ExclUsive endocRine therapy Or radiation theraPy for women aged =70 years with luminal A-like early stage breast cancer (EUROPA): a randomized phase 3 trial - EUROPA

niversity Of Florence0 个研究点目标入组 926 人开始时间: 2023年9月8日最近更新: 2024年7月22日

适应症

试验速览

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•Women aged =70 years, Histologically proven invasive adenocarcinoma of the breast, Pathological T1 (pT1) stage, Postoperative negative (no ink) final surgical margins, Clinical and pathological N0 (cN0 and pN0) stage (isolated tumor cells [i+] allowed), Any tumor grade (if pT =10 mm), G1-2 tumor grade (if pT between 11 and 19 mm), Luminal A-like biology (immunohistochemistry (IHC)-based on local assessment 50): ER and PgR positive (=10%); Human epidermal growth factor receptor 2 (HER2) negative (score 0 or 1+ and proven negative by in-situ hybridization [ISH] in case of score 2+); and Ki67 low (=20%) by IHC staining, Surgically treated with BCS with or without sentinel node biopsy (SNB), Written informed consent

•Clinical evidence of DM or LR at baseline, Preoperative systemic treatments (i. e., chemotherapy, endocrine therapy)., Current treatment with any hormonal agents such as tamoxifen, raloxifene, or other selective estrogen receptor modulators (SERMs), either for osteoporosis or BC prevention (patients are eligible if these medications are discontinued prior to randomization)., Known disorders associated with a higher risk for complications following RT such as collagen vascular disease, dermatomyositis, systemic lupus erythematosus or scleroderma., Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule., Any serious uncontrolled medical disorder, non-malignant systemic disease, or active uncontrolled infection. Examples include but are not limited to uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction or uncontrolled major seizure disorder., No other cancers in the last 5 years (except basal or squamous cell carcinoma of the skin that has been treated), unless in clinical remission at the time of randomization., Synchronous diagnosis of bilateral breast cancer

发起方

niversity Of Florence