Phase 2
N=16
Effect of Aromatase Inhibitors on Breast Magnetic Resonance Imaging (MRI)
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01129622 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
May 2014
Primary outcome: Primary: Number of Women With Reduced Breast Parenchymal Enhancement — 7 Number of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- letrozole (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Female
- Sponsor
- Mount Sinai Hospital, Canada
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Women With Reduced Breast Parenchymal Enhancement |
7 | — |
| SECONDARY Number of Participants Developed Adverse Effects of 12.5 mg of Letrozole |
3 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01129622). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.