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.
1. Age: 18-75 years (Whichever is on the day of signing the informed consent form).
HER2-negative confirmed by histological or cytological testing;
Pathological report is available to confirm HR status.
3. Assessed by the Investigator as suitable for single-agent docetaxel therapy.
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.
Parallel
HB1801
DrugHB1801, 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®)
DrugDocetaxel (Taxotere®), 75 mg/m², Q3W, intravenous infusion over 60 minutes.
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.
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).
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.
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.
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.
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