Descriptive Analyses of Clinical Characteristics and Treatment Patterns of Breast Cancer Patients Initiating Palbociclib (Ibrance®) Treatment in the US Community Oncology Setting

Study identification

• EU PAS number:
  EUPAS16710
• Study ID:
  18408
• Official title and acronym:
  Descriptive Analyses of Clinical Characteristics and Treatment Patterns of Breast Cancer Patients Initiating Palbociclib (Ibrance®) Treatment in the US Community Oncology Setting
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  Palbociclib (Ibrance®) was approved in the United States (US) in February 2015. This study will describe the characteristics of patients initiating treatment with palbociclib in terms of demographic and clinical characteristics, real-world treatment patterns (line of therapy, concomitant use of other chemotherapy/hormonal therapy/supportive drugs), dosing patterns, and adverse event/neutropenia-related outcomes (frequency of monitoring incidence, time to event) among female patients with breast cancer following US approval.
• Study status:
  Finalised

Research institutions and networks

Institutions

Cardinal Health Specialty Solutions

Study timelines

Date when funding contract was signed

Planned: 01/10/2015

Actual: 15/10/2015

Study start date

Planned: 30/11/2015

Actual: 28/10/2015

Data analysis start date

Planned: 08/01/2016

Actual: 21/12/2015

Date of interim report, if expected

Planned: 01/04/2016

Actual: 08/04/2016

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

Regulatory

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