SAHARA-04 : Adaptive Radiotherapy in Hypersensitive Patients and High Locoregional Risk Breast Cancer With ETHOS Technology

Inclusion criteria

• Women ≥ 18 years old.
• Conservative breast cancer surgery or radical mastectomy.
• At least pN1 breast cancers, regardless breast cancer subtypes.
• Tumor negative margins.
• Indication of whole breast and node irradiation.
• Extension evaluation of disease will be proven negative (M0).
• Risk level of breast fibrosis identified by the centralized NovaGray RILA Breast® test
• Must be geographically accessible for follow-up.
• Written and dated informed consent.
• Affiliated to the French national social security system.

Exclusion criteria

• Patients with distant metastases.
• Bilateral breast cancer (concomitant or prior) except in situ lesion, either ductal or lobular, of the contralateral breast.
• Patients with previous or concomitant other (not breast cancer) malignancy within the past 5 years EXCEPT adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix. Patients who have had a previous other malignancy must have been disease free for at least five years.
• Patients with other non-malignant systemic diseases (cardiovascular, renal, hepatic, lung embolism, etc.) which would prevent prolonged follow-up.
• Patients treated with systemic investigational drugs within the past 30 days (Observational cohorts are accepted if the collection of data does not interfere with the current trial)
• Untreated hypothyroidism
• Patients known to be HIV positive (no specific tests are required to determine the eligibility).
• Patients known as hypersensitive to radiation (ATM Homozygote, p53-/-,…)
• Pregnant or breast-feeding women
• Patient unable to comply with study obligations for geographic, social, or physical reasons, or who is unable to understand the purpose and procedures of the study
• Person deprived of their liberty or under protective custody or guardianship.