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

Last updated: November 4, 2024
Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
Overall Status: Active - Recruiting

Phase

N/A

Condition

Breast Cancer

Cancer

Treatment

NovaGray RILA Breast® test

Clinical Study ID

NCT04342546
PROICM 2019-07 PRE
2019-A02178-49
  • Ages > 18
  • Male

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Age ≥18 years

  • Patients with histologically confirmed breast cancer with indication of mastectomyor surgery with mastectomy performed

  • Indication of wall chest radiation after mastectomy

  • Patient's agreement to receive or having had an immediate breast reconstruction byimplant in one or two steps, with or without a dermal or synthetic matrix (dependingon 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

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 thepatient's ability to sign the informed consent

  • Participation in an interventional clinical study or planned participation duringstudy up to 12 months post-radiotherapy

Study Design

Total Participants: 250
Treatment Group(s): 1
Primary Treatment: NovaGray RILA Breast® test
Phase:
Study Start date:
December 11, 2020
Estimated Completion Date:
June 30, 2027

Study 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.

Connect with a study center

  • Centre Georges François Leclerc

    Dijon, 21079
    France

    Active - Recruiting

  • Centre Oscar Lambret

    Lille, 59000
    France

    Active - Recruiting

  • Centre Léon Bérard

    Lyon, 69373
    France

    Active - Recruiting

  • Institut Paoli Calmette

    Marseille, 13009
    France

    Active - Recruiting

  • Institut du Cancer de Montpellier

    Montpellier, 34298
    France

    Active - Recruiting

  • centre Antoine Lacassagne

    Nice, 06189
    France

    Active - Recruiting

  • Hôpital Tenon

    Paris, 75970
    France

    Active - Recruiting

  • Institut de Cancérologie de l'Ouest

    Saint-Herblain, 44805
    France

    Active - Recruiting

  • Institut Claudius Regaud

    Toulouse, 31059
    France

    Active - Recruiting

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