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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00328432
• Other study ID #: 9061
• Status: Completed
• Phase: Phase 1
• First received: May 19, 2006
• Last updated: September 15, 2008
• Start date: June 2003
• Est. completion date: December 2005

Study information

• Verified date: September 2008
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• celecoxib 400 mg bid

Locations

Country	Name	City	State
United States	University of Alabama-Birmingham	Birmingham	Alabama
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	Loyola University Medical Center	Maywood	Illinois
United States	MDDesert Comprehensive Breast Center	Palm Springs	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proliferation marker (Ki-67) in tissue specimens comparing baseline and post-drug administration specimens.
Secondary	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.