Gene Expression in Predicting Response to Paclitaxel in Patients With Breast Cancer

• Conditions: Breast Cancer

• Registration Number: NCT00898690
• Lead Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

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 Timeline

• Study Start: 2003-03
• Status Verified: 2006-05
• Study First Submitted: 2009-05-09
• Study First Submitted QC: 2009-05-09
• Study First Posted: 2009-05-12
• Last Update Submitted: 2013-12-17
• Last Update Posted: 2013-12-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of the association between tumor expression of FEZ1/LZTS1 gene and response to paclitaxel

Secondary Outcome Measures

Name	Time	Method
Utility of FEZ1/LZTS1 gene expression in predicting the full 4-level response pattern (complete response, partial response, stable disease, progressive disease)