An Examination of Predictors of Indicators of Response to Celecoxib in Women Who Have a Diagnosis of Early Breast Cancer
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: celecoxib 400 mg BID |
Phase 1 |
| Study Type: | Observational |
| 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 |
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2003 |
| Estimated Study Completion Date: | December 2005 |
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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders 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
Contacts and Locations| United States, Kansas | |
| University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160 | |
| Principal Investigator: | Carol J Fabian, MD | University of Kansas |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00291122 History of Changes |
| Other Study ID Numbers: | 9380 |
| Study First Received: | February 10, 2006 |
| Last Updated: | September 15, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Kansas:
|
breast atypia breast epithelial hyperplasia ki-67 RTPCR microdissection |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Celecoxib Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Therapeutic Uses Central Nervous System Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 16, 2013