DoD Breast Cancer, Breakthrough Award Level 4 | W81XWH 19 BCRP BTA4 2

Opportunity Information: Apply for W81XWH 19 BCRP BTA4 2

The DoD Breast Cancer Research Program (BCRP) Breakthrough Award Level 4 (Funding Opportunity Number W81XWH-19-BCRP-BTA4-2) is designed to back ambitious, high-impact breast cancer research that is positioned to produce true breakthroughs rather than incremental progress. The central expectation is that the proposed work has a strong chance to accelerate progress toward ending breast cancer by enabling a fundamentally better approach than what is already approved or currently in clinical development. Applicants are expected to be clear about who benefits from the research by identifying the breast cancer patient populations or at-risk individuals that the results are intended to help, keeping the focus on real-world clinical relevance and patient impact.

This opportunity is part of a broader Breakthrough Award structure with four distinct funding levels, each tied to a specific stage or scope of translational progress toward clinical application. A key point is that investigators must choose the funding level based on the scientific scope defined in the program announcement, not based on a preferred budget size. Applications that do not align with the chosen level’s intent and scope are not recommended for funding, even if the work might fit another Breakthrough Award level. Level 4 is covered by this particular announcement, while Levels 1 through 3 are offered through separate program announcements, and applicants are encouraged to review those other scopes before committing to Level 4.

Breakthrough Award Level 4 specifically targets large-scale projects intended to transform or revolutionize the clinical management and/or prevention of breast cancer, and it requires human clinical trials. This is not a mechanism for early exploratory work; it is meant for efforts that are ready to be executed at a scale and maturity consistent with clinical testing. Because of that, principal investigators are expected to have a track record of successfully leading large, complex projects, and they must also demonstrate the capability to carry out a clinical study effectively, either through their own experience or by including a collaborating clinical investigator with the necessary expertise and commitment.

The program also emphasizes practical readiness and feasibility. Where applicable, proposals must show that the team already has access to the essential building blocks needed to conduct the trial successfully, such as relevant datasets, human biospecimens, patient cohorts, and any critical reagents. For projects likely to require U.S. Food and Drug Administration involvement, there are explicit readiness expectations at the time the application is submitted. These include proof that the clinical reagents or therapeutics are available and meet regulatory compliance requirements, proof of access to an appropriate subject population, credible and validated projections for patient recruitment, and submission of an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application to the FDA when applicable. Collectively, these requirements signal that Level 4 is aimed at proposals that are not only scientifically bold, but also operationally prepared to launch and complete a demanding clinical trial.

Administratively, the opportunity is offered by the Department of Defense through the Department of the Army, U.S. Army Medical Research Acquisition Activity (USAMRAA). The assistance instruments listed include grants and cooperative agreements, and the activity category is Science and Technology and other Research and Development (CFDA 12.420). Eligibility is described as unrestricted, meaning it is broadly open to many entity types, subject to any specific clarifications in the full announcement. The posting indicates it was created on May 7, 2019, with an original closing date of September 25, 2019, and it anticipated making one award. The listed award ceiling is shown as 0 in the summary data, which typically means applicants need to rely on the program announcement for the actual allowable budget parameters and funding constraints rather than the simplified listing field.

• 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 07, 2019.
• Applicants must submit their applications by Sep 25, 2019. (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 19 BCRP BTA4 2

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