An Examination of Predictors of Indicators of Response to Letrozole 2.5 mg - Tabular View

Tracking Information

First Received Date ^ICMJE

February 10, 2006

Last Updated Date

September 15, 2008

Start Date ^ICMJE

January 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00291109 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

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

Study Phase

Phase I, Phase II

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Prospective

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

Drug: letrozole 2.5 mg

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00291109

Responsible Party

Study ID Numbers ^ICMJE

9298

Study Sponsor ^ICMJE

University of Kansas

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Carol J Fabian, MD

University of Kansas

Information Provided By

University of Kansas

Verification Date

September 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP