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

Study Overview
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Brief Summary
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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.

Official Title
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Per-Operative Radiotherapy (RPO) by Papillon +TM in Localized Breast Cancer : Faisability and Toxicity Study

Conditions
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Localized Breast Cancer

Intervention / Treatment
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* Radiation: Per-Operative Radiotherapy technique by Papillon +TM


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: radiotherapy treatment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Per-Operative Radiotherapy technique by Papillon +TM<br>Per-Operative Radiotherapy (1x20Gy) technique by Papillon +TM | Radiation: Per-Operative Radiotherapy technique by Papillon +TM<br>* 20Gy Per-Operative Radiotherapy technique by Papillon +TM, on localized breast cancer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| early toxicities occuring until 6 months after performing per-operative radiotherapy | pourcentage of patient with toxicities of grade 3 and more (by CTCAE v5.0) related to per-operative radiotherapy and that occured until 6 months after performing | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| global tolerance of per-operative radiotherapy | global safety (assessed by CTCAE V5.0) of per-operative radiotherapy | up to 5 years | 
| local disease free survival at 5 years of per-operative radiotherapy | To evaluate local disease free survival at 5 years of per-operative radiotherapy | up to 5 years | 
| disease free survival at 5 years of per-operative radiotherapy | To evaluate disease free survival at 5 years of per-operative radiotherapy | up to 5 years | 
| quality of life of patients | QLQ-C30 and QLQ BR-23 EORTC questionnaires | up to 6 months |