Trial Outcomes & Findings for Exemestane and Celecoxib in Postmenopausal Women at High Risk for Breast Cancer (NCT NCT00073073)

NCT ID: NCT00073073

Last Updated: 2016-05-17

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 46 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2016-05-17

Participant Flow

Participant milestones

Measure	Exemestane exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects. Exemestane: exemestane 25 mg by mouth (PO) every day for two years Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years Vitamin D: Vitamin D 400 international units PO every day x 2 years
Overall Study STARTED	46
Overall Study COMPLETED	42
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Exemestane and Celecoxib in Postmenopausal Women at High Risk for Breast Cancer

Baseline characteristics by cohort

Measure	Exemestane n=42 Participants exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects. Exemestane: exemestane 25 mg by mouth (PO) every day for two years Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years Vitamin D: Vitamin D 400 international units PO every day x 2 years
Age, Continuous	59.1 years n=5 Participants
Sex: Female, Male Female	42 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	42 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Outcome measures

Measure

Exemestane n=42 Participants exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects. Exemestane: exemestane 25 mg by mouth (PO) every day for two years Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years Vitamin D: Vitamin D 400 international units PO every day x 2 years

Percent Change in Mammographic Density at 1 Year on Exemestane

-2.4 percent change from baseline Interval -5.0 to 0.1

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Measure

Exemestane n=42 Participants exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects. Exemestane: exemestane 25 mg by mouth (PO) every day for two years Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years Vitamin D: Vitamin D 400 international units PO every day x 2 years

Effect of This Drug on Bone Mineral Density

-1.4 percent change from baseline Interval -2.5 to -0.3

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Measure

Exemestane n=42 Participants exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects. Exemestane: exemestane 25 mg by mouth (PO) every day for two years Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years Vitamin D: Vitamin D 400 international units PO every day x 2 years

Change in Breast Density at 2 Years

-4.1 percent change from baseline Interval -7.2 to -1.1

SECONDARY outcome

Timeframe: 3 months and 1 year

Population: Data were not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Population: Change in total cholesterol

Outcome measures

Measure

Exemestane n=42 Participants exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects. Exemestane: exemestane 25 mg by mouth (PO) every day for two years Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years Vitamin D: Vitamin D 400 international units PO every day x 2 years

Absolute Change of Lipid Profiles on Exemestane From Baseline

181.6 mg/dl Standard Deviation 35.9

SECONDARY outcome

Timeframe: 1 year

Population: Change in breast tissue trefoil factor 1

Outcome measures

Measure

Exemestane n=35 Participants exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects. Exemestane: exemestane 25 mg by mouth (PO) every day for two years Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years Vitamin D: Vitamin D 400 international units PO every day x 2 years

Effect of This Drug on Breast Tissue Trefoil Factor 1 and Proliferating Cell Nuclear Antigen Expression, Prolactin, and Breast Tissue Prolactin Receptor at 1 Year

-1.32 percent change from baseline Interval -1.87 to -0.76

SECONDARY outcome

Timeframe: 1 year

Population: Outcome not measured

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Population: Outcome not measured

Outcome measures

Outcome data not reported

Adverse Events

Exemestane

Serious events: 0 serious events

Other events: 41 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Exemestane n=42 participants at risk exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects. Exemestane: exemestane 25 mg by mouth (PO) every day for two years Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years Vitamin D: Vitamin D 400 international units PO every day x 2 years
Endocrine disorders Hot flashes	33.3% 14/42
Musculoskeletal and connective tissue disorders Arthralgia	31.0% 13/42
Reproductive system and breast disorders Vaginal dryness	9.5% 4/42
General disorders Fatigue	11.9% 5/42
Musculoskeletal and connective tissue disorders Myalgia	9.5% 4/42
Gastrointestinal disorders Diarrhea	7.1% 3/42

Additional Information

Dr. Claudine Isaacs

Georgetown University

Phone: (202)444-3677

Email: isaacsc@georgetown.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place