Clinical trial · Observational
A Pilot Study of Varying Doses of Tamoxifen in the Setting of Genetic Polymorphisms of CYP2D6
NCT00900744CI-TRIAL-00029275completedClinicalTrials.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)
The investigators plan to examine endoxifen and 4-OH-Tam as a function of the tamoxifen dose in patients with a genetic CYP2D6 polymorphism. The investigators also plan to investigate other genetic variations in the metabolism of tamoxifen.
Conditions
Conditions (1)
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 Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tamoxifen | Drug | Tamoxifen | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Tamoxifen
- description
- 20mg daily
- interventionNames
- Drug: Tamoxifen
Primary outcomes (1)
- measure
- Specific human 2D6 variants measurement(s) or observation(s)
- timeFrame
- every two weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women taking tamoxifen 20mg a day * Tamoxifen use for \> 90 days. * Use an accepted barrier form of contraception. Exclusion Criteria: * Patients are excluded if they are pregnant or lactating; if pre- menopausal, the patient will have a documented negative pregnancy test and use an accepted barrier form of contraception. * Patients are excluded if they have a medical history of Hepatitis B. Hepatitis C or HIV * Patients are excluded if they use Tobacco * Patients are excluded if they have a medical history of hereditary hemochromatosis * Patients are excluded if they have elevated AST (SGOT), ALT (SGPT), Bilirubin or Alkaline Phosphate o Defined as greater than 2 1/2 times the upper limit of normal * Patients are excluded if they are being treated with chemotherapy * Patients are excluded if they are taking any of the following oral medications, as they are potent CYP2D6 inhibitors: * Fluoxetine (Prozac) * Miconazole (Monistat) * Paroxetine (Paxil) * Quinidine * Ritonavir (Norvir) * Atorvastatin (Lipitor) * Carvedilol (Coreg) * Clarithromycin (Biaxin) * Dipyridamole (Persantine) * Erythromycin * Grapefruit Juice * Itraconazole (Sporanox) * Ketoconazole * Mefloquine * Nelfinavir (Viracept) * Nicardipine (Cardene) * Nilotinib * Propranolol (Inderal) * Ranolazine (Ranexa) * Saquinavir ( Invirase) * Verapamil Covera-HS * Warfarin (Coumadin) * Chlorpromazine (Thorazine) * Cinacalcet (Sensipar) * Delavirdine (Rescriptor)
References
Publications (0)
Data not yet available
No reference posted for this study.