Spots Global Cancer Trial Database for Combined Breast MRI and Biomarker Strategies in Identifying High-risk Breast Cancer Patients

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Trial Identification

Brief Title: Combined Breast MRI and Biomarker Strategies in Identifying High-risk Breast Cancer Patients

Official Title: Combined Breast MRI/Biomarker Strategies to Identify Aggressive Biology

Study ID: NCT03303846

Conditions

Healthy Subject

Interventions

Magnetic Resonance Imaging

Biospecimen Collection

Laboratory Biomarker Analysis

Study Description

Brief Summary: This clinical trial studies normal breast tissue changes combined with breast magnetic resonance imaging (MRI) that may suggest the beginnings of cancer development. Using breast tissue markers in combination with breast imaging such as MRI may help to more accurately assess a woman's risk of developing breast cancer.

Detailed Description: PRIMARY OBJECTIVES: I. To determine the number of high risk women with abnormal screening breast MRI and morphologically normal biopsy over 7 years. SECONDARY OBJECTIVES: I. To determine if WNT10B/mutant p53 expression as measured in the 0-month biopsy predicts women with an abnormal MRI/non-cancerous biopsy who will progress to cancer over 7 years. TERTIARY OBJECTIVES: I. To determine the predictive accuracy of WNT10B with MRI, of which will be compared with MRI alone using the C-index. OUTLINE: Participants undergo standard of care high risk breast cancer screening MRIs at baseline and follow-up and blood sample collection at baseline. Participants undergo collection of breast tissue samples at any breast biopsy or breast surgery.