drugset / Trial / NCT04881929
Study of KN026 in Combination With Docetaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
NaSingle-groupOpen-labelTreatment
Summary
This is an open-lable, multicenter, and single arm phase II trial to evaluate treatment with KN026 plus docetaxel as neoadjuvant therapy in patients with early-stage (T1c or 2, N1, M0; T2 or 3, N0, M0) or locally advanced (T1c or 2 or 3, N2, M0; T3N1M0; T1c or 2 or 3, N3a or 3b, M0) HER2-positive breast cancer. The subjects will receive KN026 30 mg/kg IV + Docetaxel 75/m2 every 3 weeks for four cycles prior to surgery.
Timeline
- Start
- 2021-08-09
- Primary completion
- 2022-11-15
- Completion
- 2023-02-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | KN026 | Monoclonal antibody | 30 mg/kg | Intravenous |
| Background | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |