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New drug cocktail aims to stop triple negative breast cancer from returning

NCT ID NCT07679360

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 01, 2026 · Last updated Sep 10, 2026 · Updated 3 times

Summary

This Phase 3 trial tests whether a combination of two drugs, trastuzumab rezetecan and adebrelimab, can prevent breast cancer from returning in people with triple negative breast cancer who still have cancer cells after initial chemotherapy and surgery. The study compares this new combination to standard treatments chosen by the doctor. About 1000 participants will be randomly assigned to receive either the experimental combination or a standard therapy, and researchers will track how long they live without the cancer coming back.

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 Adebrelimab
What this could lead to
If successful, this combination could offer a more effective treatment option for triple negative breast cancer patients who still have cancer after initial therapy, potentially reducing the risk of recurrence.
What could go wrong
This is an early-stage Phase 3 trial, and the combination may not prove more effective than existing treatments. Side effects from the drugs could be significant.

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 1,000 people

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

Started

Sep 2026

Expected to finish

Dec 2032

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 to 75 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. Pathologically confirmed invasive triple negative breast cancer. 2. Pathologic evidence of residual invasive carcinoma in the breast or axillary lymph nodes following completion of preoperative therapy. 3. Previous neoadjuvant therapy must meet the requirements of the protocol. 4. Has received radical surgery for breast cancer. 5. ECOG PS 0\~1. 6. Adequate organ functions. 7. Women of childbearing potential must be willing to use highly effective form of contraception. Exclusion Criteria: 1. Stage IV metastatic breast cancer. 2. Previous invasive breast cancer or ductal carcinoma in situ. 3. Bilateral breast cancer. 4. Any clinical evidence indicating the exist of recurrent diseases after surgery. 5. History of other malignancy within the last 5 years, excluding cured skin basal cell carcinoma and cervical carcinoma in situ. 6. Previously received antibody coupled drug (ADC) therapy with topoisomerase inhibitors as effective payloads. 7. Previously received HER2 targeted therapy. 8. Active or previously recorded autoimmune or inflammatory diseases. 9. History of immunodeficiency. 10. Participants with known or suspected interstitial pneumonia. 11. Presence of active Hepatitis B. 12. Known to have active tuberculosis infection. 13. Uncontrolled infections requiring intravenous injection of antibiotics, antiviral drugs, or antifungal drugs for treatment. 14. Within the 6 months prior to randomization, there was a history of myocardial infarction, severe/unstable angina, symptomatic congestive heart failure, ≥ Grade 2 supraventricular or ventricular arrhythmias, and any grade of ventricular fibrillation. 15. Known allergy to any investigational drug or its excipients. 16. Other medical conditions that would interfere with study participation or follow-up.

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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

    1 site. 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

  • Cancer Hospital of Chinese Academy of Medical Sciences

    RECRUITING

    Beijing, Beijing Municipality, 100021, China

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