A Pilot Study of Neoadjuvant Paclitaxel and Concurrent Radiation With Correlative Molecular Studies in Stage II/III Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 6
- 主要终点
- Pathologic Complete Response Rate
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving paclitaxel and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This clinical trial is studying how well giving paclitaxel together with radiation therapy works in treating patients undergoing surgery for stage II or stage III breast cancer.
详细描述
OBJECTIVES:
Primary
- Evaluate the efficacy of paclitaxel and concurrent radiotherapy (as measured by pathologic response rates) in patients with stage II or III breast cancer.
Secondary
- Evaluate the toxicities of this treatment regimen.
- Correlate paclitaxel-induced tumor response with local recurrence-free survival, distant disease-free survival, and overall survival.
- Evaluate protein expression profiles by mass spectrometry in biopsy material and blood specimens collected before and after treatment with paclitaxel.
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
- 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
Experimental
干预措施: Post-operative adjuvant therapy (Drug)
Experimental
干预措施: neoadjuvant therapy (Drug)
Experimental
干预措施: therapeutic surgical procedure (Procedure)
Experimental
干预措施: Radiation therapy with concurrent Paclitaxel (Radiation)
Experimental
干预措施: Hormonal Therapy (Drug)
结局指标
主要结局
Pathologic Complete Response Rate
时间窗: 9 weeks
次要结局
- Toxicity paclitaxel and radiation(at 18 weeks)
- Correlation of tumor response with local recurrence-free survival, distant disease-free survival, and overall survival(at time of disease progression or death by any cause)
- Protein expression profiles as measured by mass spectrometry before and after treatment with paclitaxel(Baseline and 18 weeks)
研究者
A Bapsi Chakravarthy, MD
Associate Professor; Radiation Oncologist
Vanderbilt-Ingram Cancer Center