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

Sponsor

University of Kansas (Other)

Overall Status

Completed

CT.gov ID

NCT00328432

Collaborator

Pfizer (Industry)

100

Enrollment

Locations

Duration (Months)

14.3

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: celecoxib 400 mg bid	Phase 1

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 Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Jun 1, 2003

Study Completion Date :

Dec 1, 2005

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama-Birmingham	Birmingham	Alabama	United States	35294
2	MDDesert Comprehensive Breast Center	Palm Springs	California	United States	92262
3	Loyola University Medical Center	Maywood	Illinois	United States	60153
4	University of Kansas Medical Center	Kansas City	Kansas	United States	66160
5	Cleveland Clinical Foundation	Cleveland	Ohio	United States	44195
6	The Ohio State University	Columbus	Ohio	United States	43210
7	US Oncology	Dallas	Texas	United States	75246