UNICANCER: Prospective cohort study of treatment related chronic toxicities in patients with localized breast cancer (CANTO)

TPS10125 Background: Corresponding with improved survival among breast cancer patients an awareness of the long term effects of cancer treatments has increased. There is now a call for better coordination of care and management of these patients to focus on their survivorship. This study will identify factors associated with the development and persistence of long term toxicities in patients treated for Stage I-III breast cancer. In addition, it will characterize their incidence as well as, psychological, social and economic impacts. Methods: This is a prospective cohort study enrolling newly diagnosed invasive cT0-cT3, cN0-3, M0 breast cancer patients of 26 French comprehensive cancer centers. All patients will be followed for a minimum of 5 years. Patients will be assessed at diagnosis, 3-6 (M0), 12 (M12), 36 (M36), 48 (M48), 60 (M60), months after treatment completion. Treatment completion is defined as completion of primary surgery, chemotherapy or radiotherapy, whichever comes last. Adjuvant trastuzumab, endocrine therapy or participation in clinical trials can be ongoing. CANTO collects an extensive list of clinical, treatment, and toxicity data including validated patient reported outcomes questionnaires ( Hospital Anxiety and Depression scale [HADS], Scheier et Carver’s Questionnaire, Life Orientation Test-Revised [LOT-R], Beck Depression Inventory [BDI-SF], European Organization for Research and Treatment-QOL questionnaire for breast cancer [EORTC QLQC30-BR23], EORTC-FA13, 12 Item Short Form Survey [SF12], Global physical activity questionnaire [GPAQ]6, impact of cancer questionnaire [IOCv2], economic and social questionnaires). Blood collection is available for all patients at diagnosis, M0, M12, M36 and M60. Genotyping will be performed in all samples. Biologic substudies are ongoing (e.g, microbiotic and cognitive substudy). CANTO aggregates a multidisciplinary team of French investigators and created a dedicated national network. Enrolment started in 2012 and by December 2016, 10030 patients were already enrolled, with a goal of 12.000 patients. Clinical trial information: NCT01993498.