An observational cohort study to investigate the risk factors for interstitial lung disease (ILD) among breast cancer patients treated with abemaciclib or endocrine monotherapy using the Medical Data Vision (MDV) database in Japan (I3Y-JE-B008)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/104512
• EU PAS number:
  EUPAS104511
• Study ID:
  104512
• Official title and acronym:
  An observational cohort study to investigate the risk factors for interstitial lung disease (ILD) among breast cancer patients treated with abemaciclib or endocrine monotherapy using the Medical Data Vision (MDV) database in Japan (I3Y-JE-B008)
• DARWIN EU® study:
  No
• Study countries:
  Japan
• Study description:
  The primary objective of this study is to investigate risk factors of ILD among patients with HR+/HER2– breast cancer receiving abemaciclib-containing regimens or endocrine monotherapy (both historical and concurrent cohorts) under the real world setting in Japan, and the secondary objective is to describe the baseline characteristics, incidence and prevalence of ILD in each of the study cohorts. The exploratory objective is to compare the incidence rate of ILD in patients initiating abemaciclib relative to reference cohorts of endocrine monotherapy.
• Study status:
  Planned

Research institution and networks

Institutions

Eli Lilly and Company

Study timelines

Date when funding contract was signed

Planned: 19/07/2019

Study start date

Planned: 30/11/2018

Date of final study report

Planned: 01/12/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Eli Lilly Japan K.K.

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only