RecruitingNot ApplicableNCT04342546

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

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

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Enrollment

250 participants

Start Date

Dec 11, 2020

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Capsular Contracture Associated With Breast Implant

Summary

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.

Eligibility

Sex: MALEMin Age: 18 Years

Inclusion Criteria8

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 Criteria10

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

Interventions

DEVICENovaGray RILA Breast® test

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.