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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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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


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


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

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Principal Investigator

Carol J Fabian, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Kansas

Authority:

United States: Institutional Review Board

Study ID:

9298

NCT ID:

NCT00291109

Start Date:

January 2003

Completion Date:

July 2005

Related Keywords:

  • Breast Cancer
  • breast atypia
  • breast epithelial hyperplasia
  • Ki-67
  • RTPCR
  • microdissection
  • Breast Neoplasms

Name

Location

University of Kansas Medical Center Kansas City, Kansas  66160-7353