Safety of Palbociclib Among Breast Cancer Patients in the United States

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology

  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Active surveillance study

Study drug and medical condition

• Name of medicine:
  IBRANCE
• Additional medical condition(s):
  HER-2 positive breast cancer

Population studied

• Short description of the study population:
  The study will include all new users of palbociclib aged >18 years. ; Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:; 1. At least one dispensing for palbociclib from 01 February 2015 through 31 September 2017 OR dispensing for fulvestrant from 01 January 2011 through 31 January 2015 (for secondary objective 3) OR dispensing for fulvestrant from 01 February 2015 through 31 September 2017 (for secondary objective 4); AND; 2. Aged 18 years or older at time of first dispensing of a study drug; AND; 3. At least three months membership in the HIRD with no dispensings of palbociclib (or any other CDK4/6 inhibitor such as ribociclib) before the first dispensing of palbociclib, as a minimal baseline period to define new use and characterize baseline risk.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Breast Cancer patients
• Estimated number of subjects:
  3300

Study design details

• Main study objective:
  What are the incidence rates of safety events among new users of palbociclib in a real-world setting?
• Outcomes:
  Describe patient characteristics and incidence rates of prespecified safety events among all new users of palbociclib. Compare IRs for safety events among all subgroups of new users of palbociclib.Compare IRs for safety events between new users of palbociclib with fulvestrant and new users of fulvestrant alone (identified < 2/1/2015).Compare IRs for acute liver injury (ALI) between new users of palbociclib with fulvestrant and new users of fulvestrant alone (both historical and contemporaneous controls).
• Data analysis plan:
  1) Descriptive statistics and incidence rates provided for all prespecified safety events among all new users of palbociclib and by subgroups of new users of palbociclib,2) Analyses repeated for those who also meet algorithm-defined advanced breast cancer,3) Unadjusted and propensity score adjusted hazard ratios for all prespecified safety events between new users of palbociclib with fulvestrant and new users of fulvestrant alone (identified prior to 2015), analyses repeated for those who also meet algorithm-defined advanced breast cancer.4) Unadjusted and propensity score adjusted hazard ratios for ALI between new users of palbociclib with fulvestrant and new users of fulvestrant alone a) identified prior to 2/1/2015 - historical controls and b) after 2/1/2015- contemporaneous controls,5) Adjudicate all potential cases of ALI through review of medical records.6) Comparative analyses will be reanalyzed using confirmed cases, adjusted for outcome accuracy.

Documents

Study results

A5481105 Study Report and Data Tables and Figures

a5481105-study-data

Study, other information

a5481105-abstract