OncoMatch/Clinical Trials/NCT05838066
Efficacy and Safety of KN026 in Combination With HB1801 in the First-line Treatment of Subjects With HER2-positive Recurrent or Metastatic Breast Cancer.
Is NCT05838066 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for first-line treatment of her2-positive recurrent or metastatic breast cancer.
Treatment: Recombinant Humanized Bispecific antibody against HER2，KN026 · HB1801 · Pertuzumab · Trastuzumab · Docetaxel — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) overexpression (HER2 positive by central laboratory testing)
Latest tumor tissue sample confirmed as HER2 positive by central laboratory testing.
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic chemotherapy
Exception: for recurrent or metastatic breast cancer
No prior systemic chemotherapy and/or HER2-targeted therapy for recurrent or metastatic breast cancer.
Cannot have received: HER2-targeted therapy
Exception: for recurrent or metastatic breast cancer
No prior systemic chemotherapy and/or HER2-targeted therapy for recurrent or metastatic breast cancer.
Lab requirements
Blood counts
adequate organ and bone marrow function
Kidney function
adequate organ and bone marrow function
Liver function
adequate organ and bone marrow function
Adequate organ and bone marrow function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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