Thalidomide Plus Chemotherapy Versus Chemotherapy Alone: A Phase II Study in Advanced Breast Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Progression free survival(PFS)
研究概览
简要总结
Sixty advanced breast cancer patients are planed to enrolled in this clinical trial. Forty patients are enrolled into thalidomide plus chemotherapy group. Twenty patients are enrolled into chemotherapy alone group. There is no restriction on chemotherapy regimen and lines.
详细描述
The study compares the combination of thalidomide and chemotherapy with chemotherapy alone for the treatment of stage IV breast cancer. Efficacy and safety of the chemotherapy-thalidomide combination will be evaluated. Assessing the isolated effects of thalidomide in a setting where pre and post treatment serum specimens can be obtained will provide essential information about the mechanisms by which vascular endothelial growth factor(VEGF) inhibition affects tumor growth, and represents an ideal opportunity to evaluate the molecular effects of thalidomide on breast tumor.
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 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
thalidomide plus chemotherapy
thalidomide tablet 100mg qn po
干预措施: Thalidomide (Drug)
thalidomide plus chemotherapy
thalidomide tablet 100mg qn po
干预措施: Physician's choice chemotherapy (Drug)
chemotherapy
Physician's choice chemotherapy. No constraints of the choice of chemotherapy drugs and regimens.
干预措施: Physician's choice chemotherapy (Drug)
结局指标
主要结局
Progression free survival(PFS)
时间窗: Change from Baseline RECIST at 6 months was assessed every 6 weeks up to 24 weeks. Data collection is from date of randomization until the date of first documented progression assessed up to 6 months.
PFS is defined as the months that from the anticipation of the clinical-trial to the progress of breast cancer.
次要结局
- Overall survival(OS)(Survival assessed every 8 weeks up to 100 months following objective disease progression. Data collection is from date of randomization until the date of death from any cause, assessed up to 100 months.)
研究者
LeiLei
Dr.
Zhejiang Cancer Hospital