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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: HER2-Negative Advanced Breast Cancer
• Intervention / Treatment: Drug: HB1801; Drug: Docetaxel (Taxotere®)

• Study Type: Interventional
• Enrollment (Estimated): 430
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Clinical Trials Information Group Officer; Phone Number: 86-0311-69085587; Email: ctr-contact@cspc.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 1. Age: 18-75 years (Whichever is on the day of signing the informed consent form).

• 2. Subjects have histologically or cytologically confirmed breast cancer at unresectable，recurrent/metastatic stage, with the requirements below based on the most recent pathological report:

  1. HER2-negative confirmed by histological or cytological testing;
  2. Pathological report is available to confirm HR status.
• 3. Assessed by the Investigator as suitable for single-agent docetaxel therapy.
• 4. At least one extracranial measurable lesion at baseline according to RECIST 1.1 criteria.
• 5. Has adequate organ and system functions within 7 days prior to the first dose.
• 6. Eastern Cooperative Oncology Group performance status of 0 or 1.
• 7. Expected survival ≥ 3 months.

Exclusion Criteria:

• 1. Has received prior taxane-containing single-agent or combination regimens, and have disease progression during salvage therapy for unresectable locally advanced or metastatic breast cancer (has received at least 2 cycles), or developed recurrent-metastatic disease within 12 months following adjuvant therapy.
• 2. History of severe allergy or hypersensitivity reactions (Grade ≥3 per NCI-CTCAE Version 6.0) to human serum albumin or docetaxel and/or contraindications thereto, or history of severe allergy and/or contraindications to glucocorticoids.
• 3. Untreated active brain metastases (including brain or leptomeningeal metastases). Subjects with treated brain metastases may be enrolled if lesions are stable without evidence of new or enlarging pre-existing brain metastases.
• 4. With a history of other primary malignant tumors within 5 years before administration.
• 5. Presence of serous cavity effusion requiring drainage or diuretic therapy within 2 weeks prior to the first dose.
• 6. Severe neurological diseases (e.g., epilepsy, dementia, etc.) and Grade ≥2 peripheral neuropathy.
• 7. Receipt of systemic glucocorticoid therapy within 14 days prior to the first dose.
• 8. Current clinically significant abnormal interstitial lung disease.
• 9. History of severe cardiovascular and cerebrovascular diseases within 6 months prior to the first dose.
• 10. Has arterial or venous thromboembolism (e.g., lower-extremity deep vein thrombosis, lower-extremity arterial embolism, pulmonary embolism, etc.) within 6 months prior to the first dose. Stable thrombus is permitted for enrollment if the Investigator assesses no associated cardiovascular risk.
• 11. Severe chronic or active infection requiring intravenous antibacterial, antifungal, or antiviral therapy within 2 weeks prior to the first dose.
• 12. Has undergone major visceral organ surgery (excluding puncture biopsy or infusion device implantation) within 4 weeks prior to the first dose, or who require major visceral organ surgery during the study period.
• 13. Receipt of chemotherapy, targeted therapy, immunotherapy, endocrine therapy, or other investigational study drug within 4 weeks or 5 half-lives prior to the first dose (whichever is shorter, with a minimum of 2 weeks); receipt of radiotherapy within 2 weeks prior to the first dose; receipt of traditional Chinese medicine with anti-tumor indications within 2 weeks prior to the first dose.
• 14. Toxicities from all prior anti-tumor therapies have not recovered to Grade 1 or less prior to the first dose.
• 15. Has received powerful CYP3A4 inhibitor or inducer within 2 weeks before the first dose.
• 16. Has active hepatitis B infection, hepatitis C infection, positive HIV antibody, or active syphilis.
• 17. Concurrent participation in another interventional clinical study.
• 18. Any other conditions that, in the Investigator's opinion, render the participant unsuitable for participation in this clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HB1801	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.
Experimental: Docetaxel (Taxotere®)	Drug: Docetaxel (Taxotere®); Docetaxel (Taxotere®), 75 mg/m², Q3W, intravenous infusion over 60 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival (PFS)	PFS was defined as the time from the date of randomization to the date of progressive disease (as per RECIST v1.1) or death due to any cause.	up to approximately 2 years after the first enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR) assessed per RECIST v1.1	ORR per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) assessed by investigator was defined as the percentage of participants with complete response (CR) or partial response (PR).	up to approximately 2 years after the first enrollment
Duration of Response (DOR)	DOR by investigator assessment according to RECIST 1.1 in participants with CR or PR, defined as the time from the first documented CR/PR to PD or death.	up to approximately 2 years after the first enrollment
Disease Control Rate (DCR)	DCR by investigator assessment according to RECIST 1.1, defined as the percentage of participants with CR, PR, or stable disease (SD) lasting at least 6 weeks.	up to approximately 2 years after the first enrollment
Overall Survival (OS)	OS was defined as the time from the date of randomization until death due to any cause regardless of whether the participant withdrew from study therapy or received another subsequent anticancer therapy.	up to approximately 2 years after the first enrollment
The incidence and severity of adverse events (AE) and severe adverse events (SAE)		up to approximately 2 years after the first enrollment
Plasma concentration of docetaxel (free and total)		After completion of infusion administration on Day 1 of Cycle 1

Collaborators and Investigators

• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): August 31, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: August 28, 2026
• First Submitted That Met QC Criteria: September 3, 2026
• First Posted (Actual): September 4, 2026

Study Record Updates

• Last Update Posted (Actual): September 4, 2026
• Last Update Submitted That Met QC Criteria: September 3, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Taxoids; Cyclodecanes; Diterpenes; Docetaxel
• Other Study ID Numbers: HB1801-017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No