NCT00333086已完成2 期
A PHASE II STUDY OF LETROZOLE IN PATIENTS WITH ADVANCED OR RECURRENT ENDOMETRIAL CANCER
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Response rates (complete response, partial response, no change, progressive disease) measured by tumor marker assessments and radiologic imaging at week 12 then every 12 weeks x 1 year followed by every 16 weeks
研究概览
简要总结
Currently available treatments for endometrial cancer are associated with limited efficacy and significant toxicity. This study will assess the safety and efficacy of letrozole, an aromatase inhibitor, on endometrial cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Postmenopausal women with recurrent or metastatic adeno- or adenosquamous carcinoma of the endometrium
- •No adjuvant therapy
- •Up to one prior hormonal (progestin) therapy for advanced/metastatic disease allowed
- •No chemotherapy for recurrence (adjuvant permitted)
- •Unidimensionally measurable disease
- •Good Health status 0-2 (Eastern Cooperatitve Oncology Group)
- •No prior tamoxifen or aromatase inhibitor therapy
- •No other concurrent anti-cancer treatment
- •No metastases in the central nervous system
排除标准
- •Additional protocol-defined inclusion/exclusion criteria may apply
结局指标
主要结局
Response rates (complete response, partial response, no change, progressive disease) measured by tumor marker assessments and radiologic imaging at week 12 then every 12 weeks x 1 year followed by every 16 weeks
次要结局
- Duration of clinical response, time to progression of the disease, correlation of tumor response with pretreatment ER/PR status, histological grade and aromatase levels
研究者
研究点 (1)
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