A Study of Women With an Early Diagnosis of Breast Cancer, Taking Celecoxib Between the Biopsy and Lumpectomy/Mastectomy

• Status: Completed
• Trial end date: 2005-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

To assess the effects of short term administration of celecoxib 400 mg bid between biopsy and reexcision.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Kansas
• Collaborator: Pfizer
• Treatments: Celecoxib

Criteria

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