A prospective, non-interventional study (NIS) with trastuzumab deruxtecan for patients with HER2-low expressing unresectable and/or metastatic breast cancer accompanied by a disease registry of patients treated with conventional chemotherapy (DESTINY Breast Respond HER2-low Europe)

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  ENHERTU
• Study drug International non-proprietary name (INN) or common name:
  TRASTUZUMAB DERUXTECAN
• Anatomical Therapeutic Chemical (ATC) code:
  (L01FD04) trastuzumab deruxtecan

  trastuzumab deruxtecan
• Medical condition to be studied:
  HER2 low breast cancer

Population studied

• Short description of the study population:
  Setting: ; • 1350 patients from different countries and care settings (primary care and secondary care and different specialties); ; The study population consists of adult patients with unresectable or metastatic HER2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.
• 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:
  1350

Study design details

• Study design:
  Multinational, multicenter, prospective observational, noninterventional study