Status:
UNKNOWN
Abbreviated Breast MRI for Second Breast Cancer Detection in Women With BRCA Mutation Testing
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Korean Society of Breast Imaging & Korean Society For Breast Screening
Bayer
Conditions:
Breast Cancer
BRCA1 Mutation
Eligibility:
FEMALE
25-75 years
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 ...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2022
Estimated Enrollment :
1564 Patients enrolled
Trial Details
Trial ID
NCT03475979
Start Date
May 1 2018
End Date
June 1 2022
Last Update
November 30 2020
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea