DoD Breast Cancer, Breakthrough Award Level 3 | HT9425 23 BCRP BTA3 2

Opportunity Information: Apply for HT9425 23 BCRP BTA3 2

The DoD Breast Cancer, Breakthrough Award Level 3 (Funding Opportunity Number HT9425-23-BCRP-BTA3-2) is a Department of Defense Breast Cancer Research Program grant mechanism meant for breast cancer projects that are bold, highly impactful, and positioned to change what is possible in prevention, detection, or treatment. The central expectation is that the work will push beyond incremental progress and plausibly lead to a breakthrough: a fundamentally new or substantially more effective approach than what is already approved or currently in clinical development. A key feature of the opportunity is that applicants must clearly identify which breast cancer patients, or which groups of people at increased risk, would ultimately benefit if the research succeeds. In other words, it is not enough to propose an exciting scientific idea; the application needs a clear line of sight to who benefits and how the outcome would accelerate progress toward ending breast cancer.

This award is part of a larger Breakthrough Award structure that has four funding levels, each aimed at supporting different stages along the path to clinical application. Level 3 is specifically reserved for advanced translational studies that show a high degree of readiness, meaning the project should already be mature enough that the next steps are geared toward near-term clinical investigation rather than early exploratory work. The program stresses that investigators must pick the level based on the scope and maturity described in the announcement, not based on the budget size. Selecting the wrong level is treated as a serious mismatch: an application that does not fit Level 3 intent will not be recommended for funding even if it might have been a strong fit for a different level. (Levels 1 and 2 are covered under HT9425-23-BCRP-BTA12-2, and Level 4 under HT9425-23-BCRP-BTA4-2.)

For Level 3, reviewers will expect evidence that the practical building blocks for translation are already in place. Where relevant, the application needs to document that the team has access to the needed resources such as datasets, human biospecimens, defined cohorts, and other critical reagents. If the proposed pathway would require eventual U.S. Food and Drug Administration involvement, the proposal must go further by showing availability of clinical-grade or clinically suitable reagents (for example, a therapeutic candidate) and access to appropriate patient populations to support clinical movement. The project plan must include a realistic, credible timeline for near-term clinical investigation, and the mechanism explicitly allows small-scale clinical trials when appropriate, including first-in-human and Phase 1/1b studies. Taken together, the message is that Level 3 is not meant for work that still needs years of foundational development before it can touch the clinic; it is designed for programs that are close enough to clinical testing that the remaining steps are clearly mapped and feasible.

The opportunity also offers a Partnering PI option to encourage real, productive collaborations. Under this structure there are two principal investigators: an Initiating PI who handles most submission and administrative responsibilities and a Partnering PI who shares the scientific leadership. The program is very clear that this is not meant to be a superficial collaboration. Both PIs are expected to have equal intellectual ownership of the project design and to contribute substantially to major application components such as the Project Narrative and Statement of Work. Effort levels should be similar and appropriate, and budgets are expected to be balanced unless there is a strong justification otherwise. The application should explain why combining the two investigators strengths is essential to answering the research question and completing the work, and why the project is stronger together than as two separate efforts. The announcement discourages arrangements where one PI mainly supplies materials (samples, models, investigational agents) while the other PI performs most of the experiments and analyses, because that does not meet the intent of a genuine partnership. It also cautions against listing the same person as a Partnering PI on multiple Level 3 applications unless the research questions are clearly distinct. If funded, each PI would receive an individual award within the recipient organization.

Beyond the PI structure, the program expects a robust, well-qualified research team with the combined breast cancer expertise needed to execute a sophisticated translational plan. A distinctive requirement is mandatory consumer advocate involvement: each application must include at least two breast cancer consumer advocates who are integrated into the project from planning through execution. These advocates are expected to contribute in concrete ways such as shaping the research question, influencing study design, participating in oversight, supporting recruitment and retention approaches when relevant, and helping evaluate progress and relevance. The program emphasizes that advocates should be involved continuously and meaningfully, not only through occasional attendance at seminars or periodic meetings. The advocates must be breast cancer survivors (diagnosed individuals), active in a breast cancer advocacy organization, and independent from participating institutions in the sense that they cannot be employees of any organization involved in the application. Their role is meant to provide objective patient-centered input focused on real-world impact for people with, or at risk for, breast cancer, and they are expected to have sufficient knowledge of current breast cancer issues and enough background or training in research to contribute effectively.

Administratively, this is a discretionary federal opportunity offered by the Department of Defense, Department of the Army (USAMRAA), under CFDA 12.420, using grant and cooperative agreement funding instruments. Eligibility is described as unrestricted, meaning it is broadly open to entity types, subject to any additional eligibility clarifications in the full announcement. The posting lists a creation date of May 2, 2023, and an original closing date of September 26, 2023. The synopsis also lists an expected number of awards as 1 and shows an award ceiling of 0 in the extracted data, which typically indicates that applicants must rely on the program announcement for the actual allowable costs and budget parameters rather than the summary field.

Overall, the Breakthrough Award Level 3 is aimed at teams that already have a strong translational foundation and can credibly argue that their work could rapidly set up near-term clinical investigation while offering the realistic potential for a major leap forward in breast cancer outcomes, not just a small step. The strongest fit will be projects that combine clear patient impact, strong readiness evidence (materials, data, cohorts, reagents, and access), a practical clinical path and timeline, and a team structure that includes both scientific strength and embedded patient-advocate guidance throughout the project.

• 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 May 02, 2023.
• Applicants must submit their applications by Sep 26, 2023. (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 HT9425 23 BCRP BTA3 2

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