ExclUsive endocRine therapy Or Partial breast irradiation for women aged =70 years with luminal A-like early stage breast cancer (EUROPA): a randomized phase 3 non-inferiority trial. - EUROPA TRIA

DIPARTIMENTO DI SCIENZE BIOMEDICHE SPERIMENTALI E CLINICHE, UNIVERSITà DI FIRENZE0 个研究点目标入组 962 人开始时间: 2021年2月10日最近更新: 2021年4月5日

适应症

试验速览

暂无简介。

•--Women aged >=70 years;
•-histologically proven invasive unifocal adenocarcinoma of the breast;
•-pathological T1 (pT1) stage;
•-postoperative negative (no ink) final surgical margins;
•-clinical and pathological N0 (cN0 and pN0) stage (isolated tumour cells [i+] allowed);
•-any tumour grade (if pT =10 mm), G1-2 tumour grade (if pT between 11 and 19 mm);
•- luminal A-like biology (immunohistochemistry (IHC)-based on local assessment [49]):
•- ER positive (defined as =10%);
•- Progesterone (PgR) positive (defined as >20%);
•- 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 <20% by IHC staining;
•-surgically treated with BCS with or without sentinel node biopsy (SNB);
•- written informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 962

•- 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 oestrogen 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 definitely treated), unless in clinical remission at the time of randomization.

发起方

DIPARTIMENTO DI SCIENZE BIOMEDICHE SPERIMENTALI E CLINICHE, UNIVERSITà DI FIRENZE