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:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2025-12-24 @ 6:56 PM
NCT ID:
NCT05753657
Eligibility Criteria:
Inclusion Criteria:
* Patients with ER positive HER2 negative metastatic breast cancer, harboring an activating PIK3CA mutation, scheduled to start treatment with Alpelisib and fulvestrant.
* Ages 18 - 85
* ECOG performance status 0, 1 or 2
* Ability to understand and willingness to sign a written informed consent.
Exclusion Criteria:
* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of Alpelisib
* Uncontrolled diabetes mellitus, defined as HbA1c above 8%
* Diabetes mellitus controlled by insulin
* Uncontrolled intercurrent illness including, but not limited to: active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Pregnancy
* Known allergy to pioglitazone
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT05753657
Study Brief:
Protocol Section:
NCT05753657