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Recruiting NCT04342546

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

No phase Interventional Breast Cancer Capsular Contracture Associated With Breast Implant

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: NovaGray RILA Breast® test.
Who it may be relevant to
Registry conditions: Breast Cancer, Capsular Contracture Associated With Breast Implant. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

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.

Interventions

  • Device NovaGray 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.

Primary outcome measures

  • Ability of a radiosensitivity test to predict capsular contracture [Time frame: 12 months after the end of radiotherapy]
Secondary outcome measures (12)
  • Capsular contracture prevalence [Time frame: 12 Months]
  • Accuracy of the dichotomized test based on the optimal threshold [Time frame: 12 months]
  • Precision of the radiosensitivity predictive test [Time frame: 12 months]
  • Biological prognostics factors for capsular contracture occurence [Time frame: 12 months]
  • Tumoral prognostics factors for capsular contracture occurence [Time frame: 12 months]
  • Success of each surgical strategy in terms of deposit [Time frame: 24 months]
  • Cosmetic outcomes measure [Time frame: 6, 12, 18 and 24 months]
  • Functional outcomes measure [Time frame: 6, 12, 18 and 24 months]
  • Patient satisfaction measure [Time frame: 6, 12, 18 and 24 months]
  • General quality of life measure [Time frame: 6, 12, 18 and 24 months]
  • Specific quality of life measure for breast cancer patient [Time frame: 6, 12, 18 and 24 months]
  • Stability of the test after chemotherapy [Time frame: 12 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

France · 9 centers
  • Centre Georges François Leclerc — Dijon
  • Centre Oscar Lambret — Lille
  • Centre Léon Bérard — Lyon
  • Institut Paoli Calmette — Marseille
  • Institut du Cancer de Montpellier — Montpellier
  • centre Antoine Lacassagne — Nice
  • Hôpital Tenon — Paris
  • Institut de Cancérologie de l'Ouest — Saint-Herblain
  • … and 1 more center

Publications

  • Negre G, Balcaen T, Dast S, Sinna R, Chazard E. Breast reconstruction in France, observational study of 140,904 cases of mastectomy for breast cancer. Ann Chir Plast Esthet. 2020 Feb;65(1):36-43. doi: 10.1016/j.anplas.2019.07.014. Epub 2019 Aug 2. PMID 31383624
  • Ng SK, Hare RM, Kuang RJ, Smith KM, Brown BJ, Hunter-Smith DJ. Breast Reconstruction Post Mastectomy: Patient Satisfaction and Decision Making. Ann Plast Surg. 2016 Jun;76(6):640-4. doi: 10.1097/SAP.0000000000000242. PMID 25003439
  • Howes BH, Watson DI, Xu C, Fosh B, Canepa M, Dean NR. Quality of life following total mastectomy with and without reconstruction versus breast-conserving surgery for breast cancer: A case-controlled cohort study. J Plast Reconstr Aesthet Surg. 2016 Sep;69(9):1184-91. doi: 10.1016/j.bjps.2016.06.004. Epub 2016 Jun 18. PMID 27406255
  • Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005 May 14-20;365(9472):1687-717. doi: 10.1016/S0140-6736(05)66544-0. PMID 15894097
  • Ricci JA, Epstein S, Momoh AO, Lin SJ, Singhal D, Lee BT. A meta-analysis of implant-based breast reconstruction and timing of adjuvant radiation therapy. J Surg Res. 2017 Oct;218:108-116. doi: 10.1016/j.jss.2017.05.072. Epub 2017 Jun 15. PMID 28985836
  • Barry M, Kell MR. Radiotherapy and breast reconstruction: a meta-analysis. Breast Cancer Res Treat. 2011 May;127(1):15-22. doi: 10.1007/s10549-011-1401-x. Epub 2011 Feb 20. PMID 21336948

Identifiers

NCT: NCT04342546 · PROICM 2019-07 PRE · 2019-A02178-49

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗