NCT06053086 SAHARA-04 : Adaptive Radiotherapy in Hypersensitive Patients and High Locoregional Risk Breast Cancer With ETHOS Technology
| NCT ID | NCT06053086 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institut du Cancer de Montpellier - Val d'Aurelle |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2025-03-01 |
| Primary Completion | 2030-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 500 participants in total. It began in 2025-03-01 with a primary completion date of 2030-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
BOURGIER CELINE
PRINCIPAL INVESTIGATOR
Institut du Cancer de Montpellier - Val d'Aurelle
Frequently Asked Questions
Who can join the NCT06053086 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06053086 currently recruiting?
Yes, NCT06053086 is actively recruiting participants. Contact the research team at aurore.moussion@icm.unicancer.fr for enrollment information.
Where is the NCT06053086 trial being conducted?
This trial is being conducted at Montpellier, France.
Who is sponsoring the NCT06053086 clinical trial?
NCT06053086 is sponsored by Institut du Cancer de Montpellier - Val d'Aurelle. The principal investigator is BOURGIER CELINE at Institut du Cancer de Montpellier - Val d'Aurelle. The trial plans to enroll 500 participants.
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