NCT00255788已完成2 期
A Randomized Phase II Study of Two Different Schedules of RAD001C in Patients With Recurrent/Metastatic Breast Cancer
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
- 49
- 试验地点
- 5
- 主要终点
- Early progression rate by clinical evaluation every 4 weeks and radiologic reevaluation every 8 weeks
研究概览
简要总结
RATIONALE: Everolimus may stop the growth of tumor cells by blocking blood flow to the tumor.
PURPOSE: This randomized phase II trial is studying two different schedules of everolimus to see how well they work in treating patients with recurrent or metastatic breast cancer.
详细描述
OBJECTIVES:
Primary
- Determine the efficacy of 2 different treatment schedules of everolimus, in terms of clinical/radiological response and early progression, in patients with recurrent or metastatic breast cancer.
Secondary
- Determine the time to progression and response duration in patients treated with these regimens.
- Determine the toxic effects of these regimens in these patients.
- Correlate molecular markers of mTOR activity in tumor tissue with objective tumor response in patients treated with these regimens.
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
- None
入排标准
- 年龄范围
- 16 Years 至 120 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm A
Active Comparator
Everolimus - 28 days q 4 wk
干预措施: everolimus (Drug)
Arm B
Active Comparator
Everolimus - days 1, 8, 15 and 22 q 4wks
干预措施: everolimus (Drug)
结局指标
主要结局
Early progression rate by clinical evaluation every 4 weeks and radiologic reevaluation every 8 weeks
Response rate by clinical evaluation every 4 weeks and radiologic reevaluation every 8 weeks
次要结局
- Time to progression by clinical evaluation every 4 weeks and radiologic reevaluation every 8 weeks
- Response duration by evaluation 4 weeks after response and then every 8 weeks
- Adverse event rates
- Correlative assessment of response with molecular markers of mTor activity on archival tissue
- Optional correlative assessment of response with molecular markers of mTor activity on fresh tissue
研究者
研究点 (5)
Loading locations...
相似试验
终止
2 期
Everolimus in Treating Patients With Newly Diagnosed Localized Prostate CancerProstate CancerNCT00526591Jorge A. Garcia, MD17
终止
2 期
Everolimus Therapy in People With Birt-Hogg-Dube Syndrome (BHD)-Associated Kidney Cancer or Sporadic Chromophobe Renal CancerRenal CancerBirt-Hogg-Dube SyndromeNCT02504892National Cancer Institute (NCI)3
已完成
2 期
Everolimus in Treating Patients With Locally Advanced or Metastatic Thyroid CancerHead and Neck CancerNCT01164176Yonsei University40
Unknown
2 期
Everolimus in Treating Patients With Progressive or Recurrent, Unresectable, or Metastatic Thyroid CancerHead and Neck CancerNCT01118065Leiden University Medical Center42
已完成
1 期
Everolimus, Fluorouracil, Leucovorin, Panitumumab, and Oxaliplatin in Treating Patients With Tumors That Did Not Respond to TreatmentUnspecified Adult Solid Tumor, Protocol SpecificNCT00610948UNC Lineberger Comprehensive Cancer Center74