Actively Recruiting
Per-Operative Radiotherapy by Papillon +TM in Localized Breast Cancer
Led by Centre Antoine Lacassagne · Updated on 2026-01-29
40
Participants Needed
2
Research Sites
358 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Per-Operative Radiotherapy by Papillon +TM in Localized Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient with invasive ductal adenocarcinoma 2 cm or smaller, confirmed by all radiological exams
- Women aged 65 years or older (including those turning 65 during the year)
- Grade 1 or 2 unifocal adenocarcinoma, any Ki67 index, hormone receptor positive, HER2 negative
- Tumor stage T0 or T1, with no lymph node involvement clinically or by imaging
- Eligible for breast-conserving surgery with suitable breast volume
- Patients with prior or concurrent malignancies, including bilateral breast cancer, are eligible
- Patients who have been informed and provided written consent
- Patients covered by social health insurance
You will not qualify if you...
- Age less than 65 years (unless turning 65 during the year)
- Presence of exclusive in situ carcinoma
- Lymphatic invasion, perineural involvement, or vascular emboli
- Lobular adenocarcinoma diagnosis
- Presence of metastatic disease
- Multifocal tumors
- Grade 3 tumors or positive lymph node disease
- N1 lymph node involvement proven by ultrasound-guided biopsy
- Inability to provide informed consent
- Patients under legal guardianship
- Female patients who are pregnant or breastfeeding
- Vulnerable patients as defined by relevant legal articles
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Pôle Santé République
Clermont-Ferrand, France, 63000
Not Yet Recruiting
2
Centre Antoine Lacassagne
Nice, France, 06189
Actively Recruiting
Research Team
F
Frédérique JACQUINOT
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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