NCT07076147 · University of Southern California
Breast Cancer Screening Adherence for Women at Moderate Risk for Breast Cancer
What this study is 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.
View original scientific description
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.
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
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Patient underwent a risk reducing mastectomy before their genetic counseling risk assessment
Where
- Los Angeles, California
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 1, 2026 · Source of record for eligibility and locations