Effect of Oral (Z)-Endoxifen in Premenopausal Women With Measurable Breast Density

Exclusion Criteria

• •1. Mammographic BI-RADS® malignancy code ≥3 at baseline mammography
• •3. A history of breast surgery, e.g., reduction or enlargement, which might affect mammographic density measurements
• •4. Current medical conditions:
• •1. APC (activated protein C) resistance, an inherited coagulation disorder
• •2. Systolic pressure higher than 160 mm Hg or diastolic higher than 100 mm Hg
• •3. Cataract(s)
• •4. Uncontrolled diabetes (defined as HbA1c \>50 mmol/mol)
• •5. Abnormal lab values deemed clinically significant by Investigator
• •5. BMI \> 30
• •6. Women who have an increased risk of venous thrombosis due to immobilization, e.g., using wheelchair
• •7. Agents that have the potential to decrease endoxifen levels through increased metabolic clearance:
• •1. Certain anti-epileptic therapies (carbamazepine, fenytoin, fenobarbital, lamotrigine)
• •2. Certain antibiotics (rifamycins)
• •3. St John's wort (in Swedish: johannesört)
• •4. Certain HIV medications (efavirenz, ritonavir)
• •8. Lactating, pregnant, or plan to become pregnant in the next year
• •9. History of thromboembolic disease such as embolus, deep vein thrombosis, stroke, TIA (transient ischemic attack) or myocardial infarction
• •10. Allergy to endoxifen or any of its components
• •11. Previous treatment with an anti-oestrogen, including experimental drug studies (e.g., Karma CREME, Karisma-1 or Karisma-2)
• •12. Prescribed and regular use of anticoagulants (defined as substances included in group B01A in the ATC-system)
• •13. Participation in another investigational clinical trial in the last 6 months
• •14. Not willing or able to understand the study information and/or informed consent