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Recruiting NCT06781762

Short-term Impacts of Endocrine Therapy on Cardiovascular and Brain Health Outcomes in Breast Cancer

— Observational Breast Cancer Females

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: N/A (Usual Care).
Who it may be relevant to
Registry conditions: Breast Cancer Females. Basic parameters: No limits · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Other N/A (Usual Care)
    BC survivors will be using aromatase inhibitors as prescribed in their usual care treatment.

Primary outcome measures

  • Aortic Stiffness [Time frame: Baseline, 6 months]
Secondary outcome measures (12)
  • Brachial Artery Endothelial Function [Time frame: Baseline, 6 months]
  • Carotid Artery Stiffness [Time frame: Baseline, 6 months]
  • Carotid Intima Media Thickness [Time frame: Baseline, 6 months]
  • Left Ventricular Ejection Fraction (LVEF) [Time frame: Baseline, 6 months]
  • Global Longitudinal Strain [Time frame: Baseline, 6 months]
  • Left Ventricular Diastolic Function [Time frame: Baseline, 6 months]
  • Arterial Stiffness [Time frame: Baseline, 6 months]
  • Cerebrovascular Response [Time frame: Baseline, 6 months]
  • Brain Derived Neurotrophic Factor [Time frame: Baseline, 6 months]
  • Lipid profile [Time frame: Baseline, 6 months]
  • Hemoglobin A1c [Time frame: Baseline, 6 months]
  • Insulin resistance [Time frame: Baseline, 6 months]

Eligibility criteria

Inclusion criteria

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.

Exclusion criteria

  • Previous treatment using tamoxifen endocrine therapy in a pre-or peri-menopausal setting
  • 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)
  • Unable to provide informed consent or communicate in English
  • Mobility limitations to exercise testing (i.e., wheelchair, walker use, limp impeding walking)
  • Extreme claustrophobia

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Canada · 1 center
  • University of Toronto — Toronto

Identifiers

NCT: NCT06781762 · REB #46818

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗