A Pilot Study Assessing Patterns of Response or Resistance to Preoperative Dose Dense Docetaxel in Women With Newly Diagnosed Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Correlation between change in apoptosis and proliferation with response after definitive surgery
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug before surgery may shrink the tumor so that it can be removed.
PURPOSE: This phase II trial is studying how well neoadjuvant docetaxel works in treating women who are undergoing surgery for breast cancer.
详细描述
OBJECTIVES:
Primary
- Correlate baseline and change in apoptosis and proliferation with clinical and pathological response to neoadjuvant docetaxel followed by surgery in women with newly diagnosed breast cancer.
Secondary
- Correlate baseline and change in fludeoxyglucose F 18 positron emission tomography uptake with clinical and pathological response in patients treated with this regimen.
- Correlate baseline and change in gene expression profiles with clinical and pathological response in patients treated with this regimen.
- Correlate baseline and change in tumor and serum proteomic patterns with clinical and pathological response 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
- 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
Docetaxel
Neoadjuvant therapy with docetaxel (IV, 100 mg/m2, every 14 days with growth factor support with pegfilgrastim) for a total of 4 cycles prior to conventional surgery for breast cancer.
干预措施: pegfilgrastim (Biological)
Docetaxel
Neoadjuvant therapy with docetaxel (IV, 100 mg/m2, every 14 days with growth factor support with pegfilgrastim) for a total of 4 cycles prior to conventional surgery for breast cancer.
干预措施: docetaxel (Drug)
Docetaxel
Neoadjuvant therapy with docetaxel (IV, 100 mg/m2, every 14 days with growth factor support with pegfilgrastim) for a total of 4 cycles prior to conventional surgery for breast cancer.
干预措施: conventional surgery (Procedure)
Docetaxel
Neoadjuvant therapy with docetaxel (IV, 100 mg/m2, every 14 days with growth factor support with pegfilgrastim) for a total of 4 cycles prior to conventional surgery for breast cancer.
干预措施: neoadjuvant therapy (Procedure)
结局指标
主要结局
Correlation between change in apoptosis and proliferation with response after definitive surgery
时间窗: Definitive surgery
次要结局
- Correlation between change in fludeoxyglucose F 18 positron emission tomography uptake with response after definitive surgery(Definitive surgery)