N/A N=1,071 Randomized Screening

BRAVE Strategy - Breast Cancer Risk Assessment -achieVing Equity

Breast Cancer

Bottom Line

View on ClinicalTrials.gov: NCT05051631 ↗

Enrolled (actual)

1,071

Serious AEs

0.0%

Results posted

Aug 2025

Primary outcome: Primary: Number of Eligible Women Who Received Breast Cancer Risk Assessment — 8; 56; 29 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Intervention plus 12 months maintenance (Other); Intervention plus 10 months maintenance (Other); Intervention plus 8 months maintenance (Other); Intervention plus 6 months maintenance (Other); Intervention plus 4 months maintenance (Other)
Age: Adult · 25+ yrs
Sex: Female
Sponsor: Vanderbilt University Medical Center
Primary completion: Aug 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Eligible Women Who Received Breast Cancer Risk Assessment	8; 56; 29	—
SECONDARY Number of Women Who Received Risk Assessment Who Were Identified as High Risk for Breast Cancer.	0; 3; 4	—
SECONDARY Number of Women Identified as High Risk Women Who Received Breast Cancer Screening.	0; 2; 2	—
SECONDARY Number of Cancers Detected in Women Identified at High Risk.	0; 1; 0	—

Summary

The central goal of this study is to test strategies to implement evidence-based breast cancer risk assessment in healthcare clinics in Tennessee. The BRAVE Strategy (Breast cancer Risk Assessment - achieVing Equity) study aims to assess the feasibility, reach, acceptability, and appropriateness of select customized strategies to increase uptake of breast cancer risk assessment. The investigators will achieve these aims through a conducting a stepped-wedge trial conducted in 10 healthcare clinics in the state of Tennessee. The primary outcome is the proportion of women age 25-49 having risk assessment. Secondary outcomes include the numbers of 1) women identified as high-risk; 2) pursuing risk-adherent screening; and 3) diagnosed with breast cancer.

Eligibility Criteria

Inclusion Criteria

ages 25-49

Exclusion Criteria

personal history of breast cancer

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05051631). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.