An Examination of Predictors of Indicators of Response to Celecoxib in Women Who Have a Diagnosis of Early Breast Cancer

Study Overview
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Brief Summary
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To assess the quantitative real time PCR results results of oligonucleotide probes for a number of gene transcription products that may be useful as predictors of indicators of response to celecoxib.

Detailed Description
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To assess the quantitative real time PCR results of oligonucleotide probes for a number of gene transcription products that may be useful as predictors or indicators of response to celecoxib, the feasibility of performing six different molecular assays by qRTPCR on formalin fixed paraffin embedded tissue obtained from breast cancer core biopsies and breast cancer reexcision patients, to assess change in Ki-67, PCNA, and several other markers by qRTPCR, correlate change in expression of Ki-67, PCNA, CAX-2, and bcl-2, measured by immunohistochemistry to change measured by qRTPCR, and to determine the reliability of the qRTPCR and immunohistochemical assays by performed selected assays on the same tissue in two different institutions

Official Title
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Quantitative Real Time PCR in Formalin Fixed Breast Tissue From Biopsy and Re-Excision Specimens: An Ancillary Protocol to a Chemoprevention Trial of Celecoxib

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 noninvasive 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 Exclusion Criteria: no hormone replacement therapy within 90 days prior to biopsy no history of asthma, allergy ASA, NSAIDS, celecoxib of 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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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 |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast atypia, breast epithelial hyperplasia, ki-67, RTPCR, microdissection