University of Toronto
Lead Sponsor
C
Canadian Institutes of Health Research (CIHR)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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: 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.
CONDITIONS
Official Title
Chronic Impacts of Endocrine Therapy on Cardiovascular and Brain Health Outcomes in Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Biologically female
- Post-menopausal with natural amenorrhea for at least 1 year (no bilateral oophorectomy)
- If using hormone replacement therapy, treatment limited to a maximum of 3 years and 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 approximately 1 year post-diagnosis who have received aromatase inhibitor therapy
- Breast cancer patients approximately 5 and 10 years post-diagnosis who have received aromatase inhibitor therapy for at least 2 years
- Received surgery and/or radiation therapies
- Control group: biologically female, post-menopausal with natural amenorrhea for at least 1 year, and if using hormone replacement therapy, limited to maximum 3 years and not within last 6 months
You will not qualify if you...
- Previous treatment with tamoxifen endocrine therapy in pre- or peri-menopausal setting
- Major signs or symptoms of cardiovascular diseases, diabetes, or renal disease such as chest pain or discomfort, shortness of breath at rest or with mild exertion, dizziness, loss of balance, ankle swelling, palpitations, intermittent claudication, known heart murmur, or unusual fatigue with usual activities
- American Heart Association contraindications for maximal exercise testing including myocardial infarction, artery stenosis, heart failure, pulmonary embolism, heart inflammation, uncontrolled arrhythmia, advanced heart block, stroke, high blood pressure (>200/100 mmHg), or cancer diagnosis other than skin cancer
- Unable to provide informed consent or communicate in English
- Mobility limitations affecting exercise testing (use of wheelchair, walker, or limp impeding walking)
- Extreme claustrophobia
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Toronto
Toronto, Ontario, Canada, M5S2C9
Actively Recruiting
Research Team
A
Amy A. Kirkham, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
6
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