Phase II Trial of Oral Vinorelbine for the Treatment of Metastatic Breast Cancer in Patients >65 Years of Age: A Trial of Efficacy, Toxicity, and Patients' Perceived Preference for Oral Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 18
- 主要终点
- objective response rate
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.
PURPOSE: Phase II trial to study the effectiveness of vinorelbine in treating older women who have stage IV breast cancer.
详细描述
OBJECTIVES:
- Determine the objective response rate in elderly women with stage IV breast cancer treated with oral vinorelbine.
- Determine the toxicity profile of this drug in these patients.
- Determine the time to progression in patients treated with this drug.
- Determine the quality of life of patients treated with this drug.
- Assess individual variation in responses (toxicity and/or activity), pharmacokinetic parameters, and/or biologic correlates due to genetic differences in enzymes involved in the transport, metabolism, and/or mechanism of action of this drug in these patients.
OUTLINE: Patients receive oral vinorelbine once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and then after completion of the second course.
Patients are followed every 3 months for 5 years.
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
- 65 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
vinorelbine
Patients receive oral vinorelbine once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and then after completion of the second course.
Patients are followed every 3 months for 5 years.
干预措施: vinorelbine tartrate (Drug)
结局指标
主要结局
objective response rate
时间窗: Up to 5 years
次要结局
- time to progression(Up to 5 years)
- quality of life(Up to 5 years)