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

Completed

Conditions studied: Breast Neoplasms

In brief

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.

Key facts

Study ID

NCT07096024

Run by

Pfizer

People needed

95637

Starts

2025-01-21

Expected to finish

2025-02-07

Last updated by the study team

2026-07-10

Who can join

Age: 15 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Having prescription records of drugs for endocrine therapy (aromatase inhibitors, SERDs, SERMs, and CDK4/6 inhibitors) from 25 November 2011 to 31 December 2024.
• Having any breast cancer records with definitive diagnosis in the same month as the first prescription date.
• Having any records in MDV database on or before 6 months prior to the first prescription date (<= -180 days: first prescription date = 0 day).
• Having any records in MDV database within 6 months prior to the first prescription date (-180 days to 0 day).

You may not qualify if…

• Having any records of anti-HER2 medication (e.g., trastuzumab, pertuzumab, lapatinib or trastuzumab emtansine) from 25 November 2011 to 31 December 2024.
• Having any records of second primary cancer with definitive diagnosis

Where it is running

• Pfizer — New York, New York, United States

Full record on ClinicalTrials.gov

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