Trial Outcomes & Findings for S0300, Celecoxib in Preventing Breast Cancer in Premenopausal Women (NCT NCT00088972)

Results Overview

The primary outcome measure is change in mammographic density. The null hypothesis is that there is no difference between the arms in change in mammographic density over one year versus the alternative that the treatment arm reduces mammographic density by 10 points (percent of pixels highlighted) or more over one year compared to the change in the placebo arm.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

8 participants

Primary outcome timeframe

1 year

Results posted on

2018-08-10

Participant Flow

Participant milestones

Participant milestones
Measure	Arm I Patients receive oral celecoxib twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.	Arm II Patients receive oral placebo twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
Overall Study STARTED	3	5
Overall Study COMPLETED	1	1
Overall Study NOT COMPLETED	2	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

S0300, Celecoxib in Preventing Breast Cancer in Premenopausal Women

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I n=3 Participants Patients receive oral celecoxib twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.	Arm II n=5 Participants Patients receive oral placebo twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.	Total n=8 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=39 Participants	5 Participants n=41 Participants	8 Participants n=35 Participants
Age, Categorical >=65 years	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Age, Continuous	43.8 years STANDARD_DEVIATION 3.9 • n=39 Participants	43.3 years STANDARD_DEVIATION 5.9 • n=41 Participants	43.5 years STANDARD_DEVIATION 4.9 • n=35 Participants
Sex: Female, Male Female	3 Participants n=39 Participants	5 Participants n=41 Participants	8 Participants n=35 Participants
Sex: Female, Male Male	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Region of Enrollment United States	3 participants n=39 Participants	5 participants n=41 Participants	8 participants n=35 Participants

PRIMARY outcome

Timeframe: 1 year

Population: Counts represent number of patients for by arm for whom a 1 year mammographic density image was submitted. However, since the study was closed early due to poor accrual, there was insufficient accrual to evaluate study endpoints, and these images were never analyzed.

The primary outcome measure is change in mammographic density. The null hypothesis is that there is no difference between the arms in change in mammographic density over one year versus the alternative that the treatment arm reduces mammographic density by 10 points (percent of pixels highlighted) or more over one year compared to the change in the placebo arm.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Population: Since the study was closed early due to insufficient accrual, the ki-67 data were never collected.

The difference between the two arms in the percent of patients with non-zero ki-67 expression over the two time periods (baseline and 1-year).

Outcome measures

Outcome data not reported

Adverse Events

Arm I

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Arm II

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Arm I n=3 participants at risk Patients receive oral celecoxib twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.	Arm II n=5 participants at risk Patients receive oral placebo twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
Reproductive system and breast disorders Pain - breast	33.3% 1/3 • Number of events 1	0.00% 0/5
Gastrointestinal disorders Dry mouth	33.3% 1/3 • Number of events 1	0.00% 0/5
Cardiac disorders Hypertension	33.3% 1/3 • Number of events 1	0.00% 0/5
Metabolism and nutrition disorders Weight gain	33.3% 1/3 • Number of events 1	0.00% 0/5

Additional Information

Study Statistician

SWOG

Phone: 206-667-4623

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place