Status:
NOT_YET_RECRUITING
SAHARA-04 : Adaptive Radiotherapy in Hypersensitive Patients and High Locoregional Risk Breast Cancer With ETHOS Technology
Lead Sponsor:
Institut du Cancer de Montpellier - Val d'Aurelle
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
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 Can...
Detailed Description
1. Breast cancer (BC) patients with high risk of severe radio-induced side effects Severe but also moderate toxicities after curative-intent radiotherapy (RT), such as fibrosis, retraction or tela...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2029
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06053086
Start Date
March 6 2025
End Date
April 1 2029
Last Update
February 13 2025
Active Locations (1)
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1
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, France, 34298