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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03475979
• Other study ID #: AB-MR for Second Breast Cancer
• Status: Recruiting
• Start date: May 1, 2018
• Est. completion date: June 2022

Study information

• Verified date: November 2020
• Source: Seoul National University Hospital
• Contact: Woo Kyung Moon, MD, PhD
• Phone: 82-2-2072-2584
• Email: moonwk[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1564
• Est. completion date: June 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• BRCA1 Mutation
• BRCA2 Mutation
• Breast Cancer
• Breast Neoplasms
• Metachronous Neoplasm
• Neoplasms, Second Primary
• Recurrent Breast Cancer

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Seoul National University Hospital	Bayer, Korean Society of Breast Imaging & Korean Society For Breast Screening

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cancer detection rate (CDR)	To compare the CDR (no. of detected cancers/1,000 examinations) of AB-MR, US, and mammography	1 year
Secondary	Positive predictive value (PPV)	To compare the PPV (no. of detected cancers / no. of positive examinations) of AB-MR, US, and mammography	1 year
Secondary	Negative predictive value (NPV)	To compare the NPV (no. of detected cancers / no. of negative examinations) of AB-MR, US, and mammography	1 year
Secondary	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