Breast Cancer
Conditions
Keywords
early breast cancer, double-blind randomized placebo-controlled, RCT, pre-surgical model, DCIS model, COX-2 inhibitor, celecoxib, Ki-67 placebo
Brief summary
To assess the effects of short term administration of celecoxib 400 mg bid between biopsy and reexcision.
Detailed description
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.).
Interventions
Sponsors
Pfizer
University of Kansas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proliferation marker (Ki-67) in tissue specimens comparing baseline and post-drug administration specimens. | — |
Secondary
| Measure | Time frame |
|---|---|
| Baseline and post-administration assessments of MAP kinase, pERK1 and 2, activated pAKT, change in apotosis indicators, and angiogenesis associated proteins, and Her-2/neu. | — |
Countries
United States
Outcome results
None listed