A Pilot Study of Varying Doses of Tamoxifen in the Setting of Genetic Polymorphisms of CYP2D6

Completed

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT00900744

Run by

Icahn School of Medicine at Mount Sinai

People needed

121

Starts

2009-01-01

Expected to finish

2012-01-01

Last updated by the study team

2017-08-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Women taking tamoxifen 20mg a day
• Tamoxifen use for > 90 days.
• Use an accepted barrier form of contraception.

You may not qualify if…

• 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

Where it is running

• Icahn School of Medicine at Mount Sinai — New York, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.