Menopausal Patients clinical trials

Medico Economic Study, Comparing Intrabeam® on Surgical Resection Bed to Conventional Surgery + EBRT, in Breast Cancer

Current breast cancer treatment is based on surgery, radiation, chemotherapy and hormonotherapy. Conservative surgery or mastectomy are followed by complementary externe radiotherapy. This adjuvant external breast radiotherapy (EBRT) is heavy, spread over more than 6 weeks with : - 25 sessions and delivery of a unit dose of 2 Gy to obtain a total dose of 50 Gy (5 sessions per week in general); - 16 Gy overimpression (boost) dose located in the tumour bed, in 5 to 8 fractions, in situations at high risk of recurrence. In addition, EBRT is responsible for many adverse effects, some of which can lead to lasting or permanent sequelae. Many focused partial breast irradiation techniques have been developed in recent years with the objective of reducing the duration and morbidity of overall breast irradiation. Among these techniques, intraoperative breast radiotherapy (IBRT) is recommended in cancers diagnosed at early stages for which tumorectomy is expected and which present a low risk of recurrence. The main advantages of IBRTare : - Improvement of the quality of life due to a single session of radiotherapy associated with surgical ; - Increased precision to deliver the necessary dose in tumour tissue; - Preservation of surrounding healthy tissue ; - Reduction in the overall cost of treatment through shorter hospital stays and the absence of medical transport for conventional radiotherapy sessions. RIOP SEIN is a project supported by Institut National du Cancer (INCa) , which consists of a medico-economic evaluation of IBRT, with Intrabeam® system on surgical resection bed relative to conventional surgery + EBRT in postmenopausal patients operated by conservative surgery for Low risk breast cancer