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

  • Interventional
  • Recruiting
  • NCT03729115
Eligibility Details Visit Clinicaltrials.gov

Chicago Alternate Prevention Study for Diverse Populations of High Risk Women

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


Age Group
25 Years and up

Accepting Healthy Volunteers?
Accepts Healthy Volunteers

Inclusion Criteria:

        - Known BRCA1 or BRCA2, TP53, PALB2, PTEN and CDH1 carrier. Women with pathogenic mutations in any other cancer susceptibility genes are eligible only if they also have a high Polygenic Risk Score.

        OR With life time risk of 30% or higher, based on Polygenic Risk Score that integrates genetic and non-genetic factors.

         - Without prior breast cancer.

         - Must be older than 25 years.

         - Willing to travel to University of Chicago Medical Center for imaging studies as well as any necessary follow-up procedures.

         - Be able to give informed consent.

        Exclusion Criteria

         - Active cancer 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 objects in their body that interferes with an MRI.

         - Breast surgery within two weeks of study entry.

         - History of kidney disease or abnormal kidney function.

             - Women can be taking hormone replacement therapy, tamoxifen, raloxifene, aromatase inhibitors or participating in a chemoprevention trial.

At a Glance

National Government IDNCT03729115


Lead SponsorUniversity of Chicago

Lead PhysicianOlufunmilayo Olopade


25 Years and up