Study of Breast Cancer Prevention by Letrozole in High Risk Women

Carol Fabian, MD

Status and phase

Completed

Phase 2

Conditions

Breast Cancer

Treatments

Drug: Letrozole

Drug: Placebo

Study type

Interventional

Funder types

Other

Industry

NIH

Identifiers

NCT00579826

10587

CFEM345AUS45 (Other Grant/Funding Number)

5R01CA122577-03 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This is a multi-institution double-blind placebo-controlled trial whose main objective is to determine if 6 months of letrozole (2.5 mg daily) can reduce proliferation as assessed by Ki-67 in high risk postmenopausal women on systemic hormone replacement therapy who have random periareolar fine needle aspiration (RPFNA) evidence of hyperplasia with atypia or borderline atypia, and a minimum Ki-67 of >1.5%.

The primary hypothesis is that proliferation and expression of other estrogen response genes will be favorably modulated by six months of letrozole relative to placebo without substantially increasing hot flashes or worsening overall quality of life.

Full description

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

Enrollment

55 patients

Sex

Female

Ages

30 to 69 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Post-menopausal women at high risk for development of breast cancer
stable dose of hormone replacement therapy
have cytomorphologic evidence of hyperplasia +/- atypia and Ki-67 expression >1.5% in benign breast epithelial cells acquired by RPFNA
Serum level of 25-hydroxyvitamin D of at least 30 ng/ml prior to study entry
Willing to have a repeat random periareolar fine needle aspiration (RPFNA) and mammogram at 6 months and 12 months (if participating in the open label portion of the study) following initiation of study drug

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 cyclooxygenase-2 (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.