NCT03475979

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,564 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: Female
• Age: 25 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Breast Cancer
• BRCA1 Mutation
• BRCA2 Mutation
• Recurrent Breast Cancer
• Metachronous Neoplasm

Timeline

• Start date: 2018-05-01
• Primary completion: 2022-06-01
• Completion: 2022-06-01
• First posted: 2018-03-23
• Last updated: 2020-11-30

Locations

1 site across 1 country: South Korea