A Study of Women With an Early Diagnosis of Breast Cancer, Taking Celecoxib Between the Biopsy and Lumpectomy/Mastectomy
Completed · Phase 1
Conditions studied: Breast Cancer
In brief
To assess the effects of short term administration of celecoxib 400 mg bid between biopsy and reexcision.
Key facts
- Study ID
- NCT00328432
- Run by
- University of Kansas
- People needed
- 100
- Starts
- 2003-06-01
- Expected to finish
- 2005-12-01
- Last updated by the study team
- 2008-09-17
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Alabama-Birmingham — Birmingham, Alabama, United States
- MDDesert Comprehensive Breast Center — Palm Springs, California, United States
- Loyola University Medical Center — Maywood, Illinois, United States
- University of Kansas Medical Center — Kansas City, Kansas, United States
- Cleveland Clinical Foundation — Cleveland, Ohio, United States
- The Ohio State University — Columbus, Ohio, United States
- US Oncology — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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