Breast Cancer Clinical Trial
Combined Breast MRI and Biomarker Strategies in Identifying High-risk Breast Cancer Patients
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.
Full 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.
Eligibility Criteria
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
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There are 5 Locations for this study
Duarte California, 91010, United States More Info
Principal Investigator
Sub-Investigator
Los Angeles California, 90033, United States More Info
Principal Investigator
Durham North Carolina, 27705, United States More Info
Principal Investigator
Columbus Ohio, 43212, United States More Info
Principal Investigator
Sub-Investigator
Madison Wisconsin, 53719, United States More Info
Principal Investigator
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