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

Official title

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

Overview

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

Interventions

• Device XAINET AI tool
  The AI-based prediction of arm lymphedema risk is communicated to the patient and treating physician.

Primary outcome measures

• Arm lymphedema [Time frame: At 2 years]

Secondary outcome measures (12)

• Impact of communicating the risk prediction for arm lymphedema on the choice of radiotherapy modality, fractionation, technique and nodal levels irradiated [Time frame: Up to 3 months from randomization.]
• Acute and late toxicity during the study [Time frame: Throughout study completion, up to 2 years.]
• Range of shoulder motion (ROM) of the arms [Time frame: Throughout study completion, up to 2 years.]
• Breast cosmetic result [Time frame: Throughout study completion, up to 2 years.]
• Performance of the arm lymphedema risk prediction model [Time frame: At 2 years]
• Quality of life questionnaire - Core 30 (QLQ-C30) [Time frame: At baseline, end of treatment visit, 1 year and 2 years]
• Quality of Life Questionnaire - Breast cancer module (QLQ-BR23) [Time frame: At baseline, end of treatment visit, 1 year and 2 years]
• The Developed 5-level version of EQ-5D (EQ-5D-5L) questionnaire [Time frame: At baseline, end of treatment visit, 1 year and 2 years]
• Compliance with compression arm sleeve use [Time frame: At end of treatment visit, 3-month after starting radiotherapy, at 1 year and 2 years]
• Loco-regional relapse-free survival (RFS) [Time frame: From randomization until the first invasive ipsilateral breast tumor recurrence, loco regional invasive recurrence, ipsilateral DCIS or death from any cause up to 2 years]
• Distant disease-free survival (DDFS) [Time frame: From randomization until the recurrence of disease or death from any cause up to 2 years]
• Overall survival (OS) [Time frame: From randomization to death from any cause, up to 2 years]

Eligibility criteria

Inclusion criteria

• 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)
• ECOG performance status 0-2
• 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
• 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
• 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
• Patient affiliated to or a beneficiary of the local social security system, health service or other local regulatory requirements

Exclusion criteria

• 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
• Previous radiation therapy to the chest region
• Patients having arm swelling requiring arm sleeve prescription at baseline
• 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
• Pregnant or breastfeeding women
• Patient already included in another therapeutic study involving radiotherapy dose/regimen/technique and/or arm lymphedema risk
• Person deprived of their liberty or under protective custody or guardianship
• Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

France · 26 centers

• Centre Marie Curie — Arras
• Centre Pierre Curie — Beuvry
• Clinique Tivoli Ducos — Bordeaux
• Centre François Baclesse — Caen
• ROC 37 — Chambray-lès-Tours
• Centre Jean Perrin — Clermont-Ferrand
• CHI Créteil — Créteil
• Centre Léonard de Vinci — Dechy
• … and 18 more centers

Netherlands · 1 center

• Maastro — Maastricht

Identifiers

NCT: NCT07187726 · UC-RAD-2407

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗