PRETORIA

To assess the ability of a radiosensitivity test (NovaGray RILA Breast« test) to predict radiotherapy-induced toxicity (capsular contracture) in breast cancer patients treated by mastectomy with immediate implant breast reconstruction and adjuvant radiotherapy.;To assess the capsular contracture prevalence after radiotherapy on breast implant;- To assess the accuracy of the dichotomized test based on the optimal threshold (Younden Index);- To assess the precision of the radiosensitivity predictive test (NovaGray RILA Breast« test) using the time dependent AUC (AUCt) method;- To identify the biological and tumoral prognostic factors;- To assess the reconstruction surgical strategies in one or two steps in terms of radiation toxicity and efficacy;- To assess the cosmetic outcomes;- To assess the functional outcomes and patient satisfaction;- To assess quality of life;- To assess the impact of chemotherapy on the stability of the NovaGray RILA Breast« test;- To identify the clinical and biological parameters to improve the NovaGray RILA Breast« test performance;- To set-up, test and validate a new production technique for the RILA test;PRETORIAÀ Version n¦5.0 du 05/04/2024 Page 8 on 83;RÚf interne ICM : ICM-ENR-432 Version : 001 Date dÀapplication : 24/05/2017;Study endpoints;Primary endpoint:;The primary endpoint is to identify the Area Under the Curve (AUC) of the radiosensitivity predictive test (NovaGray RILA Breast« test) of Grade 3-4 capsular contracture at 12 months after the end of radiotherapy on breast implant.