Determination Of FEZ1/LZTS1 Expression As A Predictor Of Response To Taxol
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 120
- Primary Endpoint
- Evaluation of the association between tumor expression of FEZ1/LZTS1 gene and response to paclitaxel
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Evaluation of the association between tumor expression of FEZ1/LZTS1 gene and response to paclitaxel
Secondary Outcomes
- Utility of FEZ1/LZTS1 gene expression in predicting the full 4-level response pattern (complete response, partial response, stable disease, progressive disease)