Breast Cancer Screening Adherence for Women at Moderate Risk for Breast Cancer

Last updated: December 9, 2025
Sponsor: University of Southern California
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cancer/tumors

Carcinoma

Treatment

Non-Interventional Study

Clinical Study ID

NCT07076147
1B-25-1
NCI-2025-04494
1B-25-1
P30CA014089
  • Ages 30-75
  • Female
  • Accepts Healthy Volunteers

Study Summary

This study assesses breast cancer screening adherence for women at moderately increased risk for developing breast cancer based on gene mutation status or empiric risk model estimates. It also seeks to determine facilitators and barriers to screening.

Eligibility Criteria

Inclusion

Inclusion Criteria:

    • >= 30 years
  • =< 75 years

  • Women with either:

  • Genetic test results showing moderately increased breast cancer risk dueto a pathogenic/likely pathogenic variant in ATM, CHEK2, BARD1, RAD51C, orRAD51D (Mutation carrier group) OR

  • Calculated lifetime breast cancer risk estimates between 20% and 40%according to the Tyrer-Cuzick V8.0B empiric risk model (Empiric riskgroup)

  • Patients provided breast cancer risk assessments by genetic counselors at USCNorris or LA General Hospital beginning in 2021 and at least 12 months ago

  • Women recommended to undergo annual breast MRI and/or annual mammogrambeginning at the time of their genetic counseling risk assessment

  • English or Spanish speaking patients

Exclusion

Exclusion Criteria:

    • History of breast cancer before genetic counseling at University of SouthernCalifornia (USC)
  • Any metastatic cancer diagnosis at time of genetic counseling risk assessment

  • Deceased

  • Patient underwent a risk reducing mastectomy before their genetic counselingrisk assessment

Study Design

Total Participants: 150
Treatment Group(s): 1
Primary Treatment: Non-Interventional Study
Phase:
Study Start date:
June 02, 2025
Estimated Completion Date:
June 02, 2028

Study Description

PRIMARY OBJECTIVE:

I. Among women without a history of breast cancer: to compare women with moderate risk breast cancer gene mutations (Mutation Carrier Group) to women with a 20-40% empiric lifetime risk of breast cancer (Empiric Risk Group) in terms of how likely they are to undergo recommended breast MRI screening.

OUTLINE: This is an observational study.

Patients complete a questionnaire and have their medical records reviewed on study.

Connect with a study center

  • Los Angeles General Medical Center

    Los Angeles, California 90033
    United States

    Active - Recruiting

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California 90033
    United States

    Site Not Available

  • Los Angeles General Medical Center

    Los Angeles 5368361, California 5332921 90033
    United States

    Active - Recruiting

  • USC / Norris Comprehensive Cancer Center

    Los Angeles 5368361, California 5332921 90033
    United States

    Active - Recruiting

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