Clinical Trial

A Study to Understand About the Study Medicine Palbociclib in Breast Cancer Patients After it is Out in the Japanese Market

Completed
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Summary
The purpose of the study is to: * compare the chances of getting interstitial lung disease (ILD) in new users of palbociclib plus fulvestrant to new users of fulvestrant alone (using data from before palbociclib was out in the market) * look into the factors that can cause ILD in new users of palbociclib. This study uses patient data without giving out any personal information of the patient. This data is taken from a hospital-based claims database of the MDV database, that includes data from more than 400 hospitals in Japan. This study will use data of patients who are: * diagnosed with breast cancer that include newly treated with palbociclib and/or other endocrine-based therapies for inoperable or recurrent breast cancer between 25 November 2011 and 30 November 2024.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-07-24; most recent amendment 2026-07-08.
Trial Details
NCT Number NCT07096024
Lead Sponsor Pfizer
Conditions Breast Neoplasms
Enrollment 95,637 participants
Start Date 2025-01-21
Primary Completion 2025-02-07 (estimated)
Study Completion 2025-02-07 (estimated)
Updated on ClinicalTrials.gov 2026-07-10