Actively Recruiting
A Phase III Study of KN026 in Combination With HB1801 as Adjuvant Therapy for Resectable HER2-Positive Breast Cancer
Led by Shanghai JMT-Bio Inc. · Updated on 2026-04-08
1800
Participants Needed
1
Research Sites
491 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a randomized, controlled, open-label, multicenter, Phase Ⅲ clinical study designed to compare the efficacy and safety of KN026 combined with HB1801 and chemotherapy versus trastuzumab combined with pertuzumab and chemotherapy as adjuvant therapy in participants with HER2-positive breast cancer.
CONDITIONS
Official Title
A Phase III Study of KN026 in Combination With HB1801 as Adjuvant Therapy for Resectable HER2-Positive Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily participate and sign the informed consent form.
- Age 18 years or older.
- ECOG performance status score of 0 or 1.
- Histologically or cytologically confirmed invasive breast cancer.
- Have undergone radical mastectomy or breast-conserving surgery for breast cancer.
- Pathologically confirmed positive regional lymph nodes.
- Tumor tissue confirmed as HER2-positive by local laboratory.
- Adequate organ and bone marrow function including: absolute neutrophil count 63 1.5 �D7 10�B9/L, platelet count 63 100 �D7 10�B9/L, hemoglobin 63 90 g/L, liver function within specified limits, coagulation function within specified limits, creatinine clearance 63 50 mL/min, and left ventricular ejection fraction 63 55%.
- Female participants of childbearing potential must have a negative blood pregnancy test within 7 days before randomization and agree to use effective contraception during treatment and for 7 months after last dose.
- Male participants with female partners of childbearing potential must agree to use effective contraception during treatment and for 7 months after last dose.
You will not qualify if you...
- History of any prior invasive breast cancer on the same or opposite breast.
- History of other malignancy within 5 years before randomization, except for the breast cancer under study and locally curable malignancies treated with curative intent.
- Prior systemic chemotherapy, endocrine therapy, anti-HER2 targeted therapy, or local radiotherapy for breast cancer.
- Use of strong CYP3A4 inhibitors within 14 days before randomization or planned use during chemotherapy.
- Known allergy or contraindication to any study drug or its components.
- Significant cardiovascular disease history including prior bypass or stenting, recent heart attack or stroke, heart failure or systolic dysfunction, unstable angina, prolonged QT interval, uncontrolled severe hypertension, or high-risk arrhythmias.
- Severe chronic or active infection requiring IV anti-infective therapy within 14 days before randomization.
- Participation in another interventional clinical trial within 4 weeks before randomization.
- Pregnant or breastfeeding women.
- Any condition that may interfere with study participation or affect results, such as neurological or psychiatric disorders, substance abuse, or other significant diseases or conditions.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 201318
Actively Recruiting
Research Team
C
Clinical Trials Information Group officer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here