Per-operative radiotherapy for localized breast cancer in older women
Per-Operative Radiotherapy (RPO) by Papillon +TM in Localized Breast Cancer : Faisability and Toxicity Study
This study is testing a new type of radiation treatment during surgery for older women with small breast cancer to see if it's safe and effective.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 65 Years and up |
| Sex | Female |
| Sponsor | Centre Antoine Lacassagne Academic / other |
| Locations | 2 sites (Clermont-Ferrand and 1 other locations) |
| Trial ID | NCT04680715 on ClinicalTrials.gov |
What this trial studies
This Phase II clinical trial evaluates the feasibility and toxicity of using the PAPILLON +TM device for per-operative radiotherapy in patients with localized breast cancer who are 65 years or older. The study focuses on women with invasive ductal adenocarcinoma measuring 2 cm or less, and aims to determine the safety and effectiveness of this innovative treatment approach. Participants will be monitored for any adverse effects during the treatment process. The trial is multicentric and open for recruitment across specific locations in France.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 65 years or older with operable invasive ductal adenocarcinoma that is 2 cm or less in size.
Not a fit: Patients with metastatic disease, multifocal tumors, or those under 65 years of age will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a less invasive option for older women with localized breast cancer, potentially improving their quality of life and treatment outcomes.
How similar studies have performed: While this approach is innovative, similar studies using per-operative radiotherapy techniques have shown promise, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient with invasive ductal adenocarcinoma \<=2cm, evaluate on all radiological exams; * Women aged 65 years or older (patients 65 years of age in the year may be included); * Grade 1 or 2 unifocal adenocarcinoma, all index KI67, positive HR, negative HER2 status; * T0 or T1, N0 radio-clinic; * Operable patient with breast volume compatible with conservative surgery; * Patient with prior malignancy or other concurrent malignancies are eligible, including bilateral breast cancer * Patients who have been made aware of the information sheet and have given their written signed informed consent; * Patients benefitting from social health insurance coverage Exclusion Criteria: * Age less than 65 years (except if 65 years obtained during the year) * Patient with an exclusive in situ carcinoma * Patient with lymphatic invasion / peri-nerve involvement / vascular emboli * Patient with a lobular adenocarcinoma * Patient with metastatic disease * Multifocal tumor * Patient with grade 3 or N+ disease * N1 proved by ultrasound guided * patient unable to express her consent * Patient deprived placed under the authority of a tutor * Female patients who are pregnant or breastfeeding * Vulnerable patient: as defined in article L1121-5 à -8
Where this trial is running
Clermont-Ferrand and 1 other locations
- Pôle Santé République — Clermont-Ferrand, France (Not_yet_recruiting)
- Centre Antoine Lacassagne — Nice, France (Recruiting)
Study contacts
- Study coordinator: Frédérique JACQUINOT
- Email: drci-promotion@nice.unicancer.fr
- Phone: 04 92 03 10 24
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.