Induction of tamoxifen metabolism.
- Conditions
- Breast cancerBorstkanker
- Registration Number
- NL-OMON23575
- Lead Sponsor
- Erasmus Medical Center - Daniel den Hoed Kliniek, afdeling Interne Oncologie
- Brief Summary
Binkhorst et al. Individualization of tamoxifen treatment for breast carcinoma. Clin Pharmacol Ther. 2012;92(1):62-7
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 12
Inclusion Criteria
1. Histological or cytological confirmed diagnosis of breast cancer, for which treatment with tamoxifen monotherapy is indicated;
2. Use of tamoxifen monotherapy for at least 4 weeks (to guarantee steady-state) and willing to continue the treatment until the end of the study;
Exclusion Criteria
1. Pregnant or lactating patients;
2. Impossibility to take oral drugs;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The effects of cytochrome P450 enzyme induction (including CYP3A4, CYP2C and CYP2D6) by rifampicin on the metabolism and plasma pharmacokinetics of tamoxifen and its metabolites.
- Secondary Outcome Measures
Name Time Method 1. The effects of cytochrome P450 enzyme induction on the inter-patient variability in pharmacokinetics of tamoxifen and its metabolites;<br /><br>2. The influence of genetic polymorphisms in enzymes involved in the metabolism of tamoxifen on the formation of endoxifen, in the presence and absence of rifampicin;<br /><br>3. Incidence and severity of side effects in the presence and absence of rifampicin;<br /><br>4. Validation of the previously developed dextromethorphan phenotyping test.