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

Original Study ID : 9380

NCT ID : NCT00291122

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

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

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.

Source : University of Kansas

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

Overall Status : Completed

Start Date : January 2003

End Date : December 2005

Completion Date : December 2005

Official Title : Phase 1

Phase : Observational

Study Design : N/A

Enrollment : 100

Verification Date : September 2008

First Received Date : February 10, 2006

Trial 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

Gender : Female

Minimum Age : 18 Years

Maximum Age : N/A

Healthy Volunteers : No

Facilities

Facility Name : University of Kansas Medical Center

City : Kansas City

State : Kansas

Zip Code : 66160

Country : United States

Interventions

Type : Drug

Name : celecoxib 400 mg BID

Clinical Trial Name - An Examination of Predictors of Indicators of Response to Celecoxib in Women Who Have a Diagnosis