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

NCT ID: NCT03729115

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-30
• Study Completion Date: 2028-12-31

Brief Summary

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

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Screening Arm

Enrolled patients will undergo Magnetic Resonance Imaging (MRI) every 6 months (2x/year) in addition to an annual screening mammogram.

Group Type: OTHER

Magnetic Resonance Imaging (MRI)

Intervention Type: PROCEDURE

Patients will have MRI scans every 6 months.

Interventions

Magnetic Resonance Imaging (MRI)

Patients will have MRI scans every 6 months.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 25 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olufunmilayo I Olopade, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

University Of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Cancer Clinical Intake Office

Role: CONTACT

cancerclinicaltrials@bsd.uchicago.edu

1-855-702-8222

Facility Contacts

Cancer Clinical Trials Intake

Role: primary

cancerclinicaltrials@bsd.uchicago.edu

855-702-8222

Other Identifiers

IRB18-0970

Identifier Type: -

Identifier Source: org_study_id