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A Phase 3, Multicenter, Randomized, Open-label, Active Controlled Trial of DS-8201a, an Anti-HER2-antibody Drug Conjugate (ADC), Versus Treatment of Physician's Choice for HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects

Trial Profile

A Phase 3, Multicenter, Randomized, Open-label, Active Controlled Trial of DS-8201a, an Anti-HER2-antibody Drug Conjugate (ADC), Versus Treatment of Physician's Choice for HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects

Recruiting
Phase of Trial: Phase III

Latest Information Update: 14 Jan 2019

At a glance

  • Drugs Trastuzumab-deruxtecan (Primary) ; Capecitabine; Eribulin; Gemcitabine; Paclitaxel
  • Indications Advanced breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms DESTINY-Breast04
  • Sponsors Daiichi Sankyo Inc
  • Most Recent Events

    • 14 Jan 2019 According to a Daiichi Sankyo Company media release, safety endpoints of this study include serious adverse events, treatment-emergent adverse events and adverse events of special interest. Health economics and outcomes research endpoints as well as pharmacokinetic and biomarker endpoints will also be measured.
    • 14 Jan 2019 According to a Daiichi Sankyo Company media release, the first patient has been dosed in this trial.
    • 19 Dec 2018 Status changed from not yet recruiting to recruiting.
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