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

Recruiting

• Conditions: Breast Carcinoma

• Registration Number: NCT07076147
• Lead Sponsor: University of Southern California

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2025-06-02
• Status Verified: 2025-07
• Study First Submitted: 2025-07-07
• Study First Submitted QC: 2025-07-17
• Last Update Submitted: 2025-07-17
• Study First Posted: 2025-07-21
• Last Update Posted: 2025-07-21
• Primary Completion: 2027-06-02
• Study Completion: 2028-06-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

• * >= 30 years

  • =< 75 years

  • Women with either:

    • Genetic test results showing moderately increased breast cancer risk due to a pathogenic/likely pathogenic variant in ATM, CHEK2, BARD1, RAD51C, or RAD51D (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 risk group)

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

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

  • English or Spanish speaking patients

Exclusion Criteria

• * History of breast cancer before genetic counseling at University of Southern California (USC)

  • Any metastatic cancer diagnosis at time of genetic counseling risk assessment
  • Deceased
  • Patient underwent a risk reducing mastectomy before their genetic counseling risk assessment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of women who undergo a screening breast MRI within 12 months of genetic test counseling	Up to 2 years	Will be calculated for each of the 4 Hospital-by-Age subgroups for the 2 risk groups; then a one-sided, α=0.05 Mantel Haenszel test, stratifying by hospital and age, will be used to compare the Mutation Carrier Risk and the Empiric Risk groups in terms of adherence to screening MRI. Homogeneity of odds ratios will be tested to ensure that difference (odds ratio) between the two risk groups is fairly consistent across the 4 strata.

Trial Locations

Locations (2)

Los Angeles General Medical Center; 🇺🇸 Los Angeles, California, United States

USC / Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States