Studying the relationship between the CYP3A and CYP2D6 probe dextromethorphan and the pharmackinetics of tamoxifen.

Completed

• Conditions: breast cancer; 10006291

• Registration Number: NL-OMON33769
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 37

Inclusion Criteria

Histological or cytological confirmed breast cancer
indication for treatment with monotherapy tamoxifen
18 years of age or older
written informed consent
adequate renal, hepatological and hematological lab results

Exclusion Criteria

pregnant or lactating women
impossibility for oral intake medication
serious illness or instable medical condition
symptomatic central nervous system metastases
use of strong CYP3A and/or P-glycoprotein inhibiting and inducing medication/supplements

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pharmacokinetic sampling for tamoxifen and dextromethorphan.<br /><br>The relationship between clearance of tamoxifen and of dextromethorphan.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The intra-patient variability in pharmacokinetics of tamoxifen and<br /><br>dextromethorphan.<br /><br>The effects of known polymorfismes in CYP2D6 and CYP3A and other relevant<br /><br>medication metabolizing enzyms and transporters for the pharmacokinetics of<br /><br>tamoxifen and dextromethorphan.</p><br>