Combined Breast MRI and Biomarker Strategies in Identifying High-risk Breast Cancer Patients
- 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
- 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
I. To determine the number of high risk women with abnormal screening breast MRI and morphologically normal biopsy over 7 years.
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.
I. To determine the predictive accuracy of WNT10B with MRI, of which will be compared with MRI alone using the C-index.
Participants undergo standard of care high risk breast cancer screening MRIs at baseline and follow-up and blood sample collection at baseline. Participants also undergo collection of breast tissue samples at any breast biopsy or breast surgery.
Trial Phase Phase NA
Trial Type Screening
City of Hope Comprehensive Cancer Center
Victoria Louise Seewaldt
- Primary ID 17009
- Secondary IDs NCI-2017-01757
- Clinicaltrials.gov ID NCT03303846