NCT00960336已完成2 期
Multicenter Study of PEGylated Liposomal Doxorubicin in Geriatric Oncology - Metastatic Breast Cancer - First-line Treatment PEGylated Liposomal Doxorubicin in Patients Older Than 70 Years, Breast Cancer Metastasis
ARCAGY/ GINECO GROUP1 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2008年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Response rate
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well doxorubicin hydrochloride liposome works as first-line therapy in treating older women with metastatic breast cancer.
详细描述
OBJECTIVES:
Primary
- Evaluate the effectiveness of pegylated liposomal doxorubicin hydrochloride, in terms of objective response rate, in elderly women with metastatic breast cancer.
Secondary
- Determine the feasibility of this drug in these patients.
- Evaluate chemotherapy-induced toxicities in these patients.
- Assess the disease-free survival and overall survival of these patients.
- Study the geriatric covariates.
- Assess the covariates predictive of the hematopoietic reserve and the risk of febrile neutropenia in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（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
single arm
Experimental
干预措施: pegylated liposomal doxorubicin hydrochloride (Drug)
结局指标
主要结局
Response rate
时间窗: 3 and 6 cures
次要结局
未报告次要终点
研究者
研究点 (1)
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