A Phase III Study of KN026 in Combination With HB1801 ± Carboplatin as Neoadjuvant Treatment for Early or Locally Advanced HER2-Positive Breast Cancer
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.
Timeline
- Start
- 2024-12-16
- Primary completion
- 2026-12-16
- Completion
- 2027-12-16
Outcome
Met primary endpoint
release “安尼妥单抗（KN026）联合多西他赛（白蛋白结合型，HB1801）用于HER2阳性早期或局部晚期乳腺癌新辅助治疗的Ⅲ期临床研究（研究编号：KN026-004），已达到预先设定的总体病理完全缓解率（tpCR）的主要终点。” alphamabonc.com ↗
release “KN026联合HB1801±卡铂新辅助治疗HER2阳性早期或局部晚期乳腺癌，较现有标准治疗可显著提升tpCR。” alphamabonc.com ↗
release “PHASE III CLINICAL STUDY OF ANBENITAMAB (KN026) IN COMBINAT ION WITH DOCETAXEL (ALBUMIN-BOUND) (HB1801) FOR NEOADJUVANT TREATMENT OF HER2+ BREAST CANCER MEETS PRIMARY ENDPOINT” irasia.com ↗
release “安尼妥单抗联合HB1801用于HER2阳性乳腺癌新辅助治疗的Ⅲ期临床研究达到预先设定的总体病理完全缓解率（tpCR）的主要终点” alphamabonc.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Carboplatin | Small molecule | — | — |
| Comparator | Docetaxel | Small molecule | — | — |
| Subject | HB1801 | Unknown | — | — |
| Subject | KN026 | Monoclonal antibody | — | — |
| Comparator | Pertuzumab | Monoclonal antibody | — | — |
| Comparator | Trastuzumab | Monoclonal antibody | — | — |