DoD Breast Cancer, Breakthrough Award Levels 1 and 2 | W81XWH 22 BCRP BTA12

Frequently Asked Questions (FAQs)

What is this funding opportunity?

The DoD Breast Cancer, Breakthrough Award Levels 1 and 2 (Funding Opportunity Number W81XWH-22-BCRP-BTA12) is a Department of Defense breast cancer research funding opportunity managed by the US Army Medical Research Acquisition Activity (USAMRAA). It supports research projects intended to produce true breakthroughs in breast cancer, not incremental advances.

What is the main goal of the Breakthrough Award program?

The program is built around impact. Proposed work is expected to have clear potential to accelerate progress toward ending breast cancer, either in the near term or over a longer horizon, by aiming for a meaningful leap forward rather than modest stepwise improvement.

What kinds of outcomes does the program expect from funded research?

The announcement emphasizes outcomes aligned with major impact. For Level 1, the expected outcome is proof of concept that demonstrates the core idea is plausible and worth further development. For Level 2, the expectation is stronger validation and advancement toward clinical translation in a well-defined breast cancer context.

Does the program require applicants to specify who will benefit from the research?

Yes. A key expectation is that applicants explicitly identify which breast cancer patients, survivors, or at-risk populations would ultimately benefit from the research. The program expects the clinical or public health relevance to be concrete rather than implied.

Which Breakthrough Award levels are covered by this specific announcement?

This announcement covers only Breakthrough Award Levels 1 and 2.

Are Levels 3 and 4 part of this opportunity?

No. Levels 3 and 4 are offered under separate announcements (W81XWH-22-BCRP-BTA3 and W81XWH-22-BCRP-BTA4).

How should an applicant choose between Level 1 and Level 2?

Applicants are expected to choose the level that matches the scientific maturity and scope of the project, based on the scope described in the announcement. The guidance is explicit that applicants should not pick a level simply based on how much funding they want to request.

What happens if the selected level does not match the project’s stage or intent?

If reviewers determine the project does not match the intent of the selected level, the application will not be recommended for funding, even if the project might have been a better fit under another level. Aligning the project to the correct level is treated as a gating requirement.

What is Breakthrough Award Level 1 intended to support?

Level 1 is aimed at innovative, high-risk/high-reward ideas at the earliest stages. This can include untested theories or new conceptual approaches that address an important breast cancer problem but are not yet supported by extensive evidence.

Is preliminary data required for Level 1 applications?

No. Preliminary data are not required at Level 1, to reduce barriers for proposing bold and genuinely novel ideas.

What does “proof of concept” mean in the context of Level 1?

For Level 1, proof of concept means the proposed work should be designed to generate decisive early evidence showing the core idea is plausible and worthy of further development, with a credible plan to test feasibility in a meaningful way.

What is Breakthrough Award Level 2 intended to support?

Level 2 targets more mature projects supported by substantial preliminary data and/or published findings. The focus is on research that strongly validates a path toward clinical translation in a well-defined breast cancer context and advances the work toward real-world use, adoption, or further clinical development.

Does Level 2 require preliminary or published evidence?

Yes. Level 2 is intended for approaches that have moved beyond speculation and are backed by substantial preliminary data and/or published findings.

What does “clinical translation” mean here?

In this announcement, clinical translation refers to research progress that supports movement toward real-world clinical use, adoption, or further clinical development in a clearly defined breast cancer context.

Is there a specific Level 2 category for population science and prevention?

Yes. The announcement identifies a Level 2 category for population science and prevention studies.

What are the expectations for Level 2 population science and prevention studies?

They must be backed by substantial preliminary or published data, clearly support clinical translation, and reflect the practical requirements of studies that may involve human subjects and/or human biospecimens.

Can Level 2 population science and prevention studies request more resources than other Level 2 projects?

Yes. With strong justification, Level 2 population science and prevention studies may request higher levels of funding and an additional year of performance. This allowance is tied to the added time, infrastructure, regulatory coordination, and resources often needed for rigorous human-focused studies.

What is the Partnering PI Option?

The Partnering PI Option allows an application to include two Principal Investigators: an Initiating PI and a Partnering PI. The intent is to promote meaningful, intellectually balanced collaborations where both investigators share substantial responsibility for the scientific direction of the project.

What is the role of the Initiating PI under the Partnering PI Option?

The Initiating PI handles most submission and administrative responsibilities while still contributing scientifically, as part of a shared leadership model.

What is the role of the Partnering PI under the Partnering PI Option?

The Partnering PI shares substantial responsibility for the scientific direction and is expected to contribute significantly to core elements such as project design, the Project Narrative, the Statement of Work, and other key components.

What makes a Partnering PI arrangement acceptable versus a simple service relationship?

The application is expected to show that both PIs contribute distinct, essential expertise and that combining their efforts as a partnership is necessary to address the research question effectively. It should also explain why the work should be done together rather than as separate parallel efforts.

What types of PI pairings are explicitly described as not qualifying as true partnerships?

The announcement signals that the following do not qualify as true partnerships in this context: mentor-trainee pairings framed as partnering PIs; arrangements where one PI mainly supplies materials (such as samples, animal models, or investigational agents) while the other conducts most experiments; and situations where a person is listed as a partnering PI on multiple submissions without clearly distinct research questions.

If funded, how are Partnering PIs reflected on the award?

If funded, each PI is named on an individual award within the recipient organization, reinforcing shared leadership and accountability.

Who is managing this opportunity?

The opportunity is managed by the US Army Medical Research Acquisition Activity (USAMRAA) on behalf of the Department of Defense.

What is the CFDA number associated with this opportunity?

The opportunity is listed under CFDA 12.420.

What type of award instruments may be used?

Awards may be made as grants or cooperative agreements.

What is the program category listed for this opportunity?

The listing places it in the Science and Technology and other Research and Development category.

How many awards were anticipated?

The listing notes an anticipated 19 awards.

What is the posting date and closing date for the opportunity?

The posting date was March 16, 2022, and the original closing date was May 17, 2022.

What does the listing say about eligibility?

From an administrative standpoint, it is listed as discretionary and open to unrestricted eligible applicants, meaning it is broadly available to many organization types, subject to any additional eligibility notes in the full announcement.

What does the opportunity emphasize about the research team?

Applicants are expected to assemble a robust research team with appropriate breast cancer-relevant expertise and complementary backgrounds to successfully deliver ambitious, high-impact outcomes consistent with the program’s goals.