A Phase II Study of Letrozole in Combination With Bevacizumab in Patients With Estrogen Receptor- and/or Progesterone Receptor-Positive Unresectable Locally Advanced and/or Metastatic (Stage IV) Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Safety
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes. Giving bevacizumab together with letrozole may be an effective treatment for locally advanced or metastatic breast cancer.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with letrozole works in treating postmenopausal women with locally advanced or metastatic breast cancer that cannot be removed by surgery.
详细描述
OBJECTIVES:
Primary
- Determine the safety and feasibility of bevacizumab in combination with letrozole in postmenopausal women with estrogen receptor- and/or progesterone receptor-positive, unresectable, locally advanced or metastatic breast cancer.
Secondary
- Determine the response rate (partial response [PR] and complete response [CR]) in patients treated with this regimen.
- Determine the clinical benefit rate (PR, CR, and stabilization of disease for ≥ 24 weeks) in patients treated with this regimen.
- Determine the time to progression in patients treated with this regimen.
- Determine the duration of response in patients treated with this regimen.
- Determine the proportion of patients treated with this regimen who have stable disease for ≥ 24 weeks.
- Determine the molecular profile of the patient's breast tumor and explore the relationship between these molecular characteristics and response or resistance to treatment.
- Obtain serial measurements (pre- and post-treatment) of circulating endothelial cells and epithelial cells and explore the relationship between these cells and serum markers of angiogenesis and response to treatment.
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
- 18 Years 至 120 Years（Adult, 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
Study intervention
Patients receive bevacizumab IV over 30-90 minutes on day 1 and oral letrozole once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: bevacizumab (Biological)
Study intervention
Patients receive bevacizumab IV over 30-90 minutes on day 1 and oral letrozole once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: letrozole (Drug)
结局指标
主要结局
Safety
Feasibility
次要结局
- Duration of response
- Time to progression
- Clinical benefit rate (complete response, partial response, and stable disease for at least 24 weeks)
- Response rate (complete response and partial response)