Breast CancerNCT03475979
Abbreviated Breast MRI for Second Breast Cancer Detection in Women With BRCA Mutation Testing
An observational study of Breast Cancer and BRCA1 Mutation, run by Seoul National University Hospital at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Ages 25 to 75 years, women only
- Conditions the study is for
- Breast Cancer, BRCA1 Mutation, BRCA2 Mutation
- How many people
- 1,564 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 May 2018to Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Breast cancer patients who met BRCA testing criteria and undergo post-operative surveillance for secondary breast cancer
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Woo Kyung Moon, MD, PhD, moonwk1963@gmail.com
About this study
Official title: Surveillance for Second Breast Cancer With Abbreviated Breast MRI, Ultrasound, and Mammography in Women With BRCA Mutation Testing
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.
Read the 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.
- Conditions
- Breast Cancer, BRCA1 Mutation, BRCA2 Mutation, Recurrent Breast Cancer, Metachronous Neoplasm
- Medical subject headings
- Breast Neoplasms, Neoplasms, Second Primary
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity (co-primary)
To compare the sensitivity and specificity of AB-MR, US, and mammography for the detection of secondary breast cancer
Measured: 1 year
Secondary outcomes (4)
Cancer detection rate (CDR)
To compare the CDR (no. of detected cancers/1,000 examinations) of AB-MR, US, and mammography
Measured: 1 year
Positive predictive value (PPV)
To compare the PPV (no. of detected cancers / no. of positive examinations) of AB-MR, US, and mammography
Measured: 1 year
Negative predictive value (NPV)
To compare the NPV (no. of detected cancers / no. of negative examinations) of AB-MR, US, and mammography
Measured: 1 year
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study start1 May 2018
- Primary completionJun 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,564 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Korean Society of Breast Imaging & Korean Society For Breast Screening, Bayer
- Responsible party
- Principal investigator, Woo Kyung Moon, Seoul National University Hospital
- Investigators
- Woo Kyung Moon, MD, PhD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03475979
- Sponsor's protocol ID
- AB-MR for Second Breast Cancer
- Status last verified
- Nov 2020
- First submitted
- 13 Mar 2018
- Last updated
- 30 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surveillance for Second Breast Cancer With Abbreviated Breast MRI, Ultrasound, and Mammography in Women With BRCA Mutation Testing
- ClinicalTrials.gov ID
- NCT03475979
- Acronym / sponsor ID
- AB-MR for Second Breast Cancer
- Conditions
- Breast Cancer, BRCA1 Mutation, BRCA2 Mutation, Recurrent Breast Cancer, Metachronous Neoplasm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,564 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Korean Society of Breast Imaging & Korean Society For Breast Screening, Bayer
- Study start
- 1 May 2018 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 23 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer patients who met BRCA testing criteria and undergo post-operative surveillance for secondary breast cancer
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity and Specificity (co-primary)
Time frame: 1 year
To compare the sensitivity and specificity of AB-MR, US, and mammography for the detection of secondary breast cancer
4 secondary outcomes
Cancer detection rate (CDR)
Time frame: 1 year
Positive predictive value (PPV)
Time frame: 1 year
Negative predictive value (NPV)
Time frame: 1 year
Histopathologic characteristics of secondary breast cancers
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Woo Kyung Moon, MD, PhD principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and BRCA1 Mutation, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Woo Kyung Moon, MD, PhD (82-2-2072-2584, moonwk@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and Specificity (co-primary) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2020.