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

Official Title

A Phase 3, Multicentre, Randomized, Open-label, Active Controlled Trial of DS-8201a, an Anti-HER2-antibody Drug Conjugate (ADC), Versus Treatment of Physician's Choice for HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects


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

Trial Description

Primary Outcome:

  • Progression-free Survival (PFS) Based on Blinded Independent Central Review (BICR)
Secondary Outcome:
  • PFS based on Investigator Assessment
  • Overall Survival (OS)
  • Objective Response Rate (ORR)
  • Duration of Response (DoR), Based on Blinded Independent Central Review (BICR) and Investigator Assessment
This is a randomized, 2-arm, Phase 3, open-label, multicentre study to compare the safety and efficacy of trastuzumab deruxtecan versus the physician's choice (2:1) in HER2-low, unresectable and/or metastatic breast cancer participants. The Sponsor proposes to define a new HER2-low population in this trial including tumours with IHC 1+ and IHC 2+/ISH- HER2 expression.

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