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

Institut du Cancer de Montpellier - Val d'Aurelle

Status: Enrolling

Conditions: Breast Cancer; Capsular Contracture Associated With Breast Implant

Treatments: Device: NovaGray RILA Breast® test

Study type: Interventional

Funder types: Other

Identifiers

NCT04342546

PROICM 2019-07 PRE

2019-A02178-49 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 250 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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250 participants in 1 patient group

Toxicity test

Experimental group

Description:

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

Treatment:

Device: NovaGray RILA Breast® test