Resectable HER2-positive Breast CancerPhase 3NCT07441460
A Phase III Study of KN026 in Combination With HB1801 as Adjuvant Therapy for Resectable HER2-Positive Breast Cancer
A Phase 3 study testing KN026, HB1801 and Trastuzumab in people with Resectable HER2-positive Breast Cancer, run by Shanghai JMT-Bio Inc. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resectable HER2-positive Breast Cancer
- What is being tested?
- KN026, HB1801 and Trastuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,800 participants
- Where
- 1 siteChina
- Study dates
- 6 Mar 2026to 7 Aug 2035
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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%
- 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.
Who cannot join
- 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)].
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 201318
Clinical Trials Information Group Clinical Trials Information Group, 021-64175590-88503, JJYIN555@163.com
About this study
Official title: 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.
- Conditions
- Resectable HER2-positive Breast Cancer
- Being tested
- KN026, HB1801, Trastuzumab, Pertuzumab, Docetaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KN026Drug
In accordance with the protocol
HB1801Drug
In accordance with the protocol
TrastuzumabDrug
Intravenous infusion
PertuzumabDrug
Intravenous infusion
DocetaxelDrug
Intravenous infusion
EpirubicinDrug
Intravenous infusion
DoxorubicinDrug
Intravenous infusion
CyclophosphamideDrug
Intravenous infusion
CarboplatinDrug
Intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Drug: Trastuzumab; Drug: Pertuzumab; Drug: Docetaxel; Drug: Epirubicin; Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
iDFS
Time from randomization to the first occurrence of any of the following events:
- Disease recurrence (local/regional/distant metastasis, contralateral breast metastasis, confirmed by histology/cytology or clinical diagnosis).
- Death from any cause. Note: Excludes second primary malignancies other than breast cancer.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start6 Mar 2026
- Primary completion7 Aug 2034 (estimated)
- Study completion7 Aug 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resectable HER2-positive Breast CancerStudies of the same condition, open and under way.
- More trials run by Shanghai JMT-Bio Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai JMT-Bio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07441460
- Sponsor's protocol ID
- KN026-007
- Status last verified
- Mar 2026
- First submitted
- 12 Feb 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07441460
- Acronym / sponsor ID
- KN026-007
- Conditions
- Resectable HER2-positive Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- Shanghai JMT-Bio Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Mar 2026 (actual)
- Primary completion
- 7 Aug 2034 (estimated)
- Study completion
- 7 Aug 2035 (estimated)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KN026 combined with HB1801 and chemotherapy | Experimental | Drug: KN026, Drug: HB1801, Drug: Epirubicin, Drug: Doxorubicin, Drug: Cyclophosphamide, Drug: CarboplatinRegimen 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). |
| Trastuzumab combined with pertuzumab and chemotherapy | Active comparator | Drug: Trastuzumab, Drug: Pertuzumab, Drug: Docetaxel, Drug: Epirubicin, Drug: Doxorubicin, Drug: Cyclophosphamide, Drug: CarboplatinRegimen 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KN026In accordance with the protocol | Drug | KN026 combined with HB1801 and chemotherapy |
| HB1801In accordance with the protocol | Drug | KN026 combined with HB1801 and chemotherapy |
| TrastuzumabIntravenous infusion | Drug | Trastuzumab combined with pertuzumab and chemotherapy |
| PertuzumabIntravenous infusion | Drug | Trastuzumab combined with pertuzumab and chemotherapy |
| DocetaxelIntravenous infusion | Drug | Trastuzumab combined with pertuzumab and chemotherapy |
| EpirubicinIntravenous infusion | Drug | KN026 combined with HB1801 and chemotherapy, Trastuzumab combined with pertuzumab and chemotherapy |
| DoxorubicinIntravenous infusion | Drug | KN026 combined with HB1801 and chemotherapy, Trastuzumab combined with pertuzumab and chemotherapy |
| CyclophosphamideIntravenous infusion | Drug | KN026 combined with HB1801 and chemotherapy, Trastuzumab combined with pertuzumab and chemotherapy |
| CarboplatinIntravenous infusion | Drug | KN026 combined with HB1801 and chemotherapy, Trastuzumab combined with pertuzumab and chemotherapy |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing KN026, HB1801 and Trastuzumab in people with Resectable HER2-positive Breast Cancer, run by Shanghai JMT-Bio Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Information Group officer (0311-69085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
iDFS (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.