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Early or Locally Advanced HER2-positive Breast CancerPhase 3Neo-HealerNCT06747338

A Phase III Study of KN026 in Combination With HB1801 ± Carboplatin as Neoadjuvant Treatment for Early or Locally Advanced HER2-Positive Breast Cancer

A Phase 3 study testing KN026, HB1801 and Pertuzumab in people with Early or Locally Advanced HER2-positive Breast Cancer, run by Shanghai JMT-Bio Inc. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This randomized, controlled, open-label, multicenter study will evaluate the safety and efficacy of KN026 in combination with HB1801 ± Carboplatin as neoadjuvant therapy in patients with early or locally advanced HER2-positive breast cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
KN026, HB1801 and Pertuzumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
520 participants
Where
1 siteChina
Study dates
16 Dec 2024to 16 Dec 2027
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 in the experiment and sign the informed consent;
  • Aged >= 18 years;
  • Histologically and cytologically confirmed primary invasive carcinoma of the breast with early (T2-3, N0-1, M0) or locally advanced stage (T2-3, N2-3, M0; T4, any N, M0) (AJCC 8th Edition);
  • ECOG PS 0-1;
  • HER2 positive (HER2+++ by IHC or HER2++ by IHC and ISH+);
  • Agree to receive surgical treatment for breast cancer in the participating research unit when the surgical standard is reached after neoadjuvant therapy;
  • Adequate organ and bone marrow function (no blood transfusions or hematopoietic stimulating factor classes within 14 days prior to the test);
  • Women of childbearing potential and male participants with partners of childbearing potential must agree to use effective contraception (as defined by the protocol) by the participant and/or partner for the duration of the study treatment and for at least 3 months (Docetaxel and HB1801) or 7 months (Pertuzumab, trastuzumab, KN026, and Carboplatin) after the last dose of study drug;

Who cannot join

  • Inflammatory or bilateral breast cancer;
  • History of non-breast malignancies within the 3 years prior to study entry, except for carcinoma in situ of the cervix or breast, and basal cell and squamous cell carcinomas of the skin, etc.;
  • The researchers determine that there are contraindications for breast cancer surgery;
  • Participants who underwent primary lumpectomy and/or axillary lymph node dissection biopsy prior to randomization (except for diagnostic biopsy of primary breast cancer or surgery for benign breast tumors);
  • Any previous systemic chemotherapy, endocrine therapy or anti HER2 biological therapy or local radiotherapy for breast cancer;
  • Sensitivity to any of the study medications or any of the ingredients or excipients of these medications;
Show all 12Show fewer
  • Participants with known allergies and/or contraindications to glucocorticoids;
  • Have a congenital or acquired immune deficiency (such as HIV infection); 9 . Serious cardiac or cardiovascular disease or condition; 10 Serious chronic or active infections requiring intravenous antimicrobial, antifungal, or antiviral therapy were present within 14 days prior to randomization.
  • 11. Patients who had undergone major organ surgery (excluding biopsy) within 28 days before randomization and have not fully recovered.
  • 12. Potent inhibitors or inducers of CYP3A4 were used within 14 days before randomization or continued use was required.
  • 13. Being enrolled in other clinical trials (except for non-interventional clinical trials or a follow-up period in an interventional trial) or at randomization was less than 4 weeks from the end of the previous clinical trial (end of treatment).
  • 14. Pregnant or lactating. 15. The existence of other conditions that may interfere with the participant's study procedures or that do not correspond to the participant's maximum benefit from participating in the study or to the findings of the imaging study, such as a history of neurological or mental illness, alcohol abuse, drug use or substance abuse, any other disease or condition of clinical significance.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Clinical Trials Information Group

    Shanghai

Other trials in China

About this study

Official title: A Randomized, Controlled, Open-label, Multicenter, Phase III Clinical Trial to Compare the Efficacy and Safety of KN026 Combined With HB1801 ± Carboplatin Versus Trastuzumab Combined With Pertuzumab and Docetaxel ± Carboplatin in Neoadjuvant Treatment of Early or Locally Advanced HER2-positive Breast Cancer.

This randomized, controlled, open-label, multicenter study will evaluate the safety and efficacy of KN026 in combination with HB1801 ± Carboplatin as neoadjuvant therapy in patients with early or locally advanced HER2-positive breast cancer.

Read the detailed description

In this randomized, controlled, open-label, multicenter Phase III trial, treatment-naive patients with HER2-positive breast cancer were centrally randomized (1:1) and stratified by disease stage, hormone receptor status, and the planned use of Carboplatin. Participants received six cycles of: neoadjuvant therapy: KN026 combined with HB1801 ± Carboplatin (Experimental) or Trastuzumab plus Pertuzumab and Docetaxel ± Carboplatin (Active Comparator). The primary endpoint was pathological complete response (pCR) in the breast, evaluated in the intention-to-treat (ITT) population.

Being tested
KN026, HB1801, Pertuzumab, Trastuzumab, Docetaxel

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06747338
Study groupRoleWhat they receive
KN026 plus HB1801 ± CarboplatinExperimentalKN026 HB1801 Carboplatin
Receives: Drug: KN026; Drug: HB1801
Pertuzumab and trastuzumab plus docetaxel ± CarboplatinActive comparatorPertuzumab Trastuzumab Docetaxel Carboplatin
Receives: Drug: Pertuzumab; Drug: Trastuzumab; Drug: Docetaxel; Drug: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. tpCR (BIRC, AJCC 8th)

    tpCR (ypT0/Tis ypN0) is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy.

    Measured: Through study completion, an average of 1 year

Secondary outcomes (8)

  1. EFS (INV, RECIST v1.1)

    EFS event was defined as the time between the data of randomization and the date on which any of the following events: disease progression; breast cancer recurrence; death attributable to any cause.

    Measured: Through study completion, an average of 1 year

  2. tpCR (INV, AJCC 8th)

    Description: tpCR (ypT0/Tis ypN0) is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy.

    Measured: Through study completion, an average of 1 year

  3. bpCR (BIRC and INV, AJCC 8th)

    bpCR (ypT0/Tis) is defined as an absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy.

    Measured: Through study completion, an average of 1 year

  4. ORR (INV, RECIST v1.1)

    Measured: After 2 cycles of chemotherapy (21 days as 1 cycle).

  5. iDFS (INV, RECIST v1.1)

    IDFS event was defined as the time between the date of non-invasive disease, such as the date of surgery, and the date of the first occurrence of any of the following events: breast cancer recurrence; death attributable to any cause

    Measured: 3 years after surgery

  6. Frequency and severity of TEAE and SAE

    Measured: After each cycle of chemotherapy (21 days as 1 cycle), up to 1 years.

  7. Concentration of KN026 and HB1801 in serum

    Measured: After each cycle of chemotherapy (21 days as 1 cycle), up to 6 cycles.

  8. Incidence of KN026 Anti-drug antibody (ADA) and neutralizing antibody (Nab) (if applicable)

    Measured: After each cycle of chemotherapy (21 days as 1 cycle), up to 6 cycles.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2024
  2. Study start16 Dec 2024
  3. Primary completion16 Dec 2026 (estimated)
  4. Study completion16 Dec 2027 (estimated)

Resources

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
Model description
In this randomized, controlled, open-label, multicenter phase 3 study, treatment-naive with HER2-positive breast cancer were randomly assigned (1:1) centrally and stratified by early (T2-3, N0-1, M0), locally advanced (T2-3, N2-3, M0; T4, any N, M0) breast cancer, hormone receptor status, and the planned use of Carboplatin. Participants received six cycles of:: KN026 combined with HB1801 ± Carboplatin (Experimental) or Trastuzumab plus Pertuzumab and Docetaxel ± Carboplatin (Active Comparator).
Masking
None (open label)
Enrolment
520 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06747338
Sponsor's protocol ID
KN026-004
Acronym
Neo-Healer
Status last verified
Jul 2025
First submitted
13 Dec 2024
Last updated
7 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Li J, Liu T, Yu KD, Yang H, Huang Z, Zeng Y, Ji P, Hou X, Liu C, Zhang Y, Li N, Ouyang Z, Wu X, Bai X, Guo Y, Han G, Cui S, Zhu Z, Zhang Y, Hu X, Ma X, Fu P, Zhu J, Dong Y, Wu T, Jia H, Xu F, Ren Y, Nie J, Bing D, Mu Q, Sun T, Luo J, Song Z, Kong X, Zhang H, Wu Z, Wang Z, Song D, Jia H, Tao W, Fan P, Yao F, Ru C, Lai G, Zhou X, Li T, Deng C, Jiang X, Wang X, Wang J, Xiong D, Zhang S, Yang H, Yao Y, Yin G, Yao G, Zhou L, Wang S, Yu Z, Yu Y, Lv Y, Qian H, Li H, Guo W, Huang W, Xiang S, Zou K, He H, Fan L, Shao ZM; BCTOP study group. Neoadjuvant Anbenitamab and HB1801 in ERBB2-Positive Breast Cancer: A Phase 3 Randomized Clinical Trial. JAMA Oncol. 2026 Sep 3:e263329. doi: 10.1001/jamaoncol.2026.3329. Online ahead of print.

    PubMed 42690668

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing KN026, HB1801 and Pertuzumab in people with Early or Locally Advanced 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 8 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 7 Jul 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

tpCR (BIRC, AJCC 8th) (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06747338, which also lists 1 linked publication.

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 7 Jul 2026.

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