Trial Outcomes & Findings for Effect of Aromatase Inhibitors on Breast Magnetic Resonance Imaging (MRI) (NCT NCT01129622)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

16 participants

Primary outcome timeframe

One month MRI study after letrozole compared to baseline MRI study, both with gadolinium enhancement

Results posted on

2014-05-01

Participant Flow

16 women over age 40 on hormone therapy were recruited. No previous abnormal breast imaging.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	16
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Withdrawal by Subject	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Letrozole, Breast Enhancement, Safety n=16 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	60 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment Canada	16 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Letrozole, Breast Enhancement, Safety n=14 Participants 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.
Number of Women With Reduced Breast Parenchymal Enhancement	7 Number of participants

SECONDARY outcome

Timeframe: Three days plus One Week following medication

Population: All entered subjects

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.

Outcome measures

Outcome measures
Measure	Letrozole, Breast Enhancement, Safety n=14 Participants 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.
Number of Participants Developed Adverse Effects of 12.5 mg of Letrozole	3 Number of participants

Adverse Events

Letrozole, Breast Enhancement, Safety

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Letrozole, Breast Enhancement, Safety n=14 participants at risk 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.
Nervous system disorders Headache	7.1% 1/14 • 10 months Subject report of adverse events prior to second MRI.
Musculoskeletal and connective tissue disorders Arthralgia	14.3% 2/14 • 10 months Subject report of adverse events prior to second MRI.

Additional Information

Robert F Casper

Mount Sinai Hospital

Phone: 416-972-0777

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place