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

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Locations
Study Type
Observational
Intervention
cytogenetic analysis
gene expression analysis
microarray analysis
mutation analysis
reverse transcriptase-polymerase chain reaction
immunohistochemistry staining method
Sponsored by
Sidney Kimmel Cancer Center at Thomas Jefferson University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Breast Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

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

    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)

    Full Information

    First Posted
    May 9, 2009
    Last Updated
    December 17, 2013
    Sponsor
    Sidney Kimmel Cancer Center at Thomas Jefferson University
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00898690
    Brief Title
    Gene Expression in Predicting Response to Paclitaxel in Patients With Breast Cancer
    Official Title
    Determination Of FEZ1/LZTS1 Expression As A Predictor Of Response To Taxol
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    May 2006
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2003 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Sidney Kimmel Cancer Center at Thomas Jefferson University
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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

    7. Study Design

    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Genetic
    Intervention Name(s)
    cytogenetic analysis
    Intervention Type
    Genetic
    Intervention Name(s)
    gene expression analysis
    Intervention Type
    Genetic
    Intervention Name(s)
    microarray analysis
    Intervention Type
    Genetic
    Intervention Name(s)
    mutation analysis
    Intervention Type
    Genetic
    Intervention Name(s)
    reverse transcriptase-polymerase chain reaction
    Intervention Type
    Other
    Intervention Name(s)
    immunohistochemistry staining method
    Primary Outcome Measure Information:
    Title
    Evaluation of the association between tumor expression of FEZ1/LZTS1 gene and response to paclitaxel
    Secondary Outcome Measure Information:
    Title
    Utility of FEZ1/LZTS1 gene expression in predicting the full 4-level response pattern (complete response, partial response, stable disease, progressive disease)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Carlo M. Croce, MD
    Organizational Affiliation
    Sidney Kimmel Cancer Center at Thomas Jefferson University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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