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New combo attack on aggressive breast cancer shows promise in early trial

NCT ID NCT06682195

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial is testing whether adding the immunotherapy drug toripalimab to standard chemotherapy before surgery can improve outcomes for women with triple-negative breast cancer. About 35 participants will receive the combination, then undergo surgery. The main goal is to see how many have no cancer cells left in the removed tissue.

What this could mean

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

Active substance
Toripalimab (an immunotherapy drug) combined with chemotherapy drugs epirubicin, cyclophosphamide, and albumin-bound paclitaxel
What this could lead to
If successful, this could lead to a more effective treatment approach for triple-negative breast cancer before surgery, potentially improving long-term outcomes.
What could go wrong
This is a small, early-phase trial with only 35 participants and no comparison group. The combination may cause side effects, and results may not apply to all patients.

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 35 people

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

Started

Oct 2024

Expected to finish

Oct 2029

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 proven tumors \>1cm in diameter (T1c-3; N0-2; M0) invasive breast cancer; 4. All patients had triple negative breast cancer confirmed by histopathology; 5. Pathological examination of PD-L1 expression: The Combined Positive Score (CPS) refers to the percentage of PD-L1 positive cells (including tumor cells, lymphocytes, macrophages) in all tumor cells. Our center detected the PD-L1 antibody site as 22C3. 6. The functional level of major organs must meet requirements 7. 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. 8. 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, including but not limited to the following diseases: 1\) Diagnosed history of heart failure or systolic dysfunction (LVEF less than 50%).2) High risk uncontrolled arrhythmias, such as atrial tachycardia, resting heart rate greater than 100bpm, significant ventricular arrhythmias (such as ventricular tachycardia), or higher-level atrioventricular block (i.e. Mobitz II second or third degree atrioventricular block).3) Angina requiring medication for treatment. 4) Heart valve disease with clinical significance. 5) ECG shows transmural myocardial infarction. 6) Poor control of hypertension (systolic blood pressure greater than 180mmHg and/or diastolic blood pressure greater than 180mmHg after drug treatment) 100mmHg). 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 (excluding hepatitis B virus carriers, stable hepatitis B after drug treatment \[HBV-DNA test negative or\<50IU/ml\] and cured hepatitis C patients \[HCV RNA test negative\]). 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. 11\. Pregnant and lactating female patients, female patients with fertility and positive baseline pregnancy test results, or reproductive age patients who are unwilling to take effective contraceptive measures during the entire trial period and within 6 months after the last study medication. 12\. Suffering from serious accompanying diseases or other comorbidities that may interfere with the planned treatment, or any other circumstances that the researcher deems unsuitable for the patient to participate in this study.

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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

    13 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

    NOT_YET_RECRUITING

    Harbin, China

  • Jinhua Municipal Central Hospital

    RECRUITING

    Jinhua, China

  • Nanchang People's Hospital

    NOT_YET_RECRUITING

    Nanchang, Jiangxi, China

  • Nantong First People's Hospital

    RECRUITING

    Nantong, China

  • Shanxi Provincial Cancer Hospital

    NOT_YET_RECRUITING

    Shanxi, China

  • Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

    RECRUITING

    Hangzhou, China

  • The First Affiliated Hospital of Anhui Medical University

    RECRUITING

    Hefei, China

  • The First Affiliated Hospital of Zhejiang University

    RECRUITING

    Hangzhou, China

  • The First Affiliated Hospital of Zhengzhou University

    RECRUITING

    Zhengzhou, China

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    NOT_YET_RECRUITING

    Xi'an, China

  • Xinjiang Medical University Affiliated Cancer Hospital

    NOT_YET_RECRUITING

    Xinjiang, China

  • Zhejiang Cancer Hospital

    RECRUITING

    Hangzhou, China

  • Zhongshan Hospital, Fudan University

    RECRUITING

    Shanghai, China

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