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

NCT07805135 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 430

Last updated 2026-09-04

No results posted yet for this study

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.

Conditions

  • HER2-Negative Advanced Breast Cancer

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.

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
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2028-06-01
Completion
2029-06-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07805135 on ClinicalTrials.gov