Safety of Palbociclib Among Breast Cancer Patients in the United States

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/35998
• EU PAS number:
  EUPAS21948
• Study ID:
  35998
• Official title and acronym:
  Safety of Palbociclib Among Breast Cancer Patients in the United States
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  Primary Objective:1. Describe patient characteristics and incidence rates for prespecified safety events among all new users of palbociclib. Secondary Objectives:1. Describe patient characteristics and incidence rates for prespecified safety events among all subgroups of new users of palbociclib, and 2. among all subgroups who also meet algorithm-defined advanced stage ER+/HER2- breast cancer.3. Compare the incidence rates for prespecified safety events between concomitant new users of palbociclib with fulvestrant to all new users of fulvestrant alone (identified before 2015), conduct same comparison among those who also meet algorithm defined advanced breast cancer.4. Compare IRs for acute liver injury (ALI) between concomitant new users of palbociclib with fulvestrant to a) new users of fulvestrant alone identified before 2/1/ 2015 (historical controls) and b) after 2/1/2015 (contemporaneous controls).5. Adjudicate all potential cases of ALI through medical record review.6. Repeat comparative analyses for ALI using only confirmed cases adjusted for outcomeaccuracy.
• Study status:
  Finalised

Research institutions and networks

Institutions

HealthCore

Study timelines

Date when funding contract was signed

Planned: 19/09/2017

Actual: 19/09/2017

Study start date

Planned: 02/01/2018

Actual: 16/01/2018

Data analysis start date

Planned: 05/02/2018

Actual: 12/03/2018

Date of final study report

Planned: 31/05/2020

Actual: 12/06/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer, Inc.

Study protocol

Initial protocol

A5481105_PROTOCOL_19DEC2017 V1

Updated protocol

A5481105_Palbo_Protocol_Amendment_Final.Dec 6 2018_1

Regulatory

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