NCT01088893Unknown2 期
A Randomized Study of mTOR Inhibition by RAD001 (Everolimus) in Invasive Breast Cancer Patients After Pre-operative Use of Anthracycline and/or Taxane-based Chemotherapy
Organisation for Oncology and Translational Research1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2009年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- measure change of biomarkers in pre- and post- surgery samples
研究概览
简要总结
This is a randomized controlled pilot study investigating signals involved in drug resistance to chemotherapy.
Patient will be randomized to undergo observation or to receive Everolimus after completion of neoadjvuant treatment (anthracycline and/or taxane-based) and before surgery. The patients will be monitored for efficacy and safety.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged ≥ 18 years;
- •Histologically and/or cytologically confirmed invasive ductal or lobular breast cancer;
- •Tumor of 3 cm or greater at time of diagnosis
- •Measurable primary tumor after neoadjuvant treatment before randomization
- •No prior chemotherapy for breast cancer;
- •ECOG performance status ≤1 or Karnofsky performace status ≥ 70%
- •Adequate liver/renal function
- •Able to swallow whole tablets.
- •Able to give written informed consent
- •Able to follow prescription instructions reasonably well
排除标准
- •Male patient
- •Prior history of other malignancy within 5 years of study entry, aside from contralateral breast carcinoma, appropriately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin
- •Distant metastasis, including skin involvement beyond the breast area
- •Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study
研究组 & 干预措施
Everolimus
Experimental
干预措施: Everolimus (Drug)
结局指标
主要结局
measure change of biomarkers in pre- and post- surgery samples
时间窗: baseline and 1 month
次要结局
未报告次要终点
研究者
研究点 (1)
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