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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00291109
First Posted: February 13, 2006
Last Update Posted: September 16, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Kansas Medical Center
  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 1 Phase 2

Study Type: Observational
Study Design: Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by University of Kansas Medical Center:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Medical Center
  More Information

ClinicalTrials.gov Identifier: NCT00291109     History of Changes
Other Study ID Numbers: 9298
First Submitted: February 10, 2006
First Posted: February 13, 2006
Last Update Posted: September 16, 2008
Last Verified: September 2008

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

Additional relevant MeSH terms:
Letrozole
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs