Personalized radiotherapy for breast cancer based on individual sensitivity

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 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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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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.