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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00898690
• Other study ID #: CDR0000355163
• Secondary ID: TJUH-02U.536
• Status: Active, not recruiting
• Phase: N/A
• First received: May 9, 2009
• Last updated: December 17, 2013
• Start date: March 2003

Study information

• Verified date: May 2006
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Genetic:
• cytogenetic analysis

• gene expression analysis

• microarray analysis

• mutation analysis

• reverse transcriptase-polymerase chain reaction

Other:
• immunohistochemistry staining method

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Kimmel Cancer Center (KCC)	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the association between tumor expression of FEZ1/LZTS1 gene and response to paclitaxel			No
Secondary	Utility of FEZ1/LZTS1 gene expression in predicting the full 4-level response pattern (complete response, partial response, stable disease, progressive disease)			No