EUCTR2020-004828-42-SE进行中（未招募）1 期
A Phase 2, Randomized, Double-blinded, Placebo - controlled, Dose Response Study of Oral (Z)-endoxifen in Premenopausal Women with Measurable Breast Density
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1.Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects
- •2.Attending the national mammography screening program. The screening mammogram should have been performed within 3 month of study inclusion.
- •3.Mammographic density assessed as BI-RADS® score B, C or D.
- •4.40-55 years old premenopausal women (defined as having at least one menstruation during the prior 12 months; women whose status is questionable in the mind of the PI will have an FSH test to confirm (FSH<26 U/L).
- •5.Women of childbearing potential using a highly effective method of birth control throughout the study period and willing to comply with monthly pregnancy testing.
- •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 240
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Any previous diagnosis of breast cancer, including carcinoma in situ, or any other cancer. Non-melanoma skin cancer and in situ cancer of the cervix are not exclusion criteria.
- •2.A history of breast surgery, e.g., reduction or enlargement, which might affect mammographic density measurements.
- •3.Mammographic BI-RADS® malignancy code =3 at baseline.
- •4.Previous treatment with an anti-oestrogen, including experimental drug studies (e.g., Karma CREME, Karisma-1 or Karisma-2).
- •5.A history of thromboembolic disease such as embolus, deep vein thrombosis, stroke, TIA (transient ischemic attack) or myocardial infarction.
- •6.Moderate hypertension at baseline defined as systolic pressure higher than 160 mm Hg or diastolic higher than 100 mm Hg.
- •7.BMI > 30.
- •8.Known APC (activated protein C) resistance, an inherited coagulation disorder.
- •9.Prescribed and regular use of anticoagulants (defined as substances included in group B01A in the ATC-system).
- •10.Allergy to endoxifen or any of its components.
- •11.Agents that have the potential to decrease endoxifen levels through increased metabolic clearance:
- •a.Certain anti-epileptic therapies (carbamazepine, fenytoin, fenobarbital, lamotrigine)
- •b.Certain antibiotics (rifamycins)
- •c.St John’s wort (in Swedish: johannesört)
- •d.Certain HIV medications (efavirenz, ritonavir)
- •12. Current, or within prior 6 months, use of hormone replacement therapy to treat menopausal symptoms
- •13. Women who have an increased risk of venous thrombosis due to immobilization, e.g., using wheelchair.
- •14.Uncontrolled diabetes (defined as HbA1c >50 mmol/mol).
- •15.Cataract.
- •16.Pregnant or plan to become pregnant in the next year.
- •17.Lactating.
- •18.Not able to understand the study information and/or informed consent.
- •19.Participation in another investigational clinical trial in the last 6 months.
- •20.Any reason for which the investigator considers the patient is not suitable for the study.
研究者
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