Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2025-12-29 @ 3:39 PM
Study NCT ID:
NCT06265428
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-17
First Post:
2024-01-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Compare DB-1303/BNT323 Versus T-DM1 in Breast Cancer
Sponsor:
DualityBio Inc.
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| CTR20233403 | OTHER | CENTER FOR DRUG EVALUATION, NMPA | View |