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

Phase 1

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00328432
• Lead Sponsor: University of Kansas

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.).

Study Timeline

• Study Start: 2003-06
• Study Completion: 2005-12
• Study First Submitted: 2006-05-19
• Study First Submitted QC: 2006-05-19
• Study First Posted: 2006-05-22
• Status Verified: 2008-09
• Last Update Submitted: 2008-09-15
• Last Update Posted: 2008-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Proliferation marker (Ki-67) in tissue specimens comparing baseline and post-drug administration specimens.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (7)

MDDesert Comprehensive Breast Center; 🇺🇸 Palm Springs, California, United States

University of Alabama-Birmingham; 🇺🇸 Birmingham, Alabama, United States

Loyola University Medical Center; 🇺🇸 Maywood, Illinois, United States

Cleveland Clinical Foundation; 🇺🇸 Cleveland, Ohio, United States

The Ohio State University; 🇺🇸 Columbus, Ohio, United States

US Oncology; 🇺🇸 Dallas, Texas, United States

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States