Clinical trial · Interventional
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)
NCT06265428CI-TRIAL-00096656active not recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HER2-positive Breast Cancer | HER2-Positive Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DB-1303/BNT323 | Drug | — | UNRESOLVED |
| T-DM1 | Drug | Trastuzumab Emtansine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- DB-1303/BNT323
- description
- Enrolled patients will receive DB-1303/BNT323 by intravenous (I.V.) infusion
- interventionNames
- Drug: DB-1303/BNT323
- type
- EXPERIMENTAL
- label
- T-DM1
- description
- Enrolled patients will receive T-DM1 by I.V. infusion
- interventionNames
- Drug: T-DM1
Primary outcomes (1)
- 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)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female adults ≥ 18 years at the time of voluntary signing of informed consent. * Pathologically confirmed unresectable or metastatic HER2 positive breast cancer previously treated with trastuzumab and taxane * Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1. * Presence of at least one measurable lesion according to RECIST v1.1 * Expected survival time ≥ 12 weeks. * Patients must give informed consent to this study and voluntarily sign written informed consent form prior to the study. Exclusion Criteria: * Prior anti-HER2 ADC therapy. * Previous history of interstitial lung disease/noninfectious pneumonitis/radiation pneumonitis requiring steroid therapy. * Known serious hypersensitivity to the active ingredients of the study drug, inactive ingredients in the formulation, or other antibody drugs. * Multiple primary malignancies within 3 years, except for adequately resected non-melanoma skin cancer, curatively treated in situ tumor, or contralateral breast cancer * Uncontrolled infection requiring intravenous antibiotics, antiviral or antifungal agents, autoimmune disease requiring treatment, uncontrolled diabetes, hypertension, or other systemic disease that makes compliance with study procedures difficult * Unrecovered toxicity from prior anticancer therapy, defined as toxicity (except for alopecia) not recovered to ≤Grade 1 (NCI-CTCAE v5.0) or baseline. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
References
Publications (0)
Data not yet available
No reference posted for this study.