Gene Expression in Predicting Response to Paclitaxel in Patients With Breast Cancer
Determination Of FEZ1/LZTS1 Expression As A Predictor Of Response To Taxol
RATIONALE: DNA analysis of tumor tissue may help doctors predict how patients who receive paclitaxel will respond to treatment.
PURPOSE: This laboratory study is evaluating gene expression in predicting response to paclitaxel in patients with breast cancer.
研究概览
详细说明
OBJECTIVES:
- Determine whether loss of function of the FEZ1/LZTS1 gene is a predictor of response in patients with breast cancer treated with paclitaxel.
OUTLINE: This is a single-blind study.
Tumor tissue is analyzed for FEZ1/LZTS1 gene expression by immunohistochemistry using an antibody for the gene. Tumor expression of the gene is characterized by immunohistochemistry and scored by intensity of staining, percent of cell staining, and staining index. Tumor tissue is also analyzed for FEZ1/LZTS1 gene disruption by reverse transcriptase-polymerase chain reaction and direct sequencing.
PROJECTED ACCRUAL: Approximately 120 patients will be accrued for this study.
研究类型
注册 (预期的)
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
DISEASE CHARACTERISTICS:
- Diagnosis of breast cancer
Measurable disease
- Metastatic disease identified by imaging studies OR a primary disease site that will be treated in a neoadjuvant protocol
- Lesions ≥ 10 mm by spiral CT scan
- Tumor tissue from the primary or metastatic site available for analysis by immunohistochemistry
- Previously treated OR planning to undergo treatment with paclitaxel* NOTE: *Concurrent enrollment on ECOG-2100 allowed
Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
学习计划
研究是如何设计的？
研究衡量的是什么？
主要结果指标
结果测量 |
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Evaluation of the association between tumor expression of FEZ1/LZTS1 gene and response to paclitaxel
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次要结果测量
结果测量 |
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Utility of FEZ1/LZTS1 gene expression in predicting the full 4-level response pattern (complete response, partial response, stable disease, progressive disease)
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合作者和调查者
调查人员
- 首席研究员：Carlo M. Croce, MD、Sidney Kimmel Cancer Center at Thomas Jefferson University
研究记录日期
研究主要日期
学习开始
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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