A Phase II Trial of Bortezomib and Doxorubicin in Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Overall Response Rate
研究概览
简要总结
Primary objective is to determine the effectiveness of the combination of bortezomib and doxorubicin in patients with metastatic breast cancer. The trial format is a single arm Phase II design wherein patients are treated with bortezomib IV on days 1, 4, 8, and 11 and with doxorubicin IV on days 1 and 8 of a 21-day cycle.
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
- •Cytologically or histologically confirmed metastatic breast cancer
- •Measurable or evaluable disease
- •Age > 18, PS 0,1,2
- •MUGA > 45%
- •Received one or fewer chemotherapies or investigational regimens for metastatic disease, no limit to the number of prior hormonal therapies. May have had single agent Herceptin and/or Herceptin plus single-agent chemotx.
- •Must meet designated laboratory criteria within 14 days of enrollment
排除标准
- •Doxorubicin for metatstatic disease.
- •Pregnant or lactating.
- •Active infections, no myocardial infarction within 2 months of enrollment.
- •Investigational drugs within 14 days of enrollment.
- •Chemotherapy, radiotherapy, hormonal therapy or other investigational therapy within 4 weeks of enrollment.
- •Neuropathy that is > grade
- •Active brain mets.
- •Hypersensitivity to bortezomib, boron, or mannitol.
研究组 & 干预措施
A
干预措施: PS-341, doxorubicin (Drug)
结局指标
主要结局
Overall Response Rate
时间窗: Every two cycles/42 days, up to 7 months
Determine the clinical efficacy of bortezomib and doxorubicin in patients with metastatic breast cancer. Overall response rate is defined as both complete and partial response per RECIST, where complete response is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10mm. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm.
次要结局
- Time to Progression(Up to one year)