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New drug cocktail aims to shrink breast tumors before surgery

NCT ID NCT07383818

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 2 trial is testing whether combining trastuzumab rezetecan (a targeted drug) with toripalimab (an immunotherapy) before surgery can eliminate more tumor tissue in women with HR-positive, HER2-low breast cancer. About 111 participants will receive the drug combo for 24 weeks, then undergo surgery. The main goal is to see how many achieve a pathologic complete response (no cancer cells left in the breast).

What this could mean

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

Active substance
trastuzumab rezetecan and toripalimab
What this could lead to
If successful, this combination could become a new pre-surgery treatment option for HR+/HER2-low breast cancer, potentially improving tumor clearance and long-term outcomes.
What could go wrong
This is an early Phase 2 trial with only 111 participants, so results may not apply to all patients. The combination may cause side effects, and it is not yet known if it improves survival.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 111 people

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

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Feb 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 70 years

Sex

Female participants only

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. Female patients aged 18-70 years old; 2. ECOG score is 0-1 points; 3. Histologically or pathologically confirmed invasive breast cancer, meeting the following criteria simultaneously: Invasive breast cancer staged as T1cN1-2M0 or T2-3N0-2M0; All patients must be pathohistologically confirmed as HR-positive/HER2-low. The interpretation of ER and PR status follows the 2020 ASCO/CAP Guidelines: expression ≥1% is defined as positive, and HR positivity is confirmed if either ER or PR is positive. The interpretation of HER2 status follows the 2023 ASCO/CAP Guidelines: HER2-low is defined as HER2 1+ or 2+ with negative FISH test results. Pathological testing for PD-L1 expression: The Combined Positive Score (CPS) is the percentage of PD-L1-positive cells (including tumor cells, lymphocytes, and macrophages) among the total number of tumor cells. The PD-L1 antibody clone used for detection at our center is 22C3. No prior anti-cancer treatment. 4. Function levels of major organs must meet the required criteria 5. For female patients who have not yet reached menopause or undergone surgical sterilization: during the treatment period and in the study treatment, the final use effective contraceptive methods for at least 6 months after a single administration. 6. Voluntarily join this study, sign an informed consent form, have good compliance, and are willing to cooperate with follow-up. Exclusion Criteria: 1. Stage IV breast cancer. 2. Inflammatory breast cancer. 3. Previously received anti-tumor treatment or radiation therapy for any malignant tumor, excluding those that have been cured Malignant tumors such as cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma. 4. Simultaneously undergoing anti-tumor treatment in other clinical trials, including but not limited to chemotherapy and endocrine therapy. Treatment, biological therapy, bone improvement drug therapy, or immune checkpoint inhibitor therapy, etc. 5. The patient had undergone major surgical procedures unrelated to breast cancer within 4 weeks before the first administration of the study drug, or the patient has not fully recovered from such surgical procedures. 6. Serious heart disease or discomfort. 7. Uncontrolled active infections that require treatment; History of immunodeficiency, including HIV testing positive Sexual, or suffering from other acquired or congenital immunodeficiency diseases, or having a history of organ transplantation. 8. Patients with chronic active hepatitis B or active hepatitis C 9. Have received immunotherapy and experienced adverse immune events such as immune related pneumonia and myocarditis, which have been determined by researchers to potentially affect the safety of the experimental medication. 10. Individuals with a known history of allergies to the components of this medication regimen.

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Harbin Medical University Cancer Hospital

    RECRUITING

    Harbin, China

  • The First Affiliated Hospital of Anhui Medical University

    RECRUITING

    Hefei, China

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    RECRUITING

    Xi'an, China

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    RECRUITING

    Zhengzhou, China

  • Zhongshan Hospital, Fudan University

    RECRUITING

    Shanghai, China

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