RecruitingNot ApplicableNCT04342546

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

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Enrollment

250 participants

Start Date

Dec 11, 2020

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Capsular Contracture Associated With Breast Implant

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.

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a lab test can predict which breast cancer patients will experience serious side effects from radiation therapy after mastectomy (breast removal surgery) with immediate implant reconstruction. Knowing ahead of time who is at risk could help doctors personalize treatment plans. **You may be eligible if:** - You are 18 years or older - You have confirmed breast cancer and have had or are scheduled for a mastectomy - Radiation to the chest wall after surgery is part of your treatment plan - You have agreed to immediate breast reconstruction using an implant (in one or two stages) - You are in good general health (performance status 0-1) - You are based in France and affiliated with the French national health system **You may NOT be eligible if:** - Your breast reconstruction uses a tissue flap (from your own body) rather than an implant - You have inflammatory breast cancer or cancer that involves the skin or chest wall - You have cancer that has spread to other parts of the body - You have cancer in both breasts - You have previously had radiation to the same breast - You are pregnant or breastfeeding - You are currently participating in another clinical study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICENovaGray 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.