The influence of time of administration on tamoxifen pharmacokinetics.
- Conditions
- 10006288Breast cancer
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 18
-Histological or cytological confirmed diagnosis of breast cancer, for which treatment with tamoxifen is indicated (to be evaluated by the treating physician);
-Use of tamoxifen for at least 4 weeks and willing to continue the treatment until the end of the study;
-Age > 18 years;
-WHO performance <= 1;
-Written informed consent;
-Adequate renal and hepatic functions (see protocol);
-Adequate hematological blood counts (see protocol);
-No chemotherapy within the last 4 weeks before start;
-No radiotherapy within the last 4 weeks before start.
-Pregnant or lactating patients;
-Serious illness or medical unstable condition requiring treatment, symptomatic CNS metastases or history of psychiatric disorder that would prohibit the understanding and giving of informed consent;
-More than one tamoxifen dose per day (20 or 40 mg);
-Non-compliance.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Determine differences in tamoxifen pharmacokinetics during tamoxifen<br /><br>administration in the morning compared to administration in the evening.<br /><br><br /><br>Amendment: To determine the influence of time of administration (morning,<br /><br>afternoon, evening) on the pharmacokinetics of tamoxifen.<br /><br><br /><br>Pharmacokinetic parameters which will be determined (using the program<br /><br>WinNonLin) include: area under the curve 0-24 hour (AUC0-24h), maximum<br /><br>concentration (Cmax), trough concentration (Ctrough), clearance (CL).</p><br>
- Secondary Outcome Measures
Name Time Method <p>Determine differences in adverse effects during tamoxifen administration in the<br /><br>morning compared to administration in the evening (amendment: and afternoon).<br /><br><br /><br>Adverse effects will be recorded and compared to each other depending on<br /><br>administration time.</p><br>