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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03303846.
PRIMARY OBJECTIVE:
I. To determine the number of high risk women with abnormal screening breast MRI and morphologically normal biopsy over 7 years.
SECONDARY OBJECTIVE:
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 OBJECTIVE:
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 also undergo collection of breast tissue samples at any breast biopsy or breast surgery.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationCity of Hope Comprehensive Cancer Center
Principal InvestigatorVictoria Louise Seewaldt
