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

• Status: Completed
• Trial end date: 2005-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Kansas
• Treatments: Celecoxib

Criteria

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