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Study of the Effect of Letrozole on Breast Biomarkers of High Risk Postmenopausal Women Receiving Hormone Replacement Therapy


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

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Trial Information

Study of the Effect of Letrozole on Breast Biomarkers of High Risk Postmenopausal Women Receiving Hormone Replacement Therapy


A pilot study of letrozole in postmenopausal women on hormone replacement therapy at high
risk of developing breast cancer. Subjects will have hyperplasia with atypia (or borderline
EH/AH) and evidence of ER expression by random periareolar fine needle aspiration and
baseline serum estradiol levels less than or equal to 150 pg/ml. The feasibility of
performing RT-PCR on breast specimens for aromatase expression will also be done at
baseline.


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:

- anticoagulants

- marked breast tenderness

- pregnant or within twelve months of breast feeding/childbirth

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Cytology of breast tissue aspirate using standard scoring methods and the Masood scoring system for proliferation markers.

Outcome Time Frame:

Baseline, 6 months

Safety Issue:

No

Principal Investigator

Carol J Fabian, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Kansas

Authority:

United States: Institutional Review Board

Study ID:

8884

NCT ID:

NCT00291135

Start Date:

January 2003

Completion Date:

October 2008

Related Keywords:

  • Breast Cancer
  • breast atypia
  • open label pilot study
  • letrozole
  • fine needle aspiration
  • high risk for breast cancer
  • breast epithelial hyperplasia
  • Ki-67
  • hormones plus chemoprevention
  • chemoprevention
  • Breast Neoplasms

Name

Location

University of Kansas Medical CenterKansas City, Kansas  66160-7353