A Phase II Trial of Doxil, Carboplatin and Bevacizumab in Triple Negative Previously Untreated Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 7
- 主要终点
- Progression Free Survival (PFS) After Treatment With Doxil, Carboplatin and Bevacizumab in Patients With ER, PR, HER2neu Negative Metastatic Breast Cancer
研究概览
简要总结
The purpose of this research study is to look at the effectiveness of a combination of doxil, carboplatin and bevacizumab on metastatic breast cancer. The type of breast cancer being studied is negative for a protein called HER2/neu and for estrogen receptors (ER) and progesterone receptors (PR). HER2/neu, ER and PR are part of a family of receptors found on both cancer and normal cells. This family of receptors is important for cell growth and is found in many tumor types.This study is being conducted for the following research purposes:· To find out what effects, if any, the study drug has on metastatic breast cancer. For instance, will the study drug cause the tumor(s) to shrink or stop growing?· To test the safety of the study drugs and to see what affects it has. For instance, are there any side effects? If so, what kind of side effects does the study drug cause? How severe are the side effects, and how often do they occur?· To see if the study drugs have any effect on keeping the disease from getting worse.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with previously untreated metastatic breast cancer, ER/PR/HER2/neu negative.
- •ECOG performance status <= 2
- •Normal organ and marrow function
- •Normal cardiac function as evidenced by LVEF within institutional normal limits
排除标准
- •History of hypersensitivity reactions to doxil or bevacizumab
- •Myocardial infarct or unstable angina within 6 months before enrollment
- •Prior anthracycline dose exceeding 360 mg/m2 for doxorubicin (including DOXIL) or 720 mg/m2 for epirubicin.
- •Proteinuria
研究组 & 干预措施
Doxil, Carboplatin and Bevacizumab
干预措施: Doxil (Drug)
Doxil, Carboplatin and Bevacizumab
干预措施: Carboplatin (Drug)
Doxil, Carboplatin and Bevacizumab
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Progression Free Survival (PFS) After Treatment With Doxil, Carboplatin and Bevacizumab in Patients With ER, PR, HER2neu Negative Metastatic Breast Cancer
时间窗: Two Years
次要结局
- One-year Progression-free Survival(one year)
- Median Overall Survival After Treatment With Doxil, Carboplatin and Bevacizumab in Patients With ER, PR, HER2neu Negative(From date of randomization up to two years)
- Clinical Benefit Rate (CBR=CR+PR+SD)(up to two years)
- Six-month Survival After Treatment With Doxil, Carboplatin and Bevacizumab in Patients With ER, PR, HER2neu Negative(six months)
研究者
Deborah Toppmeyer, MD
Professor, CINJ
Rutgers, The State University of New Jersey
