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

September 15, 2008 updated by: University of Kansas

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

100

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas

Collaborators

Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Study Completion

December 1, 2005

Study Registration Dates

First Submitted

May 19, 2006

First Submitted That Met QC Criteria

May 19, 2006

First Posted (Estimate)

May 22, 2006

Study Record Updates

Last Update Posted (Estimate)

September 17, 2008

Last Update Submitted That Met QC Criteria

September 15, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9061

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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