Study of KN026 in Combination With Docetaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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KN026 is an anti-HER2 bispecific antibody that can simultaneously bind two non-overlapping epitopes of HER2, leading to a dual HER2 signal blockade.

Official Title
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Study of KN026 in Combination With Docetaxel as Neoadjuvant Therapy in Patients With Early-stage or Locally Advanced HER2-positive Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: KN026


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subject >= 18 years; Histologically or cytologically confirmed HER2-positive breast cancer defined as 3+ determined by validated IHC or positive by in situ hybridization (ISH); 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) breast cancer; Adequate organ function assessed within 7 days prior to first trial treatment; ECOG score 0 or 1; Left ventricular ejection fraction (LVEF) ≥ 55% at baseline; Exclusion Criteria: Stage IV (metastatic) breast cancer; Inflammatory breast cancer; Previous anti-cancer therapy or radiotherapy for any malignancy; Major surgery for any reason within 28 days; History of uncontrolled intercurrent illness; Other medical conditions that at the discretion of investigator interfere with the requirements of the trial in terms of safety or efficacy evaluation, or treatment compliance;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KN026 + Docetaxel<br>KN026 30 mg/kg IV + Docetaxel 75/m2 every 3 weeks for four cycles | Drug: KN026<br>* KN026 in Combination With Docetaxel<br>* Other names: Docetaxel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tp CR as assessed by local pathologist | total pathological complete response as assessed by local pathologist | up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bp CR as assessed by local pathologist | breast pathological complete response assessed by local pathologist | 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 | 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 | up to 12 weeks |