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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07096024

Enrollment

95637

Registered

2025-07-31

Start date

2025-01-21

Completion date

2025-02-07

Last updated

2026-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms

Keywords

Ibrance, Post-Marketing Database Study, Incidence of interstitial lung disease (ILD), inoperable or recurrent breast cancer, palbociclib, Medical Data Vision (MDV)

Brief 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.

Interventions

DRUGpalbociclib plus fulvestrant

Patients treated with the combination of palbociclib and fulvestrant

DRUGfulvestrant

Patients treated with fulvestrant alone

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

15 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
The hazard ratios of ILD in palbociclib plus fulvestrant to new users of fulvestrant alone	25 November 2011 and 30 September 2024
The rate ratios of ILD in palbociclib plus fulvestrant to new users of fulvestrant alone	25 November 2011 and 30 September 2024
The rate differences of ILD in palbociclib plus fulvestrant to new users of fulvestrant alone	25 November 2011 and 30 September 2024
The incidence rate of ILD by each risk factor in new users of palbociclib	25 November 2011 and 30 September 2024

Secondary

Measure	Time frame
The incidence rate of ILD by each risk factor in new users of endocrine-based therapies including combination with CDK4/6 inhibitors	25 November 2011 and 30 September 2024

Countries

United States

Contacts

STUDY_DIRECTORPfizer CT.gov Call Center

Pfizer

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 11, 2026