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An Examination of Predictors of Indicators of Response to Celecoxib in Women Who Have a Diagnosis of Early Breast Cancer

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ClinicalTrials.gov Identifier: NCT00291122
Recruitment Status : Completed
First Posted : February 13, 2006
Last Update Posted : September 16, 2008
Information provided by:
University of Kansas Medical Center

Brief Summary:
To assess the quantitative real time PCR results results of oligonucleotide probes for a number of gene transcription products that may be useful as predictors of indicators of response to celecoxib.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: celecoxib 400 mg BID Phase 1

Detailed Description:
To assess the quantitative real time PCR results of oligonucleotide probes for a number of gene transcription products that may be useful as predictors or indicators of response to celecoxib, the feasibility of performing six different molecular assays by qRTPCR on formalin fixed paraffin embedded tissue obtained from breast cancer core biopsies and breast cancer reexcision patients, to assess change in Ki-67, PCNA, and several other markers by qRTPCR, correlate change in expression of Ki-67, PCNA, CAX-2, and bcl-2, measured by immunohistochemistry to change measured by qRTPCR, and to determine the reliability of the qRTPCR and immunohistochemical assays by performed selected assays on the same tissue in two different institutions

Study Type : Observational
Estimated Enrollment : 100 participants
Official Title: Quantitative Real Time PCR in Formalin Fixed Breast Tissue From Biopsy and Re-Excision Specimens: An Ancillary Protocol to a Chemoprevention Trial of Celecoxib
Study Start Date : January 2003
Estimated Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Celecoxib
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • women with a recent diagnosis of T1 or T2 noninvasive 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

Exclusion Criteria:

  • no hormone replacement therapy within 90 days prior to biopsy
  • no history of asthma, allergy ASA, NSAIDS, celecoxib of 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00291122

United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas
Principal Investigator: Carol J Fabian, MD University of Kansas Medical Center

ClinicalTrials.gov Identifier: NCT00291122     History of Changes
Other Study ID Numbers: 9380
First Posted: February 13, 2006    Key Record Dates
Last Update Posted: September 16, 2008
Last Verified: September 2008

Keywords provided by University of Kansas Medical Center:
breast atypia
breast epithelial hyperplasia

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