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 @ 2:12 AM
Ignite Modification Date:
2025-12-25 @ 2:12 AM
NCT ID:
NCT04708860
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of ER and/or PR+ metastatic or locally unresectable breast cancer
* Postmenopausal (including concurrent use of ovarian suppression)
* Initiating endocrine therapy in combination with:
* Cohort 1: alpelisib
* Cohort 2: palbociclib
* Self-reported ability to walk two blocks
* \> 18 years of age
* Approval from treating oncologist, confirmed via email or in writing
* Ability to read and understand English
Exclusion Criteria:
* Diagnosis of diabetes requiring medication
* Engaging in \>90 minutes of moderate or vigorous physical activity per week
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04708860
Study Brief:
Protocol Section:
NCT04708860