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

Breast Cancer Clinical Trial

— PRETORIA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04342546
• Other study ID #: PROICM 2019-07 PRE
• Secondary ID: 2019-A02178-49
• Status: Recruiting
• Phase: N/A
• Start date: December 11, 2020
• Est. completion date: June 2027

Study information

• Verified date: October 2023
• Source: Institut du Cancer de Montpellier - Val d'Aurelle
• Contact: Aurore MOUSSION
• Phone: 04 67 61 31 02
• Email: DRCI-icm105[@]icm.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: June 2027
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Capsular Contracture Associated With Breast Implant
• Contracture

Intervention

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.

Locations

Country	Name	City	State
France	Centre Georges François Leclerc	Dijon
France	Centre Oscar Lambret	Lille
France	Centre Léon Bérard	Lyon
France	Institut Paoli Calmette	Marseille
France	Institut du Cancer de Montpellier	Montpellier
France	centre Antoine Lacassagne	Nice
France	Hôpital Tenon	Paris
France	Institut de Cancérologie de l'Ouest	Saint-Herblain
France	Institut Claudius Regaud	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Institut du Cancer de Montpellier - Val d'Aurelle

Country where clinical trial is conducted

France, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ability of a radiosensitivity test to predict capsular contracture	To identify the Area Under the Curve (AUC) of the radiosensitive predictive test of Grade 3-4 capsular contracture	12 months after the end of radiotherapy
Secondary	Capsular contracture prevalence	Rate of capsular contracture after radiotherapy	12 Months
Secondary	Accuracy of the dichotomized test based on the optimal threshold	Accuracy of the test assessed by Sensitivity, Specificity, Positive Predictive Value and Negative Predictive Value	12 months
Secondary	Precision of the radiosensitivity predictive test	Using the time dependant AUC (AUCt) method	12 months
Secondary	Biological prognostics factors for capsular contracture occurence	Number and type of different biological prognostic factors of capsular contracture occurence	12 months
Secondary	Tumoral prognostics factors for capsular contracture occurence	Number and type of different tumoral prognostic factors of capsular contracture occurence	12 months
Secondary	Success of each surgical strategy in terms of deposit	Number of deposit according to each reconstruction surgery (one or two step)	24 months
Secondary	Cosmetic outcomes measure	Cosmetic questionnaire : BREAST-Q	6, 12, 18 and 24 months
Secondary	Functional outcomes measure	Functional questionnaire: BREAST-Q	6, 12, 18 and 24 months
Secondary	Patient satisfaction measure	Patient satisfaction questionnaire: BREAST-Q	6, 12, 18 and 24 months
Secondary	General quality of life measure	Quality of life questionnaire: QLQ-C30	6, 12, 18 and 24 months
Secondary	Specific quality of life measure for breast cancer patient	Quality of life questionnaire for breast cancer patient: QLQ-BR23	6, 12, 18 and 24 months
Secondary	Stability of the test after chemotherapy	Test score at 12 months after the end of radiotherapy	12 months