NCT06781762Recruiting
Short-term Impacts of Endocrine Therapy on Cardiovascular and Brain Health Outcomes in Breast Cancer
Beyond Cardiotoxicity: Characterizing the Short-term Cardiovascular Side Effects of Breast Cancer Endocrine Treatment
Source: ClinicalTrials.gov · Last updated 1 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Aromatase inhibitors are the most used endocrine therapy for hormone-positive breast cancer. While there is a clear linear relationship between the duration of aromatase inhibitor use and the cumulative incidence of cardiovascular events and mortality, the underlying mechanisms contributing to this risk remain unknown. This study will characterize the short-term effects of aromatase inhibitor therapy on established and novel health indices for cardiovascular diseases in breast cancer patients. Using a longitudinal case-control design this study will assess the effects of short-term (first 6 months) aromatase inhibitor use in breast cancer patients compared to age- and BMI-matched controls, aiming to determine the cardiovascular, metabolic, and behavioural health impacts of endocrine treatment during this early period. 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 blood biomarkers (lipids), blood pressure, aortic and peripheral stiffness, carotid artery stiffness and intima media thickness, endothelial function, and left ventricular ejection fraction, longitudinal strain, volumes, and mass, including the responsiveness of the cardiovascular system to an oral glucose tolerance test, 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 and bone mineral density, along with assessments of glycemic regulation in response to an oral glucose tolerance test and in 24h periods of free-living (continuous glucose monitoring), 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 cardiovascular and metabolic health outcomes will be similar between breast cancer survivors and controls at baseline but will deteriorate relative to controls within the first 6 months of aromatase inhibitor therapy.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 40 (estimated)
- First submitted
- 30 Dec 2024
- Start date
- 6 Jun 2025
- Primary completion date
- 30 Dec 2026
- Lead sponsor
- University of Toronto
- Diseases
- Obesity, Childhood cancers
- NCT number
- NCT06781762
What you commit to
- Study type: Observational
- Planned participants: 40
- From 6 Jun 2025 to the primary completion date, 30 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous treatment using tamoxifen endocrine therapy in a pre-or peri-menopausal setting
Other illness
- 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)
Other
- Unable to provide informed consent or communicate in English
- Mobility limitations to exercise testing (i.e., wheelchair, walker use, limp impeding walking)
- Extreme claustrophobia
Who the study is looking for
- 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
- Confirmed to start aromatase inhibitor therapy for the first time in next 2-3 months
- 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.
Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Toronto Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.