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

Mount Sinai Hospital, Canada

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: letrozole

Study type: Interventional

Funder types: Other

Identifiers

NCT01129622

CFWH-AI1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: Female

Ages: 40 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women are eligible to participate if they are 40 years or older and have been menopausal (had no menstrual bleeding during the past 12 months)

Exclusion criteria

• History of bilateral mastectomy, osteoporosis or renal impairment.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Letrozole, Breast enhancement, Safety

Experimental group

Description:

Single arm of healthy postmenopausal women who received baseline diagnostic MRI will receive letrozole of 12.5 mg/day orally for three successive days. A second post treatment breast MRI is done right after receiving the three days of letrozole treatment and within one month after the first MRI .

Treatment:

Drug: letrozole