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

This study has been completed.

First Received: February 10, 2006 Last Updated: September 15, 2008 History of Changes

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

Drug Information available for: Letrozole

U.S. FDA Resources

Study Type:	Observational
Study Design:	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

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

No publications provided

Study ID Numbers:	9298
Study First Received:	February 10, 2006
Last Updated:	September 15, 2008
ClinicalTrials.gov Identifier:	NCT00291109 History of Changes
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
Aromatase Inhibitors
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Antineoplastic Agents
Therapeutic Uses

Breast Neoplasms
Enzyme Inhibitors
Letrozole
Aromatase Inhibitors
Pharmacologic Actions
Breast Diseases

ClinicalTrials.gov processed this record on May 06, 2009