Effect of Aromatase Inhibitors on Breast Magnetic Resonance Imaging (MRI) (RFCLET2)
|ClinicalTrials.gov Identifier: NCT01129622|
Recruitment Status : Completed
First Posted : May 24, 2010
Results First Posted : May 1, 2014
Last Update Posted : May 1, 2014
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: letrozole||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of the Effect of Acute Aromatase Inhibition on Breast MRI Postmenopausal Women|
|Study Start Date :||October 2008|
|Primary Completion Date :||September 2009|
|Study Completion Date :||September 2010|
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 .
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
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01129622
|Mount Sinai Hospital|
|Toronto, Ontario, Canada, M5T 3H7|
|Principal Investigator:||Robert F Casper, MD||Mount Sinai Hopsital|