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

Seoul National University

Status: Unknown

Conditions: Breast Cancer; BRCA2 Mutation; Metachronous Neoplasm; BRCA1 Mutation; Recurrent Breast Cancer

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03475979

AB-MR for Second Breast Cancer

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,564 estimated patients

Sex: Female

Ages: 25 to 75 years old

Volunteers: No Healthy Volunteers

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