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A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of DS-8201a (Trastuzumab Deruxtecan), an Anti-HER2 Antibody Drug Conjugate (ADC), Versus Ado Trastuzumab Emtansine (T-DM1) for HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane

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Trial Profile

A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of DS-8201a (Trastuzumab Deruxtecan), an Anti-HER2 Antibody Drug Conjugate (ADC), Versus Ado Trastuzumab Emtansine (T-DM1) for HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane

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

Latest Information Update: 23 Dec 2025

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At a glance

  • Drugs Trastuzumab-deruxtecan (Primary) ; Trastuzumab emtansine
  • Indications Advanced breast cancer; Brain metastases; HER2 positive breast cancer; Male breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms DESTINY-B03; DESTINY-Breast03
  • Sponsors Daiichi Sankyo Company; Daiichi Sankyo Inc

Most Recent Events

  • 08 Dec 2025 According to a Daiichi Sankyo Company media release, data from this study will be presented at the at the 2025 San Antonio Breast Cancer Symposium (#SABCS25) on December 10 to 12 2025.
  • 21 Oct 2025 Planned End Date changed from 27 Nov 2025 to 30 Jul 2026.
  • 24 Sep 2025 According to AstraZeneca media release, ENHERTU is already approved in more than 85 countries as 2nd-line treatment for patients with HER2-positive breast cancer based on the results from the DESTINY-Breast03 Phase III trial.

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