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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: 17 Mar 2026

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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

  • 09 Mar 2026 According to a Daiichi Sankyo Company media release, based on DESTINY-Breast05 phase 3 trial results, supplemental Biologics License Application for ENHERTU (fam-trastuzumab deruxtecan-nxki) has been accepted and granted Priority Review in the U.S. for the treatment of adult patients with HER2 positive (immunohistochemistry [IHC] 3+ or in-situ hybridization. The PDUFA data for their regulatory decision is 7 July 2026.
  • 19 Feb 2026 According to an AstraZeneca media release, based on results from this trial, the European Medicines Agency (EMA) has validated the Type II Variation marketing authorization application for ENHERTU as a monotherapy for adult patients with HER2 positive breast cancer who have residual invasive disease after neoadjuvant HER2 targeted treatment.The validation confirms the completion of the application and commences the scientific review process by the EMA's CHMP.
  • 22 Dec 2025 According to an AstraZeneca media release, data form this trial were published in the New England Journal of Medicine.

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