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

University of Southern California

Status: Enrolling

Conditions: Breast Carcinoma

Treatments: Other: Non-Interventional Study

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT07076147

1B-25-1 (Other Identifier)

NCI-2025-04494 (Registry Identifier)

P30CA014089 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: Female

Ages: 30 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

150 participants in 1 patient group

Observational

Description:

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

Treatment:

Other: Non-Interventional Study