Breast Cancer (borstkanker)
Conditions
Interventions
Patients will switch from administration of tamoxifen in the morning to administration in the evening or vice versa.
Amendment: Patients will switch for a second time from tamoxifen administration in
Sponsors
Erasmus MC ¨C Daniel den Hoed Cancer Center, University Medical Center, Rotterdam, the Netherlands
Eligibility
Inclusion criteria
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 and willing to continue the treatment until the end of the study; 3. Age > 18 years; 4. WHO performance ¡Ü 1; 5. Written informed consent; 6. Adequate renal and hepatic functions; 7. Adequate hematological blood counts; 8. No chemotherapy or radiotherapy within the last 4 weeks before start.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating patients; 2. 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; 3. More than one tamoxifen dose per day (20 or 40 mg); 4. Non-compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine differences in tamoxifen pharmacokinetics during tamoxifen administration in the morning compared to administration in the evening. Amendment: Determine differences in tamoxifen pharmacokinetics during tamoxifen administration in the morning, afternoon and evening | — |
Secondary
| Measure | Time frame |
|---|---|
| Determine differences in adverse effects during tamoxifen administration in the morning compared to administration in the evening. Amendment: Determine differences in adverse effects during tamoxifen administration in the morning compared to administration in the afternoon and evening. | — |
Contacts
Public ContactLisette Binkhorst
Groene Hilledijk 301
Outcome results
None listed