Breast Cancer Clinical Trial

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

Summary

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

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Full 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.).

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Eligibility 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

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

100

Study ID:

NCT00328432

Recruitment Status:

Completed

Sponsor:

University of Kansas

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There are 7 Locations for this study

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University of Alabama-Birmingham
Birmingham Alabama, 35294, United States
MDDesert Comprehensive Breast Center
Palm Springs California, 92262, United States
Loyola University Medical Center
Maywood Illinois, 60153, United States
University of Kansas Medical Center
Kansas City Kansas, 66160, United States
Cleveland Clinical Foundation
Cleveland Ohio, 44195, United States
The Ohio State University
Columbus Ohio, 43210, United States
US Oncology
Dallas Texas, 75246, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

100

Study ID:

NCT00328432

Recruitment Status:

Completed

Sponsor:


University of Kansas

How clear is this clinincal trial information?

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