NCT07096024

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

Ibrance® Post-Marketing Database Study Incidence of Interstitial Lung Disease in Inoperable or Recurrent Breast Cancer Patients Treated With Palbociclib in a Post-marketing Setting: Cohort Study Using the Medical Data Vision (MDV) Database

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,772 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Neoplasms

Interventions

Type	Name	Description
DRUG	palbociclib plus fulvestrant	Patients treated with the combination of palbociclib and fulvestrant
DRUG	fulvestrant	Patients treated with fulvestrant alone

Timeline

• Start date: 2025-01-21
• Primary completion: 2025-02-07
• Completion: 2025-02-07
• First posted: 2025-07-31
• Last updated: 2025-08-28

Locations

1 site across 1 country: United States