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 (Jun 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
Treatments studied
Targeted therapy
Chemotherapy
Other
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.
Frequently asked questions
Is NCT05838066 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require ERBB2?
Yes, ERBB2 overexpression is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages