Trial Outcomes & Findings for Protocol for Women at Increased Risk of Developing Breast Cancer (NCT NCT00291694)
NCT ID: NCT00291694
Last Updated: 2016-11-07
Results Overview
Immunocytochemical staining of breast epithelial cells. Positive cells reflect proliferative activity.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
72 participants
Primary outcome timeframe
Baseline and 12 months
Results posted on
2016-11-07
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo for 12 months
|
Celecoxib
Celecoxib for 12 months
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
48
|
|
Overall Study
COMPLETED
|
21
|
43
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Protocol for Women at Increased Risk of Developing Breast Cancer
Baseline characteristics by cohort
| Measure |
Celecoxib
n=48 Participants
Celecoxib for six months
|
Placebo
n=24 Participants
Placebo for six months
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
48 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
48.7 years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
45.2 years
STANDARD_DEVIATION 8.5 • n=7 Participants
|
47.5 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
48 participants
n=5 Participants
|
24 participants
n=7 Participants
|
72 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 monthsImmunocytochemical staining of breast epithelial cells. Positive cells reflect proliferative activity.
Outcome measures
| Measure |
Celecoxib
n=43 Participants
Randomized to receive celecoxib daily for 12 months
|
Placebo
n=21 Participants
Randomized to receive placebo daily for 12 months
|
|---|---|---|
|
Change in Percent of Breast Epithelial Cells Staining Positive for Ki-67
|
-1.2 percentage of cells staining positive
Interval -18.0 to 14.8
|
-2.0 percentage of cells staining positive
Interval -8.8 to 12.2
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: Subjects completing 12 months, with baseline and 12 month mammograms suitable for density analysis, such that a change in density over time can be computed
The percent of mammographic breast area that is considered to be at increased density. Evaluated using the semi-automated computer program Cumulus.
Outcome measures
| Measure |
Celecoxib
n=44 Participants
Randomized to receive celecoxib daily for 12 months
|
Placebo
n=19 Participants
Randomized to receive placebo daily for 12 months
|
|---|---|---|
|
Mammographic Breast Density
|
-1.3 percentage of breast area at increased d
Standard Error 1.0
|
0.3 percentage of breast area at increased d
Standard Error 1.9
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsChange in serum estradiol concentration
Outcome measures
| Measure |
Celecoxib
n=43 Participants
Randomized to receive celecoxib daily for 12 months
|
Placebo
n=21 Participants
Randomized to receive placebo daily for 12 months
|
|---|---|---|
|
Serum Estradiol Concentration
|
-6.6 pg/ml
Standard Error 5.9
|
-5.7 pg/ml
Standard Error 11.7
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsChange in serum concentration
Outcome measures
| Measure |
Celecoxib
n=43 Participants
Randomized to receive celecoxib daily for 12 months
|
Placebo
n=21 Participants
Randomized to receive placebo daily for 12 months
|
|---|---|---|
|
Serum Sex Hormone Binding Globulin (SHBG) Concentration
|
-0.70 nmol/L
Standard Error 1.61
|
3.05 nmol/L
Standard Error 2.16
|
SECONDARY outcome
Timeframe: baseline to 12 monthsChange ion ratio.
Outcome measures
| Measure |
Celecoxib
n=43 Participants
Randomized to receive celecoxib daily for 12 months
|
Placebo
n=21 Participants
Randomized to receive placebo daily for 12 months
|
|---|---|---|
|
Molecular Ratio of Serum Concentration of IGF-1 to IGFBP3
|
-0.012 ratio
Standard Error 0.0039
|
-0.011 ratio
Standard Error 0.0071
|
Adverse Events
Celecoxib
Serious events: 0 serious events
Other events: 43 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Celecoxib
n=43 participants at risk
Randomized to receive celecoxib daily for 12 months
|
Placebo
n=21 participants at risk
Randomized to receive palcebo daily for 12 months
|
|---|---|---|
|
Immune system disorders
Allergic Reaction
|
7.0%
3/43 • Number of events 3 • 12 months
|
9.5%
2/21 • Number of events 2 • 12 months
|
|
General disorders
Fatigue
|
11.6%
5/43 • Number of events 5 • 12 months
|
0.00%
0/21 • 12 months
|
|
General disorders
Fever
|
4.7%
2/43 • Number of events 2 • 12 months
|
14.3%
3/21 • Number of events 3 • 12 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
23.3%
10/43 • Number of events 10 • 12 months
|
28.6%
6/21 • Number of events 6 • 12 months
|
|
Skin and subcutaneous tissue disorders
Skin-other
|
11.6%
5/43 • Number of events 5 • 12 months
|
4.8%
1/21 • Number of events 1 • 12 months
|
|
Reproductive system and breast disorders
Hot Flashes
|
11.6%
5/43 • Number of events 5 • 12 months
|
25.0%
3/12 • Number of events 3 • 12 months
|
|
Reproductive system and breast disorders
Reproductive-other
|
30.2%
13/43 • Number of events 13 • 12 months
|
14.3%
3/21 • Number of events 3 • 12 months
|
|
Gastrointestinal disorders
Constipation
|
25.6%
11/43 • Number of events 11 • 12 months
|
14.3%
3/21 • Number of events 3 • 12 months
|
|
Gastrointestinal disorders
Diarrhea
|
41.9%
18/43 • Number of events 18 • 12 months
|
33.3%
7/21 • Number of events 7 • 12 months
|
|
Gastrointestinal disorders
Dyspepsia
|
32.6%
14/43 • Number of events 14 • 12 months
|
23.8%
5/21 • Number of events 5 • 12 months
|
|
Gastrointestinal disorders
Flatulence
|
30.2%
13/43 • Number of events 13 • 12 months
|
38.1%
8/21 • Number of events 8 • 12 months
|
|
Gastrointestinal disorders
Nausea
|
16.3%
7/43 • Number of events 7 • 12 months
|
23.8%
5/21 • Number of events 5 • 12 months
|
|
Gastrointestinal disorders
Vomiting
|
4.7%
2/43 • Number of events 2 • 12 months
|
9.5%
2/21 • Number of events 2 • 12 months
|
|
Gastrointestinal disorders
GI-other
|
18.6%
8/43 • Number of events 8 • 12 months
|
14.3%
3/21 • Number of events 3 • 12 months
|
|
Gastrointestinal disorders
Rectal bleeding
|
9.3%
4/43 • Number of events 4 • 12 months
|
4.8%
1/21 • Number of events 1 • 12 months
|
|
Immune system disorders
Infection-other
|
55.8%
24/43 • Number of events 24 • 12 months
|
61.9%
13/21 • Number of events 13 • 12 months
|
|
Nervous system disorders
Insomnia
|
2.3%
1/43 • Number of events 1 • 12 months
|
9.5%
2/21 • Number of events 2 • 12 months
|
|
Gastrointestinal disorders
abdominal pain
|
23.3%
10/43 • Number of events 10 • 12 months
|
14.3%
3/21 • Number of events 3 • 12 months
|
|
Nervous system disorders
headache
|
44.2%
19/43 • Number of events 19 • 12 months
|
28.6%
6/21 • Number of events 6 • 12 months
|
|
Nervous system disorders
pain-other
|
44.2%
19/43 • Number of events 19 • 12 months
|
33.3%
7/21 • Number of events 7 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmnary-other
|
14.0%
6/43 • Number of events 6 • 12 months
|
9.5%
2/21 • Number of events 2 • 12 months
|
|
Renal and urinary disorders
Renal-other
|
0.00%
0/43 • 12 months
|
14.3%
3/21 • Number of events 3 • 12 months
|
|
Reproductive system and breast disorders
Irregular menses
|
14.0%
6/43 • Number of events 6 • 12 months
|
28.6%
6/21 • Number of events 6 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place