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 @ 10:50 PM
Ignite Modification Date:
2025-12-24 @ 10:50 PM
NCT ID:
NCT06962969
Eligibility Criteria:
Inclusion Criteria
Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
* Adult women (≥ 18 years of age) with at least one visit with a breast cancer ICD10 diagnosis code (C50.x)
* Patients with locally advanced breast cancer or metastatic breast cancer with a staging classification of stage III, stage IV (distant metastases).
* Patients with a laboratory test positive for hormone receptor (HR) and negative for human epithelial growth factor receptor 2 (HER2) before or up to 60 days after advanced/metastatic breast cancer diagnosis date.
1. HR-positive is defined as any positive test for estrogen receptor or progesterone receptor.
2. HER2-negative is defined as any HER2-negative test and the absence of a positive test (immunohistochemistry positive (3+), fluorescence in situ hybridization positive/amplified).
* Patients who received at least one initial prescription of Ibrance following a diagnosis of advanced/metastatic breast cancer
Exclusion Criteria
Patients meeting any of the following criteria will not be included in the study:
* Breast cancer with HR-negative and HER2-positive on laboratory testing.
* More than a 90-day gap between breast cancer diagnosis date and next visit.
* Patients who treated as off-label
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT06962969
Study Brief:
Protocol Section:
NCT06962969