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

NCT07076147 | Recruiting DMC

• 3 other identifiers: 1B-25-1NCI-2025-04494P30CA014089
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

• Proportion of women who undergo a screening breast MRI within 12 months of genetic test counseling

  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.

  Up to 2 years

Study Arms (1)

Observational

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

Other: Non-Interventional Study

Interventions

Non-Interventional Study OTHER

Non-interventional study

Observational

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women provided with a breast cancer risk assessment by genetic counselors at USC Norris or LA General Hospital 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 or a calculated lifetime breast cancer risk estimates between 20% and 40% according to the Tyrer-Cuzick V8.0B empiric risk model who are recommended to undergo annual breast MRI and/or annual mammogram.

You may qualify if:

• \* \>= 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

You may not qualify if:

• \* 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

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• University of Southern California: lead

Study Sites (2)

Los Angeles General Medical Center

Los Angeles, California, 90033, United States

RECRUITING

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jacob Comeaux

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: July 21, 2025
• Study Start: June 2, 2025
• Primary Completion (Estimated): June 2, 2027
• Study Completion (Estimated): June 2, 2028
• Last Updated: December 10, 2025

Record last verified: 2025-12

Locations

US (2)