Adaptive ETHOS radiotherapy for hypersensitive, high locoregional‑risk breast cancer patients
Adaptive Radiotherapy in Hypersensitive Patients and High Locoregional Risk Breast Cancer With ETHOS Technology
This trial will test whether adaptive ETHOS radiotherapy can reduce severe radiation side effects in breast cancer patients identified as radiosensitive and at high locoregional recurrence risk.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Institut du Cancer de Montpellier - Val d'Aurelle Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Montpellier) |
| Trial ID | NCT06053086 on ClinicalTrials.gov |
What this trial studies
This is a prospective, open‑label, bi‑center study enrolling 500 breast cancer patients at two French ETHOS centers. Patients are stratified using the centralized NovaGray RILA Breast® assay to identify individual risk of radiation‑induced fibrosis; a small cohort (~46 evaluable patients) will receive adaptive ETHOS radiotherapy while the remaining patients receive conventional IMRT. The trial will follow patients for clinical outcomes, late toxicity and quality of life to compare rates of severe side effects between approaches. Eligibility requires whole‑breast and nodal irradiation after breast‑conserving surgery or mastectomy and no distant metastases.
Who should consider this trial
Good fit: Women aged 18 or older with node‑positive, non‑metastatic breast cancer who need whole‑breast and nodal irradiation, have negative surgical margins, can attend follow‑up, and are covered by the French social security system with radiosensitivity classified by the NovaGray RILA Breast® test are ideal candidates.
Not a fit: Patients with distant metastases, bilateral invasive breast cancer, recent other malignancies, or those who test as low‑risk on the RILA assay are unlikely to receive benefit from the adaptive ETHOS approach in this protocol.
Why it matters
Potential benefit: If successful, this approach could lower rates of severe late radiotherapy toxicity and improve quality of life for radiosensitive breast cancer patients.
How similar studies have performed: RILA assays have shown strong negative predictive value for low late toxicity in prior breast cancer cohorts, but applying ETHOS adaptive radiotherapy specifically to RILA‑identified hypersensitive patients is a novel approach with limited prior outcome data.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Montpellier
- Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle — Montpellier, France (Recruiting)
Study contacts
- Principal investigator: Bourgier Celine — Institut du Cancer de Montpellier - Val d'Aurelle
- Study coordinator: Moussion Aurore
- Email: aurore.moussion@icm.unicancer.fr
- Phone: 0467613102
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.