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Study of Breast Cancer Prevention by Letrozole in High Risk Women

NCT00579826 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2023-06-12

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Letrozole

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • National Cancer Institute (NCI)

    collaborator NIH

  • Carol Fabian, MD

    lead OTHER

Principal Investigators

  • Carol J Fabian, MD · University of Kansas Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
69 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2015-03-31
Completion
2018-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00579826 on ClinicalTrials.gov