DS-8201a Versus T-DM1 for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane [DESTINY-Breast03]

Official Title

A Phase 3, Multicentre, Randomized, Open-Label, Active-Controlled Study of DS-8201a (Trastuzumab Deruxtecan), an Anti-HER2 Antibody Drug Conjugate (ADC), Versus Ado Trastuzumab Emtansine (T-DM1) for HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane

Summary:

This study is designed to compare the anti-tumour activity as well as the safety and efficacy of DS-8201a versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer subjects previously treated with trastuzumab and taxane.

Trial Description

Primary Outcome:

  • Progression-free survival (PFS) based on blinded independent central review (BICR)
Secondary Outcome:
  • Overall survival (OS)
  • Objective response rate (ORR) based on BICR and investigator's assessment
  • Duration of response (DoR) based on BICR and investigator's assessment
  • Clinical benefit rate (CBR)
  • Progression-free survival (PFS) based on investigator's assessment

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society