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Study of Breast Cancer Prevention by Letrozole in High Risk Women

Phase 2
30 Years
69 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Study of Breast Cancer Prevention by Letrozole in High Risk Women

Subsequent to the 6 month RPFNA for assessment of biomarkers, toxicity and quality of life
assessments, all women may receive optional open-label letrozole for an additional 6 months,
followed by a third RPFNA and biomarker

Inclusion Criteria:

- Post-menopausal women at high risk for development of breast cancer

- On a stable dose of hormone replacement therapy

- have cytomophologic evidence of hyperplasia +/- atypia and Ki-67 expression >1.5% in
benign breast epithelial cells acquired by RPFNA

- Serum level of 25-OH vitamin D of at least 30 ng/ml prior to study entry

- Willing to have a repeat RPFNA and mammogram at 6 months and 12 months (if
participating in the open label portion of the study) following initiation of study

Exclusion Criteria:

- Prior history of osteoporosis or osteoporotic fracture.

- Prior history of invasive breast cancer or other invasive cancer within five years
from date of study entry.

- Current and chronic use of COX-2 specific inhibitors or NSAIDs

- Receiving treatment for rheumatoid arthritis or fibromyalgia

- Current history of poorly controlled migraines or perimenopausal symptoms

- Currently receiving other investigational agents.

- Receipt of more than 6 months of an aromatase inhibitor (anastrozole, exemestane,
letrozole, etc.) at any time in the past.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Outcome Measure:

Assessment of proliferation rate (Ki-67 by immunocytochemistry) in benign breast epithelial cells acquired by random periareolar fine needle aspiration from women at high risk for the development of breast cancer.

Outcome Time Frame:

6 Month

Safety Issue:


Principal Investigator

Carol J Fabian, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Kansas


United States: Food and Drug Administration

Study ID:




Start Date:

October 2006

Completion Date:

July 2013

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms



University of Kansas Medical Center Kansas City, Kansas  66160-7353
University of California San Francisco San Francisco, California  941104206