Prediction of Response or Resistance to Dose Intensified Pre-Operative Epirubicin Therapy of Operable Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Complete pathological response rate by tumor analysis after surgery
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as epirubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving epirubicin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II trial is studying how well epirubicin works in treating women who are undergoing surgery for stage I, stage II, or stage III breast cancer.
详细描述
OBJECTIVES:
Primary
- Determine the complete pathological and clinical response rate in women undergoing surgery for resectable stage I-III breast cancer treated with neoadjuvant dose-intensified epirubicin hydrochloride.
Secondary
- Determine the toxicity of this regimen in these patients.
- Determine the predictive value of HER2 gene amplification and topoisomerase II-alpha gene amplification or deletion for disease progression and pathological and clinical complete response in patients treated with this regimen.
- Correlate gene expression profiles with pathologic complete response, clinical complete response, less than complete response, and disease progression 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 120 Years（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
Epirubicin
干预措施: pegfilgrastim (Biological)
Epirubicin
干预措施: epirubicin hydrochloride (Drug)
Epirubicin
干预措施: conventional surgery (Procedure)
结局指标
主要结局
Complete pathological response rate by tumor analysis after surgery
时间窗: 4 weeks
No evidence of microscopic invasive tumor at the primary tumor site in the surgical specimen.
次要结局
- Complete clinical response rate by diagnostic mammogram at baseline and at 8 weeks(4 weeks)
- Predictive value of HER2 gene amplification and topoisomerase II-alpha gene amplification or deletions for pathologic complete response, clinical complete response or disease progression after surgery(5 years)
- Toxicity by physical exam and medical history every 14 days prior to surgery(2-4 weeks)
- Gene expression after surgery(5 years)