Status:
COMPLETED
A Study of Women With an Early Diagnosis of Breast Cancer, Taking Celecoxib Between the Biopsy and Lumpectomy/Mastectomy
Lead Sponsor:
University of Kansas
Collaborating Sponsors:
Pfizer
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
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 (estra...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00328432
Start Date
June 1 2003
End Date
December 1 2005
Last Update
September 17 2008
Active Locations (7)
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1
University of Alabama-Birmingham
Birmingham, Alabama, United States, 35294
2
MDDesert Comprehensive Breast Center
Palm Springs, California, United States, 92262
3
Loyola University Medical Center
Maywood, Illinois, United States, 60153
4
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160