At a glance
ClinicalIndex Comparison Record- ✓Age 18 years or older
- ✓Recurrent or metastatic breast cancer confirmed by histology and/or cytology
- ✓HER2-positive status confirmed by central laboratory testing
- ✓No prior systemic chemotherapy or HER2-targeted therapy for recurrent or metastatic disease
- ✕Untreated or unstable parenchymal brain metastases, spinal cord metastases or compression
- ✕Carcinomatous encephalitis
- ✕Pregnant or lactating women
- ✕Conditions that may interfere with study participation or clinical significance
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT05838066Phase 3RecruitingUpdate OverdueUpdated 13mo ago · Completion was 11mo agoA Randomized, Controlled, Open-label, Multicenter, Phase Ш Clinical Study of the Efficacy and Safety of KN026 in Combination With HB1801 Versus Trastuzumab in Combination With Pertuzumab and Docetaxel in the First-line Treatment of Subjects With HER2-positive Recurrent or Metastatic Breast Cancer.
In Brief
A Phase 3 clinical trial evaluating Recombinant Humanized Bispecific antibody against HER2，KN026, HB1801, and 3 other interventions for First-line Treatment of HER2-positive Recurrent or Metastatic Breast Cancer. Currently recruiting, targeting 880 participants across 1 site.
Signals
Detailed Summary
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).
Study Details
Timeline
Interventions
IV infusion
IV infusion
840 mg loading dose followed by 420 mg per cycle, D1 Q3W, IV infusion
8 mg/kg loading dose followed by 6 mg/kg per cycle, D1 Q3W, IV infusion
75 mg/m\^2, D1 Q3W, IV infusion