Real-World Treatment Effectiveness of Palbociclib in Combination With an Aromatase Inhibitor as First Line Therapy in Post-Menopausal Women and Men With Metastatic Breast Cancer (P-REALITY 3)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/41804
• EU PAS number:
  EUPAS41803
• Study ID:
  41804
• Official title and acronym:
  Real-World Treatment Effectiveness of Palbociclib in Combination With an Aromatase Inhibitor as First Line Therapy in Post-Menopausal Women and Men With Metastatic Breast Cancer (P-REALITY 3)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This study aims to assess real-world effectiveness in post-menopausal women and men with HR+/HER2- MBC initiating palbociclib + AI or AI alone as first-line therapy during the period on or after 01 February 2015 to on or before 30 June 2020 in the United States. The primary objective is to compare OS in postmenopausal women and men treated with palbociclib + AI versus AI alone as first-line therapy for HR+/HER2- MBC.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Pfizer

Networks

Ontada

Study timelines

Date when funding contract was signed

Planned: 23/12/2020

Actual: 23/12/2020

Study start date

Planned: 01/07/2021

Actual: 14/02/2022

Data analysis start date

Actual: 10/05/2022

Date of final study report

Planned: 31/03/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Regulatory

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