Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06313086
Status:
RECRUITING
Last Update Posted:
2024-05-10
First Post:
2024-03-01
Brief Title:
DP303c Versus Trastuzumab Emtansine in in Patients With HER2-positive Advanced Breast Cancer
Sponsor:
CSPC ZhongQi Pharmaceutical Technology Co Ltd
Organization:
CSPC ZhongQi Pharmaceutical Technology Co Ltd
Study Overview
Official Title:
A Multicentre Randomized Open-label Controlled Phase Ш Clinical Study to Evaluate the Efficacy and Safety of DP303c Versus Trastuzumab Emtansine in Patients With HER2-positive Advanced Breast Cancer
Status:
RECRUITING
Status Verified Date:
2023-12
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:
A Clinical Study to Evaluate the Efficacy and Safety of DP303c versus trastuzumab emtansine in patients with HER2-positive Advanced Breast Cancer
Detailed Description:
This is a multi-centre randomized open-label controlled phase Ш clinical study to evaluate the efficacy and safety of DP303c injection versus trastuzumab emtansine in in patients with HER2-positive advanced breast cancer Patients will be treated with DP303c injection at 30 mgkg or trastuzumab emtansine at 36 mgkg every 3 weeks Patients will continue to receive treatment until disease progression intolerable toxicity withdrawal of informed consent death or any other reasons for treatment discontinuation whichever occurs first
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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 |
|---|---|---|---|
| CTR20240245 | REGISTRY | NMPA | None |