Ignite Creation Date:
2024-05-06 @ 7:26 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06018337
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2023-08-25
Brief Title:
A Study of DB-1303BNT323 vs Investigators Choice Chemotherapy in HER2-Low Hormone Receptor Positive Metastatic Breast Cancer DYNASTY-Breast02
Sponsor:
DualityBio Inc
Organization:
DualityBio Inc
Study Overview
Official Title:
A Phase 3 Randomized Multi-center Open-Label Study of DB-1303 Versus Investigators Choice Chemotherapy in Human Epidermal Growth Factor Receptor 2 HER2-Low Hormone Receptor Positive HR Metastatic Breast Cancer Patients Whose Disease Has Progressed on Endocrine Therapy ET DYNASTY-Breast02
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to assess the efficacy of DB-1303BNT323 compared with investigators choice chemotherapy in terms of progression-free survival PFS by blinded independent central review BICR in the HR HER2-low immunohistochemistry IHC2in situ hybridization ISH- and IHC 1 population
Detailed Description:
The study is a Phase III Randomized Multi-center Open-label study in HER2-low HR metastatic breast cancer subjects whose disease has progressed on at least 2 lines of prior ET or within 6 months of first line ET Cyclin-dependent kinase CDK 46 inhibitor in the metastatic setting The primary purpose of the study is to determine the efficacy and safety of DB-1303BNT323 compared with investigators choice single agent chemotherapy in the target population Approximately 532 subjects with HER2 IHC 2ISH- and IHC 1 HER2-low expression will be randomized 11 across approximately 230 centers globally to receive either DB-1303 or investigators choice single agent chemotherapy capecitabine paclitaxel or nab-paclitaxel until Response Evaluation Criteria in Solid Tumors RECIST 11 defined disease progression PD unless there is unacceptable toxicity withdrawal of consent or another criterion for discontinuation is met
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CTR20233708 | OTHER | CENTER FOR DRUG EVALUATION NMPA | None |