CClinicalTrials.gg
Status unknownNCT00898690Updated Dec 18, 2013

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

An observational study in Breast Cancer, sponsored by Sidney Kimmel Cancer Center at Thomas Jefferson University. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-12-18.

Sponsored by Sidney Kimmel Cancer Center at Thomas Jefferson University · Observational

The sponsor has not verified this record recently (last verified May 2006), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Enrollment
120
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Breast Cancer

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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
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In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 120 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Sidney Kimmel Cancer Center at Thomas Jefferson University is the lead sponsor of 125 studies on the registry; none are open to participants now.

Of its 23 completed or terminated interventional studies of FDA-regulated products, 7 (30%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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
05

Study design

Enrollment
120 participants (estimated)

Interventions

  • Geneticcytogenetic analysis
  • Geneticgene expression analysis
  • Geneticmicroarray analysis
  • Geneticmutation analysis
  • Geneticreverse transcriptase-polymerase chain reaction
  • Otherimmunohistochemistry staining method
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What researchers measure

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)

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 18, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00898690
Lead sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborators
National Cancer Institute (NCI)
First posted
May 12, 2009
Start date
Mar 2003
Last update
Dec 18, 2013

Study contacts

Carlo M. Croce, MD
principal investigator · Sidney Kimmel Cancer Center at Thomas Jefferson University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2006. You cannot join it, but the record below documents what was studied.

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