跳至主要内容
临床试验/NCT00436709
NCT00436709Unknown不适用

A Pilot Study of Bevacizumab With Dose Dense Doxorubicin and Cyclophosphamide (AC) Followed by Dose Dense Nanoparticle Albumin Bound Paclitaxel for the Treatment of Early Stage Breast Cancer

Memorial Sloan Kettering Cancer Center1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2006年7月最近更新:
适应症
相关药物

试验速览

阶段
不适用
入组人数
75
试验地点
1
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 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. Bevacizumab may also stop the growth of breast cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with chemotherapy after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This clinical trial is studying the side effects and how well giving bevacizumab together with doxorubicin and cyclophosphamide followed by paclitaxel albumin-stabilized nanoparticle formulation and bevacizumab works in treating patients who have undergone surgery for early-stage breast cancer.

详细描述

OBJECTIVES:

Primary

  • Determine the cardiac safety of adjuvant concurrent bevacizumab and dose-dense doxorubicin hydrochloride and cyclophosphamide followed by dose-dense paclitaxel albumin-stabilized nanoparticle formulation and maintenance therapy comprising bevacizumab alone in patients with early-stage breast cancer.

Secondary

  • Determine the noncardiac toxicity of this regimen in these patients.
  • Determine the efficacy of this regimen, in terms of time to tumor recurrence and overall survival, in these patients.
  • Explore changes in circulating endothelial cells and circulating tumor cells from pre-treatment levels in patients with no evidence of disease.
  • Prospectively explore the use of serial troponin I as a predictor of cardiac toxicity in patients treated with this regimen.
  • Prospectively explore the relationship between plasma renin activity and hypertension in patients treated with bevacizumab and chemotherapy.

研究设计

研究类型
Interventional
分配方式
Non Randomized
主要目的
Treatment

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Safety

次要结局

  • Noncardiac toxicity
  • Time to tumor recurrence
  • Overall survival

研究者

申办方类型
Other

研究点 (1)

Loading locations...

相似试验