To define the molecular characteristics of the tumor' patients: Copy Number alterations. To define the molecular characteristics of the tumor' patients: Mutational profiles of tumors (Whole Exome seq,) Patient reported outcomes and quality of life will be assessed using the following questionnaire : patient self-rating mood scale. Questionnaire patient self-rating mood scale. The module EORTC QLQ-FA12 assesses physical, cognitive, and emotional aspects of cancer-related fatigue. The European Organisation for Research and Treatment of Cancer (EORTC) Group has developed a multidimensional instrument measuring cancer-related fatigue to be used in conjunction with the quality of life core questionnaire (EORTC QLQ-C30). Patient reported outcomes and quality of life will be assessed using the validated following questionnaire : EORTC QLQ FA-12 Fatigue. Patient reported outcomes and quality of life will be assessed using the validated following questionnaire :The European Organization for Research and Treatment of Cancer Breast-Cancer-Specific Quality of Life Questionnaire. Several single-item symptom measures are also included. The QLQ-C30 incorporates nine multi-item scales: five functional scales (physical, role, cognitive, emotional, and social) three symptom scales (fatigue, pain, and nausea and vomiting) and a global health and quality-of-life scale. Patient reported outcomes and quality of life will be assessed using the validated following questionnaire: The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30). The assessment of safety will be based mainly on the frequency of adverse events based on the common toxicity criteria (CTCAE-V5.0) grade. Rate of patients with recurrence at 1 year and 2 year post-randomisation as well as time to recurrence will be analysed. Local-regional recurrence (LRR) refers to relapse of the primary tumor siteĭistant metastasis is defined as presence of any non-local metastatic sites.ĭisease recurrence/relapse (local or distant) Overall survival will be measured from the date of randomization to the date of death from any cause. In both arms, radiotherapy will be administered as per standard practice and has to be initiated one week before C1D1.ĭFS is defined as the time from randomization until the date of the first relapse (local/regional recurrence or distant metastasis) or death (from any cause) whichever comes firsts and regardless of whether the patient withdraws from randomised study treatment or receives another anti-cancer therapy prior to disease relapse. Arm B: Capecitabine (1000 mg/m2 twice a day, Bis In Die ), 14 days on / 7 days off for 8 cycles. Arm A: Nivolumab (360 mg IV, every 3 weeks) for 8 doses and Ipilimumab (1 mg/kg, IV, every 6 weeks or every 2 doses of Nivolumab in case of dose delays) for 4 doses.This trial is an open-label, randomised, multicentric, comparative, Phase II study aiming to evaluate the clinical benefit of a combined treatment associating radiotherapy + Nivolumab + Ipilimumab versus radiotherapy + Capecitabine (standard treatment) in early TNBC patients who have Residual cancer burden (RCB) III residual disease after neoadjuvant chemotherapy.įollowing validation of eligibility criteria, patients will be randomised (1:1) to receive: To evaluate the clinical benefit of a post-operative adjuvant therapy combining radiotherapy + Nivolumab + Ipilimumab versus radiotherapy + Capecitabine in Triple Negative Breast Cancer (TNBC) patients with residual disease after neoadjuvant chemotherapy.
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