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

Opportunity Information: Apply for W81XWH 19 BCRP BTA4

The DoD Breast Cancer Research Program (BCRP) Breakthrough Award Level 4 (Funding Opportunity Number W81XWH-19-BCRP-BTA4) is designed to back ambitious, high-impact breast cancer research that has a real chance to change the field rather than add incremental knowledge. The central expectation is that proposed work will accelerate progress toward ending breast cancer by enabling a fundamentally better approach to prevention and/or clinical management than what is already approved or currently being tested in clinical development. Applicants are expected to clearly define which breast cancer patients or at-risk groups would ultimately benefit if the project succeeds, keeping the end-user and real-world clinical relevance front and center.

This specific announcement covers only Level 4 of a four-tier Breakthrough Award structure. The program uses different levels to support different stages on the path to clinical application, and investigators are responsible for choosing the level that truly matches their project scope. Importantly, the level selection is not meant to be driven by the size of the budget, but by what the project is actually proposing to do. If an application is submitted under Level 4 but does not meet Level 4 intent and requirements, it will not be recommended for funding even if it might have fit better under another level. Levels 1 and 2 are covered under a different announcement (W81XWH-19-BCRP-BTA12), and Level 3 under another (W81XWH-19-BCRP-BTA3), so applicants are encouraged to review those scopes before committing to Level 4.

Level 4 is reserved for large-scale efforts intended to transform and potentially revolutionize how breast cancer is prevented and/or managed clinically. A key non-negotiable requirement is that the proposed project must include a human clinical trial; this funding mechanism is explicitly tied to clinical testing rather than preclinical or observational-only work. Because these projects are expected to be complex and operationally demanding, principal investigators are expected to show they can lead large, multi-faceted efforts successfully. That leadership capacity can be demonstrated through the PI's own track record or through firm commitments from collaborating clinical investigators with proven ability to execute a clinical project.

Operational readiness is a major theme of Level 4. Where relevant, proposals must show that the team has access to the practical resources needed to run the work, such as required datasets, human biospecimens, cohorts, and critical reagents. Projects that anticipate involvement with the U.S. Food and Drug Administration also face explicit readiness expectations at the time of application. These include showing that compliant clinical-grade reagents (such as therapeutics) are available and accessible, demonstrating access to an appropriate participant population, providing validated projections that support feasible recruitment, and submitting an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application to FDA when applicable. In other words, this program is aimed at trials that are not just scientifically compelling, but genuinely prepared to launch and complete enrollment on a realistic timeline.

Recruitment planning and accountability are built into the award. Applications must provide quarterly enrollment targets across all trial sites within the Statement of Work (identified as Attachment 4 in the announcement). After award, recipients work with the U.S. Army Medical Research Acquisition Activity (USAMRAA) to establish formal recruitment milestones, and continued funding support is tied to satisfactory progress toward those milestones. This structure signals that the sponsor is prioritizing execution, enrollment performance, and measurable trial advancement, not just promising ideas.

The announcement also encourages collaborative leadership through a Partnering PI Option. Under this option, two principal investigators can apply together as an Initiating PI and a Partnering PI, with each receiving a separate award. The intent is not cosmetic collaboration, but a genuinely integrated partnership where both PIs contribute substantially to the project design and core application components such as the Project Narrative and Statement of Work. The application needs to make a clear case that the combined expertise materially strengthens the project and that the work is better done as a coordinated effort rather than as two separate projects. While new collaborations are welcome, they are not required, and applicants are discouraged from naming the same person as a Partnering PI on multiple Level 4 applications unless the research questions are clearly distinct.

Team composition is another major review expectation. Given the scale and clinical-trial requirement, applicants are expected to assemble a robust, appropriately staffed team with the breast cancer expertise and operational capacity to carry out complex clinical research. Beyond typical scientific and clinical personnel, this award requires meaningful consumer advocate participation. Each application must include at least two breast cancer consumer advocates who are integrated throughout planning and execution, including shaping the research question, informing study design, contributing to oversight, supporting recruitment strategies, and helping evaluate the project. These advocates must be individuals diagnosed with breast cancer, active in an advocacy organization, and positioned to provide objective, independent input. They cannot be employees of any participating organization on the application, and their involvement is expected to be ongoing and substantive rather than limited to occasional meeting attendance.

Finally, projects must be relevant to military health, meaning the research should connect to the healthcare needs of Service members, Veterans, military beneficiaries, and/or the broader American public. Administratively, this is a discretionary Department of Defense opportunity managed by the Department of the Army through USAMRAA, offered as a grant and/or cooperative agreement under CFDA 12.420 (Science and Technology and other Research and Development). Eligibility is described as unrestricted (open to any type of entity, subject to any additional eligibility clarifications in the full announcement). The opportunity was originally posted January 22, 2019, with an original closing date of June 13, 2019, and the listing indicated an expectation of two awards.

• 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 Jan 22, 2019.
• Applicants must submit their applications by Jun 13, 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 2 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.

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