A Randomized, Controlled, Open-label, Multicenter, Phase III Clinical Study to Evaluate the Efficacy and Safety of KN026 Combined With HB1801 and Chemotherapy Versus Trastuzumab Combined With Pertuzumab and Chemotherapy as Adjuvant Therapy in Resectable HER2-positive Breast Cancer
This is a randomized, controlled, open-label, multicenter, Phase Ⅲ clinical study designed to compare the efficacy and safety of KN026 combined with HB1801 and chemotherapy versus trastuzumab combined with pertuzumab and chemotherapy as adjuvant therapy in participants with HER2-positive breast cancer.
• Voluntarily participate and sign the informed consent form.
• Age ≥ 18 years.
• ECOG performance status score of 0 or 1.
• Histologically or cytologically confirmed invasive breast cancer.
• Must have undergone prior radical mastectomy or breast-conserving surgery for breast cancer.
• Pathologically confirmed positive regional lymph nodes.
• Tumor tissue confirmed as HER2-positive by the local laboratory.
• Adequate organ and bone marrow function:
‣ Absolute neutrophil count ≥ 1.5 × 10⁹/L
⁃ Platelet count ≥ 100 × 10⁹/L
⁃ Hemoglobin ≥ 90 g/L
⁃ Liver function: Total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN for participants with Gilbert's syndrome); ALT and AST ≤ 2.5 × ULN; Alkaline phosphatase ≤ 2.5 × ULN
⁃ Coagulation function: INR ≤ 1.5 × ULN and aPTT ≤ 1.5 × ULN
⁃ Renal function: Creatinine clearance ≥ 50 mL/min
⁃ LVEF ≥ 55%
• Female participants of childbearing potential must have a negative blood pregnancy test result within 7 days prior to randomization, and agree to use reliable and effective contraception during the study treatment period and for 7 months after the last dose of study treatment. Male participants with female partners of childbearing potential must agree to use reliable and effective contraception during the study treatment period and for 7 months after the last dose of study treatment.