breast cancer
Conditions
Interventions
In case a CYP2D6 polymorphism and/or the presence of a CYP2D6 inhibitor is
found, a dose increase to tamoxifen 40mg QD will be applied and the patient
will return for measurement of the plasma endox
Sponsors
Universitair Medisch Centrum Sint Radboud
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1.Subject is at least 18 years at screening 2. Subject is able and willing to sign the Informed Consent Form prior to screening evaluations. 3. Subject is a female patient with (a history of) breast cancer; has been treated with tamoxifen 20mg QD for at least 4 weeks and is expected to be treated for at least another 4 weeks.
Exclusion criteria
Exclusion criteria: 1. Inability to understand the nature and extent of the trial and the procedures required. 2. Participation in a drug trial within 60 days prior to the first dose.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmin plasma concentrations of tamoxifen and its metabolites after 4 weeks of dosing with 40mg QD tamoxifen (compared to baseline: 20mg QD tamoxifen). | — |
Secondary
| Measure | Time frame |
|---|---|
| Influence of CYP2D6 inhibitors/polymorphism on pharmacokinetics of tamoxifen and metabolites in breast cancer patients. | — |
Countries
Netherlands
Outcome results
None listed