Actively Recruiting
Personalization of Breast Radiotherapy According to Loco-regional Recurrence Risk and Toxicity Probability
Led by Institut du Cancer de Montpellier - Val d'Aurelle · Updated on 2026-03-12
854
Participants Needed
1
Research Sites
678 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Our objective is based on a personalized approach of adjuvant breast radiotherapy by selecting patients according to tumor recurrence and toxicity risk.
CONDITIONS
Official Title
Personalization of Breast Radiotherapy According to Loco-regional Recurrence Risk and Toxicity Probability
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 years or older
- Diagnosed with invasive breast cancer treated by conservative or radical surgery
- Indication for breast irradiation
- Negative disease extension evaluation (no distant metastases)
- Negative pregnancy test within 7 days of registration for women of childbearing age
- Use of effective contraception if of childbearing potential
- Able to attend follow-up visits
- Affiliated with the French national social security system
- Provide written and dated informed consent
- For Cohorts A and B: low risk of recurrence defined by pT1-T2, low grade tumor (SBR ≤ 2), hormone receptor positive, node negative, HER2 negative, Ki67 ≤ 10%
- For Cohorts C and D: high risk of recurrence including at least one of ER and PR negative, HER2 amplified, pT3-4 tumor, high grade (SBR ≥ 3), or Ki67 > 10%
- For Cohorts A and C: low risk of breast toxicities per NovaGray RILA Breast® test
- For Cohorts B and D: high risk of breast toxicities per NovaGray RILA Breast® test
You will not qualify if you...
- Presence of distant metastases
- Diagnosis of ductal carcinoma in situ (DCIS) only
- Bilateral breast cancer occurring at the same time
- Previous breast radiotherapy
- Another malignancy within the past 5 years except treated skin basal or squamous cell carcinoma or in situ cervical carcinoma
- Non-malignant systemic diseases preventing long follow-up (e.g., cardiovascular, renal, hepatic conditions)
- Known HIV positive status
- Known hypersensitivity to radiation
- Use of systemic investigational drugs during the study (except observational cohorts not interfering with this trial)
- Pregnant or breastfeeding women
- Unable to comply with study requirements due to geographic, social, physical, or cognitive reasons
- Persons deprived of liberty or under protective custody or guardianship
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Institut Du Cancer de Montpellier
Montpellier, France
Actively Recruiting
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
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here