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

Original Study ID : 9061

NCT ID : NCT00328432

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

Official Title : Phase IB Study of Biomarker Modulation by Celecoxib vs. Placebo in Women With Newly-Diagnosed Breast Cancer

Brief Summary :

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

Source : University of Kansas

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.).

Overall Status : Completed

Start Date : June 2003

End Date : December 2005

Completion Date : December 2005

Official Title : Phase 1

Phase : Interventional

Study Design : Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Enrollment : 100

Verification Date : September 2008

First Received Date : May 19, 2006

Trial 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

Gender : Female

Minimum Age : 18 Years

Maximum Age : N/A

Healthy Volunteers : No

Facilities

Facility Name : University of Alabama-Birmingham

City : Birmingham

State : Alabama

Zip Code : 35294

Country : United States

Facility Name : MDDesert Comprehensive Breast Center

City : Palm Springs

State : California

Zip Code : 92262

Country : United States

Facility Name : Loyola University Medical Center

City : Maywood

State : Illinois

Zip Code : 60153

Country : United States

Facility Name : University of Kansas Medical Center

City : Kansas City

State : Kansas

Zip Code : 66160

Country : United States

Facility Name : Cleveland Clinical Foundation

City : Cleveland

State : Ohio

Zip Code : 44195

Country : United States

Facility Name : The Ohio State University

City : Columbus

State : Ohio

Zip Code : 43210

Country : United States

Facility Name : US Oncology

City : Dallas

State : Texas

Zip Code : 75246

Country : United States

OutComes

Primary OutComes

Measure : Proliferation marker (Ki-67) in tissue specimens comparing baseline and post-drug administration specimens.

Secondary OutComes

Measure : 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.

Interventions

Type : Drug

Name : celecoxib 400 mg bid

Clinical Trial Name - A Study of Women With an Early Diagnosis of Breast Cancer, Taking Celecoxib Between the Biopsy and