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

Breast Cancer Clinical Trial

— CAPS  

Official title:

Chicago Alternative Prevention Study for Diverse Populations of High Risk Women

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03729115
• Other study ID #: IRB18-0970
• Status: Recruiting
• Phase: N/A
• Start date: May 30, 2019
• Est. completion date: December 31, 2028

Study information

• Verified date: August 2023
• Source: University of Chicago
• Contact: Cancer Clinical Intake Office
• Phone: 1-855-702-8222
• Email: cancerclinicaltrials[@]bsd.uchicago.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• Magnetic Resonance Imaging (MRI)
Patients will have MRI scans every 6 months.

Locations

Country	Name	City	State
United States	University Of Chicago Medicine Comprehensive Cancer Center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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