Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 12:31 AM
NCT ID:
NCT05867667
Eligibility Criteria:
Inclusion Criteria:
* Breast cancer diagnosis stage I-III
* Within 18-months of treatment completion (defined as completion of all oncologic treatments expect oral maintenance therapy)
* Age 18 years or older
* At increased risk for cardiovascular disease based on one of the following; a.Treatment with either anthracycline-based or anti-HER2 therapy-based treatment regimen plus the presence of: \>2 cardiovascular heart disease risk factors (smoking, hypertension, diabetes mellitus, obesity, dyslipidemia), OR Age (\>60 years) at cancer treatment, OR Left ventricular ejection fraction \<50%as determined with a clinically ordered echo scan within 6 months of enrollment, b.Treatment with anthracycline followed by trastuzumab
* Ability to understand and the willingness to sign a written informed consent.
Exclusion Criteria:
* Planned surgery during the study period.
* Under cardiology care for known high-risk cardiovascular disease defined as the presence of any of the following: severe, unrevascularized coronary artery disease, severe valvular heart disease, advanced heart failure with a left ventricular ejection fraction \<35%)
* Metastatic cancer
* Unable to exercise (e.g., inability to complete a modified stress test or musculoskeletal condition that prevents adequate participation in exercise)
* Adults unable to give consent, pregnant or lactating women, and prisoners are excluded from this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05867667
Study Brief:
Protocol Section:
NCT05867667