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

Pfizer

Status

Completed

Conditions

Breast Neoplasms

Treatments

Drug: fulvestrant

Drug: palbociclib plus fulvestrant

Study type

Observational

Funder types

Industry

Identifiers

NCT07096024

A5481117

Details and patient eligibility

About

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.

Enrollment

2,000 patients

Sex

All

Ages

15+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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).

Exclusion criteria

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