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

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.

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
  • 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 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.

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 Institutes of Health (NIH)
• 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): August 3, 2023
• Last Update Submitted That Met QC Criteria: August 1, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: IRB18-0970

Drug and device information, study documents

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