Status:
COMPLETED
PharmacoKINEtics of TAMoxifen and Its Metabolites in Breast Cancer Patients: the Influence of a Dose Increase in Phenotypic Poor Metabolizers of CYP2D6 (KINETAM)
Lead Sponsor:
Radboud University Medical Center
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief Summary
All women on tamoxifen receive the standard dose of 20mg QD, irrespective of the use of potential CYP2D6 inhibitors, and are not tested for CYP2D6 polymorphisms prior to start of tamoxifen treatment.H...
Detailed Description
Although already some information is available on the importance of CYP2D6 polymorphisms and/or the use of CYP2D6 inhibitors as co-medication that may influence the treatment outcome of tamoxifen, thi...
Eligibility Criteria
Inclusion
- Subject is at least 18 years at screening.
- Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.
- Subject is a female patient with (a history of) breast cancer and 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
- Inability to understand the nature and extent of the trial and the procedures required.
- Participation in a drug trial within 60 days prior to the first dose.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT01192308
Start Date
July 1 2010
End Date
May 1 2012
Last Update
December 1 2020
Active Locations (1)
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1
Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands