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

Not Applicable

Recruiting

• Conditions: Breast Cancer

• Registration Number: NCT03729115
• Lead Sponsor: University of Chicago

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-12
• Study First Submitted QC: 2018-10-31
• Study First Posted: 2018-11-02
• Study Start: 2019-05-30
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-01
• Last Update Posted: 2023-08-03
• Primary Completion: 2028-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 400

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Development of faster MRI protocols for a for a Personalized Risk-based Imaging Surveillance Model for diverse populations of high risk women.	5 years	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.

Trial Locations

Locations (1)

University Of Chicago Medicine Comprehensive Cancer Center; 🇺🇸 Chicago, Illinois, United States