Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
* 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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional IMRT | Radiation | — | UNRESOLVED |
| Treatment ETHOS radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cohort A : Experimental group
- description
- In cohort A, for patients with high and undetermined risk of fibrosis (bf+), an adaptive BC RT (ETHOS) will be delivered.
- interventionNames
- Radiation: Treatment ETHOS radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- Cohort B : Control group
- description
- In cohort B, for patients with low risk of fibrosis (bf-), an IMRT will be delivered.
- interventionNames
- Radiation: Conventional IMRT
Primary outcomes (1)
- measure
- Rate of patients without any grade 2 and more toxicities within the planning target volume
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available