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Can immune markers predict breast cancer treatment success?

NCT ID NCT07570524

Knowledge-focused Sponsor: Center Eugene Marquis Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 10, 2026 · Updated 1 time

Summary

This study looks at 200 women with early-stage triple-negative breast cancer to find immune markers in tumors and blood that predict whether immunochemotherapy will work well. Researchers will compare those who have a complete response to those who don't, aiming to guide more personalized treatment in the future. Participants give extra biopsies and blood samples over 5 years.

What this could mean

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

What this could lead to
If successful, this could help doctors personalize treatment for triple-negative breast cancer by identifying who will benefit most from immunochemotherapy.
What could go wrong
This is an observational study that does not test a new treatment. It may not find clear biomarkers, and results may not change practice for years.

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.

Participants

About 200 people

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

Started

Jun 2026

Expected to finish

Jun 2036

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.

Who is studied

Patients treated in the neoadjuvant setting for triple-negative breast cancer

Ages

18 years and older

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: * Female. * Age ≥ 18 years. * Histologically confirmed invasive triple-negative breast cancer (ER and PR \< 10% by IHC, HER2 0, 1+, or 2+ with negative SISH), stage II or III. * Eligible for neoadjuvant immunochemotherapy according to the Keynote-522 regimen. Indication for intra-tumoral clip placement. \- Signed written informed consent Exclusion Criteria: * Pregnant or breastfeeding women. * Hematoma requiring Grade II analgesics after diagnostic biopsy. * Known coagulation disorders. * Adults under guardianship, curatorship, or legal protection, or deprived of liberty. * Not affiliated with a social security system.

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Conditions

The condition(s) this trial relates to.

triple-negative breast carcinoma

As listed by the trial registrant

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

Triple negative breast cancer (TNBC)

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

  • Centre Eugène Marquis

    RECRUITING

    Rennes, 35000, France

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