Predicting toxicity from radiotherapy after breast cancer surgery and reconstruction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the NovaGray RILA Breast® test's ability to predict the toxicity associated with radiotherapy following mastectomy and immediate breast implant reconstruction. It aims to identify patients at high risk for severe side effects from radiotherapy, which can negatively impact cosmetic outcomes and quality of life. By assessing T-CD8 lymphocyte apoptosis, the study seeks to personalize treatment strategies and potentially reduce unnecessary surgeries for low-risk patients. The goal is to improve patient care and outcomes in breast cancer treatment.

Why it matters

Who can join: the full rules

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

Where it's running

• Centre Georges François Leclerc
  Dijon, France Recruiting
• Centre Oscar Lambret
  Lille, France Recruiting
• Centre Léon Bérard
  Lyon, France Recruiting
• Institut Paoli Calmette
  Marseille, France Recruiting
• Institut du Cancer de Montpellier
  Montpellier, France Recruiting
• centre Antoine Lacassagne
  Nice, France Recruiting

Study contacts

• Study coordinator: Aurore MOUSSION
• Email: DRCI-icm105@icm.unicancer.fr
• Phone: 04 67 61 31 02

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.