The effects of switching antidepressants onendoxifen exposure.
- Conditions
- Breast Cancer
- Registration Number
- NL-OMON21757
- Lead Sponsor
- Erasmus Medical Center - Daniel den Hoed Cancer Center, Dept of Medical Oncology
- Brief Summary
Binkhorst et al. Augmentation of Endoxifen Exposure in Tamoxifen-Treated Women Following SSRI Switch. Clin Pharmacokinet. 2016;55(2):249-55
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 13
Inclusion Criteria
1. Histological or cytological confirmed diagnosis of breast cancer, for which treatment with tamoxifen is indicated;
2. Use of tamoxifen for at least 4 weeks (to guarantee steady-state);
Exclusion Criteria
1. Pregnant or lactating patients;
2. Serious illness or medical unstable condition requiring treatment, symptomatic CNSmetastases or history of psychiatric disorder that would prohibit the understanding and giving of informed consent;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Determine the effects of switching from the potent CYP2D6 inhibitor paroxetine to a weak CYP2D6 inhibitor (venlafaxine, escitalopram) on the plasma pharmacokinetics of tamoxifen and its metabolites (AUC, CL, Cmax).
- Secondary Outcome Measures
Name Time Method Compare toxic adverse effects in treatment courses with tamoxifen before and after switching from a potent CYP2D6 inhibitor to a weak CYP2D6 inhibitor.