A Randomised Phase 2 Study of Neoadjuvant Docetaxel and Cyclophosphamide Compared to Doxorubicin and Cyclophosphamide in Operable Node Negative Breast Cancer With Normal Topoisomerase IIα Expression
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 318
- 试验地点
- 2
- 主要终点
- Pathological complete response rate
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, docetaxel, and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known which chemotherapy regimen is more effective in treating breast cancer.
PURPOSE: This randomized phase II trial is studying cyclophosphamide given together with docetaxel to see how well it works compared with cyclophosphamide given together with doxorubicin in treating women with newly diagnosed breast cancer that can be removed by surgery.
详细描述
OBJECTIVES:
Primary
- To evaluate tumor pathological complete response rate after neoadjuvant cyclophosphamide in combination with docetaxel vs doxorubicin hydrochloride in women with operable clinically node-negative breast cancer and normal topoisomerase IIα expression.
Secondary
- To assess tumor clinical and pathological overall response rates in patients treated with these regimens.
- To assess the safety and toxicity of these regimens.
- To assess disease-free survival and overall survival of these patients.
- To assess the efficacy of short-course (3 days) filgrastim (G-CSF) as primary and secondary prophylaxis against febrile neutropenia in patients receiving docetaxel and cyclophosphamide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（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
Arm I
Patients receive cyclophosphamide IV and docetaxel IV over 1 hour on day 1.
干预措施: cyclophosphamide (Drug)
Arm I
Patients receive cyclophosphamide IV and docetaxel IV over 1 hour on day 1.
干预措施: docetaxel (Drug)
Arm II
Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1.
干预措施: cyclophosphamide (Drug)
Arm II
Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1.
干预措施: doxorubicin hydrochloride (Drug)
结局指标
主要结局
Pathological complete response rate
次要结局
- Clinical and pathological overall response rate
- Toxicity as assessed by NCI CTCAE v3.0
- Overall survival
- Disease-free survival