A pharmacokinetic study of edoxaban in patients with breast cancer using the P-glycoprotein inhibitor tamoxife

Completed

• Conditions: 10014523; trombosis; venous thromboembolism; 10006291

• Registration Number: NL-OMON49411
• Lead Sponsor: Tergooiziekenhuizen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 26

Inclusion Criteria

-Women with breast cancer who will start with tamoxifen
-Age >18

Exclusion Criteria

- Inability to provide informed consent
- Inherited bleeding disorder (e.g. von Willebrand disease)
- Major bleeding16 or clinically relevant non-major bleeding17 in the past 3
months
- History of intracranial bleeding
- Gastric or duodenal ulcer in the past 5 years
- Uncontrolled blood pressure with systolic pressure >180 mmHg
- Use of antiplatelet or anticoagulant therapy
- Chronic NSAID use
- Major surgery in the past 3 weeks (surgery which penetrates and exposes a
body cavity or
produces substantial impairment of physical function)
- Pregnancy, puerperium, or current breast feeding
- Use of strong P-gp inhibitors or inducers (see appendix B)
- Brain metastases
- Use of chemotherapy in the past 7 days or in the upcoming 32 days
- AST or ALT >3x of the upper limit in the past 7 days
- Liver cirrhosis Child Pugh A, B, or C
- Creatinine clearance of <50mL/min calculated with the Cockcroft and Gault
formula in the past
7 days
- Body weight <60kg
- Platelet count <50,000/mL in the past 7 days

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>a comparison between day 4 and 36 of edoxaban area under the plasma<br /><br>concenctration curve (AUC),maximum concentration (Cmax and several other<br /><br>coagulation, pharmacokinetic and pharmacodynamic parameters.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>NVT</p><br>