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| ID | Type | Description | Link |
|---|---|---|---|
| TJUH-02U.536 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
OBJECTIVES:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cytogenetic analysis | Genetic | |||
| gene expression analysis | Genetic | |||
| microarray analysis | Genetic | |||
| mutation analysis | Genetic | |||
| reverse transcriptase-polymerase chain reaction | Genetic | |||
| immunohistochemistry staining method | Other |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the association between tumor expression of FEZ1/LZTS1 gene and response to paclitaxel |
| 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) |
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DISEASE CHARACTERISTICS:
Diagnosis of breast cancer
Measurable disease
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:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Carlo M. Croce, MD | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University | Principal Investigator |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D020732 | Cytogenetic Analysis |
| D020869 | Gene Expression Profiling |
| D046228 | Microarray Analysis |
| D020133 | Reverse Transcriptase Polymerase Chain Reaction |
| D007150 | Immunohistochemistry |
| ID | Term |
|---|---|
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D005821 | Genetic Techniques |
| D046208 | Microchip Analytical Procedures |
| D016133 | Polymerase Chain Reaction |
| D021141 | Nucleic Acid Amplification Techniques |
| D006651 | Histocytochemistry |
| D006652 | Histological Techniques |
| D007158 | Immunologic Techniques |
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