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

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Retrospective observational study

Study drug and medical condition

• Name of medicine:
  IBRANCE
• Medical condition to be studied:
  Breast cancer metastatic

Population studied

• Short description of the study population:
  Breast cancer female patients at least 18 years of age at date of breast cancer diagnosis who had received at least one prescription for palbociclib during the index period and diagnosed with breast cancer (ICD-9 CM 174.x) anytime prior to or on the date of first prescription for palbociclib.
• 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:
  Metastatic breast cancer patients
• Estimated number of subjects:
  800

Study design details

• Main study objective:
  1. Characterize demographic/clinical characteristics of patients initiating treatment with palbociclib (PAL). 2. Describe PAL utilization by line of therapy. 3. Assess the frequency of PAL dose modification. 4. Quantify frequency of CBC including WBC monitoring including the incidence of neutropenia and 5. Describe treatment patterns pre-treatment, concomitantly, and post-PAL treatment.
• Data analysis plan:
  This study is a longitudinal, retrospective observational study. It is descriptive in nature. All female breast cancer patients newly initiating treatment with palbociclib between 01 February 2015 and 31 January 2016 will be included from the EMR database. The index date for the analysis is the date of first treatment administration of palbociclib. EMR data will be extracted for each patient backward in time to the first date of diagnosis for BC and forward up to 31 March 2016.