Phase II Trial of Fulvestrant and Bevacizumab in Patients With Metastatic Breast Cancer Previously Treated With an Aromatase Inhibitor
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 200
- 主要终点
- Six-month Progression-free Survival (PFS) Rate at 6 Months
研究概览
简要总结
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using fulvestrant may fight breast cancer by blocking the use of estrogen by the tumor cells. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Fulvestrant and bevacizumab may also stop the growth of breast cancer by blocking blood flow to the tumor. Giving fulvestrant together with bevacizumab may be an effective treatment for metastatic breast cancer.
PURPOSE: This phase II trial is studying how well giving fulvestrant together with bevacizumab works in treating patients with metastatic breast cancer.
详细描述
OBJECTIVES:
Primary
- Assess the efficacy of fulvestrant and bevacizumab, in terms of 6-month progression-free survival (PFS), in patients with metastatic breast cancer previously treated with an aromatase inhibitor.
Secondary
- Assess the quality of life of patients treated with this regimen.
- Determine the adverse-event profile in these patients.
- Determine the PFS and overall survival of these patients.
- Determine the confirmed response rate, duration of response, time to treatment failure, and time to first cytotoxic agent in patients treated with this regimen.
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 —（Adult, Older Adult）
- 性别
- All
- 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
fulvestrant + bevacizumab
Patients receive fulvestrant intramuscularly on day 1 and bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, prior to every other course, and at the completion of study treatment.
After completion of study treatment, patients are followed every 3-6 months for 5 years.
干预措施: bevacizumab (Biological)
fulvestrant + bevacizumab
Patients receive fulvestrant intramuscularly on day 1 and bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, prior to every other course, and at the completion of study treatment.
After completion of study treatment, patients are followed every 3-6 months for 5 years.
干预措施: fulvestrant (Drug)
结局指标
主要结局
Six-month Progression-free Survival (PFS) Rate at 6 Months
时间窗: at 6 months
The primary endpoint of this trial is the 6-month progression-free survival rate. A patient is considered to be a 6-month progression-free survivor if the patient is on study treatment 6 months from registration without a documentation of disease progression. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Additionally, if some patients are lost to follow-up not having been observed for at least 6 months, an estimate and 95% confidence interval for the 6-month progression-free survival rate incorporating censoring will be computed using the method of Kaplan-Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
次要结局
- Progression Free Survival(Up to 5 years)
- Quality of Life, as Measured by the Largest Mean Change in LASA Overall QOL and Physical Well-being Items(Up to 5 years)
- Objective Response Rate as Measured by RECIST Criteria in Patients With Measurable Disease(Up to 5 years)
- Duration of Response/Time to Disease Progression in Patients With Measurable Disease(Up to 5 years)
- Time to First Cytotoxic Agent(Up to 5 years)
- Overall Survival(Up to 5 years)