De wisselwerking tussen edoxaban en tamoxifen behandeling bij vrouwen met borstkanker
- Conditions
- Patients with oestrogen receptor positive breast cancer who are scheduled for adjuvant or palliative tamoxifen treatment
- Registration Number
- NL-OMON23145
- Lead Sponsor
- Daiichi Sankyo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 26
Age > 18 years
-Patients with oestrogen receptor positive breast cancer who are scheduled for adjuvant or palliative tamoxifen treatment
-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
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Secondary parameters will include: anti-factor Xa activity calibrated for edoxaban, PT, aPTT and thrombin generation on day 4 and day 36.