Clinical trial NCT04342546: Predictive Toxicity Test Linked to Radiotherapy After Mastectomy and Immediate Implant Reconstruction
Official title: Prospective Evaluation of a Predictive Toxicity Test Post Radiotherapy After Mastectomy With Immediate Implant Reconstruction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Capsular Contracture Associated With Breast Implant
Lead sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
Sponsor class: OTHER
First posted: 2020-04-13
Enrollment: 250
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: For all the 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.
Primary purpose: OTHER

Brief 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.

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.

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

Primary outcomes:
measure: Ability of a radiosensitivity test to predict capsular contracture
timeFrame: 12 months after the end of radiotherapy
Secondary outcomes:
measure: Capsular contracture prevalence
timeFrame: 12 Months
measure: Accuracy of the dichotomized test based on the optimal threshold
timeFrame: 12 months
measure: Precision of the radiosensitivity predictive test
timeFrame: 12 months
measure: Biological prognostics factors for capsular contracture occurence
timeFrame: 12 months
measure: Tumoral prognostics factors for capsular contracture occurence
timeFrame: 12 months
measure: Success of each surgical strategy in terms of deposit
timeFrame: 24 months
measure: Cosmetic outcomes measure
timeFrame: 6, 12, 18 and 24 months
measure: Functional outcomes measure
timeFrame: 6, 12, 18 and 24 months
measure: Patient satisfaction measure
timeFrame: 6, 12, 18 and 24 months
measure: General quality of life measure
timeFrame: 6, 12, 18 and 24 months
measure: Specific quality of life measure for breast cancer patient
timeFrame: 6, 12, 18 and 24 months
measure: Stability of the test after chemotherapy
timeFrame: 12 months
Other outcomes:
Locations:
city: Dijon
country: France
facility: Centre Georges François Leclerc
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lyon
country: France
facility: Centre Léon Bérard
city: Marseille
country: France
facility: Institut Paoli Calmette
city: Montpellier
country: France
facility: Institut du Cancer de Montpellier
city: Nice
country: France
facility: centre Antoine Lacassagne
city: Paris
country: France
facility: Hôpital Tenon
city: Saint-Herblain
country: France
facility: Institut de Cancérologie de l'Ouest
city: Toulouse
country: France
facility: Institut Claudius Regaud
Study officials:
affiliation: Institut du Cancer de Montpellier - Val d'Aurelle
name: Marian Gutowski
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.