Breast cancer screening for women with moderate genetic or estimated lifetime risk

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study compares women who carry moderately increased-risk gene variants (ATM, CHEK2, BARD1, RAD51C, RAD51D) with women whose Tyrer-Cuzick model gives a 20–40% lifetime breast cancer risk. Participants complete a questionnaire and allow review of their medical records to document whether they received recommended annual breast MRI and/or mammography. Eligible women had genetic counseling at USC Norris or Los Angeles General at least 12 months before enrollment and were advised to begin annual imaging at the time of counseling. The study will analyze differences in screening uptake and identify facilitators and barriers to adherence.

Why it matters

Who can join: the full rules

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

Where it's running

• Los Angeles General Medical Center
  Los Angeles, California, United States Recruiting
• USC / Norris Comprehensive Cancer Center
  Los Angeles, California, United States Recruiting

Study contacts

• Principal investigator: Jacob Comeaux — University of Southern California

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.