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Smart scan may help choose best breast cancer therapy

NCT ID NCT06195709

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests whether a special PET scan (EstroTEP) and blood tests can help doctors pick the best second-line treatment for people with ER-positive, HER2-negative metastatic breast cancer. About 300 participants will be assigned to either endocrine therapy or chemotherapy based on these test results. The goal is to see if this personalized approach improves how long the cancer stays under control.

What this could mean

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

Active substance
18F-FES (a radioactive tracer for PET scans) and circulating tumor biomarkers
What this could lead to
If successful, this approach could help doctors choose the most effective second-line therapy for each patient, potentially improving outcomes and avoiding ineffective treatments.
What could go wrong
This is a strategy trial, not testing a new drug. The benefit depends on how well the scan and biomarkers predict treatment response, which is still uncertain. 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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 300 people

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

Started

May 2024

Expected to finish

Sep 2030

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

Anyone

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. Metastatic invasive breast carcinoma of no special type. 2. Females and males of age ≥18 years. 3. Life expectancy \> 3 months. 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2. 5. Estrogen Receptor (ER)-positive (≥10%) and HER2-negative (ASCO/College of American Pathologists guidelines) breast cancer, per local assessment on the most recent breast cancer tissue examined. 6. Tumor block Formalin-Fixed Paraffin-Embedded (primary tumor or metastasis) available. 7. Patients whose disease has progressed on first line endocrine therapy with aromatase inhibitor and CDK4/6 inhibitor and who are deemed eligible, per investigator assessment, to a second line endocrine therapy. The progression on first line endocrine therapy with aromatase inhibitor and CDK4/6 inhibitor must have occurred after more than 6 months on treatment. 8. Patients with available 18F-FDG PET/CT imaging 9. Evaluable disease per RECIST criteria and measurable disease per PERCIST criteria. 10. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and any protocol-related procedures including screening evaluations. 11. Signed informed consent. 12. Patient affiliated to a social security system. Exclusion criteria: 1. Other breast cancer subtype (e.g. invasive lobular breast carcinoma). 2. One or more prior line of chemotherapy in the metastatic setting. 3. Any other systemic treatment given at metastatic disease than the first line therapy with aromatase inhibitor and CDK4/6 inhibitor. 4. Visceral crisis, per investigator's assessment. 5. Liver-only metastases. 6. Prior exposure to any authorized or experimental agent degrading the estrogen receptor (fulvestrant, oral SERDs, PROTAC, etc). 7. Pregnancy or lactation period. 8. In women of childbearing potential or premenopausal women or women with amenorrhea of less than 12 months, without adequate non-hormonal contraceptive measures (barrier methods, intrauterine contraceptive devices, sterilization; LH-RH agonist cannot be considered as an efficient contraceptive measure), positive urinary or serum pregnancy test 72 hours before 18F-FES PET/CT. 9. Known active uncontrolled or symptomatic Central Nervous System (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease. Patients with a history of CNS metastases or cord compression are eligible if they have been treated with local therapy (e.g., radiotherapy, stereotactic surgery) and are clinically stable and off anticonvulsants and steroids for at least 4 weeks before treatment start. 10. History of previous cancer or hematological malignancy within 3 years preceding patient enrollment in the trial. Multiple primary breast cancers (controlateral/ipsilateral cancers/local relapses) are allowed pending all tumors were ER+ HER2-. 11. Persons deprived of their freedom or under guardianship or incapable of giving consent.

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Conditions

The condition(s) this trial relates to.

breast carcinoma breast neoplasm estrogen-receptor positive breast cancer metastatic carcinoma Neoplasm Metastasis

As listed by the trial registrant

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

Breast carcinoma

How to take part

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

  1. The places running it

    20 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

  • Bruno MAUCHERAT

    WITHDRAWN

    Saint-Herblain, 44805, France

  • CHU Limoges

    NOT_YET_RECRUITING

    Limoges, 87000, France

  • Centre Antoine lacassagne

    RECRUITING

    Nice, 06189, France

  • Centre Eugène Marquis

    RECRUITING

    Rennes, 35042, France

  • Centre Francois Baclesse

    RECRUITING

    Caen, 14076, France

  • Centre Georges Francois Leclerc

    RECRUITING

    Dijon, 21079, France

  • Centre Henri Becquerel

    NOT_YET_RECRUITING

    Rouen, 76038, France

  • Centre Hospitalier de la Côte basque

    NOT_YET_RECRUITING

    Bayonne, 64100, France

  • Centre Leon Bérard

    NOT_YET_RECRUITING

    Lyon, 69008, France

  • Centre Oscar Lambret

    RECRUITING

    Lille, 59000, France

  • Centre de lutte contre le cancer Paul Strauss

    NOT_YET_RECRUITING

    Strasbourg, France

  • Hôpital Bretonneau-CHU Tours

    NOT_YET_RECRUITING

    Tours, 37044, France

  • Hôpital Universitaire de Nimes

    NOT_YET_RECRUITING

    Nîmes, 30029, France

  • Institut Bergonié

    NOT_YET_RECRUITING

    Bordeaux, 33076, France

  • Institut Curie

    RECRUITING

    Paris, 75005, France

  • Institut Curie

    RECRUITING

    Saint-Cloud, 92210, France

  • Institut Paoli-Calmettes

    RECRUITING

    Marseille, 13009, France

  • Institut de Cancerologie de Lorraine

    RECRUITING

    Vandœuvre-lès-Nancy, 54519, France

  • Institut du Cancer Montpellier

    RECRUITING

    Montpellier, 34298, France

  • Oncopole Claudius Regaud

    NOT_YET_RECRUITING

    Toulouse, 31059, France

  • Polyclinique Bordeaux Nord Aquitaine

    NOT_YET_RECRUITING

    Bordeaux, 33077, France

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