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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: 08 Apr 2024

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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

    • 17 Jan 2024 Planned End Date changed from 1 Apr 2024 to 1 Jun 2025.
    • 01 Dec 2023 According to Daiichi Sankyo Company Media Release, results from this study will be presented at the San Antonio Breast Cancer Symposium, 2023.
    • 24 Oct 2023 Results of exploartory pooled analysis (n=148 from studies NCT03248492; NCT03523585; NCT03529110) assessing trastuzumab deruxtecan (T-DXd) in patients (pts) with HER2-positive (HER2+) metastatic breast cancer (mBC) with brain metastases presented at the 48th European Society for Medical Oncology Congress
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