Breast Cancer
Conditions
Keywords
Letrozole, Breast MRI, Postmenopausal women
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.
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.
Interventions
DRUGletrozole
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.
Sponsors
Mount Sinai Hospital, Canada
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Women With Reduced Breast Parenchymal Enhancement | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Developed Adverse Effects of 12.5 mg of Letrozole | 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. |
Countries
Canada
Participant flow
Recruitment details
16 women over age 40 on hormone therapy were recruited. No previous abnormal breast imaging.
Participants by arm
| Arm | Count |
|---|---|
| Letrozole, Breast Enhancement, Safety Single arm of healthy postmenopausal women to have two breast MRI (baseline and post-treatment). Letrozole of 12.5 mg/day is given for three successive days just prior to the second MRI. | 16 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Letrozole, Breast Enhancement, Safety |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants |
| Age, Continuous | 60 years STANDARD_DEVIATION 11 |
| Region of Enrollment Canada | 16 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 14 |
| serious Total, serious adverse events | 0 / 14 |
Outcome results
Primary
Number of Women With Reduced Breast Parenchymal 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.
Time frame: One month MRI study after letrozole compared to baseline MRI study, both with gadolinium enhancement
Population: All participants who completed two MRIs were analysed. Percentage reduction in breast enhancement compared to baseline was determined.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Letrozole, Breast Enhancement, Safety | Number of Women With Reduced Breast Parenchymal Enhancement | 7 Number of participants |
Secondary
Number of Participants Developed Adverse Effects of 12.5 mg of Letrozole
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.
Time frame: Three days plus One Week following medication
Population: All entered subjects
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Letrozole, Breast Enhancement, Safety | Number of Participants Developed Adverse Effects of 12.5 mg of Letrozole | 3 Number of participants |