Phase IB Study of Biomarker Modulation by Celecoxib vs. Placebo in Women With Newly-Diagnosed Breast Cancer

Inclusion Criteria:

- 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