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

Sponsor
DualityBio Inc.
Study ID
NCT06265428
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • DB-1303/BNT323 — DRUG
    Administered I.V.
  • T-DM1 — DRUG
    Administered I.V.

Study Details

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.

Key Dates

Start date
Jan 29, 2024
Status verified
Oct 2025
Primary completion
Feb 28, 2026
Completion
Feb 28, 2026

Study Design

Enrollment
228 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: DB-1303/BNT323
    Enrolled patients will receive DB-1303/BNT323 by intravenous (I.V.) infusion
  • Experimental: T-DM1
    Enrolled patients will receive T-DM1 by I.V. infusion

Primary Outcome Measure

Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) assessment per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) [ Time Frame: Up to approximately 24 months. ]

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