Predictive Toxicity Test Linked to Radiotherapy After Mastectomy and Immediate Implant Reconstruction (PRETORIA)
Primary Purpose
Breast Cancer, Capsular Contracture Associated With Breast Implant
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
NovaGray RILA Breast® test
Sponsored by
About this trial
This is an interventional other trial for Breast Cancer
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 or women of childbearing potential unwilling to employ adequate contraception
- 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
Sites / Locations
- Centre Oscar LambretRecruiting
- Centre Léon BérardRecruiting
- Institut Paoli CalmetteRecruiting
- Institut du Cancer de MontpellierRecruiting
- centre Antoine LacassagneRecruiting
- Hôpital TenonRecruiting
- Institut de Cancérologie de l'OuestRecruiting
- Institut Claudius RegaudRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Toxicity test
Arm Description
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Capsular contracture prevalence
Rate of capsular contracture after radiotherapy
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
Precision of the radiosensitivity predictive test
Using the time dependant AUC (AUCt) method
Biological prognostics factors for capsular contracture occurence
Number and type of different biological prognostic factors of capsular contracture occurence
Tumoral prognostics factors for capsular contracture occurence
Number and type of different tumoral prognostic factors of capsular contracture occurence
Success of each surgical strategy in terms of deposit
Number of deposit according to each reconstruction surgery (one or two step)
Cosmetic outcomes measure
Cosmetic questionnaire : BREAST-Q
Functional outcomes measure
Functional questionnaire: BREAST-Q
Patient satisfaction measure
Patient satisfaction questionnaire: BREAST-Q
General quality of life measure
Quality of life questionnaire: QLQ-C30
Specific quality of life measure for breast cancer patient
Quality of life questionnaire for breast cancer patient: QLQ-BR23
Stability of the test after chemotherapy
Test score at 12 months after the end of radiotherapy
Full Information
NCT ID
NCT04342546
First Posted
March 25, 2020
Last Updated
January 6, 2023
Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
1. Study Identification
Unique Protocol Identification Number
NCT04342546
Brief Title
Predictive Toxicity Test Linked to Radiotherapy After Mastectomy and Immediate Implant Reconstruction
Acronym
PRETORIA
Official Title
Prospective Evaluation of a Predictive Toxicity Test Post Radiotherapy After Mastectomy With Immediate Implant Reconstruction
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 11, 2020 (Actual)
Primary Completion Date
June 2026 (Anticipated)
Study Completion Date
June 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Capsular Contracture Associated With Breast Implant
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Toxicity test
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
NovaGray RILA Breast® test
Intervention Description
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 Measure Information:
Title
Ability of a radiosensitivity test to predict capsular contracture
Description
To identify the Area Under the Curve (AUC) of the radiosensitive predictive test of Grade 3-4 capsular contracture
Time Frame
12 months after the end of radiotherapy
Secondary Outcome Measure Information:
Title
Capsular contracture prevalence
Description
Rate of capsular contracture after radiotherapy
Time Frame
12 Months
Title
Accuracy of the dichotomized test based on the optimal threshold
Description
Accuracy of the test assessed by Sensitivity, Specificity, Positive Predictive Value and Negative Predictive Value
Time Frame
12 months
Title
Precision of the radiosensitivity predictive test
Description
Using the time dependant AUC (AUCt) method
Time Frame
12 months
Title
Biological prognostics factors for capsular contracture occurence
Description
Number and type of different biological prognostic factors of capsular contracture occurence
Time Frame
12 months
Title
Tumoral prognostics factors for capsular contracture occurence
Description
Number and type of different tumoral prognostic factors of capsular contracture occurence
Time Frame
12 months
Title
Success of each surgical strategy in terms of deposit
Description
Number of deposit according to each reconstruction surgery (one or two step)
Time Frame
24 months
Title
Cosmetic outcomes measure
Description
Cosmetic questionnaire : BREAST-Q
Time Frame
6, 12, 18 and 24 months
Title
Functional outcomes measure
Description
Functional questionnaire: BREAST-Q
Time Frame
6, 12, 18 and 24 months
Title
Patient satisfaction measure
Description
Patient satisfaction questionnaire: BREAST-Q
Time Frame
6, 12, 18 and 24 months
Title
General quality of life measure
Description
Quality of life questionnaire: QLQ-C30
Time Frame
6, 12, 18 and 24 months
Title
Specific quality of life measure for breast cancer patient
Description
Quality of life questionnaire for breast cancer patient: QLQ-BR23
Time Frame
6, 12, 18 and 24 months
Title
Stability of the test after chemotherapy
Description
Test score at 12 months after the end of radiotherapy
Time Frame
12 months
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Patients with breast cancer treated by mastectomy with immediate implant breast reconstruction
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 or women of childbearing potential unwilling to employ adequate contraception
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aurore MOUSSION
Phone
04 67 61 31 02
Ext
+33
Email
DRCI-icm105@icm.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Emmanuelle TEXIER
Phone
04 67 61 31 02
Ext
+33
Email
DRCI-icm105@icm.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marian Gutowski
Organizational Affiliation
Institut du Cancer de Montpellier
Official's Role
Study Chair
Facility Information:
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie Pierre Chauvet
Email
mp-chauvet@o-lambret.fr
Facility Name
Centre Léon Bérard
City
Lyon
ZIP/Postal Code
69373
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-Adele Dammacco
Email
marie-adele.dammacco@lyon.unicancer.fr
Facility Name
Institut Paoli Calmette
City
Marseille
ZIP/Postal Code
13009
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie Bannier
Email
bannierm@ipc.unicancer.fr
Facility Name
Institut du Cancer de Montpellier
City
Montpellier
ZIP/Postal Code
34298
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marian Gutowski
Email
marian.gutowski@icm.unicancer.fr
Facility Name
centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06189
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maud DUQUESNE
Email
maud.duquesne@nice.unicancer.fr
Facility Name
Hôpital Tenon
City
Paris
ZIP/Postal Code
75970
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Atlan
Email
michael.atlan@aphp.fr
Facility Name
Institut de Cancérologie de l'Ouest
City
Saint-Herblain
ZIP/Postal Code
44805
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victoire Brillaud-Meflah
Email
victoire.brillaud-meflah@ico.unicancer.fr
Facility Name
Institut Claudius Regaud
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carole MASSABEAU
Email
massabeau.carole@iuct-oncopole.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31383624
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.
Results Reference
background
PubMed Identifier
25003439
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.
Results Reference
background
PubMed Identifier
27406255
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.
Results Reference
background
PubMed Identifier
15894097
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.
Results Reference
background
PubMed Identifier
28985836
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.
Results Reference
background
PubMed Identifier
21336948
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.
Results Reference
result
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Predictive Toxicity Test Linked to Radiotherapy After Mastectomy and Immediate Implant Reconstruction
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