DoD Breast Cancer, Breakthrough Award Level 3 | W81XWH 21 BCRP BTA3 2

Opportunity Information: Apply for W81XWH 21 BCRP BTA3 2

The Department of Defense Breast Cancer Research Program (BCRP) Breakthrough Award Level 3 (Funding Opportunity Number W81XWH-21-BCRP-BTA3-2) is designed to fund highly promising breast cancer research that can realistically drive a major leap forward, not just an incremental improvement. The core expectation is impact: proposed work should have a clear path to changing the way breast cancer is prevented, detected, or treated in a way that is meaningfully better than approaches that are already approved or currently in clinical development. Applicants are expected to be explicit about which breast cancer patients, survivor groups, or at-risk populations would ultimately benefit from the work, and why the outcomes would matter to them.

This particular announcement covers Level 3 within a four-level Breakthrough Award structure. The program is organized this way to support different stages on the road to clinical application, and investigators are expected to choose the level that matches the maturity and intent of their project rather than selecting a level based on the size of the budget they want. The DoD emphasizes that a mismatch between the proposed project and the Level 3 scope can sink an application even if the project might have fit better under a different level. (Levels 1 and 2 and Level 4 are offered under separate program announcements.)

Level 3 is aimed at advanced translational studies that show a high degree of readiness to move toward clinical testing. In practical terms, proposals should look like they are close to clinical investigation rather than early discovery work. When relevant, the application needs to provide proof that the team has real access to what is required to execute the study, such as appropriate datasets, human biospecimens, patient cohorts, and other critical reagents. If the project would ultimately require U.S. Food and Drug Administration involvement, the DoD expects applicants to demonstrate that they have access to clinical-grade or clinically usable reagents (for example, therapeutic candidates) and to the patient populations needed to support the planned next steps. A realistic timeline that shows how the project will move into near-term clinical investigation is required, and the scope can include small-scale clinical trials such as first-in-human or phase 1/1b studies when appropriate.

The opportunity also includes a Partnering PI Option intended to promote genuine, productive scientific partnerships rather than a simple division of labor. Under this structure, two principal investigators can apply together: an Initiating PI who handles most submission and administrative responsibilities, and a Partnering PI who plays an equally substantive scientific role. The application is expected to show that both investigators bring distinct, essential expertise, share comparable intellectual ownership of the project design, and devote similar and appropriate effort to executing the work. Funding is generally expected to be balanced between the two PIs unless there is a strong justification otherwise. The DoD is clear that arrangements where one PI mostly supplies materials (like samples, animal models, or investigational agents) while the other PI does nearly all of the experimental work do not meet the intent of this partnership mechanism. If funded, each PI is named on an individual award within the recipient organization.

Beyond leadership structure, the DoD expects a robust team with the right mix of breast cancer-relevant expertise to deliver on an ambitious translational plan. A notable and non-optional requirement is consumer advocate involvement. Each application must include at least two breast cancer consumer advocates who are integrated into the project from planning through execution, with meaningful roles that can include shaping the research question, informing study design, supporting oversight, advising on recruitment and retention, and contributing to evaluation and interpretation with a patient-centered lens. These advocates must be individuals who have been diagnosed with breast cancer and who are active in advocacy organizations; they also must not be employees of the organizations on the application, and their participation should be independent from any employment role. The intent is for them to provide objective, knowledgeable input focused on real-world patient impact, not ceremonial participation.

Administratively, the opportunity is offered by the Department of Defense (Department of the Army, USAMRAA) as either a grant or a cooperative agreement under CFDA 12.420 (Science and Technology and other Research and Development). Eligibility is listed as unrestricted (open to any entity type, subject to any additional eligibility language in the full announcement). The posting date is April 26, 2021, with an original closing date of October 5, 2021, and the listing indicates one expected award (noting that the public listing shows an award ceiling of 0, which typically signals that applicants must consult the full program announcement for budget limits and structure). Overall, the Level 3 Breakthrough Award is positioned for teams that have a mature, well-supported translational concept with the data, materials, collaborators, and practical clinical pathway needed to credibly move toward early clinical testing while keeping patient benefit and real-world impact at the center of the proposal.

• The Department of Defense, Dept. of the Army -- USAMRAA in the science and technology and other research and development sector is offering a public funding opportunity titled "DoD Breast Cancer, Breakthrough Award Level 3" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 12.420.
• This funding opportunity was created on Apr 26, 2021.
• Applicants must submit their applications by Oct 05, 2021. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• The number of recipients for this funding is limited to 1 candidate(s).
• Eligible applicants include: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled Additional Information on Eligibility.

Apply for W81XWH 21 BCRP BTA3 2

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