Study of Breast Cancer Prevention by Letrozole in High Risk Women

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2018-08-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Letrozole

Letrozole, 2.5 mg daily for 6 months

Group Type EXPERIMENTAL

Letrozole

Intervention Type DRUG

Letrozole 2.5 mg tablet daily. Then optional open label letrozole for another 6 months.

Placebo

Placebo, daily for 6 months

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablet daily for 6 months then optional open label letrozole for 6 months.

Interventions

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Letrozole

Letrozole 2.5 mg tablet daily. Then optional open label letrozole for another 6 months.

Intervention Type DRUG

Placebo

Placebo tablet daily for 6 months then optional open label letrozole for 6 months.

Intervention Type DRUG

Other Intervention Names

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Letrozole(Femara)

Eligibility Criteria

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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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

69 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No