Studying the relationship between the CYP3A and CYP2D6 probe dextromethorphan and the pharmacokinetics of tamoxifen.
- Conditions
- relationship between the CYP3A and CYP2D6 probe dextromethorphan and the pharmacokinetics of tamoxifen in breast cancer patients who require tamoxifen monotherapy
- Registration Number
- NL-OMON24889
- Lead Sponsor
- Prof Dr J VerweijDepartment of Internal OncologyDaniel den Hoed CenterErasmus UniversityGroene Hilledijk 3013075 AE RotterdamThe Netherlandstel 0031107041331fax 0031107041003j.verweij@erasmusmc.nl
- Brief Summary
de Graan et al. Dextromethorphan as a phenotyping test to predict endoxifen exposure in patients on tamoxifen treatment. J Clin Oncol. 2011;29(24):6240-6
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 37
Inclusion Criteria
1. Histological or cytological confirmed history of breast cancer for which treatment with tamoxifen monotherapy is indicated;
2. Age> or = 18 years;
Exclusion Criteria
1. Pregnant or lactating patients;
2. Patients with reproductive potential must use a reliable method of contraception;
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Relationships between dextromethorphan clearance and the clearance of tamoxifen in breast cancer patients.
- Secondary Outcome Measures
Name Time Method Relationships between other PK-parameters (AUC, Cmax and Tmax); effects of known polymorphisms in CYP2D6 and CYP3A and other relevant drug metabolizing enzymes and transporters on the pahrmacokinetics of tamoxifen and dextromethorphan.