Clinical Trial

A Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in High-risk HER2-positive Participants With Residual Invasive Breast Cancer Following Neoadjuvant Therapy (DESTINY-Breast05)

Active, Not Recruiting Phase 3
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Summary
Patients with HER2-positive primary breast cancer (BC) who do not achieve complete response after appropriate neoadjuvant therapy are at higher risk of disease recurrence. More effective treatment options are needed for this patient population. This study will examine the efficacy and safety of trastuzumab deruxtecan (T-DXd) compared with trastuzumab emtansine (T-DM1) in high-risk patients with residual invasive breast cancer following neoadjuvant therapy.
Protocol Amendment History 37 amendments
This ClinicalTrials.gov record has been amended 37 times since 2020-11-06; most recent amendment 2026-05-14.
Status change: Recruiting → Active, Not Recruiting 2023-12-18
Status change: Not Yet Recruiting → Recruiting 2021-01-05
Trial Details
NCT Number NCT04622319
Lead Sponsor Daiichi Sankyo
Collaborators: AstraZeneca, NSABP Foundation Inc, GBG Forschungs GmbH, Spanish Breast Cancer Research Group (SOLTI)
Conditions HER2-Positive Primary Breast Cancer, Residual Invasive Breast Cancer
Enrollment 1,600 participants
Start Date 2020-12-04
Primary Completion 2025-07-02 (estimated)
Study Completion 2028-06-20 (estimated)
Updated on ClinicalTrials.gov 2026-05-15