The interaction between the blood thinner edoxaban and the hormonal treatment tamoxifen in breast cancer patients

Phase 1

• Conditions: If there are increased plasma levels of edoxaban when used concomitantly with the P-glycoproteïne inhibitor tamoxifen for the treatment of venous thromboembolism in patients with breast cancer.; Therapeutic area: Body processes [G] - Chemical Phenomena [G02]

• Registration Number: EUCTR2018-004450-24-NL
• Lead Sponsor: Tergooi Hospital, dep of internal medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-13
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 26

Inclusion Criteria

-Age > 18 years
-Patients with oestrogen receptor positive breast cancer who are scheduled for adjuvant or palliative tamoxifen treatment

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 13
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 13

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 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 clinical trial of medicinal product
• Study Design: Not specified