Efficacy and Safety of KN026 in Combination With HB1801 in the First-line Treatment of Subjects With HER2-positive Recurrent or Metastatic Breast Cancer.
A 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.
Shanghai JMT-Bio Inc.
880 participants
Jul 23, 2023
INTERVENTIONAL
Conditions
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).
Eligibility
Plain Language Summary
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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
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05838066