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

NCT06018337 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 541

Last updated 2026-03-05

No results posted yet for this study

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.

Conditions

Interventions

DRUG

DB-1303/BNT323

IV

DRUG

Capecitabine

Oral

DRUG

Paclitaxel

IV

DRUG

Nab-paclitaxel

IV

Sponsors & Collaborators

  • BioNTech SE

    collaborator INDUSTRY

  • DualityBio Inc.

    lead INDUSTRY

Principal Investigators

  • Joyce O'Shaughnessy, PHD · Texas Oncology - Baylor Charles A. Sammons Cancer center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-18
Primary Completion
2026-05-31
Completion
2028-07-31
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Canada
  • China
  • France
  • Germany
  • Hong Kong
  • Hungary
  • Israel
  • Italy
  • Poland
  • South Korea
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

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 NCT06018337 on ClinicalTrials.gov