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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2006 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00898690
First received: May 9, 2009
Last updated: December 17, 2013
Last verified: May 2006
  Purpose

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 Intervention
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

Study Type: Observational
Official Title: Determination Of FEZ1/LZTS1 Expression As A Predictor Of Response To Taxol

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Evaluation of the association between tumor expression of FEZ1/LZTS1 gene and response to paclitaxel [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Utility of FEZ1/LZTS1 gene expression in predicting the full 4-level response pattern (complete response, partial response, stable disease, progressive disease) [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: March 2003
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00898690

Sponsors and Collaborators
Kimmel Cancer Center (KCC)
Investigators
Principal Investigator: Carlo M. Croce, MD Kimmel Cancer Center (KCC)
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00898690     History of Changes
Other Study ID Numbers: CDR0000355163, TJUH-02U.536
Study First Received: May 9, 2009
Last Updated: December 17, 2013
Health Authority: United States: Federal Government

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:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 30, 2014