An observational study in Breast Cancer, BRCA1 Mutation and BRCA2 Mutation, sponsored by Seoul National University Hospital. Status unknown at 1 site in Korea, Republic of. Open to female participants aged 25 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-11-30.
Sponsored by Seoul National University Hospital · Observational
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:
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.
Breast cancer patients who met BRCA testing criteria and undergo post-operative surveillance for secondary breast cancer
Exclusion criteria:
Sensitivity and Specificity (co-primary)
To compare the sensitivity and specificity of AB-MR, US, and mammography for the detection of secondary breast cancer
Time frame: 1 year
Cancer detection rate (CDR)
To compare the CDR (no. of detected cancers/1,000 examinations) of AB-MR, US, and mammography
Time frame: 1 year
Positive predictive value (PPV)
To compare the PPV (no. of detected cancers / no. of positive examinations) of AB-MR, US, and mammography
Time frame: 1 year
Negative predictive value (NPV)
To compare the NPV (no. of detected cancers / no. of negative examinations) of AB-MR, US, and mammography
Time frame: 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
Time frame: 1 year
This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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Seoul National University Hospital