Patients with oestrogen receptor positive breast cancer who are scheduled for adjuvant or palliative tamoxifen treatment
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 tamo
Sponsors
Daiichi Sankyo
Eligibility
Inclusion criteria
Inclusion criteria: - Age > 18 years - Patients with oestrogen receptor positive breast cancer who are scheduled for adjuvant or palliative tamoxifen treatment
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 (see appendix A) - 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 P-gp inhibitors or inducers and CYP3A4 inhibitors (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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Edoxaban plasma levels on day 4 (edoxaban alone) and day 36 (edoxaban + tamoxifen). The following pharmacokinetic parameters will be taken: the lowest plasma concentration (Ctrough), the maximum plasma concentration (Cmax); time of maximum observed concentration (Tmax). The area under the curve (AUC) over 24 hours will be calculated by Byaesian analysis by the collected 5 samples. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary parameters will include: anti-factor Xa activity calibrated for edoxaban, PT, aPTT and thrombin generation on day 4 and day 36. | — |
Contacts
Public ContactFloris Bosch
Tergooi hospital/Amsterdam UMC, location AMC
Outcome results
None listed