A Phase III Randomized Comparison of High Dose Chemotherapy G-CSF To G-CSF For Mobilization of Peripheral Blood Stem Cells For Autologous Transplantation For Patients With Responsive Metastatic Breast Cancer Or High Risk Stage II-III Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- Compare Effectiveness of Chemotherapy + Filgrastim to Filgrastim Alone
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. It is not yet known which treatment regimen is more effective for breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy plus filgrastim with filgrastim alone in treating women undergoing peripheral stem cell transplantation for stage II, stage III, or metastatic breast cancer.
详细描述
OBJECTIVES:
I. Determine whether high dose chemotherapy in addition to growth factors increases the yield of filgrastim mobilized progenitor cells.
II. Determine the kinetics of hematopoietic reconstitution following myeloablative therapy and mobilized blood stem cell transplantation.
III. Determine whether the use of high dose chemotherapy in addition to growth factors for mobilization of stem cells reduces risk of relapse as measured by time to progression in responsive relapsed breast cancer patients receiving autologous peripheral blood stem cell or bone marrow transplants.
IV. Determine the morbidity and cost differences of the use of high dose chemotherapy plus growth factors compared to growth factors alone for mobilization of peripheral blood progenitors and treatment of breast cancer with high dose chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 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
Filgrastim + Chemotherapy
干预措施: Filgrastim (G-CSF) (Biological)
Filgrastim + Chemotherapy
干预措施: Carmustine (Drug)
Filgrastim + Chemotherapy
干预措施: Cisplatin (Drug)
Filgrastim + Chemotherapy
干预措施: Cyclophosphamide (CTX) (Drug)
Filgrastim + Chemotherapy
干预措施: Etoposide (Drug)
Filgrastim + Chemotherapy
干预措施: Thiotepa (Drug)
Filgrastim + Chemotherapy
干预措施: Peripheral Blood Stem Cell Transplantation (Procedure)
Filgrastim
干预措施: Filgrastim (G-CSF) (Biological)
Filgrastim
干预措施: Carmustine (Drug)
Filgrastim
干预措施: Cyclophosphamide (CTX) (Drug)
Filgrastim
干预措施: Thiotepa (Drug)
Filgrastim
干预措施: Peripheral Blood Stem Cell Transplantation (Procedure)
结局指标
主要结局
Compare Effectiveness of Chemotherapy + Filgrastim to Filgrastim Alone
时间窗: 90 Days Post Transplant
次要结局
未报告次要终点