Treatment patterns and clinical effectiveness outcomes of palbociclib in combination with aromatase inhibitor (AI) or fulvestrant in hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer patients: an observational study using Flatiron Electronic Health Record (EHR) database

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/21046
• EU PAS number:
  EUPAS21045
• Study ID:
  21046
• Official title and acronym:
  Treatment patterns and clinical effectiveness outcomes of palbociclib in combination with aromatase inhibitor (AI) or fulvestrant in hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer patients: an observational study using Flatiron Electronic Health Record (EHR) database
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This is an observational study using de-identified EHR data from Flatiron Health Analytic Database. The main objective is to describe patient demographics, clinical characteristics, treatment patterns and clinical effectiveness outcomes in a cohort of HR+/HER2- breast cancer patients who initiated palbociclib (Ibrance®) in combination with an AI or fulvestrant for treatment of advanced or metastatic disease, using flatiron HER database. The study population includes adult patients diagnosed with breast cancer identified from FI database between 01 January 2011 and 30 June 2017 (defined as “study period”) and who initiated palbociclib for treatment of advanced or metastatic disease on or after 03 February 2015. Information on patient demographics, clinical characteristics, treatment characteristics, CBC monitoring patterns and clinical effectiveness outcomes will be identified.
• Study status:
  Ongoing

Research institution and networks

Institutions

Pfizer

Study timelines

Date when funding contract was signed

Planned: 06/07/2017

Actual: 06/07/2017

Study start date

Planned: 21/07/2017

Actual: 21/07/2017

Date of final study report

Planned: 15/03/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer Inc.

Study protocol

Initial protocol

Palbociclib A5481076 PROTOCOL AMENDMENT 2_FINAL_22AUG2017_PASS registration version

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable