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

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

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.

Conditions2

Browse More Trials