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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00291109
• Other study ID #: 9298
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 10, 2006
• Last updated: September 15, 2008
• Start date: January 2003
• Est. completion date: July 2005

Study information

• Verified date: September 2008
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Drug:
• letrozole 2.5 mg

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States,