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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
University of Kansas
ClinicalTrials.gov Identifier:
NCT00328432
First received: May 19, 2006
Last updated: September 15, 2008
Last verified: September 2008
  Purpose

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


Condition Intervention Phase
Breast Cancer
Drug: celecoxib 400 mg bid
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Phase IB Study of Biomarker Modulation by Celecoxib vs. Placebo in Women With Newly-Diagnosed Breast Cancer

Resource links provided by NLM:


Further study details as provided by University of Kansas:

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.

Estimated Enrollment: 100
Study Start Date: June 2003
Estimated Study Completion Date: December 2005
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.).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00328432

Locations
United States, Alabama
University of Alabama-Birmingham
Birmingham, Alabama, United States, 35294
United States, California
MDDesert Comprehensive Breast Center
Palm Springs, California, United States, 92262
United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Ohio
Cleveland Clinical Foundation
Cleveland, Ohio, United States, 44195
The Ohio State University
Columbus, Ohio, United States, 43210
United States, Texas
US Oncology
Dallas, Texas, United States, 75246
Sponsors and Collaborators
University of Kansas
Pfizer
Investigators
Principal Investigator: Carol J Fabian, MD University of Kansas
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00328432     History of Changes
Other Study ID Numbers: 9061
Study First Received: May 19, 2006
Last Updated: September 15, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas:
early breast cancer
double-blind randomized placebo-controlled
RCT
pre-surgical model
DCIS model
COX-2 inhibitor
celecoxib
Ki-67 placebo

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 01, 2014