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.).
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
