An Observational Study of Treatment Patterns and Safety Outcomes for Metastatic or Locally Recurrent Breast Cancer (AVF4349n)

Study type

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

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Additional medical condition(s):
  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:
  1250

Study design details

• Main study objective:
  1. To explore differences in clinical outcomes such as response rate (RR), time to treatment failure (TTF), time to next therapy, progression-free survival (PFS), and overall survival (OS) for various subpopulations of advanced breast cancer patients 2.To understand differences in the natural history of advanced breast cancer based on treatment patterns3. To describe specific safety events
• Outcomes:
  Clinical Effectiveness EndpointsClinical Safety Endpoints, -Time to loss of work ability for MBC patients who are working at baseline as measured by the WPAI:SHP-Activity Level Scale score over time-Percent of productivity loss due to MBC
• Data analysis plan:
  Safety and effectiveness outcomes will be analyzed using univariate analysis, stratified analysis by relevant baseline risk factors (including HR status, current and prior treatments), and multivariable analysis to adjust for potential confounding factors.TTF, PFS, and OS will be summarized using the Kaplan Meier method. Exploratory model-based analyses will be performed using multivariable Cox regression models to identify factors associated with TTF, PFS, and OS. Patients will be censored at study termination, loss to follow-up, patient’s decision, investigator’s decision, or Sponsor’s decision to terminate study participation, or at the data cutoff date. In addition, point estimates and 95% confidence intervals will be calculated for response rate (RR).