Trial Outcomes & Findings for Impact of Low-dose Tamoxifen on BPU (NCT NCT02979301)
NCT ID: NCT02979301
Last Updated: 2019-07-16
Results Overview
An image analysis tool to obtain a quantitative measure of background parenchymal uptake (BPU) was applied to pre-tamoxifen and post-tamoxifen MBI exams. The percent change in BPU from pre-tamoxifen to post-tamoxifen MBI was determined.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
30 days
Results posted on
2019-07-16
Participant Flow
Participant milestones
| Measure |
Tamoxifen 5 mg/Day
Women with a history of high background uptake on MBI were enrolled.
A baseline MBI was performed at Day 0. Women then took 5 mg tamoxifen per day for 30 days, followed by a post-tamoxifen MBI exam.
|
Tamoxifen 10 mg/Day
Women with a history of high background uptake on MBI were enrolled.
A baseline MBI was performed at Day 0. Women then took 10 mg tamoxifen per day for 30 days, followed by a post-tamoxifen MBI exam.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
|
Overall Study
COMPLETED
|
10
|
11
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Impact of Low-dose Tamoxifen on BPU
Baseline characteristics by cohort
| Measure |
Tamoxifen 5 mg/Day
n=10 Participants
Women with a history of high background uptake on MBI were enrolled.
A baseline MBI was performed at Day 0. Women then took 5 mg tamoxifen per day for 30 days, followed by a post-tamoxifen MBI exam.
|
Tamoxifen 10 mg/Day
n=11 Participants
Women with a history of high background uptake on MBI were enrolled.
A baseline MBI was performed at Day 0. Women then took 10 mg tamoxifen per day for 30 days, followed by a post-tamoxifen MBI exam.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.3 years
STANDARD_DEVIATION 4.4 • n=5 Participants
|
48.1 years
STANDARD_DEVIATION 4.0 • n=7 Participants
|
47.7 years
STANDARD_DEVIATION 4.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
11 participants
n=7 Participants
|
21 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 daysAn image analysis tool to obtain a quantitative measure of background parenchymal uptake (BPU) was applied to pre-tamoxifen and post-tamoxifen MBI exams. The percent change in BPU from pre-tamoxifen to post-tamoxifen MBI was determined.
Outcome measures
| Measure |
Tamoxifen 5 mg/Day
n=10 Participants
Women with a history of high background uptake on MBI were enrolled.
A baseline MBI was performed at Day 0. Women then took 5 mg tamoxifen per day for 30 days, followed by a post-tamoxifen MBI exam.
|
Tamoxifen 10 mg/Day
n=11 Participants
Women with a history of high background uptake on MBI were enrolled.
A baseline MBI was performed at Day 0. Women then took 10 mg tamoxifen per day for 30 days, followed by a post-tamoxifen MBI exam.
|
|---|---|---|
|
Change in Background Parenchymal Uptake (BPU) on Molecular Breast Imaging (MBI)
|
0.0 percent change in BPU
Standard Deviation 21
|
-12 percent change in BPU
Standard Deviation 11
|
Adverse Events
Tamoxifen 5 mg/Day
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Tamoxifen 10 mg/Day
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place