This is a randomized, controlled, open-label, multicenter, phase Ш clinical study designed to compare the efficacy and safety of KN026 in combination with HB1801 to trastuzumab in combination with pertuzumab and docetaxel in the first-line treatment of subjects with HER2-positive recurrent or metastatic breast cancer. The statistical assumption for this study is superiority. The primary study endpoint was PFS as assessed by Blinded Independ Review Committee (BIRC).
Voluntarily enrolled in this study and signed an informed consent form (ICF).
Age ≥ 18 years.
Recurrent or metastatic breast cancer confirmed by histology and/or cytology.
Latest tumor tissue sample confirmed as HER2 positive by central laboratory testing.
Ineligible for any of the agents on the study
Untreated or unstable parenchymal metastases, spinal cord metastases or compression, or carcinomatous encephalitis.
Pregnant or lactating women.
Presence of other circumstances that may interfere with the subject's participation in the study procedures or are inconsistent with the maximum benefit of the subject's participation in the study or affect the results of the study: e.g., history of mental illness, drug or substance abuse, any other disease or condition of clinical significance, etc.
Parallel
Recombinant Humanized Bispecific antibody against HER2，KN026
DrugIV infusion
HB1801
DrugIV infusion
Pertuzumab
Drug840 mg loading dose followed by 420 mg per cycle, D1 Q3W, IV infusion
Trastuzumab
Drug8 mg/kg loading dose followed by 6 mg/kg per cycle, D1 Q3W, IV infusion
Docetaxel
Drug75 mg/m\^2, D1 Q3W, IV infusion
Free-progression survival (PFS) as evaluated by BIRC (RECIST1.1).
PFS (investigator assessment, RECIST1.1)
Overall survival (OS)
Objective response rate (ORR)
Disease control rate (DCR)
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