RecruitingBreast Cancer

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

Eligible age

25+ yrs

Accepts

Women

Locations

1 state

Healthy volunteers

Yes

See if you qualify for this study

Answer a few quick questions about your location and health. Takes about a minute.

This study is aimed to establish a registry of women undergoing intensive surveillance for the early detection of breast cancer in high-risk women.

Sponsor: University of Chicago

✓ \- 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.

✕ 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.

Chicago

Source: ClinicalTrials.gov · NCT03729115 · last updated 2026-04-27