trombosis venous thromboembolism
Conditions
Interventions
Twenty-six breast cancer patients who are scheduled for adjuvant or palliative
treatment with tamoxifen, will be given edoxaban 60 mg once daily for 4 days.
On day 5, edoxaban will be stopped and ta
Sponsors
Tergooiziekenhuizen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: -Women with breast cancer who will start with tamoxifen -Age >18
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a comparison between day 4 and 36 of edoxaban area under the plasma concenctration curve (AUC),maximum concentration (Cmax and several other coagulation, pharmacokinetic and pharmacodynamic parameters. | — |
Secondary
| Measure | Time frame |
|---|---|
| NVT | — |
Countries
Netherlands
Outcome results
None listed