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

  • STATUS
    Recruiting
  • End date
    Jun 5, 2027
  • participants needed
    250
  • sponsor
    Institut du Cancer de Montpellier - Val d'Aurelle
Updated on 5 July 2022
mastectomy
adjuvant chemotherapy
breast reconstruction

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.

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.

Details
Condition Breast Cancer, Capsular Contracture Associated With Breast Implant
Treatment NovaGray RILA Breast® test
Clinical Study IdentifierNCT04342546
SponsorInstitut du Cancer de Montpellier - Val d'Aurelle
Last Modified on5 July 2022

Eligibility

Yes No Not Sure

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 or women of childbearing potential unwilling to employ adequate contraception
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
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