Trial results for the BRAVE Strategy study, focused on breast cancer risk assessment, were posted on ClinicalTrials.gov on 2025-08-28. The study, which enrolled 1071 participants, showed that 56 eligible women in the intervention group received breast cancer risk assessment, compared to 8 in the control group.
Background
Breast cancer remains a significant public health concern, and early detection through risk assessment and screening is crucial for improving patient outcomes. Identifying individuals at higher risk allows for personalized screening strategies and timely interventions. However, consistent uptake of evidence-based breast cancer risk assessment can be challenging, potentially leading to disparities in care. The BRAVE Strategy study aimed to address these challenges by testing implementation strategies to increase the proportion of women receiving appropriate risk assessments in healthcare settings.
Trial design
The BRAVE Strategy study (NCT05051631), titled "BRAVE Strategy - Breast Cancer Risk Assessment -achieVing Equity", was a completed, Phase NA stepped-wedge trial that enrolled 1071 participants. The study focused on Breast Cancer and aimed to test strategies for implementing evidence-based breast cancer risk assessment in 10 healthcare clinics in Tennessee. The central goal was to assess the feasibility, reach, acceptability, and appropriateness of customized strategies to increase the uptake of breast cancer risk assessment. The trial compared a control group, an intervention group, and a maintenance group regarding the proportion of eligible women receiving risk assessment.
Key results
The trial reported key measurements related to breast cancer risk assessment and screening:
- Number of Eligible Women Who Received Breast Cancer Risk Assessment:
- Control group: 8 participants.
- Intervention group: 56 participants.
- Maintenance group: 29 participants.
- Number of Women Who Received Risk Assessment Who Were Identified as High Risk for Breast Cancer:
- Control group: 0 participants.
- Intervention group: 3 participants.
- Maintenance group: 4 participants.
- Number of Women Identified as High Risk Women Who Received Breast Cancer Screening:
- Control group: 0 participants.
- Intervention group: 2 participants.
- Maintenance group: 2 participants.
- Number of Cancers Detected in Women Identified at High Risk:
- Control group: 0 participants.
- Intervention group: 1 participant.
- Maintenance group: 0 participants.
What this means
The results indicate that the BRAVE Strategy intervention significantly increased the number of eligible women receiving breast cancer risk assessments. The intervention group saw 56 women assessed, compared to 8 in the control group. This increased assessment also led to more women being identified as high risk for breast cancer (3 in intervention vs. 0 in control) and subsequently receiving breast cancer screening (2 in intervention vs. 0 in control). The detection of 1 cancer in the intervention group, where no cancers were detected in the control group, suggests that improved risk assessment and screening uptake can lead to earlier identification of breast cancer.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05051631, titled "BRAVE Strategy - Breast Cancer Risk Assessment -achieVing Equity", were posted on 2025-08-28 on clinicaltrials.gov.