NCT07441460

A Phase III Study of KN026 in Combination With HB1801 as Adjuvant Therapy for Resectable HER2-Positive Breast Cancer

A Randomized, Controlled, Open-label, Multicenter, Phase III Clinical Study to Evaluate the Efficacy and Safety of KN026 Combined With HB1801 and Chemotherapy Versus Trastuzumab Combined With Pertuzumab and Chemotherapy as Adjuvant Therapy in Resectable HER2-positive Breast Cancer

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,800 (estimated)
• Sponsor: Shanghai JMT-Bio Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, controlled, open-label, multicenter, Phase Ⅲ clinical study designed to compare the efficacy and safety of KN026 combined with HB1801 and chemotherapy versus trastuzumab combined with pertuzumab and chemotherapy as adjuvant therapy in participants with HER2-positive breast cancer.

Conditions

• Resectable HER2-positive Breast Cancer

Interventions

Type	Name	Description
DRUG	KN026	In accordance with the protocol
DRUG	HB1801	In accordance with the protocol
DRUG	Trastuzumab	Intravenous infusion
DRUG	Pertuzumab	Intravenous infusion
DRUG	Docetaxel	Intravenous infusion
DRUG	Epirubicin	Intravenous infusion
DRUG	Doxorubicin	Intravenous infusion
DRUG	Cyclophosphamide	Intravenous infusion
DRUG	Carboplatin	Intravenous infusion

Timeline

• Start date: 2026-03-06
• Primary completion: 2034-08-07
• Completion: 2035-08-07
• First posted: 2026-03-02
• Last updated: 2026-04-08

Locations

1 site across 1 country: China