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

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.

Inclusion criteria

• Women who are undergoing screening breast MRI as per standard of care for high-risk breast cancer screening
• Willing to donate left-over tissue if patient undergoes a breast biopsy and/or breast surgery
• Willing to have about 40 mL of blood (approximately 3 tablespoons) drawn
• Documented informed consent of the participant

Exclusion criteria

• Allergy or intolerance to gadolinium
• Inability to undergo breast MRI (e.g. claustrophobia)
• Participants with active cancer diagnosis (exception: skin cancer, biopsy-proven atypical lobular, ductal hyperplasia and/or lobular carcinoma in situ)
• Previous diagnosis of stage 4 cancer
• Participants who have received cytotoxic chemotherapy within 1 year prior to screening breast MRI
• Participants who have received endocrine therapy within 1 year prior to screening breast MRI
• Participants who have received breast radiation within 1 year prior to screening breast MRI
• Radiation to both breasts
• Pregnant and/or lactating within 1 year prior to screening breast MRI
• Receives screening breast MRIs at an outside facility other than the consenting institution