Actively Recruiting

Phase 2
Age: 65Years +
FEMALE
NCT04680715

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

Age: 65Years +
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

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

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here