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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Robert Casper, Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier:
NCT01129622
First received: May 21, 2010
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Breast Cancer
Drug: letrozole
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Phase II Study of the Effect of Acute Aromatase Inhibition on Breast MRI Postmenopausal Women

Resource links provided by NLM:


Further study details as provided by Mount Sinai Hospital, Canada:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • Number of Participants Developed Adverse Effects of 12.5 mg of Letrozole [ Time Frame: Three days plus One Week following medication ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 16
Study Start Date: October 2008
Study Completion Date: September 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01129622

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

Publications:
Responsible Party: Robert Casper, Professor, Obstetrics and Gynecology, Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier: NCT01129622     History of Changes
Other Study ID Numbers: CFWH-AI1
Study First Received: May 21, 2010
Results First Received: March 3, 2012
Last Updated: April 1, 2014
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Aromatase Inhibitors
Letrozole
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014