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

Frequently Asked Questions (FAQs)

1) What is the goal of the DoD BCRP Breakthrough Award Levels 1 and 2 opportunity?

The goal is to fund breast cancer research that is genuinely positioned to change the field rather than add incremental knowledge. Projects are expected to have clear potential to accelerate progress toward ending breast cancer by enabling a fundamentally better approach than what is already approved or currently in clinical development. Impact can be near-term or long-term, but it must rise above a minor advancement.

2) What does the program mean by "impact" and "breakthrough" in this announcement?

In this context, "impact" means the project should be capable of shifting the field in a meaningful way, not just producing small improvements. The research should point toward a fundamentally better approach than existing standards of care or approaches already in clinical development. Reviewers are looking for work that could change how breast cancer is understood, prevented, detected, or treated, rather than work that simply fills a narrow gap.

3) Do applicants need to specify who benefits from the research?

Yes. A key expectation is that the application clearly identifies who would ultimately benefit. The proposal should connect the science to specific breast cancer patient groups or populations at risk. The announcement signals that clinical relevance should not be left implied or vague.

4) Which Breakthrough Award levels are covered by this specific funding opportunity number?

This opportunity (W81XWH-22-BCRP-BTA12-2) covers only Breakthrough Award Levels 1 and 2. Levels 3 and 4 are offered under separate announcements (W81XWH-22-BCRP-BTA3-2 and W81XWH-22-BCRP-BTA4-2).

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

Applicants are expected to choose the correct level based on the defined scientific scope and intent of the level, not based on how much funding they want to request. The program explicitly warns that selecting a level that does not match the project can lead to the application being declined, even if the science is strong.

6) What happens if a project is strong but does not fit the selected level?

The announcement states that a mismatch between the project and the chosen level is a dealbreaker. Even a strong project can be declined if it does not align with the intent of the selected level, even if it might have been appropriate under a different level or announcement.

7) What types of projects are intended for Funding Level 1?

Level 1 targets bold, innovative, high-risk/high-reward ideas at the earliest point of development. This includes untested theories that tackle an important breast cancer problem. The emphasis is on opening new directions that could lead to breakthroughs.

8) Is preliminary data required for Funding Level 1?

No. For Level 1, preliminary data are not required. The expected outcome is proof of concept, so reviewers are looking for a well-reasoned and compelling approach that can demonstrate feasibility or validate a transformative idea.

9) What is the expected outcome for a Funding Level 1 project?

The expected outcome is proof of concept. The application should be structured around demonstrating feasibility or validating a transformative concept, rather than presenting a mature translational package ready for the clinic.

10) What types of projects are intended for Funding Level 2?

Level 2 is intended for projects supported by substantial preliminary or published data that strongly justify clinical translation within a well-defined breast cancer context. Compared with Level 1, Level 2 should show a clearer line of sight to patient benefit and be grounded in convincing evidence that the concept works and is positioned to move forward.

11) Is substantial preliminary or published data expected for Funding Level 2?

Yes. Level 2 is described as requiring substantial preliminary or published data, along with a strong justification for clinical translation in a defined breast cancer context.

12) Can population science or prevention research be proposed under Level 2?

Yes. Level 2 explicitly accommodates population science and prevention studies, as long as they are backed by substantial data and include a strong translational rationale. The rationale should make the case that the work could realistically influence prevention strategies, screening approaches, risk stratification, or implementation of interventions.

13) Can population science and prevention projects request more funding or more time?

The opportunity notes that, with compelling justification, population science and prevention projects may request higher levels of funding and an additional year of performance. This flexibility is framed as recognition that human subjects research and use of human biospecimens can require additional time and resources.

14) What is the Partnering PI Option?

The Partnering PI Option is a feature designed to support truly integrated collaborations between two investigators. One investigator serves as the Initiating PI and manages most administrative submission responsibilities, while the other serves as the Partnering PI. The intent is to enable a substantive, equitable collaboration that is essential to the project strategy.

15) What are the expectations for contributions under the Partnering PI Option?

Both PIs are expected to contribute meaningfully and comparably to the intellectual design of the project and to executing the statement of work, with similar and appropriate levels of effort. The application should clearly explain why combining distinct expertise is essential and why the work is better done together than as separate efforts.

16) What types of collaborations are discouraged under the Partnering PI Option?

The program discourages arrangements that resemble simple resource sharing, such as one PI primarily providing samples or models while the other performs nearly all experiments. It also states that mentor-trainee pairings (for example, a mentor and their current postdoc or junior investigator) do not meet the intent of the option.

17) If funded, how are awards handled for the two PIs in a partnering application?

If funded, each PI is named on an individual award within the recipient organization. This design reinforces that the partnership is meant to be substantive and equitable rather than hierarchical.

18) What administering organization is listed for this opportunity?

The opportunity is administered by the Department of Defense, Department of the Army, USAMRAA.

19) What assistance mechanisms are available (grant vs cooperative agreement)?

The posting indicates the opportunity allows either grants or cooperative agreements.

20) What is the CFDA number associated with this opportunity?

The CFDA number listed is 12.420.

21) Is eligibility restricted to certain entity types?

Eligibility is described as unrestricted (open broadly to entity types), subject to any additional eligibility clarifications contained in the full announcement.

22) How many awards are anticipated?

The posting indicates an anticipated total of about 15 awards.

23) What is the maximum award amount (award ceiling)?

The summary fields list an award ceiling of 0, which typically indicates applicants should rely on the program announcement for level-specific budget guidance rather than a single universal cap shown in the database entry.

24) What staffing or team expectations are emphasized?

The opportunity emphasizes that proposals should be supported by an appropriately robust research team with the breast cancer-relevant expertise needed to successfully complete the work. This aligns with the program focus on projects that are ambitious but also realistically executable and positioned to drive meaningful progress.

25) Does the program prioritize ambitious ideas even if they are high-risk?

Yes, especially at Level 1. Level 1 explicitly targets high-risk/high-reward ideas, including untested theories, as long as the approach is compelling and aims to generate proof of concept for a transformative direction.

26) Does the program require that projects be immediately ready for clinical use?

Not necessarily. Level 1 is aimed at early-stage concepts where the goal is proof of concept rather than readiness for clinical application. Level 2, however, is meant for projects with substantial supporting data and a strong justification for clinical translation, indicating a closer step toward patient benefit.

27) What does "translation" mean in the context of Level 2, based on the posting?

Based on the posting, translation in Level 2 means a strong, evidence-backed rationale that the work can move toward patient benefit within a well-defined breast cancer context. For population science and prevention, translation includes the realistic potential to shift prevention strategies, screening, risk stratification, or implementation of interventions.

28) Are Levels 3 and 4 available under this same announcement?

No. Levels 3 and 4 are offered under separate announcements (W81XWH-22-BCRP-BTA3-2 and W81XWH-22-BCRP-BTA4-2), and applicants should use those if their project aligns with those stages on the path toward clinical application.