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

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

Official Title
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Chicago Alternative Prevention Study for Diverse Populations of High Risk Women

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: Magnetic Resonance Imaging (MRI)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Screening Arm<br>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)<br>* Patients will have MRI scans every 6 months.<br>|

What is the study measuring?
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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 |