RecruitingNot ApplicableNCT06053086

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

Adaptive Radiotherapy in Hypersensitive Patients and High Locoregional Risk Breast Cancer With ETHOS Technology

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Enrollment

500 participants

Start Date

Mar 1, 2025

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

Summary

* Prospective, open-label, bi-center study, assessing the clinical outcomes of adaptive breast radiotherapy with ETHOS in hypersensitive patients. * Bi-centric with ETHOS center : ICM (Institut du Cancer de Montpellier) and ISC (Institut Sainte Catherine) Avignon * 500 patients will be included: * COHORTE A = Treatment ETHOS RT :46 evaluable patients with high risk of LRR and bf+ risk * COHORT B = Conventional IMRT : 454 others patients with high risk of LRR and bf- risk

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria10

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 Criteria11

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.