A PHASE 3 MULTICENTER RANDOMIZED OPENLABEL ACTIVE-CONTROLLED TRIAL OF DS-8201A AN ANTI-HER2-ANTIBODY DRUG CONJUGATE (ADC) VERSUS TREATMENT OF PHYSICIAN S CHOICE FOR HER2LOW UNRESECTABLE AND/OR METASTATIC BREAST CANCER SUBJECTS

Brief description of study

This is a randomized Phase 3, open-label, multicenter study to compare the safety and efficacy of DS-8201a versus the physician’s choice in HER2-low, unresectable and/or metastatic breast cancer subjects. DS-8201 (Enhertu) is FDA approved for HER 2- high metastatic breast cancer, and has shown early promise in HER 2- low cancers


Clinical Study Identifier: s19-00579
ClinicalTrials.gov Identifier: NCT03734029
Principal Investigator: Sylvia Adams.


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