Clinical Trial

A Study to Compare DB-1303/BNT323 Versus T-DM1 in Breast Cancer

Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
Record status
This record was last updated October 20, 2025 (before its estimated February 2026 completion). Its status may not reflect the trial's current state.
Summary
This study is designed to compare efficacy and safety of DB-1303/BNT323 versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer patients previously treated with trastuzumab and taxane.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-02-09; most recent amendment 2025-10-15.
Status change: Recruiting → Active, Not Recruiting 2025-10-15
Trial Details
NCT Number NCT06265428
Lead Sponsor DualityBio Inc.
Collaborators: BioNTech SE
Conditions HER2-positive Breast Cancer
Enrollment 228 participants
Start Date 2024-01-29
Primary Completion 2026-02 (estimated)
Study Completion 2026-02 (estimated)
Updated on ClinicalTrials.gov 2025-10-20