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

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.

Official Title
-----------------
Determination Of FEZ1/LZTS1 Expression As A Predictor Of Response To Taxol

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Genetic: cytogenetic analysis
* Genetic: gene expression analysis
* Genetic: microarray analysis
* Genetic: mutation analysis
* Genetic: reverse transcriptase-polymerase chain reaction
* Other: immunohistochemistry staining method


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: cytogenetic analysis|nan|
|Genetic: gene expression analysis|nan|
|Genetic: microarray analysis|nan|
|Genetic: mutation analysis|nan|
|Genetic: reverse transcriptase-polymerase chain reaction|nan|
|Other: immunohistochemistry staining method|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the association between tumor expression of FEZ1/LZTS1 gene and response to paclitaxel |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Utility of FEZ1/LZTS1 gene expression in predicting the full 4-level response pattern (complete response, partial response, stable disease, progressive disease) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, recurrent breast cancer