A Study of Women With an Early Diagnosis of Breast Cancer, Taking Celecoxib Between the Biopsy and Lumpectomy/Mastectomy

Study Overview
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Brief Summary
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To assess the effects of short term administration of celecoxib 400 mg bid between biopsy and reexcision.

Detailed Description
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A double blind randomized study of celecoxib 400 mg bid versus placebo in newly diagnosed breast cancer. Assessment of modulation of tissue markers (Ki-67, ER, VEGF, PR, etc.) and serum markers (estradiol, estrone, SHBG, etc.).

Official Title
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Phase IB Study of Biomarker Modulation by Celecoxib vs. Placebo in Women With Newly-Diagnosed Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: celecoxib 400 mg bid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women with a recent diagnosis of T1 or T2 non-invasive breast cancer by large core needle or excisional biopsy confirmation that tissue was processed in methods acceptable to protocol and sufficient tissue remains post-diagnostic analyses to perform research assessments reexcision planned within 10 days to 6 weeks from study start if on prevention tamoxifen or raloxifene, must have begun administration at least six weeks prior to initial biopsy and continue through reexcision Exclusion Criteria: no hormone replacement therapy within the 90 days prior to biopsy if on prevention tamoxifen or raloxifene, must have begun administration at least six weeks prior to initial biopsy and continue through reexcision no evidence of metastatic malignancy of any kind no history of asthma, allergy ASA, NSAIDS, celecoxib or other COX-2 inhibitors for a chronic non-oncological condition with the excision of low dose ASA (160 mg daily) during 4 weeks prior to biopsy and for the duration of the study. no celecoxib or rofecoxib use within one month of biopsy no history of gastrointestinal ulcer or ulcerative colitis requiring treatment no current anticoagulants no neoadjuvant antihormone or chemotherapy as treatment following biopsy prior to study entry or concurrently with participation on study no aromatase inhibitor in the six months prior to participation no concomitant lithium no known significant bleeding disorder

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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No

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

| Intervention/Treatment |
| --- |
|Drug: celecoxib 400 mg bid|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proliferation marker (Ki-67) in tissue specimens comparing baseline and post-drug administration specimens. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline and post-administration assessments of MAP kinase, pERK1 and 2, activated pAKT, change in apotosis indicators, and angiogenesis associated proteins, and Her-2/neu. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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early breast cancer, double-blind randomized placebo-controlled, RCT, pre-surgical model, DCIS model, COX-2 inhibitor, celecoxib, Ki-67 placebo