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OpenTrials
Completed

NCT Number: NCT07096024

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

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.

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Key information

Conditions

Breast Neoplasms Breast Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer

New York, 10001, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

palbociclib plus fulvestrant

Drug

Patients treated with the combination of palbociclib and fulvestrant

Other names: Ibrance, fulvestrant

Fulvestrant

Drug

Patients treated with fulvestrant alone

Primary outcomes

  1. The hazard ratios of ILD in palbociclib plus fulvestrant to new users of fulvestrant alone

    Time frame: 25 November 2011 and 30 September 2024

  2. The rate ratios of ILD in palbociclib plus fulvestrant to new users of fulvestrant alone

    Time frame: 25 November 2011 and 30 September 2024

  3. The rate differences of ILD in palbociclib plus fulvestrant to new users of fulvestrant alone

    Time frame: 25 November 2011 and 30 September 2024

  4. The incidence rate of ILD by each risk factor in new users of palbociclib

    Time frame: 25 November 2011 and 30 September 2024

Secondary outcomes

  1. The incidence rate of ILD by each risk factor in new users of endocrine-based therapies including combination with CDK4/6 inhibitors

    Time frame: 25 November 2011 and 30 September 2024

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 31, 2025
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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