“Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]”
This study will compare DS-8201a to physician choice standard treatment. Participants must have HER2-low breast cancer that has been treated before. Participants' cancer: - Cannot be removed by an operation - Has spread to other parts of the body
Drug - Trastuzumab deruxtecan (DS-8201a)
DS-8201a is a lyophilized powder reconstituted into a sterile aqueous solution (100 mg/5 mL) to be administered intravenously
Drug - Capecitabine
Administered according to label, as one option for Physician's Choice (determined before randomization)
Drug - Eribulin
Administered according to label, as one option for Physician's Choice (determined before randomization)
Drug - Gemcitabine
Administered according to label, as one option for Physician's Choice (determined before randomization)
Drug - Paclitaxel
Administered according to label, as one option for Physician's Choice (determined before randomization)
Drug - Nab-paclitaxel
Administered according to label, as one option for Physician's Choice (determined before randomization)
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
NCT03734029
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