Adaptive ETHOS radiotherapy for hypersensitive, high locoregional‑risk breast cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.