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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00291109

Enrollment

Registered

2006-02-13

Start date

2003-01-31

Completion date

2005-07-31

Last updated

2008-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

breast atypia, breast epithelial hyperplasia, Ki-67, RTPCR, microdissection

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

Interventions

DRUGletrozole 2.5 mg

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026