DoD Breast Cancer, Breakthrough Award Level 4 | HT9425 23 BCRP BTA4 2

Opportunity Information: Apply for HT9425 23 BCRP BTA4 2

The DoD Breast Cancer Research Program (BCRP) Breakthrough Award Level 4 is designed to fund ambitious, high-impact breast cancer research that is positioned to produce real breakthroughs rather than incremental progress. The central idea is impact: proposed work should have strong potential to substantially change how breast cancer is prevented and/or managed clinically, with a clear line of sight to who benefits (specific breast cancer patient groups or people at elevated risk). The program emphasizes that a breakthrough can be near-term or longer-term, but it must plausibly enable a fundamentally new approach or a major leap beyond what is already approved or currently being tested in clinical development.

Level 4 is the most clinically advanced tier described here, and it is specifically aimed at large-scale projects intended to transform and revolutionize clinical practice. A key requirement is that human clinical trials are mandatory for this level, meaning the research must be ready to move into, or already be structured around, testing in people rather than only preclinical or exploratory studies. Because of the scale and complexity, the Principal Investigator is expected to demonstrate experience leading large projects and the capacity to successfully execute a clinical program, either through their own track record or through a committed collaborating clinical investigator. Applications also need to show that the project is feasible in practical terms, including access to the right data resources, human biospecimens, cohorts, and other critical materials needed to complete the study.

If the project involves U.S. Food and Drug Administration (FDA) engagement, the announcement makes it clear that readiness is evaluated at the time of application. Applicants should be prepared to document access to clinical-grade reagents or investigational products that meet regulatory compliance expectations, show that appropriate participant populations are available, provide credible and validated recruitment projections, and, when applicable, have already submitted an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application. In other words, this mechanism is structured for teams that are not just proposing a clinical trial in concept, but are operationally prepared to run it.

The funding opportunity also includes an optional Partnering PI structure to support true co-leadership between two investigators. Under this model, one PI serves as the Initiating PI and handles most administrative submission responsibilities, while the Partnering PI shares major scientific leadership. The program expects both PIs to contribute substantially and comparably to the intellectual design, project narrative, statement of work, and execution, with similar and appropriate effort levels. Budgets are generally expected to be balanced between the two PIs unless there is a strong justification otherwise. The partnership must be meaningful: the application should explain why the combined expertise is essential, why the work is better done together than as separate projects, and how each PI brings distinct, critical capabilities. The announcement discourages arrangements where one PI mainly provides samples or an agent while the other does most of the research, and it also discourages an investigator from serving as a Partnering PI on multiple Level 4 applications unless the research questions are clearly distinct.

Team composition is treated as a core part of feasibility. Applicants are expected to assemble a robust, appropriately staffed team with the breadth of expertise needed for a complex breast cancer clinical trial and the associated scientific, operational, regulatory, and analytical work. A notable and required feature is the integration of consumer advocates: the project must include at least two breast cancer consumer advocates who are involved throughout planning and implementation. Their role is not meant to be symbolic or limited to occasional meetings; they are expected to be engaged in shaping the research question, study design, oversight, recruitment strategy, evaluation, and other major project activities. These advocates must be breast cancer survivors who are active in advocacy organizations, must provide independent and objective input, and cannot be employees of any participating organization. The intent is to keep the work grounded in patient priorities and real-world relevance, while ensuring the advocates have sufficient knowledge and training to contribute effectively.

Administratively, this opportunity is offered by the Department of Defense through the U.S. Army Medical Research Acquisition Activity (USAMRAA). The opportunity is listed as discretionary funding and supports science and technology research and development, using grant and/or cooperative agreement instruments. Eligibility is described as broadly open (unrestricted) subject to any specific clarifications in the full announcement. The listing information provided includes the funding opportunity title "DoD Breast Cancer, Breakthrough Award Level 4" and the opportunity number "HT9425-23-BCRP-BTA4-2," with the original closing date shown as September 26, 2023, and an expected single award indicated in the source data.

• 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 4" 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 BTA4 2

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