Status:
COMPLETED
An Examination of Predictors of Indicators of Response to Celecoxib in Women Who Have a Diagnosis of Early Breast Cancer
Lead Sponsor:
University of Kansas
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Brief Summary
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
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 feas...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2003
Trial Type :
OBSERVATIONAL
End Date :
December 1 2005
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00291122
Start Date
January 1 2003
End Date
December 1 2005
Last Update
September 16 2008
Active Locations (1)
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1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160