Arm Swelling Occurence in Breast Cancer Patients With Nodal Radiotherapy: Impact of Informing Them of AI-predicted Risk

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