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Risk Assessment Strategies for Breast Cancer Screening (BRAVE Trial)

N/A

Recruiting

Led By Lucy B Spalluto, MD MPH

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ages 25-49

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 24 months

Awards & highlights

BRAVE Trial Summary

This trial will test different strategies to get women aged 25-49 to do breast cancer risk assessment in healthcare clinics in Tennessee, with the goal of increasing uptake of this screening.

Who is the study for?

This trial is for women aged 25-49 in Tennessee who have never had breast cancer. It aims to test different strategies for assessing breast cancer risk and improving early detection in healthcare clinics.Check my eligibility

What is being tested?

The BRAVE Strategy study is testing the effectiveness of various durations (4, 6, 8, 10, or 12 months) of maintenance interventions designed to increase breast cancer risk assessment uptake among young women.See study design

What are the potential side effects?

Since this trial focuses on risk assessment strategies rather than medical treatments, it does not involve typical medication side effects. However, participants may experience stress or anxiety related to the process.

BRAVE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 25 and 49 years old.

BRAVE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of eligible women who receive breast cancer risk assessment

Secondary outcome measures

Number of cancers detected in high risk women

Number of high risk women who received screening

Number of women identified as high risk for breast cancer

BRAVE Trial Design

5Treatment groups

Experimental Treatment

Group I: Intervention plus 8 months maintenanceExperimental Treatment1 Intervention

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.

Group II: Intervention plus 6 months maintenanceExperimental Treatment1 Intervention

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.

Group III: Intervention plus 4 months maintenanceExperimental Treatment1 Intervention

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.

Group IV: Intervention plus 12 months maintenanceExperimental Treatment1 Intervention

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.

Group V: Intervention plus 10 months maintenanceExperimental Treatment1 Intervention

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.

0 / 1Eligibility criteria met

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Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor

856 Previous Clinical Trials

671,692 Total Patients Enrolled

4 Trials studying Breast Cancer

562 Patients Enrolled for Breast Cancer

Lucy B Spalluto, MD MPHPrincipal InvestigatorVanderbilt University Medical Center

Media Library

Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05051631 — N/A

Breast Cancer Research Study Groups: 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

Breast Cancer Clinical Trial 2023: Intervention Highlights & Side Effects. Trial Name: NCT05051631 — N/A

Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05051631 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many subjects are involved in this clinical experiment?

"Correct. Clinicaltrials.gov confirms that this experiment, which was first made available on March 9th 2022, is actively searching for participants. Approximately 500 individuals need to be sourced from 1 site."

Answered by AI

Who can be accepted into this clinical investigation?

"This treatment trial is aiming to recruit 500 patients with breast cancer between the ages of 25 and 49. Crucially, these individuals must meet this specific age bracket requirement."

Answered by AI

Is this trial open to seniors as participants?

"This medical trial is welcoming patient applicants aged 25-49."

Answered by AI

Is there presently an opportunity for volunteers to join this investigation?

"According to the data housed on clinicaltrials.gov, this research is actively seeking participants. The trial was first advertised in March of 2022 and has been revised as recently as July 1st 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

BRAVE Strategy - Breast Cancer Risk Assessment -achieVing Equity

Lucy Spalluto 2022. "BRAVE Strategy - Breast Cancer Risk Assessment -achieVing Equity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05051631.

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