DS-8201a Versus T-DM1 for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane [DESTINY-Breast03]

Investigator: Polly Niravath, MD

Study Coordinator: Jose Cruz

Status: Enrolling

ClinicalTrials.gov Number: NCT03523585

Phone: 713.441.4457

Protocol Number: Pro00021210

Description

Primary Objective: • To compare the efficacy of DS-8201a to investigator’s choice by means of progression-free survival (PFS). Secondary Objectives: • To further investigate the efficacy of DS-8201a compared to investigator’s choice on: ? Overall survival (OS); ? Objective response rate (ORR); ? Duration of response (DoR); ? Clinical benefit rate (CBR). • To further determine pharmacokinetics (PK) of DS-8201a. • To further evaluate safety of DS-8201a compared to investigator’s choice. • To evaluate Health Economics and OutcomesResearch (HEOR) endpoints for DS-8201a compared to investigator’s choice. Exploratory Objectives: • To evaluate potential biomarkers (eg, serum HER2-extracellular domain [HER2ECD]). • To evaluate exposure-response relationships for efficacy and safety endpoints.
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