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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00898690

Enrollment

120

Registered

2009-05-12

Start date

2003-03-31

Completion date

Unknown

Last updated

2013-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

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

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.

Interventions

GENETICcytogenetic analysis

GENETICgene expression analysis

GENETICmicroarray analysis

GENETICmutation analysis

GENETICreverse transcriptase-polymerase chain reaction

OTHERimmunohistochemistry staining method

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Evaluation of the association between tumor expression of FEZ1/LZTS1 gene and response to paclitaxel	—

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026