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Can a blood test and special scan spot breast cancer relapse before symptoms?

NCT ID NCT06225505

Knowledge-focused 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 24, 2026 · Updated 2 times

Summary

This study looks at whether regular blood tests (ctDNA monitoring) combined with a special type of PET scan can detect the return of triple negative breast cancer earlier than standard methods. About 450 women who finished treatment for early-stage triple negative breast cancer will take part. If the blood test shows signs of cancer, some participants will get the special scan to see if it helps find relapses sooner.

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 450 people

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

Started

Jan 2026

Expected to finish

Aug 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 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. Patients must have signed a written informed consent before inclusion 2. Patients must be female ≥ 18 years old 3. Patients diagnosed with a non-metastatic TNBC (ER \& PR \<10%, HER2- per ASCO/CAP guidelines). Patients must have been previously evaluated by a 18F-FDG PET-CT or a bone scintigraphy combined with a thorax, abdomen and pelvis CT scan with contrast 4. Patients who have undergone surgery with curative intent for their non-metastatic TNBC. Surgery must have been performed between 3 to 24 months before inclusion. Patients must have initiated their adjuvant therapy, whenever indicated, since at least 12 weeks. For patients receiving an experimental adjuvant treatment in a clinical trial, any intervention planned as part of this trial must be completed before inclusion. 5. High-risk primary tumor, defined as: 1. Lack of pathological complete response after neoadjuvant chemotherapy (RCB I, II or III; RCB I being capped to a maximum of 30% of included patients) OR, in the absence of neoadjuvant chemotherapy, 2. Stage IIB-III (i.e., T2N1, any T3-T4, any N2-3) OR 3. Any loco-regional relapse occurring after a prior ipsilateral, curatively treated TNBC 6. No sign of local or distant relapse, as per investigator assessment 7. Performance status \< 2 8. Available FFPE tumor block with \> 10% cellularity or 11 tumor sections with \>10% cellularity 9. Patient able to comply with protocol requirements 10. Patients covered by a health insurance Exclusion Criteria: 1. Any uncontrolled disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding or any other medical condition that, in the opinion of the investigator, interferes with the trial procedures 2. Male participants 3. Patients with altered mental status or psychiatric disorder that, in the opinion of the investigator, would preclude a valid patient informed consent. 4. Patients who have difficulty undergoing trial procedures for geographic, social or psychological reasons 5. Person deprived of liberty or under guardianship 6. History of another primary malignancy except for the following : 1. Basal cell carcinoma or any in situ carcinoma treated with curative intent 2. Any stage I-II malignancy treated with curative intent with no evidence of active disease in the last five years 7. For step #2 (randomization after ctDNA detection): clinical/radiological metastatic relapse before the detection of the molecular relapse.

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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

    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

  • CHU Nîmes

    NOT_YET_RECRUITING

    Nîmes, 30900, France

  • Centre Eugène Marquis

    NOT_YET_RECRUITING

    Rennes, 35000, France

  • Centre Jean Perrin

    NOT_YET_RECRUITING

    Clermont-Ferrand, 63011, France

  • Centre Leon Bérard

    NOT_YET_RECRUITING

    Lyon, 69008, France

  • Hôpital Saint-Louis

    NOT_YET_RECRUITING

    Paris, 75010, France

  • Hôpital Tenon

    NOT_YET_RECRUITING

    Paris, 75020, France

  • Institut Bergonié

    NOT_YET_RECRUITING

    Bordeaux, 33000, France

  • Institut Curie

    RECRUITING

    Saint-Cloud, 92340, France

  • Institut Paoli-Calmettes

    NOT_YET_RECRUITING

    Marseille, 13009, France

  • Institut de cancérologie de Lorraine

    NOT_YET_RECRUITING

    Vandœuvre-lès-Nancy, 54519, France

  • Institut du cancer de Montpellier

    NOT_YET_RECRUITING

    Montpellier, 34298, France

  • ONCOPOLE Claudius Regaud

    NOT_YET_RECRUITING

    Toulouse, 31059, France

  • Sainte-Catherine Institut du Cancer Avignon-Provence

    NOT_YET_RECRUITING

    Avignon, 84918, France

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