Actively Recruiting
Beyond Cardiotoxicity: Characterizing the Short-term Cardiovascular Side Effects of Breast Cancer Endocrine Treatment
Led by University of Toronto · Updated on 2025-10-01
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Toronto
Lead Sponsor
C
Cancer Research Society
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the short-term effects of aromatase inhibitor therapy on cardiovascular, metabolic, and behavioral health in women with hormone-positive breast cancer. This study uses a longitudinal case-control design to compare breast cancer survivors starting aromatase inhibitors with age- and BMI-matched women without cancer, aiming to understand how endocrine treatment influences early risk indicators for cardiovascular disease, brain health, body composition, and lifestyle factors during the first six months of treatment. Participants include breast cancer patients beginning aromatase inhibitor therapy and matched controls without cancer. The study observes these groups over six months, measuring cardiovascular function (such as aortic stiffness and left ventricular function), cerebrovascular health, cognitive tests, body composition, bone mineral density, and glycemic regulation. Behavioral assessments include diet, physical activity, sleep, stress, and quality of life. Blood biomarkers and responses to glucose tolerance tests are also evaluated. During the study, participants undergo detailed assessments at baseline and after six months, including blood tests, blood pressure, arterial stiffness measurements, heart function imaging, cerebrovascular response tests, cognitive evaluations, continuous glucose monitoring, and questionnaires about lifestyle factors. Researchers track changes in these measures to understand the impact of aromatase inhibitors. The study spans from initial assessment through six months of therapy, comparing results between breast cancer survivors and matched controls to identify treatment-related changes in cardiovascular and brain health.
CONDITIONS
Brief Title
Short-term 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 none within the last 6 months
- Diagnosis of stage I, II, or III hormone receptor positive breast cancer
- HER negative (ER+/PR+/HER-) breast cancer
- Confirmed to start aromatase inhibitor therapy for the first time within the next 2 to 3 months
- Received surgery or radiation therapies
- For controls: biologically female, post-menopausal with natural amenorrhea for at least 1 year, hormone replacement 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, loss of balance, ankle swelling, palpitations, unusual fatigue
- Absolute or relative contraindications for maximal exercise testing including myocardial infarction, artery stenosis, heart failure, pulmonary embolism, heart inflammation, uncontrolled arrhythmia, advanced heart block, stroke or transient ischemic attack, elevated 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 (e.g., wheelchair, walker, limp)
- Extreme 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 - 6 months
Participants who are breast cancer survivors using aromatase inhibitors or matched non-cancer controls are observed to assess cardiovascular and brain health outcomes.
2 visits (baseline and 6 months)
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
2
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