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

April 2, 2026 updated by: Shanghai JMT-Bio Inc.

A Randomized, Controlled, Open-label, Multicenter, Phase III Clinical Study to Evaluate the Efficacy and Safety of KN026 Combined With HB1801 and Chemotherapy Versus Trastuzumab Combined With Pertuzumab and Chemotherapy as Adjuvant Therapy in Resectable HER2-positive Breast Cancer

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1800

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Clinical Trials Information Group officer
  • Phone Number: 0311-69085587
  • Email: ctr-contact@cspc.cn

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 201318
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:
          • Clinical Trials Information Group Clinical Trials Information Group
          • Phone Number: 021-64175590-88503
          • Email: JJYIN555@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Voluntarily participate and sign the informed consent form.
  2. Age ≥ 18 years.
  3. ECOG performance status score of 0 or 1.
  4. Histologically or cytologically confirmed invasive breast cancer.
  5. Must have undergone prior radical mastectomy or breast-conserving surgery for breast cancer.
  6. Pathologically confirmed positive regional lymph nodes.
  7. Tumor tissue confirmed as HER2-positive by the local laboratory.

  8. Adequate organ and bone marrow function:

    1. Absolute neutrophil count ≥ 1.5 × 10⁹/L
    2. Platelet count ≥ 100 × 10⁹/L
    3. Hemoglobin ≥ 90 g/L
    4. 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
    5. Coagulation function: INR ≤ 1.5 × ULN and aPTT ≤ 1.5 × ULN
    6. Renal function: Creatinine clearance ≥ 50 mL/min
    7. LVEF ≥ 55%
  9. Female participants of childbearing potential must have a negative blood pregnancy test result within 7 days prior to randomization, and agree to use reliable and effective contraception during the study treatment period and for 7 months after the last dose of study treatment. Male participants with female partners of childbearing potential must agree to use reliable and effective contraception during the study treatment period and for 7 months after the last dose of study treatment.

Exclusion Criteria:

  1. History of any prior ipsilateral and/or contralateral invasive breast cancer.
  2. 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.
  3. Prior systemic chemotherapy, endocrine therapy, anti-HER2 targeted therapy, or local radiotherapy for breast cancer.
  4. Use of strong CYP3A4 inhibitors within 14 days prior to randomization or planned use during the combination chemotherapy period.
  5. Known contraindication to any study drug or history of hypersensitivity to any component or known excipient of the study drugs.
  6. 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)].
  7. Severe chronic or active infection requiring intravenous anti-infective therapy within 14 days prior to randomization.
  8. Participation in another interventional clinical trial within 4 weeks prior to randomization.
  9. Pregnant or lactating women.
  10. 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: KN026 combined with HB1801 and chemotherapy

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: Cyclophosphamide
Intravenous infusion
Drug: Carboplatin
Intravenous infusion
Drug: KN026
In accordance with the protocol
Drug: Doxorubicin
Intravenous infusion
Drug: HB1801
In accordance with the protocol
Drug: Epirubicin
Intravenous infusion
Active Comparator: Trastuzumab combined with pertuzumab and chemotherapy

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: Cyclophosphamide
Intravenous infusion
Drug: Docetaxel
Intravenous infusion
Drug: Carboplatin
Intravenous infusion
Drug: Doxorubicin
Intravenous infusion
Drug: Epirubicin
Intravenous infusion
Drug: Trastuzumab
Intravenous infusion
Drug: Pertuzumab
Intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
iDFS
Time Frame: 5 years

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai JMT-Bio Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2026

Primary Completion (Estimated)

August 7, 2034

Study Completion (Estimated)

August 7, 2035

Study Registration Dates

First Submitted

February 12, 2026

First Submitted That Met QC Criteria

February 26, 2026

First Posted (Actual)

March 2, 2026

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KN026-007

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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