Protocol for Women at Increased Risk of Developing Breast Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Double-blinded Phase II Study of the Expression of Ki-67/MIB-1 in Women With Hyperplasia of the Breast Randomized to Receive Daily Celecoxib 400 mg BID or Placebo

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: celecoxib
* Other: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women who have a high risk of breast cancer older than 18 years Exclusion Criteria: anticoagulants marked breast tenderness pregnant or within twelve months of breast feeding/childbirth

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Oral Celecoxib 400 mg twice daily for 12 months | Drug: celecoxib<br>* Celecoxib 400 mg BID<br>* Other names: Celebrex;|
| Placebo Comparator: 2<br>Matched blinded placebo twice daily for 12 months | Other: placebo<br>* placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast atypia, double-blind randomized clinical trial, RCT, celecoxib, COX-2 inhibitor, placebo, high risk for breast cancer, breast epithelial hyperplasia, ki-67, chemoprevention