Personalized radiotherapy for breast cancer based on individual sensitivity
Establishment of a Prospective Evaluation of Daily Practice Including the Individual Radiosensitivity Test to the Decision of Daily Practice
This study is testing a personalized approach to radiotherapy for breast cancer patients to see if it can reduce side effects while still being effective, especially for those with a lower risk of recurrence.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 65 Years and up |
| Sex | Female |
| Sponsor | Institut du Cancer de Montpellier - Val d'Aurelle Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Montpellier, Occ) |
| Trial ID | NCT04282122 on ClinicalTrials.gov |
What this trial studies
This observational study aims to create a clinical database that assesses the safety and effectiveness of personalized adjuvant radiotherapy for breast cancer patients, focusing on individual radiosensitivity. It utilizes a rapid radiosensitivity assay to evaluate the risk of toxicity from radiotherapy, particularly in patients with luminal A tumors who may have a low risk of recurrence. The study combines biological and clinical parameters to improve the prediction of adverse effects from treatment, potentially leading to tailored radiotherapy approaches that minimize harm while maintaining efficacy.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 65 and older with luminal A breast cancer who have undergone conservative surgery and are eligible for whole breast irradiation.
Not a fit: Patients with distant metastases, those requiring node irradiation, or those who have undergone radical mastectomy will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of toxicities associated with radiotherapy, improving the quality of life for breast cancer patients.
How similar studies have performed: Previous studies have validated the radiosensitivity test used in this study, indicating a promising approach to personalized radiotherapy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Compliant women ≥ 65 years old. 2. Conservative breast cancer surgery. 3. T1-T2; N sentinel negative/N0. 4. Luminal A tumors. 5. Tumor negative margins. 6. Indication of whole breast irradiation only. 7. Extension evaluation of disease will be proven negative (M0). 8. Must be geographically accessible for follow-up. 9. Written and dated informed consent. 10. Affiliated to the French social security system. Exclusion Criteria: 1. Patients with distant metastases. 2. Indications of node irradiation. 3. Synchronous bilateral breast cancer. 4. Patients treated by radical mastectomy. 5. Patients with neoadjuvant therapy. 6. Patients with previous or concomitant other (not breast cancer) malignancy within the past 3 years EXCEPT adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix. Patients who have had a previous other malignancy must have been disease free for at least three years. 7. Patients with other unstable or untreated non-malignant systemic diseases (cardiovascular, renal, hepatic, lung embolism, etc.) which would prevent prolonged follow-up. 8. Patients treated with systemic investigational drugs within the past 30 days
Where this trial is running
Montpellier, Occ
- Institut Régional du Cancer de Montpellier — Montpellier, Occ, France (Recruiting)
Study contacts
- Study coordinator: Jean-Pierre BLEUSE, MD
- Email: DRCI-icm105@icm.unicancer.fr
- Phone: 0467613102
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.