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

NCT ID: NCT00328432

Last Updated: 2008-09-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-06-30
• Study Completion Date: 2005-12-31

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.).

Conditions

Breast Cancer

Keywords

early breast cancer; double-blind randomized placebo-controlled; RCT; pre-surgical model; DCIS model; COX-2 inhibitor; celecoxib; Ki-67 placebo

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Interventions

celecoxib 400 mg bid

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

University of Kansas

OTHER

Sponsor Role: lead

Principal Investigators

Carol J Fabian, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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

Countries

United States

Other Identifiers

9061

Identifier Type: -

Identifier Source: org_study_id