A Multi-Modality Surveillance Program for Women at High Risk for Breast Cancer

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 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 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.

• Patients with prior history of breast or ovarian cancer are eligible if they have completed all active treatments and are cancer free for two years.

Exclusion criteria

• Undergoing active cancer treatment at the time of enrollment.
• Current pregnancy or plans for pregnancy within two years of enrollment.
• Presence of a pacemaker or any other metallic foreign object 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.