OncRef

Clinical Trial: NCT04622319

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)

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 3

Lead Sponsor:Daiichi Sankyo
Information Provided By:Daiichi Sankyo
Last Update Posted:2026-05-15

Study Overview

Brief 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.

Official Title

A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in Participants With High-Risk HER2-Positive Primary Breast Cancer Who Have Residual Invasive Disease in Breast or Axillary Lymph Nodes Following Neoadjuvant Therapy (DESTINY-Breast05)

Conditions

HER2-Positive Primary Breast Cancer, Residual Invasive Breast Cancer

Intervention / Treatment

  • Drug: DS-8201a
  • Drug: T-DM1

Other Study ID Numbers

  • DS8201-A-U305
  • 2020-003982-20
  • DESTINY-Breast05
  • NSABP B-60
  • GBG-103
  • SOLTI-2001

Start Date (Actual)

2020-12-04

Primary Completion Date (Actual)

2025-07-02

Study Completion Date (Estimated)

2028-06-20

Enrollment (Estimated)

1600

Study Type

Interventional

Phase

Phase 3