PharmacoKINEtics of TAMoxifen and Its Metabolites in Breast Cancer Patients: the Influence of a Dose Increase in Phenotypic Poor Metabolizers of CYP2D6 (KINETAM)
18 Years
N/A
Female
Breast Cancer
Trial Information
PharmacoKINEtics of TAMoxifen and Its Metabolites in Breast Cancer Patients: the Influence of a Dose Increase in Phenotypic Poor Metabolizers of CYP2D6 (KINETAM)
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, this information does currently not lead to a change in the management
of this patient population. 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.
In an attempt to at least resolve some of these issues we propose a prospective study in
women taking tamoxifen at a dose of 20mg QD who are being followed at several large oncology
clinics in the south-eastern part of the Netherlands (Nijmegen (CWZ & Radboud), Den Bosch,
Harderwijk and Arnhem). In each woman, information will be collected on endoxifen levels,
CYP2D6 status, adherence and use of co-medication. In women who are phenotypically poor
metabolizers of tamoxifen, a dose increase to 40mg QD will be applied and the effect of this
intervention on tamoxifen pharmacokinetics will be evaluated after 4 weeks.
Inclusion Criteria:
- 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 Criteria:
- 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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Tamoxifen and metabolites plasmaconcentration
Outcome Description:
Trough samples
Outcome Time Frame:
week 0 and 4
Safety Issue:
No
Principal Investigator
David M Burger, PharmD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Radboud University
Authority:
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study ID:
KINETAM
NCT ID:
NCT01192308
Start Date:
July 2010
Completion Date:
May 2012
Related Keywords:
- Breast Cancer
- Breast cancer
- Tamoxifen
- Pharmacokinetics
- Pharmacogenetics
- CYP2D6
- Breast Neoplasms
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