Using AI to predict and share risk of arm swelling after nodal radiotherapy

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

This trial will test whether showing women having lymph‑node radiotherapy after breast cancer surgery their personalized AI-predicted risk of arm swelling helps guide care decisions.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 724 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Unicancer (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 12 sites (Arras and 11 other locations)
• Trial ID: NCT07187726 on ClinicalTrials.gov

What this trial studies

Women with unilateral invasive breast cancer who require regional lymph node irradiation after mastectomy or breast‑conserving surgery are randomly assigned to two groups. One group and their physicians see a web app that gives a personalized AI risk estimate for arm lymphedema and explains contributing factors and risk-reduction suggestions such as compression sleeves; the other group receives usual care information. The study tracks whether providing the AI risk estimate changes treatment or preventive choices and measures subsequent occurrence of arm lymphedema and related outcomes. Participants must be adults with cT1-4, cN0-N3, M0 disease and acceptable performance status to enroll.

Who should consider this trial

Good fit: Women aged 18 or older with unilateral invasive breast cancer (cT1-4, cN0-N3, M0) who are scheduled for regional nodal radiotherapy after mastectomy or breast‑conserving surgery are ideal candidates.

Not a fit: Patients who do not require regional nodal irradiation, who have metastatic or bilateral disease, or who cannot access or use the web app are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, this approach could help patients and doctors choose preventive measures or treatment options that reduce the chance of long-term arm swelling.

How similar studies have performed: Predictive models for lymphedema risk exist, but using an AI tool to communicate individualized risk to patients to influence decisions is relatively new and not yet widely proven.

Eligibility criteria

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

Where this trial is running

Arras and 11 other locations

• Centre Marie Curie — Arras, France (Recruiting)
• Centre Pierre Curie — Beuvry, France (Recruiting)
• Clinique Tivoli Ducos — Bordeaux, France (Recruiting)
• Roc 37 — Chambray-lès-Tours, France (Recruiting)
• CHI Créteil — Créteil, France (Recruiting)
• Centre Georges François Leclerc — Dijon, France (Recruiting)
• Centre Guillaume Le Conquérant — Le Havre, France (Recruiting)
• Centre Antoine Lacassagne — Nice, France (Recruiting)
• Institut Godinot — Reims, France (Recruiting)
• ICO Nantes Saint Herblain — Saint-Herblain, France (Recruiting)
• Institut de Cancérologie Strasbourg Europe — Strasbourg, France (Recruiting)
• Gustave Roussy — Villejuif, France (Recruiting)

Study contacts

• Study coordinator: Marie Bergeaud, PhD

Conditions Unilateral Breast Neoplasms; Arm lymphedema; Individualized AI-based risk prediction