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

NCT06053086 | Recruiting DMC

• 1 other identifier: PROICM 2023-01 SAH
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Breast Cancer

Keywords

radiotherapy; breast cancer; cancer; ETHOS

Outcome Measures

Primary Outcomes (1)

• Rate of patients without any grade 2 and more toxicities within the planning target volume

  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.

  at 3 years

Secondary Outcomes (8)

• rate of Acute & late toxicity

  From the start of RT to 12 weeks post RT and from 12 weeks post RT to 3 years post RT

• Quality of life by using QLQ-C30 (and BR 23 module) questionnaire score

  at 0/3/6/12/18/24/30/36 months post RT

• Quality of life by using GPAQ questionnaire score

  at 0/3/6/12/18/24/30/36 months post RT

• Quality of life by using MFI questionnaire score

  at 0/3/6/12/18/24/30/36 months post RT

• Local recurrence rate (LRR)

  at 3 years

Study Arms (2)

Cohort A : Experimental group

EXPERIMENTAL

In cohort A, for patients with high and undetermined risk of fibrosis (bf+), an adaptive BC RT (ETHOS) will be delivered.

Radiation: Treatment ETHOS radiotherapy

Cohort B : Control group

ACTIVE COMPARATOR

In cohort B, for patients with low risk of fibrosis (bf-), an IMRT will be delivered.

Radiation: Conventional IMRT

Interventions

Treatment ETHOS radiotherapy RADIATION

• Cohort A: Adaptive RT: PTV = CTV + 2 mm (except for IMC with 5mm), excluding 5mm beneath the skin

Cohort A : Experimental group

Conventional IMRT RADIATION

• Cohort B: IMRT: PTV = CTV + 7mm, excluding 5mm beneath the skin

Cohort B : Control group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Breast cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (1)

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

Montpellier, 34298, France

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• BOURGIER CELINE

  Institut du Cancer de Montpellier - Val d'Aurelle

  PRINCIPAL INVESTIGATOR

• ARNAUD ANTOINE

  INSTITUT SAINTE CATHERINE / AVIGNON

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MOUSSION AURORE

CONTACT

0467613102; aurore.moussion@icm.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: * COHORT 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

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: September 25, 2023
• Study Start: March 1, 2025
• Primary Completion (Estimated): November 30, 2030
• Study Completion (Estimated): November 30, 2030
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)