Real life safety, effectiveness and quality of life of trastuzumab deruxtecan in patients with metastatic or unresectable HER2-positive breast cancer: a French ambispective multicentre 2 year-follow-up cohort study

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Safety 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
• Medical condition to be studied:
  Breast cancer

Population studied

• Short description of the study population:
  Unresectable or metastatic HER2+ breast cancer, treated at least once with T-DXd (under the ATU or after the market authorization according to the drug SmPC).
• Estimated number of subjects:
  270

Study design details

• Study design:
  National (France), multicentre, ambispective, longitudinal, observational study
• Main study objective:
  To describe the safety of T-DXd in real life conditions, i.e. the occurrence of T-DXd-related ADRs of interest:; -Any grade: ; o ILD / pneumonitis,; o Gastro-intestinal disorders (nausea / vomiting), ; o Alopecia,; o Left ventricular ejection fraction (LVEF) decrease,; - Grade ≥ 3 (according to NCI-CTCAE v5.0): other T-DXd-related ADRs.; The primary endpoint is the percentage of subjects with at least one T-DXd related ADR of interest during the 2 years following the start of administration of T-DXd.;
• Setting:
  Planned recruitment period: 13 months.; ; Study duration per patient: at most 2 years.; - From 9 months to 1.5 year in the ATU cohort; o FPI: 14/12/2021; o LPO: 06/2024; - At most 2 years in the post-MA cohort.;