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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: 17 Mar 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

  • 02 Dec 2024 According to a Daiichi Sankyo Company media release, exploratory biomarker analysis from this study will be presented as a Spotlight Poster Session on Thursday, December 12, 7:00 - 8:30 am, at San Antonio Breast Cancer Symposium (#SABCS24).
  • 01 Sep 2024 Results assessing subgroup analysis of enrolled in DESTINY-Breast03 (n=309 At data cutoff (July 25, 2022) were published in the Cancer Science.
  • 01 Aug 2024 Results (At data cutoff, 20 November 2023) assessing updated efficacy and safety analyses published in the Nature Medicine.

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