Effect of Aromatase Inhibitors on Breast Magnetic Resonance Imaging (MRI) — RFCLET2  

Breast Cancer Clinical Trial

Official title: Phase II Study of the Effect of Acute Aromatase Inhibition on Breast MRI Postmenopausal Women

Status Completed

Clinical Trial Summary

This study is a primary investigation to determine the usefulness and safety of a short course of a relatively high dose of letrozole (a medication used to decrease the female hormone estrogen which is produced locally inside the breast after menopause) in improving the performance of of breast MRI (Magnetic Resonance Imaging). The inhibition of estrogen in the breast by letrozole might help better identifying of suspicious areas in the breast and could assist radiologists in distinguishing between benign breast areas and cancer tissue. This might help reducing the rate of call backs and unnecessary biopsies for patients. We expect to enroll 20 healthy postmenopausal women in this study.

Clinical Trial Description

A breast MRI will be performed in the standard way for diagnosis and to serve as a baseline. A second MRI will be performed within a month and following administration of letrozole 12.5 mg daily for three days to reduce breast estrogen levels and in anticipation of lowering breast gadolinium dye uptake. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer

• NCT number: NCT01129622
• Study type: Interventional
• Source: Mount Sinai Hospital, Canada
• Status: Completed
• Phase: Phase 2
• Start date: October 2008
• Completion date: September 2010