Understanding Early and Ongoing Treatment Utilization of Palbociclib in a US Community Oncology Setting

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/18421
• EU PAS number:
  EUPAS16706
• Study ID:
  18421
• Official title and acronym:
  Understanding Early and Ongoing Treatment Utilization of Palbociclib in a US Community Oncology Setting
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This is a retrospective observational longitudinal rolling cohort study to assess adult metastatic breast cancer patients initiating treatment with palbociclib from February 2015 to January 2016. Data was cumulatively extracted from The US Oncology Network/McKesson Specialty Health electronic health record database every 2 months. Patients on clinical trial were excluded. Demographic and clinical characteristics, prior treatment, dosing patterns, and duration of treatment were characterized.
• Study status:
  Finalised

Research institutions and networks

Institutions

US Oncology Network

Study timelines

Date when funding contract was signed

Planned: 23/11/2015

Actual: 23/11/2015

Study start date

Planned: 01/06/2015

Actual: 01/06/2015

Data analysis start date

Planned: 15/06/2015

Actual: 15/06/2015

Date of interim report, if expected

Planned: 31/12/2015

Actual: 01/12/2015

Date of final study report

Planned: 28/02/2017

Actual: 28/02/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Study protocol

Initial protocol

CT24-GSOP-RF03 3 0 NI Study Protocol Palbociclib in BC RH 5-12_v2 clean signed

Regulatory

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