NCT00107016已完成2 期
A Phase 2, Double-blind, Randomized, Placebo-controlled, Multi-center Study Assessing the Value of Adding Everolimus to Letrozole as Preoperative Therapy of Primary Breast Cancer in Postmenopausal Women
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 267
- 试验地点
- 11
- 主要终点
- To assess the added efficacy obtained by combining RAD001 and letrozole as preoperative therapy for four months in hormone-receptor positive breast cancer in postmenopausal women
研究概览
简要总结
The purpose of this study is to examine the effect of the combination of everolimus and letrozole compared to placebo and letrozole as pre-surgical therapy in patients with newly diagnosed estrogen receptor positive breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically-confirmed diagnosis of invasive breast cancer, previously untreated
- •Patients must be postmenopausal
- •Candidates for mastectomy or breast-conserving surgery
- •Primary tumor of above 2 cm diameter, measured by imaging
- •Clinical Stage M0
- •WHO performance status ≤1
- •Adequate bone marrow, liver, and renal function
排除标准
- •Multicentric invasive tumors
- •Bilateral or inflammatory breast cancer
- •Receiving concomitant anti-cancer treatments such as chemotherapy
- •Patients with an uncontrolled infection
- •Patients with other concurrent severe and/or uncontrolled medical disease
- •Additional protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
RAD001 + letrozole 2.5mg
Experimental
干预措施: RAD001, Letrozole 2.5mg (Drug)
Letrozole 2.5mg
Active Comparator
干预措施: Letrozole 2.5mg (Drug)
结局指标
主要结局
To assess the added efficacy obtained by combining RAD001 and letrozole as preoperative therapy for four months in hormone-receptor positive breast cancer in postmenopausal women
次要结局
- To assess the four month treatment as being predictive of clinical tumor response
研究者
研究点 (11)
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