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Official Title: A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of DS-8201a (Trastuzumab Deruxtecan), an Anti-HER2 Antibody Drug Conjugate (ADC), Versus Ado Trastuzumab Emtansine (T-DM1) for HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03529110

Primary Outcome Measures:
1. Progression-free survival (PFS) based on blinded independent central review (BICR) [Time Frame: Within 45 months]

Time from the date of randomization to the earliest date of the first objective documentation of radiographic disease progression via BICR according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1 or death due to any cause

Official Title: 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

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03734029

Primary Outcome Measures:
1. Progression-free survival (PFS) based on blinded independent central review (BICR) [Time Frame: within approximately 3 years]

PFS based on BICR is defined as the time from randomization to the first objective (radiographic) documentation of disease progression or death.

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