Non-interventional, real-world study of patients with early stage, human epidermal growth factor receptor 2 (HER2) positive breast cancer (BC) receiving Trazimera (VESTA)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Drug utilisation

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  TRAZIMERA
• Medical condition to be studied:
  HER2 positive 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:
  350

Study design details

• Main study objective:
  To describe treatment patterns in patients with early stage (stage 0-3) HER2 positive BC and treated with Trazimera, including combination therapies, as neoadjuvant or adjuvant treatment in a real-world setting
• Outcomes:
  Duration of treatment, treatment adherence, treatment discontinuation rates and rationale, Demographic characteristics, tolerability, patient reported quality of life, and healthcare resource utilization
• Data analysis plan:
  Descriptive statistics to characterize treatment patterns, tolerability, demographics, patient related quality of life, and healthcare resource utilization