Prospective Analysis of Changes in Background Parenchymal Enhancement (BPE) and Amount of Fibroglandular Tissue on Breast MRI in Early Stage Breast Cancer Patients on Tamoxifen
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- To compare the level of BPE on breast MRI
研究概览
简要总结
Tamoxifen is a hormonal treatment for breast cancer. It prevents recurrent disease and decreases death. Tamoxifen is given to women with and at high risk for breast cancer. These women also commonly have breast MRI to monitor for breast cancer. Some features of normal breast tissue visible on breast MRI change depending on patient hormonal status. It has been questioned if hormonal changes due to tamoxifen are seen on breast MRI. Pilot data suggests this is true. If tamoxifen causes changes in normal breast tissue on MRI, more study could be done looking at whether breast MRI could tell us anything about whether tamoxifen is working.
This study is being done to see if tamoxifen changes normal breast tissue on MRI. It will also look at if other factors like taking anti-depressants or gene type have any effect.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females with stage 0-3 breast cancer who have had or are planned to have a breast MRI within 1 year prior to starting tamoxifen
- •Premenopausal status is defined as intact ovaries and still menstruating
- •Clinical and MRI follow-up planned at MSKCC or MCKCC regional facility
- •Willing and able to undergo all study procedures
排除标准
- •Contraindication to breast MRI (such as non-compatible cardiac pacemakers or intracranial vascular clips, allergy to Gadolinium)
- •Bilateral breast cancer or treatment such as:
- •History of or planned bilateral breast irradiation
- •History of or planned bilateral mastectomy
- •Bilateral breast cancer
- •History of unilateral mastectomy or radiation treatment with contralateral breast cancer
- •Taking chemo- or hormonal therapy at the time of the baseline breast MRI
- •Estrogen and progesterone receptor negative breast cancer
- •GFR less than GFR < 30 mL/min/1.73m2
- •Postmenopausal women
- •Pregnant and/or nursing women
- •Less than 21 years of age
结局指标
主要结局
To compare the level of BPE on breast MRI
时间窗: 3 years
on breast MRI in premenopausal patients with breast cancer before and during 9-12 months on tamoxifen to determine whether tamoxifen results in a significant decrease in BPE and/or amount of fibroglandular tissue
次要结局
- To compare the amount of fibroglandular tissue on breast MRI(3 years)