NCT00898690

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
6.2 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
Last Updated

December 18, 2013

Status Verified

May 1, 2006

First QC Date

May 9, 2009

Last Update Submit

December 17, 2013

Conditions

Breast Cancer

Keywords

stage I breast cancerstage II breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancerstage IV breast cancerrecurrent breast cancer

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

cytogenetic analysisGENETIC
gene expression analysisGENETIC
microarray analysisGENETIC
mutation analysisGENETIC
reverse transcriptase-polymerase chain reactionGENETIC
immunohistochemistry staining methodOTHER

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cytogenetic AnalysisGene Expression ProfilingMicroarray AnalysisReverse Transcriptase Polymerase Chain ReactionImmunohistochemistry

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesGenetic TechniquesMicrochip Analytical ProceduresPolymerase Chain ReactionNucleic Acid Amplification TechniquesHistocytochemistryHistological TechniquesImmunologic Techniques

Study Officials

  • Carlo M. Croce, MD

    Sidney Kimmel Cancer Center at Thomas Jefferson University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

March 1, 2003

Last Updated

December 18, 2013

Record last verified: 2006-05