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A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in Participants With High-Risk HER2-Positive Primary Breast Cancer Who Have Residual Invasive Disease in Breast or Axillary Lymph Nodes Following Neoadjuvant Therapy (DESTINY-Breast05)

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Trial Profile

A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in Participants With High-Risk HER2-Positive Primary Breast Cancer Who Have Residual Invasive Disease in Breast or Axillary Lymph Nodes Following Neoadjuvant Therapy (DESTINY-Breast05)

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 12 Dec 2025

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At a glance

  • Drugs Trastuzumab-deruxtecan (Primary) ; Trastuzumab emtansine
  • Indications Carcinoma; Early breast cancer; HER2 positive breast cancer; Male breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms DESTINY-Breast05
  • Sponsors Daiichi Sankyo Company; Daiichi Sankyo Inc

Most Recent Events

  • 18 Oct 2025 Primary endpoint has been met. (Invasive Disease-free Survival (IDFS) in Participants Who Were Administered Trastuzumab Deruxtecan (T-DXd) Compared With Trastuzumab Emtansine (T-DM1) Treatment), according to a Daiichi Sankyo Inc Media Release.
  • 18 Oct 2025 Results presented in the Daiichi Sankyo Inc Media Release.
  • 18 Oct 2025 According to an AstraZeneca media release, Overall survival (OS) was not mature at the time of this planned interim analysis (2.9% maturity at data cut-off) and will be assessed in future analyses (HR 0.61; 95% CI 0.34-1.10).

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