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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1800

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 6, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 7, 2034

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 7, 2035

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 12, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 2, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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