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

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

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.

View this trial on ClinicalTrials.gov

Interested in this trial?

Print this page and take it to your doctor to discuss your eligibilty and treatment options. Only your doctor can refer you to a clinical trial.

Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society