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New scan may predict who will beat Triple-Negative breast cancer

NCT ID NCT06349512

Diagnosis Sponsor: Institut Curie 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study is testing whether a new type of PET scan (68Ga-FAPI-46) can predict if triple-negative breast cancer will completely respond to chemotherapy plus immunotherapy before treatment begins. About 60 women with early-stage, high-risk breast cancer will get the scan before starting standard treatment. The goal is to see if the scan can accurately tell doctors which patients will have no cancer left after treatment.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

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

Started

Oct 2024

Expected to finish

Nov 2032

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 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: 1. Female with age ≥ 18 years, 2. Patients with previously untreated, non-metastatic, centrally confirmed TNBC for whom a neoadjuvant treatment with chemotherapy + pembrolizumab is the recommended option as standard of care, 3. Patients with measurable targets according to RECIST/PERCIST criteria, 4. Patients without distant metastasis based on staging 18F-FDG PET/CT, 5. Patients with tumor tissue available, 6. Patients who provided a signed written informed consent, 7. Patient ability to comply with protocol requirements, 8. Patients covered by a health insurance system. Exclusion Criteria: 1. Pregnant and lactating women, 2. Patients with prior anti-PD(L)1 immunotherapy, 3. Patients with any contra-indication to chemo-immunotherapy standard of care therapy, per investigator assessment, 4. Patients with altered mental status or psychiatric disorder that, in the opinion of the investigator, would preclude a valid patient informed consent, 5. Patients who have difficulty undergoing trial procedures for geographic, social or psychological reasons, 6. Person deprived of liberty or under guardianship

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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

How to take part

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

  1. The places running it

    6 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

  • GH Diaconesses Croix Saint-Simon

    RECRUITING

    Paris, 75020, France

  • HIA Begin

    RECRUITING

    Saint-Mandé, 94160, France

  • Hôpital FOCH

    RECRUITING

    Suresnes, 92150, France

  • Hôpital Privé d'Antony

    RECRUITING

    Antony, 92160, France

  • Institut Curie -site Paris

    RECRUITING

    Paris, 75005, France

  • Institut Curie -site St Cloud

    RECRUITING

    Saint-Cloud, 92210, France

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