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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01129622
Recruitment Status : Completed
First Posted : May 24, 2010
Results First Posted : May 1, 2014
Last Update Posted : May 1, 2014
Information provided by (Responsible Party):
Robert Casper, Mount Sinai Hospital, Canada

Brief 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: letrozole Phase 2

Detailed 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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Phase II Study of the Effect of Acute Aromatase Inhibition on Breast MRI Postmenopausal Women
Study Start Date : October 2008
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Letrozole

Arm Intervention/treatment
Experimental: Letrozole, Breast enhancement, Safety
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 .
Drug: letrozole
Letrozole (12.5 mg/day ) which is higher than the dose routinely used for therapeutic indications is given for a brief duration (3 successive days) aiming to promote acute aromatase inhibition suitable for pre-diagnostic regimens.
Other Name: Femara TM Novartis Pharmaceuticals Canada Inc., Dorval, QC

Primary Outcome Measures :
  1. Number of Women With Reduced Breast Parenchymal Enhancement [ Time Frame: One month MRI study after letrozole compared to baseline MRI study, both with gadolinium enhancement ]
    Image analysis was done using the e-film workstation. A region of interest was selected in all images. The signal intensity of enhancement was recorded and the relative enhancement (percentage of increase in signal intensity) was calculated as (SIc − SI)/SI × 100, where SI and SIc are the precontrast and the postcontrast signal intensities, respectively. Relative enhancement was compared at the baseline MRI study and the after one month MRI study for all participants.

Secondary Outcome Measures :
  1. Number of Participants Developed Adverse Effects of 12.5 mg of Letrozole [ Time Frame: Three days plus One Week following medication ]
    The number of participants who developed short term hypoestrogenic side effects or other adverse effects of letrozole during the intake of the medication or in the following week.

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01129622

Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5T 3H7
Sponsors and Collaborators
Mount Sinai Hospital, Canada
Principal Investigator: Robert F Casper, MD Mount Sinai Hopsital

Publications of Results:
Responsible Party: Robert Casper, Professor, Obstetrics and Gynecology, Mount Sinai Hospital, Canada Identifier: NCT01129622     History of Changes
Other Study ID Numbers: CFWH-AI1
First Posted: May 24, 2010    Key Record Dates
Results First Posted: May 1, 2014
Last Update Posted: May 1, 2014
Last Verified: April 2014

Keywords provided by Robert Casper, Mount Sinai Hospital, Canada:
Breast MRI
Postmenopausal women

Additional relevant MeSH terms:
Aromatase Inhibitors
Antineoplastic Agents
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs