NCT00386087已完成2 期
A Phase II Study of Oral Enzastaurin in Patients With Metastatic Breast Cancer Previously Treated With an Anthracycline and a Taxane-Containing Regimen
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 5
- 主要终点
- To determine the effects of enzastaurin in the treatment of patients with breast cancer by measuring its ability to reduce the size of the tumor or prevent further increases in tumor size.
研究概览
简要总结
The purpose of this study is to determine the effectiveness of enzastaurin in the treatment of patients with metastatic breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Clinical diagnosis of metastatic breast cancer or recurrent breast cancer where surgery can not be done for curative intent
- •Have received prior therapy with an anthracycline (class of drugs) and a taxane (class of drugs).
- •Tumors must not be positive for HER2, but if positive, the treatment plan should not include further treatment with the drug Herceptin.
- •Disease that can be definitely measured on Cat Scans or other radiological tests.
- •May have received high dose chemotherapy for autologous stem cell support greater than or equal to 6 months of starting this study.
排除标准
- •More than 2 chemotherapy regimens for metastatic or locally recurrent disease.
- •Have brain cancer from breast cancer
- •Pregnant or breastfeeding
- •Have an inability to swallow tablets
- •Within 6 months have had a serious heart condition
结局指标
主要结局
To determine the effects of enzastaurin in the treatment of patients with breast cancer by measuring its ability to reduce the size of the tumor or prevent further increases in tumor size.
次要结局
- To evaluate the length of time that enzastaurin is able to effect control of the disease.
- To evaluate the side effects of enzastaurin in patients with breast cancer
- To determine whether changes in laboratory tests of patients treated with enzastaurin is associated with the response of their tumors to the drug.
研究者
研究点 (5)
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