Study of KN026 in Combination With Docetaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
NCT04881929 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2022-06-22
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.
Conditions
Interventions
- DRUG
-
KN026
KN026 in Combination With Docetaxel
Sponsors & Collaborators
-
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
lead INDUSTRY
Principal Investigators
-
Jiong Wu, professor · Fudan University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-08-09
- Primary Completion
- 2022-11-15
- Completion
- 2023-02-15
Countries
- China
Study Locations
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