NCT00121836已完成4 期
An Open-label Study of Xeloda Plus Avastin at Time of Disease Progression in Treatment-naïve Women With HER2-negative Metastatic Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 109
- 主要终点
- Overall Survival
研究概览
简要总结
This single-arm study was designed to evaluate the efficacy and safety of oral Xeloda plus intravenous Avastin as first-line treatment in women with metastatic breast cancer. Patients received Xeloda 1000 mg/m² orally (PO) twice daily (BID) on Days 1-15, and Avastin 15 mg intravenously (IV) on Day 1 of each 3-week cycle. The anticipated time on study treatment was until disease progression or unacceptable toxicity. The target sample size was <100 individuals.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women >=18 years of age
- •HER2-negative metastatic breast cancer
- •Previous adjuvant chemotherapy or hormonal treatment
- •>=1 measurable target lesion
排除标准
- •Previous treatment with chemotherapy, an anti-angiogenic agent, or a biologic therapy for advanced or metastatic cancer
- •Radiation therapy within 4 weeks of study treatment start or insufficient recovery from the effects of prior radiation therapy
- •Central nervous system metastases
- •Other malignancy within last 5 years, except cured basal cell carcinoma of skin and carcinoma in situ of uterine cervix
- •Serious concurrent infection
研究组 & 干预措施
1
Experimental
干预措施: Capecitabine (Drug)
1
Experimental
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Overall Survival
时间窗: approximately 505 days (Median Time to Death)
Overall survival was defined as the time from date of first treatment dose (Day 1) to date of death, across the study phases regardless of the cause of death
次要结局
- Number of Subjects With Adverse Events(Throughout study)
- Premature Withdrawal From Study Due to Adverse Events(Throughout study)
- Number of Participants With Marked Laboratory Abnormalities(until progressive disease or for up to 3 years)
研究者
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