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Clinical Trials in France / NCT06053086
Recruiting Not applicable

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

NCT06053086 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2025-03-01
Last updated
2026-03-12

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

Treatment ETHOS radiotherapyConventional IMRT

Treatment ETHOS radiotherapy: • Cohort A: Adaptive RT: PTV = CTV + 2 mm (except for IMC with 5mm), excluding 5mm beneath the skin

Conventional IMRT: • Cohort B: IMRT: PTV = CTV + 7mm, excluding 5mm beneath the skin

Study 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
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle Montpellier France Recruiting

More Institut du Cancer de Montpellier - Val d'Aurelle trials in France

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06053086 on ClinicalTrials.gov ↗ ← All trials in France