A EUROPEAN DISEASE REGISTRY STUDY TO PROSPECTIVELY OBSERVE TREATMENT PATTERNS AND OUTCOMES IN PATIENTS WITH HER2-POSITIVE UNRESECTABLE LOCALLY ADVANCED OR METASTATIC BREAST CANCER (SAMANTHA)

Study type

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

  Disease epidemiology

  Drug utilisation

  Effectiveness study (incl. comparative)

  Other
• If ‘other’, further details on the scope of the study:
  Health Economic Assessment

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Disease Registry

Study drug and medical condition

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

  TRASTUZUMAB EMTANSINE
• Medical condition to be studied:
  Breast cancer

Population studied

• 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)
• Estimated number of subjects:
  465

Study design details

• Main study objective:
  In patients with unresectable LA or HER2 positive mBC, 1.) to estimate and describe progression-free survival (PFS) and 2.) to describe treatment regimens and their sequencing
• Outcomes:
  In patients with unresectable LA or HER2 positive mBC, 1.) to estimate and describe progression-free survival (PFS) and 2.) to describe treatment regimens and their sequencing, To observe and describe overall survival, duration of response, objective response rate, and safety of anti-cancer treatment regimen of different subpopulations of mBC or LA. To observe and describe incidence of and reasons for changes to anti-cancer treatment, treatment of special interest population and incidence of AEs of interest related to Roche products use and their combination partners.
• Data analysis plan:
  The analysis will make use of descriptive statistical methods. Exploratory statistical testing and modelling will be used to highlight interesting aspects of the data. Any test performed will be two-sided and carried out with a 5% α error rate without correction for multiplicity. The main safety parameter is the incidence of SAEs. The proportion of patients experiencing at least one event within each line of treatment will be estimated with 95% Clopper–Pearson confidence intervals (CI). Analysis of PFS and OS is based on the survivor function. The survival function will be estimated using Kaplan–Meier methodology and summarized using the range, the 25th and 75th percentiles, the median overall survival and a 95% CI for the median. The plot of Kaplan–Meier estimates for the single treatment group will be presented.