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| Name | Class |
|---|---|
| Susan G. Komen Breast Cancer Foundation | OTHER |
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To assess the effects of twelve months of celecoxib administration by evaluating breast tissue needle aspirations, to determine if cell growth can be slowed.
A blind randomized study of celecoxib in women at high risk of developing breast cancer. Subjects are to take twelve months of drug/placebo. At baseline and after twelve months subjects will have a random periareolar fine needle breast aspiration that will be assessed for epithelial cell growth and other markers of risk. Baseline and twelve month serum samples will also be assessed for hormones and growth factors which may be associated with breast cancer risk. Mammograms at baseline and twelve months will also be assessed for breast density changes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Oral Celecoxib 400 mg twice daily for 12 months |
|
| 2 | Placebo Comparator | Matched blinded placebo twice daily for 12 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| celecoxib | Drug | Celecoxib 400 mg BID |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Percent of Breast Epithelial Cells Staining Positive for Ki-67 | Immunocytochemical staining of breast epithelial cells. Positive cells reflect proliferative activity. | Baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mammographic Breast Density | The percent of mammographic breast area that is considered to be at increased density. Evaluated using the semi-automated computer program Cumulus. | Baseline and 12 months |
| Serum Estradiol Concentration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carol J Fabian, MD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo for 12 months |
| FG001 | Celecoxib | Celecoxib for 12 months |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Celecoxib | Celecoxib for six months |
| BG001 | Placebo | Placebo for six months |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Percent of Breast Epithelial Cells Staining Positive for Ki-67 | Immunocytochemical staining of breast epithelial cells. Positive cells reflect proliferative activity. | Posted | Median | Full Range | percentage of cells staining positive | Baseline and 12 months |
|
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Celecoxib | Randomized to receive celecoxib daily for 12 months |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic Reaction | Immune system disorders | CTCAE | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Carol Fabian | University of Kansas Medical Center | 913-588-3666 | cfabian@kumc.edu |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| placebo |
| Other |
placebo |
|
Change in serum estradiol concentration
| Baseline to 12 months |
| Serum Sex Hormone Binding Globulin (SHBG) Concentration | Change in serum concentration | Baseline to 12 months |
| Molecular Ratio of Serum Concentration of IGF-1 to IGFBP3 | Change ion ratio. | baseline to 12 months |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
|
| Secondary | Mammographic Breast Density | The percent of mammographic breast area that is considered to be at increased density. Evaluated using the semi-automated computer program Cumulus. | 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 | Posted | Median | Standard Error | percentage of breast area at increased d | Baseline and 12 months |
|
|
|
|
| Secondary | Serum Estradiol Concentration | Change in serum estradiol concentration | Posted | Median | Standard Error | pg/ml | Baseline to 12 months |
|
|
|
|
| Secondary | Serum Sex Hormone Binding Globulin (SHBG) Concentration | Change in serum concentration | Posted | Median | Standard Error | nmol/L | Baseline to 12 months |
|
|
|
|
| Secondary | Molecular Ratio of Serum Concentration of IGF-1 to IGFBP3 | Change ion ratio. | Posted | Median | Standard Error | ratio | baseline to 12 months |
|
|
|
|
| 0 |
| 43 |
| 43 |
| 43 |
| EG001 | Placebo | Randomized to receive palcebo daily for 12 months | 0 | 21 | 21 | 21 |
| Fatigue | General disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Fever | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Skin-other | Skin and subcutaneous tissue disorders | CTCAE | Non-systematic Assessment |
|
| Hot Flashes | Reproductive system and breast disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Reproductive-other | Reproductive system and breast disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | CTCae | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| GI-other | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Rectal bleeding | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Infection-other | Immune system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Insomnia | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| abdominal pain | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| headache | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| pain-other | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Pulmnary-other | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Renal-other | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Irregular menses | Reproductive system and breast disorders | CTCAE (3.0) | Non-systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |