* 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
Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Rate of patients without any grade 2 and more toxicities within the planning target volume — at 3 years A toxicity of grade 2 and more is defined as an observation of grade 2 and more, in case of late toxicities it should be at least confirmed by two consecutive visits.
Trial sites (1)
Facility
City
Region
Status
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier
France
Recruiting
More Institut du Cancer de Montpellier - Val d'Aurelle trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.