Informations générales (source: ClinicalTrials.gov)
Multicenter Randomized Pivotal Stage Clinical Investigation Assessing the Communication of an Individualized AI-based Risk Prediction of Arm Lymphedema to Breast Cancer Patients With an Indication for Regional Lymph Node Irradiation and Their Physician as Part of Treatment Shared-decision
Interventional
N/A
UNICANCER (Voir sur ClinicalTrials)
octobre 2025
janvier 2029
20 mai 2026
Radiotherapy after breast cancer surgery can lead to side effects like arm lymphedema
(arm swelling). Lymphedema can cause long-term discomfort and affect quality of life.
The goal of this clinical investigation is to determine whether using an artificial
intelligence (AI) tool to predict the risk of developing arm lymphedema after breast
cancer radiotherapy can help patients and physicians make better treatment decisions.
This AI tool has been developed to determine each patient's personalized risk of
developing lymphedema. The risk is shown using a web app that explains the factors
involved and offers suggestions like using a compression sleeve to reduce the risk.
Women (≥18 years) with breast cancer (cT1-4, cN0-N3, M0) requiring regional lymph node
irradiation post-mastectomy or breast-conserving surgery are eligible, regardless of
hormone receptor status, tumor grade, or HER2 status.
Patients will be randomly divided into two groups:
- Experimental group: Patients and physicians will see the AI-predicted risk and use
it to guide treatment choices.
- Control group: The risk is not shown.
The radiotherapy treatment will be exactly the same as the treatment that you would have
received if you had not taken part in this clinical investigation. The only intervention
will be whether or not the risk you are informed of the risk of developing lymphedema.
All patients will be followed for two years to monitor:
- How risk communication influences radiotherapy treatment choices
- The occurrence of side effects
- The predictive performance of the AI tool
- Patients' quality of life
- Compliance with compression sleeve use
- Loco-regional recurrence-free survival, distant disease-free survival, and overall
survival
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Sofia RIVERA | 01/09/2026 19:40:33 | Contacter | ||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Guillaume Le Conquérant - Le Havre - France | Romain MALLET, MD | Contact (sur clinicalTrials) | |||
| Centre Jean Perrin - Clermont-Ferrand - France | Aurélie BELLIERE, MD | Contact (sur clinicalTrials) | |||
| Centre Léon Bérard - Lyon - France | Séverine RACADOT, MD | Contact (sur clinicalTrials) | |||
| Centre Marie Curie - Arras - France | Alexandre HENNI, MD | Contact (sur clinicalTrials) | |||
| Centre Paul Strauss - Strasbourg - France | Jean-Baptiste CLAVIER, MD, PhD | Contact (sur clinicalTrials) | |||
| Centre Pierre Curie - Beuvry - France | Laurent BASSON, MD | Contact (sur clinicalTrials) | |||
| CH Lyon Sud - Oullins - France | Ionela CARAIVAN, MD | Contact (sur clinicalTrials) | |||
| CHU Sud La Réunion - Saint-Pierre - France | Shakeel SUMODHEE, MD | Contact (sur clinicalTrials) | |||
| Clinique Mutualiste de l'Estuaire - Saint-Nazaire - France | Benoit SAMAIN, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Antoine Lacassagne - Nice - France | Contact (sur clinicalTrials) | ||||
| Centre de Radiothérapie de Seine-et-Marne - Melun - France | Louisa ABBASSI, MD | Contact (sur clinicalTrials) | |||
| Centre François Baclesse - Caen - France | Adeline MOREL, MD | Contact (sur clinicalTrials) | |||
| Centre Georges François Leclerc - Dijon - France | Karine PEIGNAUX-CASASNOVAS, MD | Contact (sur clinicalTrials) | |||
| Centre Henri Becquerel - Rouen - France | Ahmed BENYOUCEF, MD | Contact (sur clinicalTrials) | |||
| Centre Léonard de Vinci - Dechy - France | Alexandre ESCANDE, MD | Contact (sur clinicalTrials) | |||
| Centre Oscar Lambret - Lille - France | David PASQUIER, MD | Contact (sur clinicalTrials) | |||
| CH de Saint Quentin - Saint-Quentin - France | Hanene OUESLATI, MD | Contact (sur clinicalTrials) | |||
| CHD Vendée - La Roche-sur-Yon - France | Florence LEGOUTÉ, MD | Contact (sur clinicalTrials) | |||
| CHI Créteil - Créteil - France | Soumia ANANE ABROUS, MD | Contact (sur clinicalTrials) | |||
| Clinique Tivoli Ducos - Bordeaux - France | Pauline REGNAULT DE LA MOTHE, Md | Contact (sur clinicalTrials) | |||
| Clinique Victor Hugo - Le Mans - France | Amandine RUFFIER LOUBIERE, MD | Contact (sur clinicalTrials) | |||
| Gustave Roussy - Villejuif - France | Sofia RIVERA, MD, PhD | Contact (sur clinicalTrials) | |||
| ICO Nantes Saint Herblain - Saint-Herblain - France | Augustin MERVOYER, MD | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie de Lorraine - Vandœuvre-lès-Nancy - France | Marie BRUAND, MD | Contact (sur clinicalTrials) | |||
| Institut Godinot - Reims - France | Philippe GUILBERT, MD | Contact (sur clinicalTrials) | |||
| ROC 37 - Chambray-lès-Tours - France | Guillemette BERNADOU, MD | Contact (sur clinicalTrials) | |||
Critères
Femme
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