NCT06265428

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

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 Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 228 (actual)
• Sponsor: DualityBio Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a randomized controlled, 2-arm, open-label, multicenter phase III study to assess the efficacy and safety of DB-1303/BNT323 versus Trastuzumab Emtansine (T-DM1) in patients with human epidermal growth factor receptor 2 (HER2) -positive unresectable/metastatic breast cancer who have been treated with trastuzumab and taxanes. Approximately 224 patients with unresectable or metastatic HER2-positive breast cancer will be randomized 1:1 to receive DB-1303/BNT323 or T-DM1, respectively.

Conditions

• HER2-positive Breast Cancer

Interventions

Type	Name	Description
DRUG	DB-1303/BNT323	Administered I.V.
DRUG	T-DM1	Administered I.V.

Timeline

• Start date: 2024-01-29
• Primary completion: 2026-02-01
• Completion: 2026-02-01
• First posted: 2024-02-20
• Last updated: 2025-10-20

Locations

48 sites across 1 country: China

Regulatory

• FDA-regulated drug study