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AI predicts lymphedema risk to guide breast cancer radiation decisions

NCT ID NCT07187726

Knowledge-focused Sponsor: UNICANCER 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether an artificial intelligence tool can predict a breast cancer patient's risk of developing arm lymphedema (swelling) after radiation therapy. About 724 women will be randomly assigned to either see their personalized risk prediction or not. The goal is to see if knowing this risk helps patients and doctors choose safer radiation options, reducing side effects and improving quality of life over two years.

What this could mean

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

Active substance
AI-based risk prediction tool (XAINET)
What this could lead to
If successful, this could help breast cancer patients and doctors make more informed decisions about radiotherapy, potentially reducing arm swelling and improving quality of life.
What could go wrong
This is a study about communication, not a new treatment. The AI tool's predictions may not be accurate for everyone, and the trial is still recruiting, so results are uncertain.

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 724 people

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

Started

Oct 2025

Expected to finish

Jan 2029

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. Patient must have signed a written informed consent form prior to inclusion visit and to any study specific procedures 2. Women ≥ 18 years 3. Patients with unilateral invasive breast cancer, cT1-4, cN0-N3, M0 who had undergone radical surgery defined as mastectomy or breast conservation surgery with negative margins +/- (neo)-adjuvant systemic treatment. The patient can be included no matter the status of estrogen and progesterone receptors, malignancy grade, and HER2 status 4. Axillary lymph node staging (by axillary dissection or sentinel lymph node biopsy and/or marked lymph node biopsy \[Marking Axillary lymph nodes with Radioactive Iodine seeds (MARI) procedure/ (Targeted Axillary Dissection (TAD) procedure\] in case of neo-adjuvant systemic treatment) defining the indication for regional nodal irradiation to levels I+/- II+/- III+/- IV+/- interpectoral nodes (Rotter) +/- the IMC(Internal Mammary Chain) 5. ECOG performance status 0-2 6. Patient must be randomized within the recommended time period from last surgery or the last series of chemotherapy whichever comes last as per national or institutional guidelines in order not to delay radiotherapy treatment start 7. Women of childbearing potential must agree to use adequate contraception for the duration of study participation and up to 3 months following completion of radiotherapy 8. Patient is willing and able to comply with the protocol for the duration of the clinical investigation including undergoing treatment and scheduled visits, and examinations including follow-up 9. Patient affiliated to or a beneficiary of the local social security system, health service or other local regulatory requirements Exclusion Criteria: 1. Previous breast cancer or Ductal Carcinoma in Situ (DCIS) of the ipsilateral breast 2. Bilateral breast cancer 3. Patient with previous non-breast malignancy, with the exception of cancer in complete remission for over 5 years and low risk of recurrence. Patients with the following diseases can be accepted despite less than 5 years disease free interval: carcinoma in situ of the cervix, melanoma in situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin 4. Patient who has an indication for boost to one or more regional nodes 5. Previous radiation therapy to the chest region 6. Patients having arm swelling requiring arm sleeve prescription at baseline 7. Any condition that prevents the patient from wearing a compression sleeve for 8h/day from the first day of radiation therapy until 3 months after the initiation of adjuvant radiotherapy 8. Pregnant or breastfeeding women 9. Patient already included in another therapeutic study involving radiotherapy dose/regimen/technique and/or arm lymphedema risk 10. Person deprived of their liberty or under protective custody or guardianship 11. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

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Conditions

The condition(s) this trial relates to.

breast neoplasm invasive breast carcinoma Unilateral Breast Neoplasms

As listed by the trial registrant

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

Unilateral breast neoplasms

How to take part

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

  1. The places running it

    27 sites in 2 countries. 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

  • CH Lyon Sud

    RECRUITING

    Oullins, France

  • CH de Saint Quentin

    RECRUITING

    Saint-Quentin, France

  • CHD Vendée

    RECRUITING

    La Roche-sur-Yon, France

  • CHI Créteil

    RECRUITING

    Créteil, France

  • CHU Sud La Réunion

    RECRUITING

    Saint-Pierre, France

  • Centre Antoine Lacassagne

    RECRUITING

    Nice, France

  • Centre François Baclesse

    RECRUITING

    Caen, France

  • Centre Georges François Leclerc

    RECRUITING

    Dijon, France

  • Centre Guillaume Le Conquérant

    RECRUITING

    Le Havre, France

  • Centre Henri Becquerel

    RECRUITING

    Rouen, France

  • Centre Jean Perrin

    RECRUITING

    Clermont-Ferrand, France

  • Centre Léon Bérard

    RECRUITING

    Lyon, France

  • Centre Léonard de Vinci

    RECRUITING

    Dechy, France

  • Centre Marie Curie

    RECRUITING

    Arras, France

  • Centre Oscar Lambret

    RECRUITING

    Lille, France

  • Centre Paul Strauss

    RECRUITING

    Strasbourg, France

  • Centre Pierre Curie

    RECRUITING

    Beuvry, France

  • Centre de Radiothérapie de Seine-et-Marne

    RECRUITING

    Melun, France

  • Clinique Mutualiste de l'Estuaire

    RECRUITING

    Saint-Nazaire, France

  • Clinique Tivoli Ducos

    RECRUITING

    Bordeaux, France

  • Clinique Victor Hugo

    RECRUITING

    Le Mans, France

  • Gustave Roussy

    RECRUITING

    Villejuif, France

  • ICO Nantes Saint Herblain

    RECRUITING

    Saint-Herblain, France

  • Institut Godinot

    RECRUITING

    Reims, France

  • Institut de Cancérologie de Lorraine

    RECRUITING

    Vandœuvre-lès-Nancy, France

  • Maastro

    RECRUITING

    Maastricht, Netherlands

  • ROC 37

    RECRUITING

    Chambray-lès-Tours, France