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

This study has been completed.
Sponsor:
Information provided by:
University of Kansas
ClinicalTrials.gov Identifier:
NCT00291109
First received: February 10, 2006
Last updated: September 15, 2008
Last verified: September 2008
  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:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

ClinicalTrials.gov Identifier: NCT00291109     History of Changes
Other Study ID Numbers: 9298
Study First Received: February 10, 2006
Last Updated: September 15, 2008
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 18, 2014