BREAST: METASTATIC: HER2+: Prior T-DM1: DESTINY-Breast02

A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study of DS-8201a, an Anti-HER2-antibody Drug Conjugate, Versus Treatment of Investigator's Choice for HER2-positive, Unresectable and/or Metastatic Breast Cancer Subjects Pretreated With Prior Standard of Care HER2 Therapies, Including T-DM1

Title
Daiichi Sankyo DS8201-A-U301
Study Title

A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study of DS-8201a, an Anti-HER2-antibody Drug Conjugate, Versus Treatment of Investigator's Choice for HER2-positive, Unresectable and/or Metastatic Breast Cancer Subjects Pretreated With Prior Standard of Care HER2 Therapies, Including T-DM1

Site Link
Malignancy
Breast Cancer, Invasive breast Cancer, BC, IBC
Stage
Disease Setting
Metastatic/Palliative
Line Of Therapy
2nd Line or 3rd line (prior T-DM1)
Investigational Agent
Trastuzumab deruxtecan (DS8201a)
Drug Class
HER-2 targeted ADC
PI
Greg Vidal, MD, PhD
Sponsor
Daiichi Sankyo, Inc.
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Histologically confirmed unresectable or metastatic breast cancer
  • HER-2 positive (HER2+) by ASCO-CAP guidelines and confirmed by central lab
  • Previously treated with T-DM1
  • Progression following last treatment (cannot go on after stopping treatment for toxicity alone)
  • No prior capecitabine
  • No history of insterstitial lung disease or pneumonitis requiring steroids
  • No active CNS disease
Objective
  • Primary- PFS
  • Secondary- OS, ORR, DoR, CBR, PFS by investigator assessment
Assessment Frequency
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Assessment Frequency 2
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Assessment Frequency Link
Path
HER2 positive
Dosing Frequency
Control Agents
Study Protocol
Randomized
Yes
X