Breast Neoplasms Clinical Trial
— MHSLabCorp1Official title:
Tamoxifen Pharmacogenomics and the Prevention of Recurrent Breast Cancer
Verified date | October 2009 |
Source | Medco Health Solutions, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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 prevention of recurrent breast cancer.
Status | Completed |
Enrollment | 184 |
Est. completion date | January 2009 |
Est. primary completion date | December 2008 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 50 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Robert Epstein | Franklin Lakes | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Medco Health Solutions, Inc. | Indiana University School of Medicine, International Business Machines (IBM), Laboratory Corporation of America (LabCorp), Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determine the prevalence of different CYP450 2D6 phenotypes including poor metabolism status | 14 months | No | |
Secondary | Determine the prevalence of concomitant drug therapy involving tamoxifen and potent CYP450 2D6 inhibitors | 14 months | No | |
Secondary | Determine the effect of CYP450 2D6 genotyping that indicates poor metabolism status has on physician willingness to change tamoxifen therapy within 60 days of receiving test results and accompanying interpretations | 60 days | No |
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