Surveillance for Second Breast Cancer With Abbreviated Breast MRI, Ultrasound, and Mammography in Women With BRCA Mutation Testing
试验速览
- 阶段
- 不适用
- 入组人数
- 1,564
- 试验地点
- 1
- 主要终点
- Sensitivity and Specificity (co-primary)
研究概览
简要总结
Study Purpose:
A multicenter prospective study to evaluate the outcome of second breast cancer surveillance with abbreviated breast MR (AB-MR) or ultrasound (US) in addition to annual mammography in women with BRCA1/2 mutation testing
Study Scheme:
- AB-MR, US, and digital mammography will be performed on the same day and interpreted independently at baseline and then after 1 year.
- After completion of study, patients are followed-up for at least 1 year.
详细描述
For women with a BRCA1/2 mutation who are treated for breast cancer, screening of remaining breast tissue with annual mammography and breast MRI is recommended. For women who met BRCA testing criteria but show an uninformative negative result or a variant of unknown significance (VUS) result, there is no established recommendation for second breast cancer surveillance.
Abbreviated breast MRI (AB-MR) is a fast and low-cost examination that show equivalent diagnostic accuracy to that of the standardized dynamic protocol breast MRI. Breast ultrasound (US) can detect additional cancers that are occult on mammography and is indicated in high-risk patients who cannot tolerate MRI.
The purpose of this multicenter prospective study is to evaluate the outcome of second breast cancer surveillance with AB-MR or US in addition to annual mammography in women with BRCA1/2 mutation testing.
AB-MR, US, and digital mammography will be performed on the same day at baseline and then after 1 year and images will be interpreted independently according to the Breast Imaging Reporting and Data System (BI-RADS) by experienced radiologists. The BI-RADS category 3 or higher is defined as test-positive. The reference standard will be a biopsy or at least 1 year of follow-up.
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
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged between 25 years and 75 years with a personal history of breast cancer
- •BRCA mutation test done (meeting any of the following criteria): 1) early-age-onset breast cancer (40 years or younger), 2) bilateral breast cancers (synchronous) 3) personal history of ovarian cancer and/or other multiple primary cancers 4) family history of breast and/or ovarian cancer in first- or second-degree relatives
- •No symptom or sign of secondary breast cancer (no palpable mass, bloody nipple discharge, abnormal skin change, nipple retraction)
- •Written informed consent is given
- •Exclusion criteria:
- •Initial breast cancer stage IV
- •Bilateral mastectomy done
- •Diagnosis of second breast cancer or regional/distant metastasis
- •Systemic chemotherapy for any cancer
- •Pregnant or lactating
- •Contraindication to breast MRI with contrast enhancement
排除标准
- 未提供
结局指标
主要结局
Sensitivity and Specificity (co-primary)
时间窗: 1 year
To compare the sensitivity and specificity of AB-MR, US, and mammography for the detection of secondary breast cancer
次要结局
- Cancer detection rate (CDR)(1 year)
- Positive predictive value (PPV)(1 year)
- Negative predictive value (NPV)(1 year)
- Histopathologic characteristics of secondary breast cancers(1 year)
研究者
Woo Kyung Moon
Professor
Seoul National University Hospital