Predictive Toxicity Test Linked to Radiotherapy After Mastectomy and Immediate Implant Reconstruction

Study Overview
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Brief Summary
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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.

Detailed Description
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Immediate reconstruction after mastectomy may help women with breast cancer to deal with their fear of mastectomy, spare them one or more second surgery and additional hospital stays in case of late breast reconstruction. However, in France, most patients with invasive breast carcinoma and treated with mastectomy are not offered immediate reconstruction. One reason is the need for postoperative radiotherapy for most patients (40 to 70% according to the centers). Indeed, radiotherapy induces side-effects which can alter the cosmetic result of the breast reconstruction as well as the patient's quality of life. Since 1995, a significant correlation is observed between the RILA test (measurement by flux cytometry of the lymphocyte T-CD8 apoptosis induced by radiotherapy) and the risk of occurrence of severe radio-induced breast fibrosis. Such accurate personalized medical care could allow identifying before any treatment high risk of toxicity patients and thus help establishing the therapeutic strategy. Identification of low-risk patients could also allow limiting autologous samplings and thus their associated morbidity.

Official Title
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Prospective Evaluation of a Predictive Toxicity Test Post Radiotherapy After Mastectomy With Immediate Implant Reconstruction

Conditions
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Breast Cancer, Capsular Contracture Associated With Breast Implant

Intervention / Treatment
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* Device: NovaGray RILA Breast® test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Performance Status 0-1 Consent signed before any study procedure Patient geographically accessible for follow-up Affiliated to the French national social security system Exclusion Criteria: Breast reconstruction with flap Inflammatory breast cancer (cT4d) Skin or parietal breast cancer (cT4 a, b or c) Metastatic patients Patients with bilateral breast cancer History of homolateral breast cancer treated with radiotherapy History of contralateral breast cancer Pregnant or breastfeeding women Legal incapacity or physical, psychological or mental status interfering with the patient's ability to sign the informed consent Participation in an interventional clinical study or planned participation during study up to 12 months post-radiotherapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: For all the patients, the NovaGray RILA Breast® 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Toxicity test<br>For all patients, the NovaGray RILA Breast® 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 in the case of neoadjuvant chemotherapy, between day -30 and until the first day of chemotherapy (before any injection) and in the case of adjuvant chemotherapy, between day -30 and until the first day of chemotherapy (before any injection). The test consists of a blood sample of 2x4 mL | Device: NovaGray RILA Breast® test<br>* The 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 months after the end of radiotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Capsular contracture prevalence | Rate of capsular contracture after radiotherapy | 12 Months | 
| 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 | 12 months | 
| Precision of the radiosensitivity predictive test | Using the time dependant AUC (AUCt) method | 12 months | 
| Biological prognostics factors for capsular contracture occurence | Number and type of different biological prognostic factors of capsular contracture occurence | 12 months | 
| Tumoral prognostics factors for capsular contracture occurence | Number and type of different tumoral prognostic factors of capsular contracture occurence | 12 months | 
| Success of each surgical strategy in terms of deposit | Number of deposit according to each reconstruction surgery (one or two step) | 24 months | 
| Cosmetic outcomes measure | Cosmetic questionnaire : BREAST-Q | 6, 12, 18 and 24 months | 
| Functional outcomes measure | Functional questionnaire: BREAST-Q | 6, 12, 18 and 24 months | 
| Patient satisfaction measure | Patient satisfaction questionnaire: BREAST-Q | 6, 12, 18 and 24 months | 
| General quality of life measure | Quality of life questionnaire: QLQ-C30 | 6, 12, 18 and 24 months | 
| Specific quality of life measure for breast cancer patient | Quality of life questionnaire for breast cancer patient: QLQ-BR23 | 6, 12, 18 and 24 months | 
| Stability of the test after chemotherapy | Test score at 12 months after the end of radiotherapy | 12 months |