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


N/A
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer

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Trial Information

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


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.

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

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

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

Safety Issue:

No

Principal Investigator

Carlo M. Croce, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Kimmel Cancer Center (KCC)

Authority:

United States: Federal Government

Study ID:

CDR0000355163

NCT ID:

NCT00898690

Start Date:

March 2003

Completion Date:

Related Keywords:

  • Breast Cancer
  • 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
  • Breast Neoplasms

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