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

NCT07096024 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1772

Last updated 2025-08-28

No results posted yet for this study

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

DRUG

palbociclib plus fulvestrant

Patients treated with the combination of palbociclib and fulvestrant

DRUG

fulvestrant

Patients treated with fulvestrant alone

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-21
Primary Completion
2025-02-07
Completion
2025-02-07

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07096024 on ClinicalTrials.gov