Predicting toxicity from radiotherapy after breast cancer surgery and reconstruction
Prospective Evaluation of a Predictive Toxicity Test Post Radiotherapy After Mastectomy With Immediate Implant Reconstruction
This study is testing a new test to see if it can help identify breast cancer patients who might experience severe side effects from radiation after surgery and reconstruction, so they can receive better care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Institut du Cancer de Montpellier - Val d'Aurelle Academic / other |
| Drugs / interventions | radiation |
| Locations | 9 sites (Dijon and 8 other locations) |
| Trial ID | NCT04342546 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include women aged 18 and older with histologically confirmed breast cancer who are undergoing mastectomy and are eligible for immediate breast reconstruction with implants.
Not a fit: Patients with inflammatory breast cancer, metastatic disease, or those requiring flap reconstruction will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized treatment plans that minimize the risk of severe side effects from radiotherapy in breast cancer patients.
How similar studies have performed: Other studies have shown promise in using predictive tests for radiotherapy toxicity, but this specific approach with the NovaGray RILA Breast® test is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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 * 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 this trial is running
Dijon and 8 other locations
- 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)
- Hôpital Tenon — Paris, France (Recruiting)
- Institut de Cancérologie de l'Ouest — Saint-Herblain, France (Recruiting)
- Institut Claudius Regaud — Toulouse, France (Recruiting)
Study contacts
- Study coordinator: Aurore MOUSSION
- Email: DRCI-icm105@icm.unicancer.fr
- Phone: 04 67 61 31 02
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.