Breast Cancer Screening Adherence for Women at Moderate Risk for Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Non-Interventional Study.
- Who it may be relevant to
- Registry conditions: Breast Carcinoma. Basic parameters: 30 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Other Non-Interventional Study
Non-interventional study
Primary outcome measures
- Proportion of women who undergo a screening breast MRI within 12 months of genetic test counseling [Time frame: Up to 2 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-only
Study locations
United States · 2 centers
- Los Angeles General Medical Center — Los Angeles
- USC / Norris Comprehensive Cancer Center — Los Angeles
Identifiers
NCT: NCT07076147 · 1B-25-1 · NCI-2025-04494 · 1B-25-1 · P30CA014089