Abbreviated Breast MRI for Second Breast Cancer Detection in Women With BRCA Mutation Testing

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Surveillance for Second Breast Cancer With Abbreviated Breast MRI, Ultrasound, and Mammography in Women With BRCA Mutation Testing

Conditions
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Breast Cancer, BRCA1 Mutation, BRCA2 Mutation, Recurrent Breast Cancer, Metachronous Neoplasm

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and Specificity (co-primary) | To compare the sensitivity and specificity of AB-MR, US, and mammography for the detection of secondary breast cancer | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cancer detection rate (CDR) | To compare the CDR (no. of detected cancers/1,000 examinations) of AB-MR, US, and mammography | 1 year | 
| Positive predictive value (PPV) | To compare the PPV (no. of detected cancers / no. of positive examinations) of AB-MR, US, and mammography | 1 year | 
| Negative predictive value (NPV) | To compare the NPV (no. of detected cancers / no. of negative examinations) of AB-MR, US, and mammography | 1 year | 
| Histopathologic characteristics of secondary breast cancers | To describe the histologic type, tumor grade, and molecular tumor subtype of secondary breast cancers detected at AB-MR, US, and mammography | 1 year |