NCT00104624终止2 期
Phase II Trial Assessing the Impact on Instrumental and Daily Living Autonomy of a Chemotherapy With Biweekly Docetaxel in the Treatment of Metastatic Breast Cancer in Patients Over 70
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- UNICANCER
- 入组人数
- 53
- 试验地点
- 14
- 主要终点
- Degree of autonomy in instrumental activities of daily living as measured by Lawton's Instrumental Activities of Daily Living Scale during therapy and at 6 and 12 months
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as docetaxel, 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 docetaxel works in treating older women with metastatic breast cancer and whether it helps improve the ability to perform daily activities.
详细描述
OBJECTIVES:
Primary
- Determine degree of autonomy in instrumental activities of daily living on-therapy and at 6 and 12 months, as measured by Lawton's Instrumental Activities of Daily Living Scale, in older women with metastatic adenocarcinoma of the breast treated with docetaxel.
Secondary
- Determine the response rate in patients treated with this drug.
- Determine overall and progression-free survival of patients treated with this drug.
- Determine the degree of autonomy in daily activities as measured by Katz's Activities of Daily Living Scale, in patients treated with this drug.
- Determine mood status, as measured by the Geriatric Depression Scale, of patients treated with this drug.
- Determine toxicity of this drug in these patients.
研究设计
- 研究类型
- Interventional
- 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
结局指标
主要结局
Degree of autonomy in instrumental activities of daily living as measured by Lawton's Instrumental Activities of Daily Living Scale during therapy and at 6 and 12 months
次要结局
- Degree of autonomy in daily activities as measured by Katz's Activities of Daily Living Scale
- Progression-free survival
- Response rate
- Overall survival
- Mood status as measured by the Geriatric Depression Scale
- Toxicity
研究者
研究点 (14)
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