Status:
COMPLETED
A Pilot Study of Varying Doses of Tamoxifen in the Setting of Genetic Polymorphisms of CYP2D6
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Brief Summary
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 va...
Detailed Description
Endocrine therapy has proven to be an extremely effective therapy in breast cancer. For women with hormone-receptor-positive tumors, tamoxifen given for as little as two years results in a statistical...
Eligibility Criteria
Inclusion
- Women taking tamoxifen 20mg a day
- Tamoxifen use for \> 90 days.
- Use an accepted barrier form of contraception.
Exclusion
- 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)
Key Trial Info
Start Date :
January 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT00900744
Start Date
January 1 2009
End Date
January 1 2012
Last Update
August 25 2017
Active Locations (1)
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1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029