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An Examination of Predictors of Indicators of Response to Letrozole 2.5 Mg

This study has been completed.

Sponsored by: University of Kansas
Information provided by: University of Kansas
ClinicalTrials.gov Identifier: NCT00291109
  Purpose

To assess the quantitative real time PCR results of oligonucleotide probes for a number of gene transcription products that may be useful as predictors or indicators of response to letrozole


Condition Intervention Phase
Breast Cancer
Drug: letrozole 2.5 mg
Phase I
Phase II

Genetics Home Reference related topics:   breast cancer   

MedlinePlus related topics:   Breast Cancer    Cancer   

ChemIDplus related topics:   Letrozole    Formaldehyde   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Screening, Cross-Sectional, Random Sample, Prospective Study
Official Title:   Quantitative Real Time PCR in Cytolytic Formalin Fixed Breast Cells Obtained by Periareolar Fine Needle Aspiration. An Ancillary Protocol to a Chemoprevention Trial of Letrozole

Further study details as provided by University of Kansas:

Estimated Enrollment:   40
Study Start Date:   January 2003
Estimated Study Completion Date:   July 2005

Detailed Description:

To assess the quantitative real time PCR results of oligonucleotide probes for a number of gene transcription products (PCNA, cyclin-D1, ER alpha, PR, pS2, )450 aromatase, bcl-2, bax, caspase-3, and VEGFR) that may be useful as predictors or indicators of response to letrozole

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • evidence of hyperplasia with/without atypia upon random periareolar fine needle aspiration of breast
  • on hormone replacement therapy
  • postmenopausal
  • increased risk of developing breast cancer based on personal or family history
  • never have taken aromatase inhibitors or selective estrogen receptor modulators in last six months
  • women who have a high risk of breast cancer
  • older than 18 years

Exclusion Criteria:

  • no anticoagulants
  • no marked breast tenderness
  • not pregnant or within twelve months of breast feeding/childbirth
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00291109

Locations
United States, Kansas
University of Kansas Medical Center    
      Kansas City, Kansas, United States, 66160

Sponsors and Collaborators
University of Kansas

Investigators
Principal Investigator:     Carol J Fabian, MD     University of Kansas    
  More Information

Study ID Numbers:   9298
First Received:   February 10, 2006
Last Updated:   June 16, 2006
ClinicalTrials.gov Identifier:   NCT00291109
Health Authority:   United States: Institutional Review Board

Keywords provided by University of Kansas:
breast atypia  
breast epithelial hyperplasia  
Ki-67  
RTPCR  
microdissection  

Study placed in the following topic categories:
Hyperplasia
Skin Diseases
Formaldehyde
Breast Neoplasms
Letrozole
Breast Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Aromatase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008




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