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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
celecoxib 400 mg BID
Sponsored by
University of Kansas
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Breast Cancer focused on measuring breast atypia, breast epithelial hyperplasia, ki-67, RTPCR, microdissection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Kansas Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 10, 2006
Last Updated
September 15, 2008
Sponsor
University of Kansas
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1. Study Identification

Unique Protocol Identification Number
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
Study Type
Observational

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Kansas

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast atypia, breast epithelial hyperplasia, ki-67, RTPCR, microdissection

7. Study Design

Enrollment
100 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
celecoxib 400 mg BID

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carol J Fabian, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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