PharmacoKINEtics of TAMoxifen and its metabolites in breast cancer patients: the influence of a dose increase in phenotypic poor metabolizers of CYP2D6 (KINETAM)
Completed
- Conditions
- breast cancermamma carcinoma10006232
- Registration Number
- NL-OMON34869
- Lead Sponsor
- niversitair Medisch Centrum Sint Radboud
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 150
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Cmin plasma concentrations of tamoxifen and its metabolites after 4 weeks of<br /><br>dosing with 40mg QD tamoxifen (compared to baseline: 20mg QD tamoxifen).</p><br>
- Secondary Outcome Measures
Name Time Method <p>Influence of CYP2D6 inhibitors/polymorphism on pharmacokinetics of tamoxifen<br /><br>and metabolites in breast cancer patients.</p><br>