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.
KN026 is an anti-HER2 bispecific antibody that can simultaneously bind two non-overlapping epitopes of HER2, leading to a dual HER2 signal blockade.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
KN026 in Combination With Docetaxel
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGtp CR as assessed by local pathologist
total pathological complete response as assessed by local pathologist
Time frame: up to 12 weeks
bp CR as assessed by local pathologist
breast pathological complete response assessed by local pathologist
Time frame: up to 12 weeks
ORR as assessed by the investigator according to RECIST 1.1
Objective response rate as assessed by the investigator according to RECIST 1.1
Time frame: up to 12 weeks
safety as assessed by the investigator according to RECIST 1.1
Incidence, type, and severity of adverse events and serious adverse events
Time frame: up to 12 weeks
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