Clinical Trial

A Study of DB-1303/BNT323 vs Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Metastatic Breast Cancer (DYNASTY-Breast02)

Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
The goal of this clinical trial is to assess the efficacy of DB-1303/BNT323 compared with investigator's choice chemotherapy in terms of progression-free survival (PFS) by blinded independent central review (BICR) in the HR+, HER2-low (immunohistochemistry \[IHC\]2+/in situ hybridization \[ISH\]- and IHC 1+) population.
Protocol Amendment History 3 changes
notable Trial sites reduced: 261 -> 258 locations 2026-06-03
notable Primary completion pushed: 2026-05 -> 2026-06 2026-06-03
minor Completion pushed: 2028-07 -> 2028-08 2026-06-03
Trial Details
NCT Number NCT06018337
Lead Sponsor DualityBio Inc.
Collaborators: BioNTech SE
Conditions Metastatic Breast Cancer
Enrollment 541 participants
Start Date 2024-01-18
Primary Completion 2026-06 (estimated)
Study Completion 2028-08 (estimated)
Updated on ClinicalTrials.gov 2026-06-02