Trial Identifiers
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Scientific Title
A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study of DS-8201a, an Anti-HER2-antibody Drug Conjugate, Versus Treatment of Investigator's Choice for HER2-positive, Unresectable and/or Metastatic Breast Cancer Subjects Pretreated With Prior Standard of Care HER2 Therapies, Including T-DM1
Commercial Sponsor
Daiichi Sankyo Ltd.
Summary
To be included in this trial, patients must have HER2 breast cancer that has been treated before, cannot be removed with an operation and has spread to other parts of the body. Patients in this trial will be randomised to receive the study drug, DS-8201a, or standard of care therapy consisting of Trastuzumab/capecitabine or Lapatinib/capecitabine.