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

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

Chicago Alternative 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, CDH1 and STK11 carrier. Women with pathogenic mutations in any other cancer susceptibility genes are eligible only if they also have a high PRS.


         - 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.

At a Glance

National Government IDNCT03729115


Lead SponsorUniversity of Chicago

Lead PhysicianOlufunmilayo Olopade


25 Years and up