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

NCT ID: NCT03475979

Last Updated: 2020-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1564 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-01

Study Completion Date

2022-06-30

Brief Summary

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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

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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

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Breast Cancer BRCA1 Mutation BRCA2 Mutation Recurrent Breast Cancer Metachronous Neoplasm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Korean Society of Breast Imaging & Korean Society For Breast Screening

UNKNOWN

Sponsor Role collaborator

Bayer

INDUSTRY

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Woo Kyung Moon

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Woo Kyung Moon, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Professor

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Woo Kyung Moon, MD, PhD

Role: CONTACT

Phone: 82-2-2072-2584

Email: [email protected]

Facility Contacts

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Woo Kyung Moon, MD, PhD

Role: primary

Other Identifiers

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AB-MR for Second Breast Cancer

Identifier Type: -

Identifier Source: org_study_id