Combined Breast MRI/Biomarker Strategies to Identify Aggressive Biology
Description
Brief 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.
Detailed Description
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.
Phase
N/AInclusion and Exclusion 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
- 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
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.