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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00898690
Recruitment Status : Unknown
Verified May 2006 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : May 12, 2009
Last Update Posted : December 18, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment
Breast Cancer Genetic: cytogenetic analysis Genetic: gene expression analysis Genetic: microarray analysis Genetic: mutation analysis Genetic: reverse transcriptase-polymerase chain reaction Other: immunohistochemistry staining method

Detailed Description:


  • 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.

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Study Type : Observational
Estimated Enrollment : 120 participants
Official Title: Determination Of FEZ1/LZTS1 Expression As A Predictor Of Response To Taxol
Study Start Date : March 2003

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Evaluation of the association between tumor expression of FEZ1/LZTS1 gene and response to paclitaxel

Secondary Outcome Measures :
  1. Utility of FEZ1/LZTS1 gene expression in predicting the full 4-level response pattern (complete response, partial response, stable disease, progressive disease)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • Not specified


  • See Disease Characteristics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00898690

Sponsors and Collaborators
Sidney Kimmel Cancer Center at Thomas Jefferson University
National Cancer Institute (NCI)
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Principal Investigator: Carlo M. Croce, MD Sidney Kimmel Cancer Center at Thomas Jefferson University
Layout table for additonal information Identifier: NCT00898690    
Other Study ID Numbers: CDR0000355163
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: December 18, 2013
Last Verified: May 2006
Keywords provided by National Cancer Institute (NCI):
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
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases