2023-508094-88-00招募中3 期
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
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 926
- 试验地点
- 19
- 主要终点
- IBTR rate at 5 years.
研究概览
简要总结
- To determine the IBTR rate of exclusive RT as compared to exclusive ET after BCS in low-risk early BC patients aged ≥70 years.
- To determine the PROMs HRQoL, as assessed by the QLQ-C30 and module BR45 questionnaires, of exclusive RT as compared to exclusive ET after BCS in low-risk early BC patients aged ≥70 years.
入排标准
- 年龄范围
- 65 years 至 65+ years（65+ Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
IBTR rate at 5 years.
IBTR rate at 5 years.
PROMs HRQoL measured by global quality of life score (QLQ-C30) using the GHS at 24 months
PROMs HRQoL measured by global quality of life score (QLQ-C30) using the GHS at 24 months
次要结局
- LRR rate at 5 years
- CBC rate at 5 years
- DM rate at 5 years
- BCSS at 5 years
- OS at 5 years
- Safety, as assessed by the number and grade of participants with reported AEs at 5 years
- Individual scales from QLQ-C30 and QLQ-BR45 scores at baseline, 3, 6, 12, 24 months, and 5 years
- Rate of cosmesis assessment grade at baseline, 3, 6, 12, 24 months, and 5 years
- PROMs HRQoL measured by ELD14 questionnaire (optional) at baseline, 12, 24 months, and 5 years
研究者
Lorenzo Livi
Scientific
University Of Florence
研究点 (19)
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