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

NCT ID: NCT07076147

Last Updated: 2025-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-02

Study Completion Date

2028-06-02

Brief Summary

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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

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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.

Conditions

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Breast Carcinoma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Observational

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

Non-Interventional Study

Intervention Type OTHER

Non-interventional study

Interventions

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Non-Interventional Study

Non-interventional study

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Southern California

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jacob Comeaux

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

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Los Angeles General Medical Center

Los Angeles, California, United States

Site Status RECRUITING

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Jacob Comeaux

Role: primary

323-865-0474

Jacob Comeaux

Role: primary

323-865-0474

Other Identifiers

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NCI-2025-04494

Identifier Type: REGISTRY

Identifier Source: secondary_id

1B-25-1

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA014089

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1B-25-1

Identifier Type: -

Identifier Source: org_study_id

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