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 @ 2:22 PM
Ignite Modification Date:
2025-12-24 @ 2:22 PM
NCT ID:
NCT03159195
Eligibility Criteria:
Physician inclusion criteria
* Oncologist or gynecologist
* Responsible for treating a minimum of ≥2-6 (depending on country) ABC/MBC patients who meet the eligibility criteria.
* Agrees to participate in the study and complete the eCRFs within the data collection period.
Patient inclusion criteria
* Female
* ≥18 years old.
* HR+/HER2- breast cancer diagnosis with confirmed metastatic or advanced disease.
* Received palbociclib plus letrozole/aromatase inhibitor or palbociclib plus fulvestrant in line with the licenced indication(s).
* No prior or current enrolment in an interventional clinical trial for ABC/MBC.
* Minimum of three months of follow up data since palbociclib with fulvestrant initiation, or minimum of six months of follow up data since palbociclib with letrozole/aromatase inhibitor initiation (core medical record review).
* Minimum of three months of follow up data since palbociclib initiation (German interim medical record review only).
* Inoperable or recurrent breast cancer (Japan only)
Exclusion criteria:
Physician exclusion criteria
* Qualified less than 2 years ago or more than 35 years ago
* Participated in observational research for ABC/MBC in the last 3 months
* Have not prescribed either palbociclib plus fulvestrant or palbociclib plus aromatase inhibitor in line with the licenced indication(s).
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03159195
Study Brief:
Protocol Section:
NCT03159195