Pilot Study of Neoadjuvant Dose Dense Docetaxel With Correlative Molecular Studies in Stage II/III Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Number Participants to Achieve Pathologic Complete Response
研究概览
简要总结
RATIONALE: Dose-dense scheduling with (peg)filgrastim support may improve the clinical and pathologic complete response rate (pCR) and safety profile of single agent neoadjuvant docetaxel therapy.
PURPOSE: To evaluate whether dose-dense scheduling with (peg)filgrastim support may improve the clinical and pathologic complete response rate (pCR) and safety profile of single agent neoadjuvant docetaxel therapy. To determine the changes in molecular markers that occurs with single agent docetaxel, tissue will be obtained at the end of the four cycles of docetaxel (either by repeat biopsy or definitive surgery).
详细描述
OBJECTIVES:
Primary
- Pathologic complete response rate (pCR) of dose dense docetaxel in the neoadjuvant setting.
Secondary
- Safety and toxic effects of this regimen in these patients.
- Tumor response rate (as measured by ultrasound) in patients treated with this regimen.
- Determine whether early changes in markers of cell cycle position, proliferation, or apoptosis correlate with pathologic complete response rate in these patients.
- Determine whether the molecular profile that predicts for chemoresponsiveness also predicts for response to radiotherapy (as measured by local recurrence) in these patients.
- Determine whether tumors that demonstrate the greatest degree of change in protein expression patterns from pre- to post-docetaxel treatment will also be those that are most sensitive to chemotherapy (as measured by pathologic response rate) in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
Therapeutic Intervention
干预措施: docetaxel (Drug)
Therapeutic Intervention
干预措施: protein expression analysis (Genetic)
Therapeutic Intervention
干预措施: laboratory biomarker analysis (Other)
Therapeutic Intervention
干预措施: biopsy (Procedure)
Therapeutic Intervention
干预措施: conventional surgery (Procedure)
Therapeutic Intervention
干预措施: neoadjuvant therapy (Procedure)
结局指标
主要结局
Number Participants to Achieve Pathologic Complete Response
时间窗: 3 month
whether or not patient has pathologic complete response (pCR) to dose dense docetaxel in the neoadjuvant setting (pCR = no residual viable tumor on histologic analysis)
次要结局
- Safety Profile Based on Number of Patients With Each Worst-grade Toxicity(Through 30 days after completion of treatment)
- Tumor Response as Measured by Ultrasound(At screening, 8 weeks and at surgery (within 14-21 days))
研究者
Bapsi Chak, MD
Associate Professor; Radiation Oncologist
Vanderbilt-Ingram Cancer Center