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

Chicago Alternative Prevention Study for BreAst CAncer inHigh Risk Women - CAPSBRACA

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

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: Magnetic Resonance Imaging (MRI)

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cancer Clinical Intake Office; Phone Number: 1-855-702-8222; Email: cancerclinicaltrials@bsd.uchicago.edu

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92093
      • Recruiting
      • University of California, San Diego
      • Contact: Lorena Pineda; Phone Number: 858-534-2010; Email: lopineda@health.ucsd.edu
    • Sacramento, California, United States, 95817
      • Recruiting
      • University of California, Davis
      • Contact: Genella Cipar; Phone Number: 916-734-9004; Email: research-radiology-som@health.ucdavis.edu
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • University Of Chicago Medicine Comprehensive Cancer Center
      • Principal Investigator: Olufunmilayo Olopade, MD
      • Contact: Cancer Clinical Trials Intake; Phone Number: 855-702-8222; Email: cancerclinicaltrials@bsd.uchicago.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Known carrier of PV in BRCA1, BRCA2, TP53, PALB2, PTEN, CDH1 or STK11 gene. Women with PV in any other cancer susceptibility genes are eligible if they also have an estimated lifetime risk of 30% or higher based on the integrated risk score, as described below.

OR

• Results from a CLIA approved laboratory with estimated lifetime risk of 30% or higher, based on integrated risk score that includes polygenic risk score (PRS) e.g Myriad Model.

OR

• WISDOM study participant recommended to have MRI every 6 months. OR
• Patients with history of chest wall radiation received before age 35. AND
• 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 or any cancer associated with inherited pathogenic mutations in BRCA1/2, PALB2, CDH1, TP53, PTEN or STK11 related mutation are eligible if they meet the inclusion criteria, have completed all active treatments and are cancer free.
  • Willing to travel to the University of Chicago Medicine

Exclusion Criteria

• Undergoing active cancer treatment at the time of enrollment.
• Current pregnancy.
• 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.
  • Women who are pregnant can return to the study after pregnancy. Expected timeframe to return back to the study after pregnancy is within 6 months post-delivery.
  • Women can return to the study after being treated for early-stage breast cancer. Timing of return to the study will be per investigator's discretion.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Screening Arm; Enrolled patients will undergo Magnetic Resonance Imaging (MRI) every 6 months (2x/year) in addition to an annual screening mammogram.	Procedure: Magnetic Resonance Imaging (MRI); Patients will have MRI scans every 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Development of faster MRI protocols for a for a Personalized Risk-based Imaging Surveillance Model for diverse populations of high risk women.	We will test whether an abbreviated MRI (AB-MRI) is diagnostically equivalent to a full MRI. Eligible women will be scanned every 6 months with a full protocol MRI.	5 years

Collaborators and Investigators

• Sponsor: University of Chicago
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Olufunmilayo I Olopade, MD, University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2019
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: October 12, 2018
• First Submitted That Met QC Criteria: October 31, 2018
• First Posted (Actual): November 2, 2018

Study Record Updates

• Last Update Posted (Actual): September 1, 2026
• Last Update Submitted That Met QC Criteria: August 28, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Investigative Techniques; Chemistry Techniques, Analytical; Spectrum Analysis; Magnetic Resonance Spectroscopy
• Other Study ID Numbers: IRB18-0970; 5R01CA276652 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No