Clinical trial NCT03475979: Abbreviated Breast MRI for Second Breast Cancer Detection in Women With BRCA Mutation Testing
Official title: Surveillance for Second Breast Cancer With Abbreviated Breast MRI, Ultrasound, and Mammography in Women With BRCA Mutation Testing
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
BRCA1 Mutation
BRCA2 Mutation
Recurrent Breast Cancer
Metachronous Neoplasm
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Korean Society of Breast Imaging & Korean Society For Breast Screening
name: Bayer
First posted: 2018-03-23
Enrollment: 1564
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Breast cancer patients who met BRCA testing criteria and undergo post-operative surveillance for secondary breast cancer

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity and Specificity (co-primary)
timeFrame: 1 year
Secondary outcomes:
measure: Cancer detection rate (CDR)
timeFrame: 1 year
measure: Positive predictive value (PPV)
timeFrame: 1 year
measure: Negative predictive value (NPV)
timeFrame: 1 year
measure: Histopathologic characteristics of secondary breast cancers
timeFrame: 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Professor
name: Woo Kyung Moon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: