MedTrace Logo

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

NCT06265428 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 228

Last updated 2025-10-17

No results posted yet for this study

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.

Conditions

Interventions

DRUG

DB-1303/BNT323

Administered I.V.

DRUG

T-DM1

Administered I.V.

Sponsors & Collaborators

  • BioNTech SE

    collaborator INDUSTRY

  • DualityBio Inc.

    lead INDUSTRY

Principal Investigators

  • Lily Hu · DualityBio Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-29
Primary Completion
2026-02-28
Completion
2026-02-28
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06265428 on ClinicalTrials.gov