A Phase III Study of KN026 in Combination With HB1801 as Adjuvant Therapy for Resectable H
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.
| Condition(s) | Resectable HER2-positive Breast Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: 1. Voluntarily participate and sign the informed consent form. 2. Age ≥ 18 years. 3. ECOG performance status score of 0 or 1. 4. Histologically or cytologically confirmed invasive breast cancer. 5. Must have undergone prior radical mastectomy or breast-conserving surgery for breast cancer. 6. Pathologically confirmed positive regional lymph nodes. 7. Tumor tissue confirmed as HER2-positive by the local laboratory. 8. Adequate organ and bone marrow function: 1. Absolute neutrophil count ≥ 1.5 × 10⁹/L 2. Platelet count ≥ 100 × 10⁹/L 3. Hemoglobin ≥ 90 g/L 4. Liver function: Total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN for participants with Gilbert's syndrome); ALT and AST ≤ 2.5 × ULN; Alkaline phosphatase ≤ 2.5 × ULN 5. Coagulation function: INR ≤ 1.5 × ULN and aPTT ≤ 1.5 × ULN |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Shanghai JMT-Bio Inc. |
| Locations | Shanghai, Shanghai Municipality, China |
| Start date | 2026-03-06 |
| NCT ID | NCT07441460 |
| Official listing | https://clinicaltrials.gov/study/NCT07441460 |