NCT00328432
A Study of Women With an Early Diagnosis of Breast Cancer, Taking Celecoxib Between the Biopsy and Lumpectomy/Mastectomy
PHASE1
COMPLETED
NCT00328432
INTERVENTIONAL
Phase IB Study of Biomarker Modulation by Celecoxib vs. Placebo in Women With Newly-Diagnosed Breast Cancer
To assess the effects of short term administration of celecoxib 400 mg bid between biopsy and reexcision.
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
Breast Cancer
- PREVENTION
-
- Type: DRUG
- Name: celecoxib 400 mg bid
- Description:
- Arm Group Labels:
- University of Kansas