Protocol for Women at Increased Risk of Developing Breast Cancer

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Drug: letrozole

• Registration Number: NCT00291135
• Lead Sponsor: Carol Fabian, MD

Brief Summary

A pilot study to assess the effects of six months of letrozole on breast tissue risk markers in postmenopausal women on hormone replacement therapy at high risk of developing breast cancer.

Detailed Description

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 Epithelial Hyperplasia/Atypical Hyperplasia) and evidence of Estrogen Receptor 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-qPCR on breast specimens for aromatase expression will also be done at baseline.

Study Timeline

• Study Start: 2003-01
• Study First Submitted: 2006-02-10
• Study First Submitted QC: 2006-02-10
• Study First Posted: 2006-02-13
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Results First Submitted: 2013-06-24
• Results First Submitted QC: 2014-01-08
• Results First Posted: 2014-02-07
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-11
• Last Update Posted: 2016-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	letrozole	Oral Letrozole 2.5 mg daily for six months

Primary Outcome Measures

Name	Time	Method
Change in Proliferation of Breast Epithelial Cells Obtained by Random Periareolar Fine Needle Aspiration.	Baseline, 6 months	Proliferation assessment by immunocytochemistry using Ki-67. Expressed as percent of cells staining positive for Ki-67.

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States