Clinical trial · Observational
The Clinical and Economic Impact of Pharmacogenomic Testing for Tamoxifen Metabolism in Postmenopausal Women Receiving Tamoxifen for Prevention of Recurrent Breast Cancer
Tamoxifen Pharmacogenomics and the Prevention of Recurrent Breast Cancer
NCT00830973CI-TRIAL-00002707MHSLabCorp1completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Tamoxifen | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CYP2D6 Inhibiting Drugs | Other | — | UNRESOLVED |
| Poor Metabolism Status Follow Up Therapy Considerations | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Active Study Group
- description
- The active study group consists of 50 year or older postmenopausal women taking tamoxifen for the prevention of reoccurrence of breast cancer, do not meet exclusion criteria, meet all inclusion criteria, and are enrolled members for Medco clients agreeing to participate.
- interventionNames
- Other: Poor Metabolism Status Follow Up Therapy Considerations
- Other: CYP2D6 Inhibiting Drugs
Primary outcomes (1)
- measure
- Determine the prevalence of different CYP450 2D6 phenotypes including poor metabolism status
- timeFrame
- 14 months
Secondary outcomes (2)
- measure
- Determine the prevalence of concomitant drug therapy involving tamoxifen and potent CYP450 2D6 inhibitors
- timeFrame
- 14 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.