This study evaluates the capacity of the NovaGray RILA Breast® test to predict the toxicity linked to radiotherapy and the impact of implant breast reconstruction.
Age ≥18 years
Patients with histologically confirmed breast cancer with indication of mastectomy or surgery with mastectomy performed
Indication of wall chest radiation after mastectomy
Patient's agreement to receive or having had an immediate breast reconstruction by implant in one or two steps, with or without a dermal or synthetic matrix (depending on the habits of the center)
Breast reconstruction with flap
Inflammatory breast cancer (cT4d)
Skin or parietal breast cancer (cT4 a, b or c)
Metastatic patients
Single group
NovaGray RILA Breast® test
DeviceThe test consists of a blood sample of 2x4 mL. This test will be performed between day -30 and until the first day of radiotherapy (before the start of this one) and then 12 months after the end of radiotherapy and between day -30 and until the first day of chemotherapy (before any injection) in the case of neoadjuvant chemotherapy and between day -30 and until the first day of chemotherapy (before any injection) in the case of adjuvant chemotherapy.
Ability of a radiosensitivity test to predict capsular contracture
To identify the Area Under the Curve (AUC) of the radiosensitive predictive test of Grade 3-4 capsular contracture
Capsular contracture prevalence
Rate of capsular contracture after radiotherapy
Accuracy of the dichotomized test based on the optimal threshold
Accuracy of the test assessed by Sensitivity, Specificity, Positive Predictive Value and Negative Predictive Value
Precision of the radiosensitivity predictive test
Using the time dependant AUC (AUCt) method
Biological prognostics factors for capsular contracture occurence
Number and type of different biological prognostic factors of capsular contracture occurence
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