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

StatusRecruiting
PhasePhase 3
Started2026-03-06
View on ClinicalTrials.gov ↗

Amendment history

2026-04-02
notable
Study Status, Contacts/Locations v1
Recruitment opened
Start dateestimated 2026-03-07→confirmed 2026-03-06
Study sites0→1
2026-02-26
minor
Original filing
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.
Trial Details
NCT Number NCT07441460
Lead Sponsor Shanghai JMT-Bio Inc.
Conditions Resectable HER2-positive Breast Cancer
Enrollment 1,800 participants
Start Date 2026-03-06
Primary Completion 2034-08-07 (estimated)
Study Completion 2035-08-07 (estimated)
Updated on ClinicalTrials.gov 2026-04-08