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

NCT ID: NCT00291122

Last Updated: 2008-09-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2003-01-31
• Study Completion Date: 2005-12-31

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.

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

Conditions

Breast Cancer

Keywords

breast atypia; breast epithelial hyperplasia; ki-67; RTPCR; microdissection

Interventions

celecoxib 400 mg BID

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Kansas

OTHER

Sponsor Role: lead

Principal Investigators

Carol J Fabian, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

University of Kansas Medical Center

Kansas City, Kansas, United States

Countries

United States

Other Identifiers

9380

Identifier Type: -

Identifier Source: org_study_id