RECRUITINGINTERVENTIONAL
Predictive Toxicity Test Linked to Radiotherapy After Mastectomy and Immediate Implant Reconstruction
Prospective Evaluation of a Predictive Toxicity Test Post Radiotherapy After Mastectomy With Immediate Implant Reconstruction
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- Age ≥18 years
- Patients with diagnosed by tissue sample (biopsy-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
Who Should NOT Join This Trial:
- 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 willing to sign a consent form
- Participation in an interventional clinical study or planned participation during study up to 12 months post-radiotherapy
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
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 (9)
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, France