Docetaxel in Patients With Metastatic Breast Cancer Who Have Been Heavily Pretreated, Including Prior Treatment With Paclitaxel or Docetaxel.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- disease free interval
研究概览
简要总结
There is clinical benefit of docetaxel administered to patients who have progressed to 3 or more lines of chemotherapy including prior exposure to paclitaxel or docetaxel; using docetaxel in metastatic stage breast cancer previously exposed to taxanes equal therapeutic responses are obtained that it never received taxanes.
详细描述
Methodology:
Prospective non-randomized phase IIa. The selected patients with metastatic breast cancer heavily pretreated including those previously treated with taxanes, receive docetaxel administered at a dose of 45mg/m2 body surface every 2 weeks to assess the activity of this drug.
Variables:
Age. Menopausal status. Hormone receptor status. Overexpression of HER2 neu. Location of metastatic sites. Performance status (PS) 0-3. comorbidities.
Case management in the variables (patient subgroups )
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
- 21 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women over 21 years of age diagnosed with breast cancer in clinical stage IV, who had received 3 or more lines of cytotoxic chemotherapy, which may have included paclitaxel or docetaxel, which have measurable or evaluable tumor activity in any distant organ and who are fully conscious and well oriented to permit informed consent.
排除标准
- •Male patients with metastatic breast cancer. Patients with grade 3 neuropathy by prior exposure to taxanes. Patients under 21 and over 85 years of age. Metastasis of one site in the central nervous system.
研究组 & 干预措施
docetaxel
measurement evaluation every 2 months tomography of all measurable lesions in millimeters, to assess response rate, partial and complete responses.
干预措施: Docetaxel (Drug)
结局指标
主要结局
disease free interval
时间窗: 4 months
more than 4 months free of clinically detectable cancer until recurrent cancer is diagnosed
次要结局
- partial response(2 months)
- rate response(3 months)
研究者
Jesus Livio Jimenez Santos
medical oncology resident
Centro Universitario contra el Cáncer