This trial is active, not recruiting.

Condition breast cancer
Treatments cytogenetic analysis, gene expression analysis, microarray analysis, mutation analysis, reverse transcriptase-polymerase chain reaction, immunohistochemistry staining method
Sponsor Kimmel Cancer Center (KCC)
Collaborator National Cancer Institute (NCI)
Start date March 2003
Trial size 120 participants
Trial identifier NCT00898690, CDR0000355163, TJUH-02U.536


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.

United States No locations recruiting
Other Countries No locations recruiting

Primary Outcomes

Evaluation of the association between tumor expression of FEZ1/LZTS1 gene and response to paclitaxel
time frame:

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Determination Of FEZ1/LZTS1 Expression As A Predictor Of Response To Taxol
Principal investigator Carlo M. Croce, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).