Status:
NOT_YET_RECRUITING
A Study to Understand the Patients Confirmed to Have Advanced or Metastatic Breast Cancer and Receiving Palbociclib Treatment Using a Real-world Database
Lead Sponsor:
Pfizer
Conditions:
Advanced or Metastatic Breast Cancer
Eligibility:
FEMALE
18+ years
Brief Summary
The purpose of this real-world study is to look at breast cancer patients receiving Palbociclib using a large real-world database collected under real-world practice. This study also looks at the safe...
Eligibility Criteria
Inclusion
- 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.
- HR-positive is defined as any positive test for estrogen receptor or progesterone receptor.
- 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
Exclusion
Key Trial Info
Start Date :
June 30 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 28 2025
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT06962969
Start Date
June 30 2025
End Date
November 28 2025
Last Update
June 10 2025
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