NCT02183805终止2 期
Phase II Study of Chemotherapy Followed by Peripheral Stem Cell Transplantation as First Line Therapy for Metastatic Triple-negative Breast Cancer
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2014年6月17日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Progression free Survival
研究概览
简要总结
Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
详细描述
To explore the progression-free survival of patients with metastatic triple-negative breast cancer treated with peripheral blood stem cell transplant (PBSCT) followed by high dose chemotherapy.
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Eastern Cooperative Oncology Group (ECOG) 0 or
- •Histologically or cytologically proven diagnosis of breast cancer with evidence of locally recurrent or metastatic disease.
- •Documentation of estrogen and progestin receptor (ER/PR) negative status and HER2/neu receptor negative status (ie, FISH negative or immunohistochemistry 0 or +1).
- •Obtained complete response or Good partial response after first line chemotherapy.
- •Normal organ function required prior to study entry.
- •Willingness to comply with treatment plans and other study procedures.
排除标准
- •Uncontrolled central nervous system (CNS) involvement with disease
- •Fertile women unwilling to use contraceptive techniques during treatment
- •Females who are pregnant
- •Organ dysfunction.
- •Patients may not be receiving any other investigational agents.
研究组 & 干预措施
Metastatic triple negative breast cancer
Experimental
Abraxane,Cyclophosphamide,Carboplatin
干预措施: Abraxane,Cyclophosphamide,Carboplatin (Drug)
结局指标
主要结局
Progression free Survival
时间窗: 24 months
次要结局
- Overall Survival(24 months)
研究者
Zhong-yu Yuan
Sun Yat-sen University Cancer Center
Sun Yat-sen University
研究点 (1)
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