NCT05068388已完成2 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
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Change of mammographic density area (cm2) assessed by iCAD® software
研究概览
简要总结
This is a randomized, double-blinded, placebo-controlled dose-response efficacy study of oral (Z)-endoxifen in premenopausal women with measurable breast density. There will be 5 in-clinic visits (Screening, Day 1, Months 1, 3 and 6) and 3 self-report visits (Months 2, 4 and 5). Standard of care mammograms will be used for the screening mammogram as well as the 24-month follow up visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Premenopausal women (defined as having at least one menstruation during the prior 12 months; women with an intrauterine device are considered premenopausal if <52 years)
- •Women of childbearing potential using a highly effective method of birth control* throughout the study period and willing to comply with monthly pregnancy testing
- •Screening mammogram performed within 3 month of study inclusion
- •Mammographic density assessed as BI-RADS® score B, C, or D
- •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
排除标准
- •Mammographic BI-RADS® malignancy code ≥3 at baseline mammography
- •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)
- •A history of breast surgery, e.g., reduction or enlargement, which might affect mammographic density measurements
- •Current medical conditions:
- •APC (activated protein C) resistance, an inherited coagulation disorder
- •Systolic pressure higher than 160 mm Hg or diastolic higher than 100 mm Hg
- •Cataract(s)
- •Uncontrolled diabetes (defined as HbA1c >50 mmol/mol)
- •Abnormal lab values deemed clinically significant by Investigator
- •Women who have an increased risk of venous thrombosis due to immobilization, e.g., using wheelchair
- •Agents that have the potential to decrease endoxifen levels through increased metabolic clearance:
- •Certain anti-epileptic therapies (carbamazepine, fenytoin, fenobarbital, lamotrigine)
- •Certain antibiotics (rifamycins)
- •St John's wort (in Swedish: johannesört)
- •Certain HIV medications (efavirenz, ritonavir)
- •Lactating, pregnant, or plan to become pregnant in the next year
- •History of thromboembolic disease such as embolus, deep vein thrombosis, stroke, TIA (transient ischemic attack) or myocardial infarction
- •Allergy to endoxifen or any of its components
- •Previous treatment with an anti-oestrogen, including experimental drug studies (e.g., Karma CREME, Karisma-1 or Karisma-2)
- •Prescribed and regular use of anticoagulants (defined as substances included in group B01A in the ATC-system)
- •Participation in another investigational clinical trial in the last 6 months
- •Not willing or able to understand the study information and/or informed consent
研究组 & 干预措施
Placebo
Placebo Comparator
oral capsule
干预措施: Placebo (Drug)
1 mg (Z)-endoxifen
Experimental
oral capsule
干预措施: Z-Endoxifen (Drug)
2 mg (Z)-endoxifen
Experimental
oral capsule
干预措施: Z-Endoxifen (Drug)
结局指标
主要结局
Change of mammographic density area (cm2) assessed by iCAD® software
时间窗: 6 months
Change from baseline
次要结局
- Change of mammographic density area (cm2) assessed by iCAD® software(3 months)
- Change of mammographic density area (cm2) assessed by Stratus software(3 months)
- Change from baseline responses to the Breast Cancer Prevention Trial Eight Symptom Scale (BESS)(6 months)
- Comparison of adverse events(6 months)
研究者
研究点 (1)
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