Status:
COMPLETED
The Clinical and Economic Impact of Pharmacogenomic Testing for Tamoxifen Metabolism in Postmenopausal Women Receiving Tamoxifen for Prevention of Recurrent Breast Cancer
Lead Sponsor:
Medco Health Solutions, Inc.
Collaborating Sponsors:
Laboratory Corporation of America
International Business Machines (IBM)
Conditions:
Breast Neoplasms
Tamoxifen
Eligibility:
FEMALE
50+ years
Brief Summary
This study will assess the impact of CYP450 2D6 genotype pharmacogenetic testing and the corresponding prescribing impact for postmenopausal women using tamoxifen in a patient care setting for prevent...
Detailed Description
Tamoxifen is a non-steroidal hormonal drug with weak estrogen agonist and potent estrogen antagonist actions. The liver CYP450 metabolic enzyme systems are responsible for metabolizing tamoxifen (the ...
Eligibility Criteria
Inclusion
- Patient currently has a pharmacy benefit with Medco for an enrolled client
- Patient has a adjudicated tamoxifen pharmacy claims within the last six months
- Patient is still taking tamoxifen to prevent recurrent breast cancer
- Patient is a natural postmenopausal women 50 years of age or older
- Patient signs consent
- Patient is willing to provide sample for genetic testing
- Physician managing tamoxifen therapy is willing to order pharmacogenetic test
Exclusion
- Patient is male
- Patient is under 50 years old
- Patient has previous history of CYP450 2D6 testing
- Patient is no longer taking tamoxifen
- Patient refuses to sign consent
- Patient wishes to no longer participate after testing
- Patient's physician refuses to order pharmacogenetic test
Key Trial Info
Start Date :
October 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT00830973
Start Date
October 1 2007
End Date
January 1 2009
Last Update
October 14 2009
Active Locations (1)
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Robert Epstein
Franklin Lakes, New Jersey, United States, 07417