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

NCT03475979 | Unknown DMC

• 1 other identifier: AB-MR for Second Breast Cancer
• Study Type: observational
• Target: 1,564
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; BRCA1 Mutation; BRCA2 Mutation; Recurrent Breast Cancer; Metachronous Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Cancer detection rate (CDR)

  1 year

• Positive predictive value (PPV)

  1 year

• Negative predictive value (NPV)

  1 year

• Histopathologic characteristics of secondary breast cancers

  1 year

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Breast cancer patients who met BRCA testing criteria and undergo post-operative surveillance for secondary breast cancer

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Korean Society of Breast Imaging & Korean Society For Breast Screening: collaborator
• Bayer: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms, Second Primary

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Woo Kyung Moon, MD, PhD

  Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Woo Kyung Moon, MD, PhD

CONTACT

82-2-2072-2584; moonwk@snu.ac.kr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 13, 2018
• First Posted: March 23, 2018
• Study Start: May 1, 2018
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: November 30, 2020

Record last verified: 2020-11

Locations

KR (1)