NCT00291135

Protocol for Women at Increased Risk of Developing Breast Cancer

Study of the Effect of Letrozole on Breast Biomarkers of High Risk Postmenopausal Women Receiving Hormone Replacement Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Carol Fabian, MD · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	letrozole	Letrozole 2.5 mg daily

Timeline

• Start date: 2003-01-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2006-02-13
• Last updated: 2016-06-15
• Results posted: 2014-02-07

Locations

1 site across 1 country: United States