Our objective is based on a personalized approach of adjuvant breast radiotherapy by selecting patients according to tumor recurrence and toxicity risk.
Women ≥ 18 years old.
Invasive breast cancer treated by conservative or radical surgery.
Conservative breast cancer surgery or radical mastectomy.
Indication of breast irradiation.
1. Patients with distant metastases.
Parallel
COHORT A
RadiationIMRT 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
RadiationBreast 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
RadiationWhole 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
RadiationBreast 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.
Rate of patients without any grade 2 or more fibrosis, nor radio-induced sarcoma
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.
Acute toxicity
according to NCI-CTCAE v5 is defined as side effects observed
Late toxicity
according to NCI-CTCAE v5 is defined as side effects observed
Local recurrence rate (LRR)
LRR will be deducted from the local recurrence survival defined as the interval between date of inclusion and the occurrence of local relapse. Patients without local relapse at the analysis will be censored at the date of last follow-up
Relapse-free survival (RFS) rate
RFS is defined as the interval between date of inclusion and the occurrence of relapse. Patients without relapse at the analysis will be censored at the date of last follow-up
Click on the lead sponsor to view all of their trials.
