Localized Breast Cancer
Conditions
Brief 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.
Interventions
RADIATIONPer-Operative Radiotherapy technique by Papillon +TM
20Gy Per-Operative Radiotherapy technique by Papillon +TM, on localized breast cancer
Sponsors
Centre Antoine Lacassagne
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
radiotherapy treatment
Eligibility
Sex/Gender
FEMALE
Age
65 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| early toxicities occuring until 6 months after performing per-operative radiotherapy | up to 6 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| global tolerance of per-operative radiotherapy | up to 5 years | global safety (assessed by CTCAE V5.0) of per-operative radiotherapy |
| local disease free survival at 5 years of per-operative radiotherapy | up to 5 years | To evaluate local disease free survival at 5 years of per-operative radiotherapy |
| disease free survival at 5 years of per-operative radiotherapy | up to 5 years | To evaluate disease free survival at 5 years of per-operative radiotherapy |
| quality of life of patients | up to 6 months | QLQ-C30 and QLQ BR-23 EORTC questionnaires |
Countries
France
Contacts
CONTACTFrédérique JACQUINOT
Outcome results
None listed