NCT00165308已完成不适用
A Feasibility Study of Tamoxifen Prevention of Breast Cancer in Hodgkin's Disease Survivors
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- To determine the feasibility of a randomized trial testing the effectiveness of tamoxifen in reducing the risk of radiogenic breast cancer.
研究概览
简要总结
The purpose of this study is determine whether or not tamoxifen reduces the chance of Hodgkin's Disease survivors developing breast cancer.
详细描述
- Patients will receive tamoxifen orally once daily to be taken at home for 1 year. They will be asked to complete a daily drug log to keep track of the pills taken or missed.
- Patients will also be asked to give a blood/DNA sample which will be stored for possible further testing for the presence of cancer related genes that are known nor or discovered in the future.
- Patients will also receive a mammogram that will be reviewed by study officials.
- Side effects will be monitored every 2 months for one year, between visits to the clinic.
- A follow-up visit will be conducted at the 6 month mark and includes a physical exam, blood work, health and wellness surveys)
- A follow-up visit will be performed at the 1 year mark and includes a mammogram, gynecological exam, physical exam, blood work, health and wellness surveys.
- Patients active participation will be for 1 year. However, tamoxifen has been shown to be effective after a 5-year course in other women at increased risk for breast cancer, the patient may decide to stay on tamoxifen for 4 additional years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females diagnosed with Hodgkin's Disease at age < 35 years
- •> 5 years from mantle or chest radiation
- •Current age > 30 years
- •Has completed childbearing
- •Willingness to discontinue use of oral contraceptives or other hormonal contraception for duration of the study
排除标准
- •History of secondary malignancy after Hodgkin's disease, except thyroid cancer of basal cell cancer
- •Recurrence of Hodgkin's disease in the 5 years before study entry
- •Current participation in any other cancer prevention study
- •Current or prior use of tamoxifen
- •Current use of coumadin
- •History of deep venous thrombosis, pulmonary embolism, or a condition known to be associated with hypercoagulability
- •History of cerebrovascular accident
- •History of macular degeneration
- •Current use of chemotherapy for benign disease
研究组 & 干预措施
Tamoxifen
Experimental
Single arm: Tamoxifen 20mg daily
干预措施: Tamoxifen (Drug)
结局指标
主要结局
To determine the feasibility of a randomized trial testing the effectiveness of tamoxifen in reducing the risk of radiogenic breast cancer.
时间窗: 2 years
次要结局
- To determine the safety and effect on quality of life in participating women.(2 years)
研究者
Judy E. Garber, MD
Principal Investigator
Dana-Farber Cancer Institute
研究点 (2)
Loading locations...
相似试验
撤回
4 期
Tamoxifen Versus Estradiol for Unscheduled Bleeding in Etonogestrel Implant Users, a Randomized Pilot TrialVaginal BleedingNCT04933240Virginia Commonwealth University
招募中
不适用
Tamoxifen preventive studyBreast cancerJPRN-jRCTs031200222akamura Seigo210
进行中（未招募）
3 期
Trial of Low Dose Tamoxifen in Women With Breast Intraepithelial Neoplasia - Long Term Follow-upCarcinoma, Intraductal, NoninfiltratingRecurrence, Local NeoplasmBreast NeoplasmsAtypical HyperplasiaNCT01357772Andrea DeCensi500
招募中
2 期
Low Dose Tamoxifen With or Without Omega-3 Fatty Acids for Breast Cancer Risk ReductionBreast Atypical HyperplasiaBreast CarcinomaBreast Ductal Carcinoma In SituBreast Lobular Carcinoma In SituNCT06195306National Cancer Institute (NCI)66
进行中（未招募）
3 期
Phase III, Randomized, Double Blind Trial Low Dose Tamoxifen Versus Placebo in Hormone Replacement Therapy (HRT) UsersBreast CancerNCT01579734European Institute of Oncology1,884