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

NCT07805135 | Not Yet Recruiting Phase 3

• 1 other identifier: HB1801-017
• Study Type: interventional
• Target: 430
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Objective Response Rate (ORR) assessed per RECIST v1.1

  up to approximately 2 years after the first enrollment

• Duration of Response (DOR)

  up to approximately 2 years after the first enrollment

• Disease Control Rate (DCR)

  up to approximately 2 years after the first enrollment

• Overall Survival (OS)

  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

Study Arms (2)

HB1801

EXPERIMENTAL

Drug: HB1801

Docetaxel (Taxotere®)

EXPERIMENTAL

Drug: Docetaxel (Taxotere®)

Interventions

HB1801 DRUG

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

HB1801

Docetaxel (Taxotere®) DRUG

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

Docetaxel (Taxotere®)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age: 18-75 years (Whichever is on the day of signing the informed consent form).
• \. Subjects have histologically or cytologically confirmed breast cancer at unresectable，recurrent/metastatic stage, with the requirements below based on the most recent pathological report:
• HER2-negative confirmed by histological or cytological testing;
• Pathological report is available to confirm HR status.
• \. Assessed by the Investigator as suitable for single-agent docetaxel therapy.
• \. At least one extracranial measurable lesion at baseline according to RECIST 1.1 criteria.
• \. Has adequate organ and system functions within 7 days prior to the first dose.
• \. Eastern Cooperative Oncology Group performance status of 0 or 1.
• \. Expected survival ≥ 3 months.

You may not qualify if:

• \. 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.
• \. 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.
• \. 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.
• \. With a history of other primary malignant tumors within 5 years before administration.
• \. Presence of serous cavity effusion requiring drainage or diuretic therapy within 2 weeks prior to the first dose.
• \. Severe neurological diseases (e.g., epilepsy, dementia, etc.) and Grade ≥2 peripheral neuropathy.
• \. Receipt of systemic glucocorticoid therapy within 14 days prior to the first dose.
• \. Current clinically significant abnormal interstitial lung disease.
• \. History of severe cardiovascular and cerebrovascular diseases within 6 months prior to the first dose.
• \. 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.
• \. Severe chronic or active infection requiring intravenous antibacterial, antifungal, or antiviral therapy within 2 weeks prior to the first dose.
• \. 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.
• \. 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.
• \. Toxicities from all prior anti-tumor therapies have not recovered to Grade 1 or less prior to the first dose.
• \. Has received powerful CYP3A4 inhibitor or inducer within 2 weeks before the first dose.

Sponsors & Collaborators

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

MeSH Terms

Interventions

Docetaxel

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Central Study Contacts

Clinical Trials Information Group Officer

CONTACT

86-0311-69085587; ctr-contact@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized in a 1:1 ratio to receive treatment in either the experimental group (HB1801) or the control group (Taxotere®).

Study Record Dates

• First Submitted: August 28, 2026
• First Posted: September 4, 2026
• Study Start: August 31, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: September 4, 2026

Record last verified: 2026-09