NCT00328432

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for phase_1 breast-cancer

Timeline
Completed

Started Jun 2003

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 22, 2006

Completed
Last Updated

September 17, 2008

Status Verified

September 1, 2008

First QC Date

May 19, 2006

Last Update Submit

September 15, 2008

Conditions

Breast Cancer

Keywords

early breast cancerdouble-blind randomized placebo-controlledRCTpre-surgical modelDCIS modelCOX-2 inhibitorcelecoxibKi-67 placebo

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

  • 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

celecoxib 400 mg bidDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University of Alabama-Birmingham

Birmingham, Alabama, 35294, United States

Location

MDDesert Comprehensive Breast Center

Palm Springs, California, 92262, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Cleveland Clinical Foundation

Cleveland, Ohio, 44195, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

US Oncology

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

CelecoxibBID protein, human

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Carol J Fabian, MD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 19, 2006

First Posted

May 22, 2006

Study Start

June 1, 2003

Study Completion

December 1, 2005

Last Updated

September 17, 2008

Record last verified: 2008-09

Locations

US(7)