Clinical Trial

Efficacy and Safety of KN026 in Combination With HB1801 in the First-line Treatment of Subjects With HER2-positive Recurrent or Metastatic Breast Cancer.

Recruiting Phase 3
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Record status
This record was last updated May 30, 2025 (before its estimated July 31, 2025 completion). Its status may not reflect the trial's current state.
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).
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2023-04-20.
Status change: Not Yet Recruiting → Recruiting 2025-05-26
Trial Details
NCT Number NCT05838066
Lead Sponsor Shanghai JMT-Bio Inc.
Conditions First-line Treatment of HER2-positive Recurrent or Metastatic Breast Cancer
Enrollment 880 participants
Start Date 2023-07-23
Primary Completion 2025-07-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-05-30