Breast CancerBRAVENCT05051631

BRAVE Strategy - Breast Cancer Risk Assessment -achieVing Equity

A study testing Intervention plus 12 months maintenance, Intervention plus 10 months maintenance and Intervention plus 8 months maintenance in people with Breast Cancer, run by Vanderbilt University Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 25 to 49 years, women onlyHealthy volunteers can take part
Conditions the study is for: Breast Cancer
What is being tested?: Intervention plus 12 months maintenance, Intervention plus 10 months maintenance and Intervention plus 8 months maintenance
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,071 participants
Where: 1 siteUnited States
Study dates: 9 Mar 2022to 30 Aug 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 25 to 49 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

ages 25-49

Who cannot join

personal history of breast cancer

Trial locations and contacts

1 site in 1 country.

United States1 site

Vanderbilt University Medical Center
Nashville, Tennessee, 37232

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About this study

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.

Conditions: Breast Cancer
Being tested: Intervention plus 12 months maintenance, Intervention plus 10 months maintenance, Intervention plus 8 months maintenance, Intervention plus 6 months maintenance, Intervention plus 4 months maintenance
Keywords: breast cancer, mammogram, screening, risk assessment
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Intervention plus 12 months maintenanceOther
The intervention will include 2 months of data collection in the control period, 4 months of education and awareness training, and 12 months of data collection in the maintenance time period.
Intervention plus 10 months maintenanceOther
The intervention will include 4 months of data collection in the control period, 4 months of education and awareness training, and 10 months of data collection in the maintenance time period.
Intervention plus 8 months maintenanceOther
The intervention will include 6 months of data collection in the control period, 4 months of education and awareness training, and 8 months of data collection in the maintenance time period.
Intervention plus 6 months maintenanceOther
The intervention will include 8 months of data collection in the control period, 4 months of education and awareness training, and 6 months of data collection in the maintenance time period.
Intervention plus 4 months maintenanceOther
The intervention will include 10 months of data collection in the control period, 4 months of education and awareness training, and 4 months of data collection in the maintenance time period.

Study groups in NCT05051631
Study group	Role	What they receive
Intervention plus 12 months maintenance	Experimental	Clinics in this group will be in the control phase for 2 months, receive the 4 month intervention, and be in the maintenance phase for 12 months. Receives: Other: Intervention plus 12 months maintenance
Intervention plus 10 months maintenance	Experimental	Clinics in this group will be in the control phase for 4 months, receive the 4 month intervention, and be in the maintenance phase for 10 months. Receives: Other: Intervention plus 10 months maintenance
Intervention plus 8 months maintenance	Experimental	Clinics in this group will be in the control phase for 6 months, receive the 4 month intervention, and be in the maintenance phase for 8 months. Receives: Other: Intervention plus 8 months maintenance
Intervention plus 6 months maintenance	Experimental	Clinics in this group will be in the control phase for 8 months, receive the 4 month intervention, and be in the maintenance phase for 6 months. Receives: Other: Intervention plus 6 months maintenance
Intervention plus 4 months maintenance	Experimental	Clinics in this group will be in the control phase for 10 months, receive the 4 month intervention, and be in the maintenance phase for 4 months. Receives: Other: Intervention plus 4 months maintenance

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Eligible Women Who Received Breast Cancer Risk Assessment
The number of women eligible for risk assessment who received documented breast cancer risk assessment.
Measured: Baseline (2-months prior to intervention) to 9 months post-intervention

Secondary outcomes (3)

Number of Women Who Received Risk Assessment Who Were Identified as High Risk for Breast Cancer.
Number of women who received risk assessment who were identified as high risk for breast cancer. Women are considered high risk if they have 20% or greater lifetime risk of breast cancer using the Tyrer Cuzick risk assessment tool. The Tyrer Cuzick risk assessment tool is an 11 question electronic risk assessment tool about a woman's family history of cancer and personal history to immediately calculate a lifetime risk percentage.
Measured: Baseline (2-months prior to intervention) to 9 months post-intervention
Number of Women Identified as High Risk Women Who Received Breast Cancer Screening.
Screening is defined as screening mammography or breast MRI. The number of women who received screening will be identified through from electronic health record review. For this measure, the denominator includes only those who were identified as high risk.
Measured: Baseline (2-months prior to intervention) to 9 months post-intervention
Number of Cancers Detected in Women Identified at High Risk.
Cancers will include invasive cancers and cancer in situ. Cancers will be identified from electronic health records. For this measure, the denominator includes only those who were identified as high risk.
Measured: Baseline (2-months prior to intervention) to 9 months post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Mar 202230 Aug 2024

First posted21 Sep 2021
Study start9 Mar 2022
Primary completion30 Aug 2024
Study completion30 Aug 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Breast CancerStudies of the same condition, open and under way.
More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Screening
Allocation: Randomised
Intervention model: Parallel groups
Model description: Stepped-Wedge Trial. 10 clinics will be assigned to 5 arms to receive the intervention at sequential times. The time at which each arm receives the intervention will be randomized.
Masking: None (open label)
Enrolment: 1,071 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05051631
Sponsor's protocol ID: 211753
Acronym: BRAVE
Status last verified: Aug 2025
First submitted: 10 Sep 2021
Last updated: 28 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: BRAVE Strategy - Breast Cancer Risk Assessment -achieVing Equity
ClinicalTrials.gov ID: NCT05051631
Acronym / sponsor ID: BRAVE / 211753
Conditions: Breast Cancer
Keywords: breast cancer, mammogram, screening, risk assessment
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,071 participants (actual)
Lead sponsor: Vanderbilt University Medical CenterUniversity, hospital or other
Study start: 9 Mar 2022 (actual)
Primary completion: 30 Aug 2024 (actual)
Study completion: 30 Aug 2024 (actual)
First posted: 21 Sep 2021 (actual)
Results: Posted 28 Aug 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Screening
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5
Model description: Stepped-Wedge Trial. 10 clinics will be assigned to 5 arms to receive the intervention at sequential times. The time at which each arm receives the intervention will be randomized.

Arm	Type	Receives
Intervention plus 12 months maintenance	Experimental	Other: Intervention plus 12 months maintenanceClinics in this group will be in the control phase for 2 months, receive the 4 month intervention, and be in the maintenance phase for 12 months.
Intervention plus 10 months maintenance	Experimental	Other: Intervention plus 10 months maintenanceClinics in this group will be in the control phase for 4 months, receive the 4 month intervention, and be in the maintenance phase for 10 months.
Intervention plus 8 months maintenance	Experimental	Other: Intervention plus 8 months maintenanceClinics in this group will be in the control phase for 6 months, receive the 4 month intervention, and be in the maintenance phase for 8 months.
Intervention plus 6 months maintenance	Experimental	Other: Intervention plus 6 months maintenanceClinics in this group will be in the control phase for 8 months, receive the 4 month intervention, and be in the maintenance phase for 6 months.
Intervention plus 4 months maintenance	Experimental	Other: Intervention plus 4 months maintenanceClinics in this group will be in the control phase for 10 months, receive the 4 month intervention, and be in the maintenance phase for 4 months.

Who may qualify

Ages: 25 to 49 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

ages 25-49

Key exclusion criteria (1 listed)

personal history of breast cancer

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Intervention plus 12 months maintenanceThe intervention will include 2 months of data collection in the control period, 4 months of education and awareness training, and 12 months of data collection in the maintenance time period.	Other	Intervention plus 12 months maintenance
Intervention plus 10 months maintenanceThe intervention will include 4 months of data collection in the control period, 4 months of education and awareness training, and 10 months of data collection in the maintenance time period.	Other	Intervention plus 10 months maintenance
Intervention plus 8 months maintenanceThe intervention will include 6 months of data collection in the control period, 4 months of education and awareness training, and 8 months of data collection in the maintenance time period.	Other	Intervention plus 8 months maintenance
Intervention plus 6 months maintenanceThe intervention will include 8 months of data collection in the control period, 4 months of education and awareness training, and 6 months of data collection in the maintenance time period.	Other	Intervention plus 6 months maintenance
Intervention plus 4 months maintenanceThe intervention will include 10 months of data collection in the control period, 4 months of education and awareness training, and 4 months of data collection in the maintenance time period.	Other	Intervention plus 4 months maintenance

Primary outcome

Number of Eligible Women Who Received Breast Cancer Risk Assessment
Time frame: Baseline (2-months prior to intervention) to 9 months post-intervention
The number of women eligible for risk assessment who received documented breast cancer risk assessment.

3 secondary outcomes

Number of Women Who Received Risk Assessment Who Were Identified as High Risk for Breast Cancer.
Time frame: Baseline (2-months prior to intervention) to 9 months post-intervention
Number of Women Identified as High Risk Women Who Received Breast Cancer Screening.
Time frame: Baseline (2-months prior to intervention) to 9 months post-intervention
Number of Cancers Detected in Women Identified at High Risk.
Time frame: Baseline (2-months prior to intervention) to 9 months post-intervention

Results and safety

Results posted to the registry on 28 Aug 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm 1	1,071	1,071

Primary outcome: Number of Eligible Women Who Received Breast Cancer Risk Assessment

Time frame: Baseline (2-months prior to intervention) to 9 months post-intervention. Count of participants. Unit: Participants

Measure	Control n = 299	Intervention n = 362	Maintenance n = 410
Value	8	56	29

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline (2-months prior to intervention) to 9 months post-intervention. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control Group	0 of 299 (0%)	0 of 299 (0%)	0 of 299
Intervention Group	0 of 362 (0%)	0 of 362 (0%)	0 of 362
Maintenance Group	0 of 410 (0%)	0 of 410 (0%)	0 of 410

Limitations and caveats (from the sponsor): We had significant difficulty enrolling community clinics during this trial due to the impacts of the COVID 19 pandemic and resulting limitations in clinic resources. We enrolled a single clinic. This clinic was in Arm 1 - (2 months control, 4 months intervention,12 months maintenance). Due to clinic limited resources, we were also limited to 9 months of data collection in the maintenance time period, rather than the full 12 months.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lucy B Spalluto, MD MPH principal investigator

Vanderbilt University Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Eligible Women Who Received Breast Cancer Risk Assessment (time frame: Baseline (2-months prior to intervention) to 9 months post-intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05051631.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.