Retrospective Assessment of Treatment Patterns and Outcomes Associated with Palbociclib in Combination With Letrozole in Postmenopausal Women With HR+/HER2– Advanced Breast Cancer

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/26344
• EU PAS number:
  EUPAS13869
• Study ID:
  26344
• Official title and acronym:
  Retrospective Assessment of Treatment Patterns and Outcomes Associated with Palbociclib in Combination With Letrozole in Postmenopausal Women With HR+/HER2– Advanced Breast Cancer
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  To describe the patient and clinical characteristics, treatment patterns, and clinical outcomes of patients who received palbociclib plus letrozole for the treatment of HR+/ HER2- advanced breast cancer.
• Study status:
  Finalised

Research institutions and networks

Institutions

Pfizer

Multiple centres: 7 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 12/09/2015

Actual: 12/09/2015

Study start date

Planned: 30/06/2016

Actual: 01/08/2016

Data analysis start date

Planned: 01/08/2016

Actual: 01/12/2017

Date of final study report

Planned: 31/10/2016

Actual: 16/10/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer Inc

Study protocol

Initial protocol

A5481064 Breast Cancer Retrospective Study Protocol 02June2016 FINAL

Regulatory

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