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

NCT ID: NCT00291109

Last Updated: 2008-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-01-31

Study Completion Date

2005-07-31

Brief Summary

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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

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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

Conditions

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Breast Cancer

Keywords

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breast atypia breast epithelial hyperplasia Ki-67 RTPCR microdissection

Study Design

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Study Time Perspective

PROSPECTIVE

Interventions

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letrozole 2.5 mg

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Kansas

OTHER

Sponsor Role lead

Principal Investigators

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Carol J Fabian, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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9298

Identifier Type: -

Identifier Source: org_study_id