A Phase III Study of KN026 in Combination With HB1801 as Adjuvant Therapy for Resectable HER2-Positive Breast Cancer

NCT07441460 | Recruiting Phase 3

• 1 other identifier: KN026-007
• Study Type: interventional
• Target: 1,800
• Locations: 1 country
• Sites: 1

Brief Summary

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

Resectable HER2-positive Breast Cancer

Outcome Measures

Primary Outcomes (1)

• iDFS

  Time from randomization to the first occurrence of any of the following events: 1. Disease recurrence (local/regional/distant metastasis, contralateral breast metastasis, confirmed by histology/cytology or clinical diagnosis). 2. Death from any cause. Note: Excludes second primary malignancies other than breast cancer.

  5 years

Study Arms (2)

KN026 combined with HB1801 and chemotherapy

EXPERIMENTAL

Regimen 1 (Anthracycline-containing chemotherapy): Epirubicin/Doxorubicin combined with cyclophosphamide for 4 cycles → HB1801 for 4 cycles + KN026 for up to 1 year (18 cycles). Regimen 2 (Carboplatin-containing chemotherapy): HB1801 combined with carboplatin for 6 cycles + KN026 for up to 1 year (18 cycles).

Drug: KN026; Drug: HB1801; Drug: Epirubicin; Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: Carboplatin

Trastuzumab combined with pertuzumab and chemotherapy

ACTIVE COMPARATOR

Regimen 1 (Anthracycline-containing chemotherapy): Epirubicin/Doxorubicin combined with cyclophosphamide for 4 cycles → Docetaxel for 4 cycles + Trastuzumab and Pertuzumab for up to 1 year (18 cycles). Regimen 2 (Carboplatin-containing chemotherapy): Docetaxel combined with carboplatin for 6 cycles + Trastuzumab and Pertuzumab for up to 1 year (18 cycles).

Drug: Trastuzumab; Drug: Pertuzumab; Drug: Docetaxel; Drug: Epirubicin; Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: Carboplatin

Interventions

KN026 DRUG

In accordance with the protocol

KN026 combined with HB1801 and chemotherapy

HB1801 DRUG

In accordance with the protocol

KN026 combined with HB1801 and chemotherapy

Trastuzumab DRUG

Intravenous infusion

Trastuzumab combined with pertuzumab and chemotherapy

Pertuzumab DRUG

Intravenous infusion

Trastuzumab combined with pertuzumab and chemotherapy

Docetaxel DRUG

Intravenous infusion

Trastuzumab combined with pertuzumab and chemotherapy

Epirubicin DRUG

Intravenous infusion

KN026 combined with HB1801 and chemotherapy; Trastuzumab combined with pertuzumab and chemotherapy

Doxorubicin DRUG

Intravenous infusion

KN026 combined with HB1801 and chemotherapy; Trastuzumab combined with pertuzumab and chemotherapy

Cyclophosphamide DRUG

Intravenous infusion

KN026 combined with HB1801 and chemotherapy; Trastuzumab combined with pertuzumab and chemotherapy

Carboplatin DRUG

Intravenous infusion

KN026 combined with HB1801 and chemotherapy; Trastuzumab combined with pertuzumab and chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily participate and sign the informed consent form.
• Age ≥ 18 years.
• ECOG performance status score of 0 or 1.
• Histologically or cytologically confirmed invasive breast cancer.
• Must have undergone prior radical mastectomy or breast-conserving surgery for breast cancer.
• Pathologically confirmed positive regional lymph nodes.
• Tumor tissue confirmed as HER2-positive by the local laboratory.
• Adequate organ and bone marrow function:
• Absolute neutrophil count ≥ 1.5 × 10⁹/L
• Platelet count ≥ 100 × 10⁹/L
• Hemoglobin ≥ 90 g/L
• Liver function: Total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN for participants with Gilbert's syndrome); ALT and AST ≤ 2.5 × ULN; Alkaline phosphatase ≤ 2.5 × ULN
• Coagulation function: INR ≤ 1.5 × ULN and aPTT ≤ 1.5 × ULN
• Renal function: Creatinine clearance ≥ 50 mL/min
• LVEF ≥ 55%

You may not qualify if:

• History of any prior ipsilateral and/or contralateral invasive breast cancer.
• History of other malignancy within 5 years prior to 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 prior to randomization or planned use during the combination chemotherapy period.
• Known contraindication to any study drug or history of hypersensitivity to any component or known excipient of the study drugs.
• Significant cardiovascular disease history, including: prior coronary artery bypass graft or coronary stenting; myocardial infarction or cerebrovascular accident within 6 months prior to randomization; history of congestive heart failure/systolic dysfunction (LVEF \< 50%) or unstable angina; history of clinically significant prolonged QT interval or QTcF (Fridericia) \> 450 ms at screening; uncontrolled severe hypertension (systolic BP \> 180 mmHg and/or diastolic BP \> 100 mmHg); high-risk arrhythmias \[e.g., atrial tachycardia with resting heart rate ≥ 100 bpm, significant ventricular arrhythmia (ventricular tachycardia), or high-grade atrioventricular block (Mobitz type II second-degree or third-degree AV block)\].
• Severe chronic or active infection requiring intravenous anti-infective therapy within 14 days prior to randomization.
• Participation in another interventional clinical trial within 4 weeks prior to randomization.
• Pregnant or lactating women.
• Any other condition that may interfere with the participant's ability to comply with study procedures, may not be in the participant's best interest to participate, or may affect study results (e.g., history of neurological or psychiatric disorders, alcohol or drug abuse, or any other clinically significant disease or condition).

Sponsors & Collaborators

• Shanghai JMT-Bio Inc.: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 201318, China

RECRUITING

MeSH Terms

Interventions

Trastuzumab; pertuzumab; Docetaxel; Epirubicin; Doxorubicin; Cyclophosphamide; Carboplatin

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Coordination Complexes

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

0311-69085587; ctr-contact@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: March 2, 2026
• Study Start: March 6, 2026
• Primary Completion (Estimated): August 7, 2034
• Study Completion (Estimated): August 7, 2035
• Last Updated: April 8, 2026

Record last verified: 2026-03

Locations

CN (1)