A Study Comparing the Efficacy and Safety of HB1801 With Taxotere® in Advanced Breast Cancer
NCT07083505 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2025-07-24
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).
Conditions
Interventions
- DRUG
-
HB1801
HB1801 \[administered according to the clinical trial protocol\]
- DRUG
-
Taxotere®
Taxotere® 75 mg/ m\^2 \[administered according to the clinical trial protocol\]\]
Sponsors & Collaborators
-
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-08-15
- Primary Completion
- 2026-10-11
- Completion
- 2026-12-31
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