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

NCT04342546 | Recruiting

• 2 other identifiers: PROICM 2019-07 PRE2019-A02178-49
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 9

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.

Conditions

Breast Cancer; Capsular Contracture Associated With Breast Implant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Capsular contracture prevalence

  12 Months

• Accuracy of the dichotomized test based on the optimal threshold

  12 months

• Precision of the radiosensitivity predictive test

  12 months

• Biological prognostics factors for capsular contracture occurence

  12 months

• Tumoral prognostics factors for capsular contracture occurence

  12 months

Study Arms (1)

Toxicity test

EXPERIMENTAL

For all 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 and in the case of neoadjuvant chemotherapy, between day -30 and until the first day of chemotherapy (before any injection) and in the case of adjuvant chemotherapy, between day -30 and until the first day of chemotherapy (before any injection). The test consists of a blood sample of 2x4 mL

Device: NovaGray RILA Breast® test

Interventions

NovaGray RILA Breast® test DEVICE

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.

Toxicity test

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Patients with breast cancer treated by mastectomy with immediate implant breast reconstruction
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (9)

Centre Georges François Leclerc

Dijon, 21079, France

RECRUITING

Centre Oscar Lambret

Lille, 59000, France

RECRUITING

Centre Léon Bérard

Lyon, 69373, France

RECRUITING

Institut Paoli Calmette

Marseille, 13009, France

RECRUITING

Institut du Cancer de Montpellier

Montpellier, 34298, France

RECRUITING

centre Antoine Lacassagne

Nice, 06189, France

RECRUITING

Hôpital Tenon

Paris, 75970, France

RECRUITING

Institut de Cancérologie de l'Ouest

Saint-Herblain, 44805, France

RECRUITING

Institut Claudius Regaud

Toulouse, 31059, France

RECRUITING

Related Publications (6)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Marian Gutowski

  Institut du Cancer de Montpellier - Val d'Aurelle

  STUDY CHAIR

Central Study Contacts

Aurore MOUSSION

CONTACT

04 67 61 31 02; DRCI-icm105@icm.unicancer.fr

Emmanuelle TEXIER

CONTACT

04 67 61 31 02; DRCI-icm105@icm.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 25, 2020
• First Posted: April 13, 2020
• Study Start: December 11, 2020
• Primary Completion (Estimated): December 10, 2029
• Study Completion (Estimated): December 10, 2031
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (9)