HER2-Negative Advanced Breast Cancer
Conditions
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.
Interventions
DRUGHB1801
HB1801, 100 mg/m² in Cycle 1, 75 mg/m² starting from Cycle 2, once every 3 weeks (Q3W), intravenous infusion over 60 minutes.
Docetaxel (Taxotere®), 75 mg/m², Q3W, intravenous infusion over 60 minutes.
Sponsors
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Subjects will be randomized in a 1:1 ratio to receive treatment in either the experimental group (HB1801) or the control group (Taxotere®).
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival (PFS) | up to approximately 2 years after the first enrollment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma concentration of docetaxel (free and total) | After completion of infusion administration on Day 1 of Cycle 1 | — |
| The incidence and severity of adverse events (AE) and severe adverse events (SAE) | up to approximately 2 years after the first enrollment | — |
| Duration of Response (DOR) | up to approximately 2 years after the first enrollment | 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. |
| Disease Control Rate (DCR) | up to approximately 2 years after the first enrollment | 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. |
| Overall Survival (OS) | up to approximately 2 years after the first enrollment | 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. |
| Objective Response Rate (ORR) assessed per RECIST v1.1 | up to approximately 2 years after the first enrollment | 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). |
Contacts
CONTACTClinical Trials Information Group Officer
Outcome results
None listed