Beyond Cardiotoxicity: Characterizing the Long-term Cardiovascular Side Effects of Breast Cancer Endocrine Treatment

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Healthy Volunteers: t
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⁃ 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.

Locations
Other Locations
Canada
University of Toronto
RECRUITING
Toronto
Contact Information
Primary
Amy A. Kirkham, PhD
amy.kirkham@utoronto.ca
416-946-4069
Time Frame
Start Date: 2025-02-01
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 112
Treatments
Aromatase Inhibitors (1 year)
Breast cancer patients at 1-year post-diagnosis, who were treated with aromatase inhibitors
Aromatase Inhibitors (5 year)
Breast cancer patients at 5-year post-diagnosis, who were treated with aromatase inhibitors
Aromatase Inhibitors (10 years)
Breast cancer patients at 10-years post-diagnosis, who were treated with aromatase inhibitors
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)
Related Therapeutic Areas
Sponsors
Collaborators: Canadian Institutes of Health Research (CIHR), Cancer Research Society
Leads: University of Toronto

This content was sourced from clinicaltrials.gov