R01CA276652

Chicago Alternative Prevention Study for Breast Cancer in Diverse Populations of High-Risk Women (CAPSBRACA) - Project Summary

Risk-stratified breast cancer screening strategies are a paradigm shift from the one-size-fits-all screening approach. Previous age-based screening strategies proved to be disadvantageous to specific high-risk populations, particularly BRCA1 and BRCA2 mutation carriers and individuals of African ancestry at high risk for aggressive young onset interval breast cancers.

There is an unmet clinical need to identify women who are at high risk of aggressive interval breast cancer that would have a poorer outcome without intensive surveillance.

Since joining the Women Informed to Screen Based on Measures of Risk (WISDOM) study (ClinicalTrials.gov: NCT02620852) in 2020, the UChicago site has enrolled 1691 participants; 64.7% white, 23.5% black, and 6.8% Hispanic because of our location on the South Side of Chicago and highly effective recruitment efforts in communities of color.

A growing number of studies have demonstrated the diagnostic equivalency of abbreviated MRI to the full MRI protocol.

We launched the Chicago Alternative Prevention Study for Breast Cancer (CAPSBRACA; ClinicalTrials.gov: NCT00989638) as a P20 Breast Cancer Disparities SPORE Population Science Project to test the hypothesis that state-of-the-art genomic testing to identify women at increased risk, combined with state-of-the-art MRI techniques, could effectively detect and downstage aggressive interval breast cancers, and provide a personalized approach for management of high-risk women in diverse populations.

At our single institution, 130 genomically defined high-risk participants (mean age 42 SD+12) have been enrolled including 44 BRCA1, 42 BRCA2, 7 PALB2, and 25 with PRS >30%, suggesting common genetic variants can identify extremely high-risk women in practice.

We have demonstrated the feasibility of our approach and the proposed study will test that it is clinically effective, adaptable, and can scale to optimize a comprehensive surveillance program for high-risk women using the WISDOM platform.

Our overall objective is to expand to three additional sites in California to broaden the diversity of study sites and participants.

The specific aims are to:
1) Implement biannual abbreviated MRI that includes ultrafast-DCE-MRI, with multicenter standardization; refine and expand our high-risk biannual abbreviated protocol to be fast, while both clinically accurate and generalizable across imaging facilities;
2) Perform correlative science and quantitative analysis of MRI images and build an analysis package that can be disseminated to other centers; and
3) Develop and evaluate self-supervised deep learning (SSL) methods using UF DCE-MRI to enable fast and accurate computational biomarkers of breast cancer risk.

CAPSBRACA translates innovative genomics and imaging research from the laboratory into meaningful clinical interventions and has the potential to address an unmet clinical need for early and accurate detection of aggressive young-onset breast cancers in mutation carriers.

It will impact the nearly 10,000 unscreened women in the US diagnosed each year with symptomatic breast cancer under 40 years of age, and the thousands of screened women at high risk of aggressive interval cancers.

University Of Chicago

TO IDENTIFY CANCER RISKS AND RISK REDUCTION STRATEGIES, TO IDENTIFY FACTORS THAT CAUSE CANCER IN HUMANS, AND TO DISCOVER AND DEVELOP MECHANISMS FOR CANCER PREVENTION AND PREVENTIVE INTERVENTIONS IN HUMANS. RESEARCH PROGRAMS INCLUDE: (1) CHEMICAL, PHYSICAL AND MOLECULAR CARCINOGENESIS, (2) SCREENING, EARLY DETECTION AND RISK ASSESSMENT, INCLUDING BIOMARKER DISCOVERY, DEVELOPMENT AND VALIDATION, (3) EPIDEMIOLOGY, (4) NUTRITION AND BIOACTIVE FOOD COMPONENTS, (5) IMMUNOLOGY AND VACCINES, (6) FIELD STUDIES AND STATISTICS, (7) CANCER CHEMOPREVENTION AND INTERCEPTION, (8) PRE-CLINICAL AND CLINICAL AGENT DEVELOPMENT, (9) ORGAN SITE STUDIES AND CLINICAL TRIALS, (10) HEALTH-RELATED QUALITY OF LIFE AND PATIENT-CENTERED OUTCOMES, AND (11) SUPPORTIVE CARE AND MANAGEMENT OF SYMPTOMS AND TOXICITIES. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM: TO EXPAND AND IMPROVE THE SBIR PROGRAM, TO STIMULATE TECHNICAL INNOVATION, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT FUNDING, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION IN INNOVATION AND ENTREPRENEURSHIP BY WOMEN AND SOCIALLY/ECONOMICALLY DISADVANTAGED PERSONS. SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM: TO STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO FOSTER TECHNOLOGY TRANSFER THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT FUNDING, AND FOSTER PARTICIPATION IN INNOVATION AND ENTREPRENEURSHIP BY WOMEN AND SOCIALLY/ECONOMICALLY DISADVANTAGED PERSONS.

93.393 - Cancer Cause and Prevention Research

National Cancer Institute (NCI) [HHS - NIH]

Chicago, Illinois 606375418 United States

Single Zip Code

Cancer Prevention and Control Clinical Trials Grant Program (R01 Clinical Trial Required) (PAR-21-035)

Amendment Since initial award the total obligations have increased 191% from $1,268,206 to $3,690,580.