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