A Randomized, Open Pilot Study to Investigate the Mammographic Density Reduction on Healthy Women, Within the Karma Cohort, for Two Different Doses of Tamoxifen
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 主要终点
- Mammographic Breast Density
研究概览
简要总结
A feasibility study, randomising to either 10 or 20 mg of tamoxifen. The primary aim is to identify the time to mammographic density change and piloting the procedures. It is known that a density change is seen after 12 months of 20 mg of tamoxifen, but the clinical experience indicates that an effect of drugs influencing mammographic density could be seen already after a few months. The second aim is to evaluate if there is a density change from 10 mg of tamoxifen equivalent to 20 mg.
详细描述
The investigators want to conduct a feasibility study including 42 women who will be randomised to either 10 or 20 mg of daily oral tamoxifen. The primary aim of the study is to identify the time to mammographic density change and piloting the procedures. It is known that a density change is seen after 12 months of 20 mg of daily tamoxifen, but the clinical experience indicates that an effect of drugs influencing mammographic density could be seen already after a few months. The second aim of the pilot study is to see if there is a density change from 10 mg of tamoxifen equivalent to 20 mg and if there is a difference in adverse reactions between the two doses. Interim analysis will be performed at 6 months, monitoring both safety and level of mammographic density change.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 74 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Previously participated in the Karma study
- •Attending the national mammography screening program, i.e. aged 40-74
- •A mammogram, including a stored raw image, must have been taken within 3 weeks of baseline and start of therapy
- •Having a mammographic volumetric density above the lowest 1/6, measured by Volpara
- •Informed consent must be signed before any study specific assessments have been performed
排除标准
- •Being pregnant or planning to become pregnant during the study
- •Any previous or current diagnosis of breast cancer (including carcinoma in situ)
- •Recalled (mammographic code 3 or above) after baseline screening mammography
- •Any previous diagnosis of cancer, with the exception of non-melanoma skin cancer and in situ cancer of the cervix
- •Currently using oestrogen and progesterone-based hormone replacement therapy
- •Current use of hormone contraceptive with hormones, e.g. hormonal contraceptive pills, or progesterone implants. Hormonal intrauterine devices are accepted.
- •A history of thromboembolic disease such as embolism, deep vein thrombosis, stroke, TIA or cardiac arrest.
- •A history of immobilization, e.g. using wheelchair
- •Uncontrolled diabetes defined as known untreated diabetes
- •Hypertension at baseline, defined as systolic pressure higher than 140 mm Hg and diastolic higher than 90 mm Hg
- •Use of drugs that interfere with CYP2D6 expression such as paroxetine, fluoxetine and bupropion
研究组 & 干预措施
Tamoxifen 10mg
Randomised dose of daily oral Tamoxifen 10mg, for 180 days
干预措施: Tamoxifen (Drug)
Tamoxifen 20mg
Randomised dose of daily oral Tamoxifen 20mg, for 180 days
干预措施: Tamoxifen (Drug)
结局指标
主要结局
Mammographic Breast Density
时间窗: 6 months
Mean change in mammographic breast density at 6 months compared to baseline (=0 months) for each dose arm, using the fully automated STRATUS method. The average percent density (fibroglandular dense tissue area divided by total breast area) of left and right breasts at baseline was calculated and compared with average percent density at the end of the trial period and density change was defined as the difference between these two measures.
次要结局
- Symptom Score(9 months)
研究者
Per Hall
Professor
Karolinska Institutet