Clinical Trial

Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]

Active, Not Recruiting Phase 3
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Summary
This study will compare DS-8201a to physician choice standard treatment. Participants must have HER2-low breast cancer that has been treated before. Participants' cancer: * Cannot be removed by an operation * Has spread to other parts of the body
Protocol Amendment History 32 amendments
This ClinicalTrials.gov record has been amended 32 times since 2018-11-06; most recent amendment 2025-09-16.
Status change: Recruiting → Active, Not Recruiting 2021-01-07
Status change: Not Yet Recruiting → Recruiting 2018-12-19
Trial Details
NCT Number NCT03734029
Lead Sponsor Daiichi Sankyo
Collaborators: Daiichi Sankyo Co., Ltd., AstraZeneca
Conditions Breast Cancer
Enrollment 557 participants
Start Date 2018-12-27
Primary Completion 2022-01-11 (estimated)
Study Completion 2026-08-01 (estimated)
Updated on ClinicalTrials.gov 2025-10-06