Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT06053086

SAHARA-04 : Adaptive Radiotherapy in Hypersensitive Patients and High Locoregional Risk Breast Cancer With ETHOS Technology

Led by Institut du Cancer de Montpellier - Val d'Aurelle · Updated on 2026-03-12

500

Participants Needed

1

Research Sites

300 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

* 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

Official Title

SAHARA-04 : Adaptive Radiotherapy in Hypersensitive Patients and High Locoregional Risk Breast Cancer With ETHOS Technology

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women 18 years old or older
  • Have undergone conservative breast cancer surgery or radical mastectomy
  • Diagnosed with breast cancer having at least one positive lymph node (pN1 or higher)
  • Tumor margins must be negative
  • Require whole breast and lymph node irradiation
  • No evidence of distant disease spread (M0)
  • Breast fibrosis risk determined by centralized NovaGray RILA Breast�AE test
  • Must be able to attend follow-up visits regularly
  • Provide written and dated informed consent
  • Affiliated with the French national social security system
Not Eligible

You will not qualify if you...

  • Presence of distant metastases
  • Bilateral breast cancer except for certain in situ lesions in the opposite breast
  • Other cancers within the past 5 years except treated skin basal/squamous cell carcinoma or cervical in situ carcinoma
  • Other serious systemic diseases preventing long-term follow-up
  • Treatment with systemic investigational drugs within the past 30 days
  • Untreated hypothyroidism
  • Known HIV positive status
  • Known hypersensitivity to radiation (e.g., ATM Homozygote, p53-/-)
  • Pregnant or breastfeeding
  • Unable to comply with study requirements or understand study purpose
  • Under legal guardianship or deprived of liberty

AI-Screening

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Trial Site Locations

Total: 1 location

1

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, France, 34298

Actively Recruiting

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Research Team

M

MOUSSION AURORE

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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