A Randomized Phase II Study of Bevacizumab in Combination With Docetaxel in Locally Advanced Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 5
- 主要终点
- To evaluate the ability of bevacizumab and docetaxel to reduce microvessel density and induce apoptosis of endothelial and tumor cells.
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells.
PURPOSE: This randomized phase II trial is to see if docetaxel with or without bevacizumab followed by surgery, radiation therapy, and combination chemotherapy works better in treating patients who have stage III or stage IV breast cancer.
详细描述
OBJECTIVES:
- Determine the effect of bevacizumab and docetaxel on reduction of microvessel density and induction of apoptosis of endothelial and tumor cells in patients with locally advanced breast cancer.
- Determine the safety profile of this regimen in these patients.
- Compare the effect of docetaxel and bevacizumab, in terms of objective response, stabilization of disease, and progression-free survival, in these patients.
OUTLINE: This is a randomized study. Patients are stratified according to disease stage. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive docetaxel IV over 1 hour once weekly on weeks 1-6 and bevacizumab IV over 60 minutes once every 2 weeks on weeks 1-8.
- Arm II: Patients receive docetaxel as in arm I. Treatment in both arms repeats every 8 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
After the second course, patients with stable or responsive disease undergo modified radical mastectomy or breast-conserving surgery. Three to six weeks after surgery, patients undergo radiotherapy 5 days a week for 7 weeks.
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
- 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
Docetaxel
Patients receive docetaxel IV over 1 hour once weekly on weeks 1-6.
干预措施: cyclophosphamide (Drug)
Docetaxel
Patients receive docetaxel IV over 1 hour once weekly on weeks 1-6.
干预措施: docetaxel (Drug)
Docetaxel
Patients receive docetaxel IV over 1 hour once weekly on weeks 1-6.
干预措施: doxorubicin hydrochloride (Drug)
Docetaxel
Patients receive docetaxel IV over 1 hour once weekly on weeks 1-6.
干预措施: adjuvant therapy (Procedure)
Docetaxel
Patients receive docetaxel IV over 1 hour once weekly on weeks 1-6.
干预措施: conventional surgery (Procedure)
Docetaxel
Patients receive docetaxel IV over 1 hour once weekly on weeks 1-6.
干预措施: neoadjuvant therapy (Procedure)
Docetaxel
Patients receive docetaxel IV over 1 hour once weekly on weeks 1-6.
干预措施: radiation therapy (Radiation)
Combine bevacizumab and docetaxel.
Patients receive docetaxel IV over 1 hour once weekly on weeks 1-6 and bevacizumab IV over 60 minutes once every 2 weeks on weeks 1-8.
干预措施: bevacizumab (Biological)
Combine bevacizumab and docetaxel.
Patients receive docetaxel IV over 1 hour once weekly on weeks 1-6 and bevacizumab IV over 60 minutes once every 2 weeks on weeks 1-8.
干预措施: cyclophosphamide (Drug)
Combine bevacizumab and docetaxel.
Patients receive docetaxel IV over 1 hour once weekly on weeks 1-6 and bevacizumab IV over 60 minutes once every 2 weeks on weeks 1-8.
干预措施: doxorubicin hydrochloride (Drug)
Combine bevacizumab and docetaxel.
Patients receive docetaxel IV over 1 hour once weekly on weeks 1-6 and bevacizumab IV over 60 minutes once every 2 weeks on weeks 1-8.
干预措施: adjuvant therapy (Procedure)
Combine bevacizumab and docetaxel.
Patients receive docetaxel IV over 1 hour once weekly on weeks 1-6 and bevacizumab IV over 60 minutes once every 2 weeks on weeks 1-8.
干预措施: conventional surgery (Procedure)
Combine bevacizumab and docetaxel.
Patients receive docetaxel IV over 1 hour once weekly on weeks 1-6 and bevacizumab IV over 60 minutes once every 2 weeks on weeks 1-8.
干预措施: neoadjuvant therapy (Procedure)
Combine bevacizumab and docetaxel.
Patients receive docetaxel IV over 1 hour once weekly on weeks 1-6 and bevacizumab IV over 60 minutes once every 2 weeks on weeks 1-8.
干预措施: radiation therapy (Radiation)
结局指标
主要结局
To evaluate the ability of bevacizumab and docetaxel to reduce microvessel density and induce apoptosis of endothelial and tumor cells.
时间窗: weeks 8 and 17
The primary outcome measure is the difference in change in biologic parameters between the two arms. Tumor biopsies are required to perform pre- and post-treatment tumor microvessel density determination, apoptosis by TUNEL assay, proliferation markers by immunohistochemistry(e.g. PCNA, Ki-67), and expression of nuclear clusterin/XIP8.
次要结局
- Number of patients with objective response(5 years)