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Clinical Trials in France / NCT04680715
Recruiting Phase 2

Per-Operative Radiotherapy by Papillon +TM in Localized Breast Cancer

NCT04680715 · tracked via the Priya Life Science France tracker
Phase
Phase 2
Started
2021-07-16
Last updated
2026-01-29

Condition(s) studied

Localized Breast Cancer

Investigational drug(s) / intervention(s)

Per-Operative Radiotherapy technique by Papillon +TM

Per-Operative Radiotherapy technique by Papillon +TM: 20Gy Per-Operative Radiotherapy technique by Papillon +TM, on localized breast cancer

Study summary

Phase II study; open recruitment, multicentrique. The aim of this clinical research is to evaluate faisability and toxicity of the per-operative radiotherapy using PAPILLON + TM device for localized breast cancers patients over 65 years.

Eligibility

Sex
FEMALE
Min age
65 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Pôle Santé République Clermont-Ferrand France Not Yet Recruiting
Centre Antoine Lacassagne Nice France Recruiting

More Centre Antoine Lacassagne trials in France

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04680715 on ClinicalTrials.gov ↗ ← All trials in France