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A Phase III, Multicenter, Open-label, Randomized Study to Compare DB-1303 Versus T-DM1 in Patients With HER2-positive Unresectable/Metastatic Breast Cancer Who Have Been Treated With Trastuzumab and a Taxane (Dynasty-Breast01)

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Trial Profile

A Phase III, Multicenter, Open-label, Randomized Study to Compare DB-1303 Versus T-DM1 in Patients With HER2-positive Unresectable/Metastatic Breast Cancer Who Have Been Treated With Trastuzumab and a Taxane (Dynasty-Breast01)

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 26 Apr 2026

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At a glance

  • Drugs BNT 323 (Primary) ; Trastuzumab emtansine
  • Indications Advanced breast cancer; HER2 positive breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms Dynasty-Breast01
  • Sponsors BioNTech; Duality Biologics

Most Recent Events

  • 09 Apr 2026 According to Duality Biologics media release, announced that the Biologics License Application trastuzumab pamirtecan , has been accepted for review by the China National Medical Products Administration (NMPA). With the BLA filing, DualityBio is seeking approval for trastuzumab pamirtecan as second-line treatment for patients with unresectable or metastatic HER2-positive breast cancer. The application is based on this study.
  • 20 Oct 2025 Status changed from recruiting to active, no longer recruiting.
  • 09 Feb 2024 Status changed from planning to recruiting.

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