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
Conditions the study is for: Early or Locally Advanced HER2-positive Breast Cancer
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

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;

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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.

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.

Conditions: Early or Locally Advanced HER2-positive Breast Cancer
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.

KN026Drug
KN026
HB1801Drug
HB1801
PertuzumabDrug
Pertuzumab
TrastuzumabDrug
Trastuzumab
DocetaxelDrug
Docetaxel
CarboplatinDrug
Carboplatin

Study groups in NCT06747338
Study group	Role	What they receive
KN026 plus HB1801 ± Carboplatin	Experimental	KN026 HB1801 Carboplatin Receives: Drug: KN026; Drug: HB1801
Pertuzumab and trastuzumab plus docetaxel ± Carboplatin	Active comparator	Pertuzumab 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.

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)

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
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
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
ORR (INV, RECIST v1.1)
Measured: After 2 cycles of chemotherapy (21 days as 1 cycle).
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
Frequency and severity of TEAE and SAE
Measured: After each cycle of chemotherapy (21 days as 1 cycle), up to 1 years.
Concentration of KN026 and HB1801 in serum
Measured: After each cycle of chemotherapy (21 days as 1 cycle), up to 6 cycles.
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.

16 Dec 202416 Dec 2027

First posted24 Dec 2024
Study start16 Dec 2024
Primary completion16 Dec 2026 (estimated)
Study completion16 Dec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Early or Locally Advanced HER2-positive Breast CancerStudies of the same condition, open and under way.
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
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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