DoD Breast Cancer, Breakthrough Award Level 3 | W81XWH 21 BCRP BTA3

FAQs: DoD BCRP Breakthrough Award Level 3 (W81XWH-21-BCRP-BTA3)

1) What is the purpose of the BCRP Breakthrough Award Level 3?

The Breakthrough Award Level 3 is intended to push breast cancer research beyond incremental improvements and toward work with a credible chance to change the field. The central expectation is impact: the project should aim for a breakthrough that could accelerate progress toward ending breast cancer, either in the near term or over a longer horizon, and should clearly go beyond a minor improvement over what already exists.

2) What does the program mean by a “breakthrough” in this context?

Based on the opportunity description, a breakthrough is an outcome that could become a fundamentally better approach than what is already approved or currently being tested clinically. The application is expected to make a strong case that the proposed results would represent more than a small step forward.

3) What kinds of projects are the best fit for Level 3?

Level 3 focuses on advanced translational studies that are close to clinical use and demonstrate a high degree of readiness. The intended scope is work that has progressed far enough that the next logical steps involve translational validation and preparation for clinical investigation.

4) Are early-stage discovery or exploratory studies appropriate for this award level?

No. The solicitation states that Level 3 is not meant for early discovery work. It is aimed at projects that are nearer to clinical use and ready for translational validation and clinical preparation.

5) How specific do applicants need to be about who benefits from the research?

Applicants are expected to identify the breast cancer patient group(s) or at-risk individuals who would ultimately benefit if the research succeeds. The proposal should be specific about the intended beneficiaries and connect the project’s aims to patient-centered impact.

6) What evidence of “readiness” is expected for a Level 3 application?

A key expectation is that the applicant can demonstrate access to what is needed to execute the work without speculative gaps. Where relevant, the application must include proof of availability and access to essential inputs such as datasets, human biospecimens, patient cohorts, and other critical reagents.

7) What does “proof of availability and access” refer to?

It refers to documenting that the project team already has access to critical resources needed to complete the proposed work, such as datasets, human biospecimens, patient cohorts, and other essential reagents, when those inputs are relevant to the project.

8) If FDA involvement is likely later, what does the application need to show now?

If later stages are likely to require U.S. Food and Drug Administration involvement, the application must show that the team has access to necessary clinical-grade reagents (for example, therapeutic molecules) and the patient population(s) needed to move forward.

9) Does the opportunity expect a timeline toward clinical investigation?

Yes. The proposal must lay out a realistic timeline that points toward near-term clinical investigation.

10) Are clinical trials allowed within the scope of Level 3?

Small-scale clinical trials may fit within the intended scope. The opportunity specifically notes that first-in-human or Phase I/Ib studies may be appropriate.

11) What is the Partnering PI Option?

The Partnering PI Option is a structural option designed to support a genuine two-investigator collaboration rather than a simple division of labor. Under this model, an Initiating PI manages most submission and administrative responsibilities, while a Partnering PI contributes equally to the intellectual leadership of the project.

12) How should responsibilities be divided between the Initiating PI and the Partnering PI?

The Initiating PI handles most submission and administrative responsibilities. The Partnering PI is expected to contribute equally to the intellectual leadership. The application should show that both PIs had meaningful input into the project design and Statement of Work.

13) What does “genuine collaboration” mean for the Partnering PI Option?

The application is expected to demonstrate that both investigators bring distinct, necessary expertise and that both contribute to leadership and project design. The program discourages arrangements where one PI mainly provides materials (such as samples, animal models, or investigational agents) while the other PI conducts most of the scientific work, because that is not considered the intended collaborative structure.

14) Are the two PIs expected to have similar effort levels?

Yes. The opportunity indicates that effort levels should be similar and appropriate, consistent with equal intellectual leadership.

15) Do budgets need to be balanced between the two investigators under the Partnering PI Option?

Budgets are expected to be balanced between the two investigators unless there is a clear and well-justified reason for an imbalance.

16) Are new PI partnerships required?

No. The program encourages new partnerships but does not require them.

17) If selected for funding under the Partnering PI Option, how are awards issued?

If selected, each PI is named on an individual award within the recipient organization.

18) What does the solicitation say about the research team?

Applications are expected to propose a robust research team with the combined expertise needed to successfully deliver an advanced translational project in breast cancer.

19) Is consumer advocate involvement required?

Yes. Consumer advocate involvement is required and treated as a core element rather than a formality.

20) How many consumer advocates are required on each project?

Each project must include at least two breast cancer consumer advocates.

21) How are consumer advocates expected to be involved in the project?

They must be integrated throughout planning and implementation, including shaping the research question, contributing to project design, supporting oversight, advising on recruitment, and participating in evaluation and other major project activities. The solicitation emphasizes that interactions should be ongoing and well integrated, not limited to occasional meetings.

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

Consumer advocates must be breast cancer survivors (diagnosed individuals), active in a breast cancer advocacy organization, independent in their project role, and not employees of any participating organization. The intent is for them to provide objective, patient-centered input.

23) What qualities or capabilities are expected of the consumer advocates?

The solicitation indicates they should provide objective input on relevance, feasibility, and real-world impact, supported by a strong understanding of current breast cancer issues and sufficient familiarity with research to contribute meaningfully.

24) What agency and program manage this opportunity?

This is a discretionary Department of Defense opportunity managed by the U.S. Army Medical Research Acquisition Activity (USAMRAA) under the DoD Breast Cancer Research Program (BCRP).

25) What funding mechanisms are used?

The opportunity uses grant and/or cooperative agreement mechanisms.

26) What is the CFDA number listed for this program?

The listing references CFDA 12.420.

27) Who is eligible to apply?

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

28) When was this opportunity posted and what was the original closing date?

The opportunity was posted January 6, 2021, with an original closing date of June 23, 2021.

29) How many awards were expected?

The notice indicated an expectation of approximately three awards.

30) What is the award ceiling for this opportunity?

The listing shows an award ceiling of 0, which the description notes typically means applicants should rely on the program announcement for specific funding limits and any level-based caps rather than treating the database field as a meaningful maximum.