Abbreviated DCE-MRI Surveillance for Screening Women at High Risk for Breast Cancer in Diverse Populations, CAPS Trial

Inclusion Criteria

• Known BRCA1 or BRCA2, TP53, PALB2, PTEN, CDH1 and STK11 carrier. Women with pathogenic mutations in any other cancer susceptibility genes are eligible only if they also have a high Polygenic Risk Score (PRS). OR
• With life time risk of 30% or higher, based on Polygenic Risk Score that integrates genetic and non-genetic factors. OR
• 5-years risk >= 6% for women 40-64 OR
• 5-years risk >= 6% for women 65+ AND breast density C or D AND a lifetime risk >= 20% (BCSC + PRS LTR or Tyrer-Cuzick LTR) OR
• Patients with history of chest wall radiation received before age 35 OR
• To promote health equity, women of African Ancestry ≤ 45 years with at least one 1st or 2nd degree relative with breast or ovarian cancer are eligible because PRS Scores are not currently reported for African-American (AA) women
• Must be at least 25 years old
• Willing to travel to participating site for imaging studies as well as any necessary follow-up procedures.
• Be able to give informed consent.
• An expanded cohort of 1000 women will be recruited to capture Image Biomarkers. This is cohort of participants who have been consented to #8962, #16352A at the University of Chicago and have given permission to use their images. The cohort will serve as control group for the analysis. * Patients with prior history of breast or ovarian or any cancer associated with inherited pathogenic mutations in BRCA1/2, PALB2, CDH1, TP53, PTEN or STK11 related mutation are eligible if they meet the inclusion criteria, have completed all active treatments and are cancer free. * Participants underrepresented in research will be over accrued if after genetic testing are mutation negative, are unable to be assigned a PRS (polygenic risk score) but are interested in participating and being followed for image-based biomarker procedures. * Willing to travel to the University of Chicago Medicine. * Be able to give informed consent.

Exclusion Criteria

• Undergoing active cancer treatment at the time of enrollment.
• Currently pregnancy or plans for pregnancy within two years of enrollment.
• Presence of a pacemaker or any other metallic foreign objects in their body that interferes with an MRI.
• Breast surgery within two weeks of study entry.
• Women with history of bilateral mastectomy are not eligible
• History of kidney disease or abnormal kidney function.
• History of dye allergy unless it can be mediated with antihistamines and/or steroids
• Women can be taking hormone replacement therapy, tamoxifen, raloxifene, aromatase inhibitors, Parp Inhibitors as adjuvant therapy or participating in a chemoprevention trial.