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Adaptive Radiotherapy in Hypersensitive Patients and High Locoregional Risk Breast Cancer With ETHOS Technology

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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 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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
RECRUITING
Montpellier
Contact Information
Primary
MOUSSION AURORE
aurore.moussion@icm.unicancer.fr
0467613102
Time Frame
Start Date: 2025-03-01
Estimated Completion Date: 2030-11-30
Participants
Target number of participants: 500
Treatments
Experimental: Cohort A : Experimental group
In cohort A, for patients with high and undetermined risk of fibrosis (bf+), an adaptive BC RT (ETHOS) will be delivered.
Active_comparator: Cohort B : Control group
In cohort B, for patients with low risk of fibrosis (bf-), an IMRT will be delivered.
Related Therapeutic Areas
Sponsors
Leads: Institut du Cancer de Montpellier - Val d'Aurelle

This content was sourced from clinicaltrials.gov