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

Completed

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID: NCT00291122
Run by: University of Kansas
People needed: 100
Starts: 2003-01-01
Expected to finish: 2005-12-01
Last updated by the study team: 2008-09-16

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

University of Kansas Medical Center — Kansas City, Kansas, United States

Full record on ClinicalTrials.gov

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