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 @ 9:45 PM
Ignite Modification Date:
2025-12-24 @ 9:45 PM
NCT ID:
NCT05853432
Eligibility Criteria:
Inclusion Criteria:
* Had a curated record for advanced or metastatic breast cancer diagnosis.
* Note: Diagnosis of a/mBC is based on a curated record of M stage=M1, Stage 4/4a/4b, presence of metastatic tumor, Stage 3b/3c or presence of secondary neoplasm.
* Had patient activity documented in ConcertAI Patient 360 Breast Cancer database (defined as a record of a clinic visit, medication administration, vital test, or lab test) or death within 90 days after the advanced or metastatic breast cancer diagnosis date.
* Had documented receipt of treatment with alpelisib plus fulvestrant on or after the advanced or metastatic diagnosis date.
* Had documented receipt of treatment with fulvestrant before the index date (start date of the earliest alpelisib plus fulvestrant regimen). This included (neo) adjuvant therapies.
* Age ≥18 years on the index date.
Exclusion Criteria:
* Had documented hormone receptor-negative (defined as both estrogen receptor-negative and progesterone receptor-negative) or HER2-positive status any time prior to index date (but prioritizing results closest to index date, if there were conflicting results).
* Patient had a clinical trial registration date (i.e., participated in a clinical trial) on or before the index date.
* Patients with "negative" PIK3CA test before index date (in case of multiple tests, the one closer to the index date was used).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05853432
Study Brief:
Protocol Section:
NCT05853432