Clinical Trial

A Phase III Study of KN026 in Combination With HB1801 ± Carboplatin as Neoadjuvant Treatment for Early or Locally Advanced HER2-Positive Breast Cancer

Study acronym: Neo-Healer
Active, Not Recruiting Phase 3
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Summary
This randomized, controlled, open-label, multicenter study will evaluate the safety and efficacy of KN026 in combination with HB1801 ± Carboplatin as neoadjuvant therapy in patients with early or locally advanced HER2-positive breast cancer.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-12-18; most recent amendment 2026-07-03.
Status change: Recruiting → Active, Not Recruiting 2026-07-03
Status change: Not Yet Recruiting → Recruiting 2025-04-18
Trial Details
NCT Number NCT06747338
Lead Sponsor Shanghai JMT-Bio Inc.
Conditions Early or Locally Advanced HER2-positive Breast Cancer
Enrollment 520 participants
Start Date 2024-12-16
Primary Completion 2026-12-16 (estimated)
Study Completion 2027-12-16 (estimated)
Updated on ClinicalTrials.gov 2026-07-07