Clinical Trial

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]

Active, Not Recruiting Phase 3
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Summary
This study is designed to compare the anti-tumor activity as well as the safety and efficacy of DS-8201a versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer subjects previously treated with trastuzumab and taxane.
Protocol Amendment History 42 amendments
This ClinicalTrials.gov record has been amended 42 times since 2018-05-07; most recent amendment 2025-10-17.
Status change: Recruiting → Active, Not Recruiting 2020-07-08
Status change: Not Yet Recruiting → Recruiting 2018-08-07
Trial Details
NCT Number NCT03529110
Lead Sponsor Daiichi Sankyo
Collaborators: Daiichi Sankyo Co., Ltd., AstraZeneca
Conditions Breast Cancer
Enrollment 524 participants
Start Date 2018-08-09
Primary Completion 2021-05-21 (estimated)
Study Completion 2026-07-30 (estimated)
Updated on ClinicalTrials.gov 2025-10-21