Gene Expression in Predicting Response to Paclitaxel in Patients With Breast Cancer
NCT ID: NCT00898690
Last Updated: 2013-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
120 participants
OBSERVATIONAL
2003-03-31
Brief Summary
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PURPOSE: This laboratory study is evaluating gene expression in predicting response to paclitaxel in patients with breast cancer.
Detailed Description
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* 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.
Conditions
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Keywords
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Interventions
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cytogenetic analysis
gene expression analysis
microarray analysis
mutation analysis
reverse transcriptase-polymerase chain reaction
immunohistochemistry staining method
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Sidney Kimmel Cancer Center at Thomas Jefferson University
OTHER
Principal Investigators
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Carlo M. Croce, MD
Role: PRINCIPAL_INVESTIGATOR
Sidney Kimmel Cancer Center at Thomas Jefferson University
Other Identifiers
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TJUH-02U.536
Identifier Type: -
Identifier Source: secondary_id
CDR0000355163
Identifier Type: -
Identifier Source: org_study_id