Personalization of Breast Radiotherapy According to Loco-regional Recurrence Risk and Toxicity Probability

NCT06382818 · tracked via the Priya Life Science France tracker

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Phase

Not applicable

Started

2025-03-06

Last updated

2026-03-12

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

COHORT ACOHORT BCOHORT CCOHORT D

COHORT A: IMRT radiotherapy on whole breast according to the investigator's decision among: * Moderate whole breast hypofractionated RT according to the START B schema with Fixed Field IMRT Technique: 40.05 Gy in 15 daily fractions over 3 weeks and a Sequential boost (+ 16 Gy/8 fr) or (+13.5/5 fr) if applicable. * Extreme whole breast hypofractionated RT according to : * The FAST schema: Once-a-week ultra-HypoRT with Fixed Field IMRT Technique, 28.5 Gy in 5 fractions in 5 weeks * The FAST-Forward schema: Very accelerated course of HypoRT with Fixed Field IMRT Technique, 26 Gy in 5 fractions in 5 consecutive days

COHORT B: Breast radiotherapy according to the investigator's decision among: * External partial VMAT: 40 Gy in 15 fractions to the partial breast only (tumorectomy bed). * Exclusive Brachytherapy: 30.1 Gy in 7 fractions or 32.0 Gy in 8 fractions of high-dose-rate brachytherapy in 5 days or as 50 Gy of pulsed-dose-rate brachytherapy over 5 treatment days. * Whole Breast Normo fractionated IMRT with Fixed Field IMRT Technique: 50 Gy in 25 daily fractions over 5 weeks +/- Sequential (+ 16 Gy/8fr) or SIB (60 Gy/25 fr) treatment for boost if applicable.

COHORT C: Whole breast and nodes Hypofractionated VMAT and a localized simultaneous boost according to the HypoG01 schema protocol: VMAT Technique, 42.3 Gy in 18 fractions on all target volume on 3.5 weeks +/- SIB boost if need (52.2Gy in 18 fractions).

COHORT D: Breast radiotherapy based on available clinical trials: \- Whole Breast and Nodes Hypofractionated VMAT with adaptive treatment (margin reduction): HypoG01 Schema with VMAT Technique, 42.3 Gy in 18 fractions on all target volume over 3.5 weeks +/- SIB boost if need (52.2Gy in 18 fr) In case of patient refusal or technique unavailable, a standard treatment available in the center for this indication will be delivered.

Study summary

Our objective is based on a personalized approach of adjuvant breast radiotherapy by selecting patients according to tumor recurrence and toxicity risk.

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: General criteria (for all cohorts): 1. Women ≥ 18 years old. 2. Invasive breast cancer treated by conservative or radical surgery. 3. Conservative breast cancer surgery or radical mastectomy. 4. Indication of breast irradiation. 5. Extension evaluation of disease will be proven negative (M0). 6. Negative pregnancy test (blood or urine at the choice of investigator), to be carried out within 7 days of registration, for women of childbearing age only. 7. Effective contraception for women of childbearing age 8. Must be geographically accessible for follow-up. 9. Written and dated informed consent. 10. Affiliated to the French national social security system. Cohort A and B: \- Low risk of recurrence (all of the criteria) • pT1-T2 * SBR (Scarff Bloom et Richardson grade) grade ≤ 2 (low grade) * ER+ and / or PR+ (hormone-receptor positive) * cN0/pN- * HER 2 - * Ki67 ≤10% pN- with T3-4 and grade 3 and internal tumor will be considered at high risk of recurrence and will be proposed node irradiation (and will be switched to COHORT C or D). Cohort C and D: \- High risk of recurrence (pN+ and at least one of all) adapted from the UK PREDICT • ER- and PR- • HER2 amplified • pT3-4 • SBR grade ≥ 3 * KI67 \> 10% Cohort A and C: * Low risk of breast toxicities identified by the NovaGray RILA Breast® test Cohort B and D: \- High risk of breast toxicities identified by the NovaGray RILA Breast® test Exclusion Criteria: * 1\. Patients with distant metastases. 2\. Patients with breast DCIS (ductal carcinoma in situ) 3. Concomitant bilateral breast cancer 4. Previous breast radiotherapy 5. 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. 6\. Patients with other non-malignant systemic diseases (cardiovascular, renal, hepatic, lung embolism, etc.) which would prevent prolonged follow-up. 7\. Patients known to be HIV positive (no specific tests are required to determine the eligibility). 8\. Patients known as hypersensitive to radiation 9. Patients treated with systemic investigational drugs during the present study (Observational cohorts are accepted if the collection of data does not interfere with the current trial) 10. Pregnant or breast-feeding women 11. 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 12. Person deprived of their liberty or under protective custody or guardianship

Primary outcome measure(s)

Rate of patients without any grade 2 or more fibrosis, nor radio-induced sarcoma — at 10 years
Toxicity free survival is defined as the interval between date of inclusion and the occurrence of fibrosis grade 2 or more or radio-induced sarcoma. Patients without event at the analysis will be censored at the date of last follow-up.

Trial sites (1)

Facility	City	Region	Status
Institut Du Cancer de Montpellier	Montpellier	France	Recruiting

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Official registry record

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.

View NCT06382818 on ClinicalTrials.gov ↗ ← All trials in France