Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2026-01-13 @ 5:39 PM
Study NCT ID:
NCT07083505
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-24
First Post:
2025-07-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Comparing the Efficacy and Safety of HB1801 With Taxotere® in Advanced Breast Cancer
Sponsor:
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Organization:
Study Overview
Official Title:
A Multicenter, Randomized, Open-Label Phase II Clinical Trial Comparing Efficacy and Safety of HB1801 With Taxotere® in Advanced Breast Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-07
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 is a randomized, open-label, multicenter Phase II clinical trial evaluating the efficacy and safety of HB1801 compared with Taxotere® in patients with advanced breast cancer. A total of 60 subjects with advanced breast cancer are planned to be enrolled.The trial consists of three phases: screening period, open-label treatment period, and follow-up period. HB1801 is Docetaxel for injection (Albumin-bound).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: