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
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
- 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.