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
Patient must have signed a written informed consent form prior to inclusion visit and to any study specific procedures
Women ≥ 18 years
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
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)
Previous breast cancer or Ductal Carcinoma in Situ (DCIS) of the ipsilateral breast
Bilateral breast cancer
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
Patient who has an indication for boost to one or more regional nodes
Parallel
XAINET AI tool
DeviceThe AI-based prediction of arm lymphedema risk is communicated to the patient and treating physician.
Arm lymphedema
Cumulative incidence of arm lymphedema on the treated side 2 years after adjuvant radiotherapy. The definition of arm lymphedema is ≥5% increased arm circumference measured 15 cm proximal and/or 10 cm distal of the olecranon of the treated side from baseline, compared to the contralateral side circumference and to its baseline value
Impact of communicating the risk prediction for arm lymphedema on the choice of radiotherapy modality, fractionation, technique and nodal levels irradiated
Radiotherapy modalities: technique used, fractionation (use of moderately and ultra-hypofractionated), and lymph node levels treated will be compared in both arms
Acute and late toxicity during the study
The National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5) is widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale, divided into 5 grades (1 = "mild", 2 = "moderate", 3 = "severe", 4 = "life-threatening", and 5 = "death") determined by the investigator, will make it possible to assess the severity of the disorders
Range of shoulder motion (ROM) of the arms
The range of shoulder motion (ROM) of the arms (flexion/abduction) will be reported by the radiation oncologist according to a circular scale
Breast cosmetic result
The global cosmetic result after breast conservation surgery will be based on Harris 4-point scale (4-point Likert scale: Excellent, Good, Fair, Poor)
