Actively Recruiting
Beyond Cardiotoxicity: Characterizing the Long-term Cardiovascular Side Effects of Breast Cancer Endocrine Treatment
Led by University of Toronto · Updated on 2025-01-15
112
Participants Needed
1
Research Sites
N/A
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
Researchers are investigating the long-term effects of aromatase inhibitor therapy on heart and blood vessel health in women who have had hormone-positive breast cancer. This observational study compares breast cancer survivors at 1, 5, and 10 years after diagnosis with healthy women matched by age and body mass index. The study aims to understand how this therapy affects cardiovascular risk factors and brain health over time, as well as lifestyle factors and body composition. Participants include breast cancer survivors who received aromatase inhibitors as part of their usual care for up to 10 years post-diagnosis, along with matched healthy controls. The groups are categorized based on the time since diagnosis (1, 5, or 10 years). The study does not involve any new treatments but focuses on detailed health assessments to evaluate the impact of past endocrine therapy. During the study, participants will undergo several in-person sessions to measure heart and blood vessel function, including aortic stiffness, artery stiffness, blood pressure, and heart performance. They will also have tests for brain health, cognitive function, blood biomarkers like lipids and insulin resistance, and assessments of body composition and protein metabolism at home. Lifestyle factors such as diet, exercise, sleep, stress, and quality of life will be evaluated. The main outcome is aortic stiffness, with many secondary measures collected to understand cardiovascular and brain health comprehensively.
CONDITIONS
Brief 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, no more than 3 years total and not used within the last 6 months
- Diagnosis of stage I, II, or III breast cancer
- Hormone receptor positive, HER negative breast cancer (ER+/PR+/HER-)
- 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 or radiation therapies
- Control group: biologically female, post-menopausal with natural amenorrhea for at least 1 year, with the same hormone therapy limits as above
You will not qualify if you...
- Previous treatment with tamoxifen endocrine therapy in pre- or peri-menopausal setting
- Major signs or symptoms of cardiovascular disease, diabetes, or renal disease such as chest pain, shortness of breath, dizziness, palpitations, ankle swelling, or unusual fatigue
- Absolute or relative contraindications for maximal exercise testing including myocardial infarction, artery stenosis, heart failure, blood clots, heart inflammation, uncontrolled arrhythmia, advanced heart block, stroke, blood pressure over 200/100 mmHg, or cancer diagnosis other than skin cancer
- Unable to provide informed consent or communicate in English
- Mobility limitations affecting exercise testing (wheelchair, walker, limp)
- Severe claustrophobia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo in-person assessments to measure cardiovascular and brain health outcomes.
1 visit (in-person)
Duration - 1 day
Participants complete at-home sessions for collection of protein metabolism data.
1 at-home session
Duration - Up to 10 years post-diagnosis depending on cohort
Participants are observed over time to understand long-term cardiovascular effects after endocrine therapy.
Follow-up visits may occur depending on study needs
Trial Site Locations
Total: 1 location
1
University of Toronto
Toronto, Ontario, Canada, M5S2C9
Actively Recruiting
Research Team
A
Amy A. Kirkham, PhD
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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