First-line Gemcitabine Plus Cisplatin in Locally Advanced (IIIC Stage) Breast Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Clinical tumor regression rate
研究概览
简要总结
The goal of the study is to investigate of the prognostics and predictive role of TUBB3 expression in locally advanced breast cancer
详细描述
Using combination of gemcitabine plus cisplatine as first line treatment patients with locally advanced breast cancer with high TUBB3 expression
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •IIIC stage breast cancer patients
排除标准
- •Other stages breast cancer patients
研究组 & 干预措施
Experimental group
1250 mg/m2 Gemcitabine 1st and 8th days of 6 cycles and 75mg/m2 Cisplatine 1st day every 3 weeks of 6 cycles
干预措施: Cisplatin (Drug)
Control group
Doxorubicin 60mg/m2(Adriblastin) plus Cyclophosphamide 600mg/m2 (endoxan) IV, on 1st days every 3 weeks of 4 cycles. Paclitaxel (Taxol) 80mg/m2, IV every week of 12 cycles or 175mg/m2, IV, on 1st days every 3 weeks of 4 cycles.
干预措施: Doxorubicin (Drug)
Control group
Doxorubicin 60mg/m2(Adriblastin) plus Cyclophosphamide 600mg/m2 (endoxan) IV, on 1st days every 3 weeks of 4 cycles. Paclitaxel (Taxol) 80mg/m2, IV every week of 12 cycles or 175mg/m2, IV, on 1st days every 3 weeks of 4 cycles.
干预措施: Cyclophosphamide (Drug)
Control group
Doxorubicin 60mg/m2(Adriblastin) plus Cyclophosphamide 600mg/m2 (endoxan) IV, on 1st days every 3 weeks of 4 cycles. Paclitaxel (Taxol) 80mg/m2, IV every week of 12 cycles or 175mg/m2, IV, on 1st days every 3 weeks of 4 cycles.
干预措施: Paclitaxel (Drug)
Experimental group
1250 mg/m2 Gemcitabine 1st and 8th days of 6 cycles and 75mg/m2 Cisplatine 1st day every 3 weeks of 6 cycles
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Clinical tumor regression rate
时间窗: 4 months
Chemotherapy combination Gemcitabine with Cisplatin
次要结局
- Increasing PFS and OS(5 years and 10 years)
研究者
Elchin Mansurov
Head of the Chemothrapy II
The National Center of Oncology, Azerbaijan