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

Pfizer2 个研究点分布在 1 个国家目标入组 95,637 人开始时间: 2025年1月21日最近更新: 2026年7月10日

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Pfizer
入组人数: 95,637
试验地点: 2
主要终点: The hazard ratios of ILD in palbociclib plus fulvestrant to new users of fulvestrant alone

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Retrospective

入排标准

年龄范围: 15 Years 至 —（Child, Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Having prescription records of drugs for endocrine therapy (aromatase inhibitors, SERDs, SERMs, and CDK4/6 inhibitors) from 25 November 2011 to 31 December
•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).

排除标准

•Having any records of anti-HER2 medication (e.g., trastuzumab, pertuzumab, lapatinib or trastuzumab emtansine) from 25 November 2011 to 31 December
•Having any records of second primary cancer with definitive diagnosis

研究组 & 干预措施

New prescription of palbociclib with fulvestrant.

Patients treated with the combination of palbociclib and fulvestrant

干预措施: palbociclib plus fulvestrant (Drug)

New prescription of fulvestrant monotherapy before the launch of palbociclib

Patients treated with fulvestrant alone

干预措施: fulvestrant (Drug)

New prescription of palbociclib with fulvestrant.

Patients treated with the combination of palbociclib and fulvestrant

干预措施: fulvestrant (Drug)