Actively Recruiting

FEMALE
Healthy Volunteers
ID06776458

Long-Term Cardiovascular and Brain Health Effects of Aromatase Inhibitor Therapy in Breast Cancer Survivors A Study to Understand Heart and Vessel Changes After Endocrine Treatment Led by the University of Toronto

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

Researchers are investigating the long-term cardiovascular and brain health effects of aromatase inhibitor therapy in female breast cancer survivors. This study focuses on hormone receptor-positive, HER-negative breast cancer patients who have received aromatase inhibitors, examining health outcomes 1, 5, and 10 years after diagnosis. The goal is to understand how this common endocrine treatment may impact heart and vessel structure and function, cerebrovascular health, cognitive function, body composition, bone density, protein metabolism, and lifestyle factors compared to controls. Breast cancer survivors in this study will have undergone usual care with aromatase inhibitors for up to 10 years following their diagnosis. The study compares these survivors to control participants without breast cancer. It evaluates a range of cardiovascular and cerebrovascular health indicators, including aortic stiffness, artery stiffness, blood biomarkers, blood pressure, carotid intima media thickness, endothelial function, heart function measures, brain-derived neurotrophic factor, heart rate variability, cerebrovascular response to physical challenges, and cognitive tests. Additionally, body composition, bone mineral density, protein metabolism, diet, physical activity, sleep, stress, and quality of life are assessed. Participants will be evaluated through clinical assessments, imaging, blood tests, and questionnaires to track these health indices. The primary outcome measure is aortic stiffness assessed during an in-person session on day 2. Secondary measures include various vascular and cardiac function tests, cerebrovascular and cognitive assessments, and lifestyle evaluations. The study aims to characterize biological and behavioral cardiovascular health changes over time, hypothesizing that impairments may begin as early as one year post-diagnosis and worsen with longer therapy duration.

CONDITIONS

Official Title

Chronic Impacts of Endocrine Therapy on Cardiovascular and Brain Health Outcomes in Breast Cancer

Who Can Participate

FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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Long-Term Cardiovascular and Brain Health Effects of Aromatase Inhibitor Therapy in Breast Cancer Survivors A Study to Understand Heart and Vessel Changes After Endocrine Treatment Led by the University of Toronto | DecenTrialz