New two-drug combo aims to wipe out HER2 breast cancer before surgery

NCT ID NCT06747338

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time

Summary

This phase 3 trial compares a new drug combination (KN026 plus HB1801, with or without carboplatin) against the standard treatment (trastuzumab, pertuzumab, and docetaxel, with or without carboplatin) in people with early or locally advanced HER2-positive breast cancer. The goal is to see if the new combination works better at eliminating cancer before surgery. About 520 participants will be enrolled across multiple centers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
KN026 (a bispecific antibody) combined with HB1801 (a chemotherapy drug)
What this could lead to
If successful, this could offer a more effective pre-surgery treatment option for people with HER2-positive breast cancer, potentially improving the chance of eliminating all cancer before surgery.
What could go wrong
This is an early-phase comparison; the new combination may not be more effective than the current standard and could have unexpected side effects. Results are not yet known.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 520 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Voluntarily participate in the experiment and sign the informed consent; 2. Aged \>= 18 years; 3. 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); 4. ECOG PS 0-1; 5. HER2 positive (HER2+++ by IHC or HER2++ by IHC and ISH+); 6. Agree to receive surgical treatment for breast cancer in the participating research unit when the surgical standard is reached after neoadjuvant therapy; 7. Adequate organ and bone marrow function (no blood transfusions or hematopoietic stimulating factor classes within 14 days prior to the test); 8. 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; Exclusion Criteria: 1. Inflammatory or bilateral breast cancer; 2. 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.; 3. The researchers determine that there are contraindications for breast cancer surgery; 4. 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); 5. Any previous systemic chemotherapy, endocrine therapy or anti HER2 biological therapy or local radiotherapy for breast cancer; 6. Sensitivity to any of the study medications or any of the ingredients or excipients of these medications; 7. Participants with known allergies and/or contraindications to glucocorticoids; 8. 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Clinical Trials Information Group

    Shanghai, China