Randomized Phase II Trial of Capecitabine Plus Oral Vinorelbine Day 1 and 8 vs Metronomic Capecitabine Plus Oral Vinorelbine as Treatment of Metastatic Breast Cancer.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Primary endpoint is overall response rate i both arms.
研究概览
简要总结
The study hypothesis is that metronomic treatment is more efficient than standard treatment.
详细描述
Purpose: In an open-label randomized phase II trial, patients with metastatic Human Epidermal Growth Factor Receptor 2-negative breast cancer with normal organ function sant WHO performance status < 3 are randomized to receive either capecitabine (day 1-14) plus vinorelbine oral (day 1 and 8) or capecitabine (day 1-14) plus vinorelbine oral metronomic (3 days a week).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Locally advanced or metastatic Human Epidermal Growth Factor Receptor2-Negative breast cancer
- •WHO performance status < 3
排除标准
- •Former treatment with Capecitabine or Vinorelbine
- •Patients who have received more than one line of chemotherapy for metastatic disease
- •Brain metastases
- •Malabsorption syndrome
- •Abnormal organ function
- •pregnant or lactating women
研究组 & 干预措施
Arm A
Vinorelbine (Navelbine Oral) 60 mg/m2 day 1 and day 8 Plus Capecitabine (Xeloda) 1000 mg/m2 2 times daily day 1 to 14 in a 3 weekly schedule.
干预措施: Arm A Vinorelbine (Navelbine oral) Capecitabine (Xeloda) (Drug)
Arm B
Oral Vinorelbine (Navelbine oral) 50 mg 3 times weekly, monday, wednesday and friday plus Capecitabine (Xeloda) 1000 mg/m2 2 times daily day 1-14 in a 3 weekly schedule.
干预措施: Arm B Vinorelbine (Navelbine oral) Capecitabine (Xeloda) (Drug)
结局指标
主要结局
Primary endpoint is overall response rate i both arms.
时间窗: up to 60 month
Response evaluation at 3rd and 6th cycle by resist criterias. The number of patients that respond to treatment in percent of the total number of patients treated.
次要结局
- Overall survival.(up to 60 month)
- Time to progression.(up to 60 month)
研究者
Sven Langkjer
consultant, MD, ph.d.
University of Aarhus