PRETORIA: Predictive Toxicity Test Linked to Radiotherapy After Mastectomy and Immediate Implant Reconstruction
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Toxicity test 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
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.
|
Outcome Measures
Primary Outcome Measures
- Ability of a radiosensitivity test to predict capsular contracture [12 months after the end of radiotherapy]
To identify the Area Under the Curve (AUC) of the radiosensitive predictive test of Grade 3-4 capsular contracture
Secondary Outcome Measures
- Capsular contracture prevalence [12 Months]
Rate of capsular contracture after radiotherapy
- Accuracy of the dichotomized test based on the optimal threshold [12 months]
Accuracy of the test assessed by Sensitivity, Specificity, Positive Predictive Value and Negative Predictive Value
- Precision of the radiosensitivity predictive test [12 months]
Using the time dependant AUC (AUCt) method
- Biological prognostics factors for capsular contracture occurence [12 months]
Number and type of different biological prognostic factors of capsular contracture occurence
- Tumoral prognostics factors for capsular contracture occurence [12 months]
Number and type of different tumoral prognostic factors of capsular contracture occurence
- Success of each surgical strategy in terms of deposit [24 months]
Number of deposit according to each reconstruction surgery (one or two step)
- Cosmetic outcomes measure [6, 12, 18 and 24 months]
Cosmetic questionnaire : BREAST-Q
- Functional outcomes measure [6, 12, 18 and 24 months]
Functional questionnaire: BREAST-Q
- Patient satisfaction measure [6, 12, 18 and 24 months]
Patient satisfaction questionnaire: BREAST-Q
- General quality of life measure [6, 12, 18 and 24 months]
Quality of life questionnaire: QLQ-C30
- Specific quality of life measure for breast cancer patient [6, 12, 18 and 24 months]
Quality of life questionnaire for breast cancer patient: QLQ-BR23
- Stability of the test after chemotherapy [12 months]
Test score at 12 months after the end of radiotherapy
Eligibility Criteria
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
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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
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Consent signed before any study procedure
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Patient geographically accessible for follow-up
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Affiliated to the French national social security system
Exclusion Criteria:
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Breast reconstruction with flap
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Inflammatory breast cancer (cT4d)
-
Skin or parietal breast cancer (cT4 a, b or c)
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Metastatic patients
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Patients with bilateral breast cancer
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History of homolateral breast cancer treated with radiotherapy
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History of contralateral breast cancer
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Pregnant or breastfeeding women or women of childbearing potential unwilling to employ adequate contraception
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Legal incapacity or physical, psychological or mental status interfering with the patient's ability to sign the informed consent
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Participation in an interventional clinical study or planned participation during study up to 12 months post-radiotherapy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre Oscar Lambret | Lille | France | 59000 | |
| 2 | Centre Léon Bérard | Lyon | France | 69373 | |
| 3 | Institut Paoli Calmette | Marseille | France | 13009 | |
| 4 | Institut du Cancer de Montpellier | Montpellier | France | 34298 | |
| 5 | centre Antoine Lacassagne | Nice | France | 06189 | |
| 6 | Hôpital Tenon | Paris | France | 75970 | |
| 7 | Institut de Cancérologie de l'Ouest | Saint-Herblain | France | 44805 | |
| 8 | Institut Claudius Regaud | Toulouse | France | 31059 |
Sponsors and Collaborators
- Institut du Cancer de Montpellier - Val d'Aurelle
Investigators
- Study Chair: Marian Gutowski, Institut du Cancer de Montpellier
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- Nègre 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.
- 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.
- 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. Review.
- PROICM 2019-07 PRE
- 2019-A02178-49