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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
StatusActive, Not Recruiting
PhasePhase 3
Started2024-12-16
View on ClinicalTrials.gov ↗

Amendment history

2026-07-03
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v3
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 1 of 1 site
2025-04-18
Not Yet Recruiting→Recruiting Study Identification, Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Study sites0→1
InterventionsDocetaxel (Drug), HB1801 (Drug), KN026 (Drug), Pertuzumab (Drug), Trastuzumab (Drug)→Carboplatin (Drug), Docetaxel (Drug), HB1801 (Drug), KN026 (Drug), Pertuzumab (Drug), Trastuzumab (Drug)
Eligibility criteria+14 characters
[...] (Docetaxel and HB1801) or 7 months (Pertuzumab, trastuzumab, KN026, and KN026Carboplatin) after the last dose of study drug; Exclusion Criteria: Inf [...]
Secondary endpointsdetails revised at 7 of 8 entries
Study description+69 characters
In this randomized, controlled, open-label, multicenter phasePhase 3III studytrial, treatment-naive patients with HER2-positive breast cancer were randomlycentrally assignedrandomized (1:1) centrally and stratified by earlydisease stage, locally advanced breast cancer, and by hormone receptor expressionstatus, toand receivethe planned use of Carboplatin. Participants received six neoadjuvant cycles of: neoadjuvant therapy: KN026 pluscombined with HB1801 ± Carboplatin (Experimental) or pertuzumabTrastuzumab plus Pertuzumab and trastuzumabDocetaxel plus± docetaxelCarboplatin (Active Comparator). [...] [...]
Study title+16 characters
A Phase III Study of KN026 in Combination With HB1801 ± Carboplatin as Neoadjuvant TherapyTreatment for Early or Locally Advanced HER2-Positive Breast Cancer
2024-12-22
Study Status, Outcome Measures v1
Secondary endpointsdetails revised at 3 of 8 entries
2024-12-18
Original filing
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.
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