Study type

Study type

Non-interventional study

Scope of the study

Drug utilisation
Effectiveness study (incl. comparative)
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Study drug International non-proprietary name (INN) or common name

PALBOCICLIB

Medical condition to be studied

Breast cancer metastatic

Additional medical condition(s)

Advanced or metastatic, hormonal receptor positive, HER2- negative breast cancer
Population studied

Age groups

  • Adult and elderly population (≥18 years)
    • Adults (18 to < 65 years)
      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)
      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)

Estimated number of subjects

190
Study design details

Main study objective

To determine the progression free survival in patients with advanced or metastatic, hormone receptor positive, HER2- negative breast cancer, treated with palbociclib in combination with fulvestrant or letrozol

Outcomes

Progression free survival, Death Objective response Other variables: • Demographic and clinical characteristics • Patterns treatment • Persistence of Treatment • Date of the first treatment for breast cancer • Access to care for the treatment of metastatic breast cancer • Access to care from the attending physician • Reasons to produce discontinuation or dosage reduction

Data analysis plan

Descriptive statistics will be produced for all variables. These will include estimates of the mean, standard deviation, 95% confidence intervals of the mean, median, interquartile ranges and frequency distributions for continuous scale variables and frequency distributions for categorical scale variables. Histograms will be produced for both continuous and categorical scale variables while box plots will be produced for continuous scale variables. For the purposes of this study, the baseline will be the time of initiation of treatment with palbociclib. For the follow up periods longitudinal descriptive data will be produced at time intervals that will be dependent on the distribution of follow up visits. Time to event data including time to disease progression, death, partial response, complete response and treatment discontinuation will be described using the Kaplan Meier estimator of the Survival Function.