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NOT YET RECRUITING
NCT07805135
PHASE3

A Study of HB1801 Versus Docetaxel (Taxotere®) in Patients With Advanced Breast Cancer

Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

View on ClinicalTrials.gov

Summary

This is a randomized, open-label, multicenter Phase Ⅲ clinical trial designed to evaluate the efficacy and safety of HB1801 versus Taxotere® in patients with HER2-negative advanced breast cancer.

Official title: A Randomized, Open-Label, Multicenter Phase Ⅲ Clinical Trial to Evaluate the Efficacy and Safety of HB1801 Versus Docetaxel (Taxotere®) in Patients With Advanced Breast Cancer

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

430

Start Date

2026-08-31

Completion Date

2029-06-01

Last Updated

2026-09-04

Healthy Volunteers

No

Interventions

DRUG

HB1801

HB1801, 100 mg/m² in Cycle 1, 75 mg/m² starting from Cycle 2, once every 3 weeks (Q3W), intravenous infusion over 60 minutes.

DRUG

Docetaxel (Taxotere®)

Docetaxel (Taxotere®), 75 mg/m², Q3W, intravenous infusion over 60 minutes.