DoD Breast Cancer, Breakthrough Award Level 3 | W81XWH 19 BCRP BTA3

FAQs: DoD BCRP Breakthrough Award Level 3 (W81XWH-19-BCRP-BTA3)

What is the Breakthrough Award Level 3 opportunity?

The DoD Breast Cancer Research Program (BCRP) Breakthrough Award Level 3 is a discretionary Department of Defense grant/cooperative agreement opportunity managed by the U.S. Army Medical Research Acquisition Activity (USAMRAA). It is intended to support ambitious breast cancer research that is positioned to deliver a true "breakthrough" rather than an incremental advance.

What is the main goal of this funding opportunity?

The central goal is to fund research that plausibly accelerates progress toward ending breast cancer by moving toward approaches that could be fundamentally better than what is already approved or currently advancing through clinical development, with a clear line of sight to meaningful patient benefit.

What type of research is this award meant to support?

This Level 3 announcement is intended for advanced translational studies that show a high degree of readiness to move toward clinical testing. The work should be beyond early discovery and should look like it is preparing to cross into human investigation.

Is this award focused on incremental progress or major advances?

The program emphasizes "breakthrough" potential and explicitly distinguishes this from incremental improvements. Applications are expected to make the case that the project could lead to a major advance compared with current approaches.

Do projects need to show a clear path to patient benefit?

Yes. Projects are expected to have a clear line of sight to meaningful patient benefit, either in the near term or over a longer horizon, but the application should explain how the work could translate into real-world impact.

Do applicants need to specify which patient populations may benefit?

Yes. A strong application is expected to name the specific breast cancer patient populations or at-risk groups that would ultimately benefit, making the intended impact explicit rather than implied.

How clinically ready should a Level 3 project be?

Level 3 is described as advanced translational work with readiness to move toward clinical testing. Applicants should demonstrate that the project is positioned for near-term clinical investigation with a credible and concrete timeline.

Are small clinical trials allowed under Level 3?

Yes. The announcement notes that small-scale clinical trials may fit the Level 3 scope, including first-in-human efforts and Phase I/Ib-style studies.

What kind of evidence is expected to show the team can execute the project?

Applicants are expected to demonstrate execution capability by providing proof, where relevant, that they have access to enabling resources such as datasets, human biospecimens, cohorts, and other critical reagents needed to carry out the proposed work.

If a project may require FDA involvement, what does the application need to show?

If FDA involvement would eventually be required, the application is expected to show that key clinical-grade materials or reagents (for example, a therapeutic molecule) and access to appropriate patient populations are already available or realistically obtainable.

Is there an expectation for a timeline toward clinical investigation?

Yes. The program expects a credible, concrete timeline that supports near-term movement toward clinical investigation.

What is the optional Partnering PI mechanism?

The Partnering PI option is an optional structure designed to support genuine collaborations between two principal investigators. Under this model, there is an Initiating PI and a Partnering PI, and each PI receives a separate award with distinct submission requirements for each side.

Is the Partnering PI option the same as adding a co-investigator?

No. The intent is not simply to add a co-investigator. The program expects a two-PI partnership in which both leaders materially shape major components such as the Project Narrative and the Statement of Work.

Do the two PIs need to bring different strengths?

Yes. The program expects each PI to contribute distinct, non-overlapping strengths, and the application should explain why the combined approach is more powerful than two separate efforts.

Do partnering collaborators have to be from different disciplines or organizations?

Not necessarily. The program allows collaborators to come from the same or different disciplines. The key expectation is that each PI brings distinct strengths that strengthen the overall project.

Are new collaborations required for the Partnering PI option?

No. New collaborations are welcomed but are not mandatory.

Can someone serve as a Partnering PI on multiple Level 3 applications?

The announcement discourages serving as a Partnering PI on multiple Level 3 applications unless the projects clearly address different research questions, to avoid superficial or overly spread-thin partnering.

What does the opportunity require in terms of the research team?

Applicants are expected to assemble a robust, appropriately experienced research group with strong breast cancer-related expertise matched to the demands of advanced translational work and potential early clinical testing.

Is consumer advocate participation required?

Yes. Consumer advocate participation is not optional. Each application must include at least two breast cancer consumer advocates who are integrated throughout planning and execution.

How should consumer advocates be involved in the project?

The advocates are expected to be integrated across major activities, such as shaping the research question, guiding study design, supporting oversight, contributing to recruitment approaches (when relevant), and participating in evaluation of progress and impact. They should not be included as symbolic advisors.

Who qualifies as a breast cancer consumer advocate for this opportunity?

Advocates must be individuals diagnosed with breast cancer who are active in advocacy organizations and who can serve as independent lay representatives.

Can consumer advocates be employees of a participating organization?

No. The announcement specifies that advocates cannot be employees of any participating organization, and their role should not be tied to their employment.

Do the consumer advocates need research knowledge or training?

Yes. The program indicates advocates should be sufficiently knowledgeable about breast cancer issues and have enough research-related background or training to contribute meaningfully and consistently.

What is meant by "relevance to military health"?

Proposals must demonstrate relevance to military health by connecting the work to the healthcare needs of Service members, Veterans, military beneficiaries, and/or the broader American public.

Who manages this grant/cooperative agreement opportunity?

The opportunity is managed by the U.S. Army Medical Research Acquisition Activity (USAMRAA) under the Department of Defense.

What is the Funding Opportunity Number for this announcement?

The Funding Opportunity Number is W81XWH-19-BCRP-BTA3.

What CFDA number is associated with this opportunity?

The posting indicates CFDA 12.420 under Science and Technology/Research and Development.

What types of applicants are eligible?

The posting indicates it is open to unrestricted applicant types, subject to any clarifications in the full announcement.

How many awards were anticipated?

The administrative summary indicates a small number of awards were anticipated, listed as 2.

What were the posted creation and closing dates?

The original posting shows a creation date of January 22, 2019 and an original closing date of June 13, 2019.

Why does the listing show an award ceiling of 0?

The summary field shows an award ceiling of 0, which typically indicates that budgets and limits are controlled in the full program announcement rather than the summary listing. Applicants are expected to rely on the official announcement text for definitive budget constraints and submission requirements.

Where should applicants look for definitive budget limits and submission requirements?

Based on the posting details, definitive budget constraints and submission requirements are typically provided in the full official program announcement text rather than in the summary fields.