DoD Breast Cancer, Breakthrough Award Level 4 | W81XWH 20 BCRP BTA4

Opportunity Information: Apply for W81XWH 20 BCRP BTA4

The Department of Defense Breast Cancer Research Program (BCRP) Breakthrough Award Level 4 (Funding Opportunity Number W81XWH-20-BCRP-BTA4) is designed to fund ambitious, high-stakes breast cancer research that is positioned to produce a true breakthrough rather than an incremental improvement. The central expectation is clear: proposed work should have the potential for major impact on breast cancer outcomes and should accelerate progress toward ending breast cancer. That impact can be near-term or long-term, but it must plausibly lead to a new approach that is fundamentally better than what is already approved or currently moving through clinical development. Applicants are also expected to be explicit about who benefits, meaning they should identify the breast cancer patient populations or at-risk groups that the research is intended to help and explain why the project matters for them.

This opportunity focuses specifically on Breakthrough Award Level 4, which represents the most advanced and resource-intensive scope within the Breakthrough Award structure. While the broader Breakthrough Award program is divided into four funding levels (each aimed at different stages on the path to clinical application), Level 4 is reserved for large-scale efforts intended to transform and potentially revolutionize clinical management and/or prevention of breast cancer. A key non-negotiable feature of Level 4 is that human clinical trials are required. In practice, this means applicants need to propose a clinical study that is not merely exploratory, but built to rigorously test an intervention, strategy, or approach with meaningful clinical relevance. The program also emphasizes that investigators must choose the funding level based on the defined research scope, not based on the size of the budget they would like. If a proposal does not match the Level 4 intent and requirements, it can be deemed noncompetitive even if it would have fit better under another level.

Because Level 4 projects are expected to be complex, multi-faceted, and operationally demanding, the program places strong weight on demonstrated leadership capacity and readiness. Principal Investigators are expected to have experience successfully leading large-scale projects, along with the practical capability to execute a clinical trial either through their own background or through a firm commitment from an appropriately qualified collaborating clinical investigator. Applications should also show that the team has access to what is needed to do the work, such as critical datasets, human samples, relevant cohorts, and specialized reagents. When the research involves U.S. Food and Drug Administration oversight, the program signals that applicants must be prepared at the time of submission. That readiness includes proof of access to clinical-grade reagents that meet regulatory compliance standards, proof of access to an appropriate subject population, credible and validated recruitment projections, and, when applicable, submission of an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application to the FDA.

Recruitment planning is treated as a core scientific and operational requirement rather than an administrative afterthought. The application must include quarterly enrollment targets across all participating sites in the Statement of Work (Attachment 4). Awardees will then work with USAMRAA (U.S. Army Medical Research Acquisition Activity) to finalize recruitment milestones, and continued funding support is tied to satisfactory progress toward those enrollment goals. In other words, the program is explicitly milestone-driven, and the ability to recruit participants on schedule is positioned as a make-or-break factor for project continuation.

The announcement also encourages collaboration through a formal Partnering PI option that allows two Principal Investigators to lead together in a structured way. One investigator serves as the Initiating PI and handles most submission-related administrative responsibilities, while the second serves as the Partnering PI. Even though the submission roles differ, both are expected to contribute substantially to the science and planning, including the project narrative and statement of work. If funded, each PI is named on an individual award within the recipient organization. The program is looking for complementary, distinct contributions, whether the investigators come from similar disciplines or different ones, and applicants are expected to justify why the partnership strengthens the project and why the work should be conducted jointly rather than split into separate efforts. The opportunity also cautions against listing the same person as a Partnering PI on multiple Level 4 applications unless the projects clearly address different research questions, reinforcing the emphasis on meaningful, not symbolic, collaboration.

Team composition requirements extend beyond academic and clinical expertise. Applications are expected to assemble a robust and appropriately staffed research team with strong breast cancer-relevant experience to ensure the clinical trial can be executed successfully. In addition, consumer advocate involvement is mandatory and substantial. Each application must include two or more breast cancer consumer advocates who are integrated into the project throughout planning and implementation. Their involvement is expected to be continuous and operationally real, spanning areas like refining the research question, shaping study design, helping guide oversight, supporting recruitment approaches, and contributing to evaluation. The program draws clear boundaries around independence: these consumer advocates must be individuals diagnosed with breast cancer, active in breast cancer advocacy organizations, and they cannot be employees of any participating organization on the application. Their role must be independent of their employment and focused on providing objective patient-centered input about relevance, feasibility, and real-world impact. The announcement also expects advocates to have enough knowledge of current breast cancer issues and sufficient background or training to contribute effectively to research discussions rather than serving as passive observers.

Administratively, this is a discretionary federal research and development funding opportunity offered by the Department of Defense (Department of the Army, USAMRAA). The funding instruments listed include both grants and cooperative agreements, indicating that some awards may involve a more substantial programmatic role for the funder than a traditional grant would. Eligibility is described as unrestricted (open to any type of entity), subject to clarifications in the full announcement. The listing includes CFDA 12.420, an original posting date of December 23, 2019, and an original closing date of June 24, 2020. The opportunity indicates an expectation of a very small number of awards (listed as 1), underscoring how competitive and selective Level 4 funding is likely to be.

• 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 Dec 23, 2019.
• Applicants must submit their applications by Jun 24, 2020. (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 20 BCRP BTA4

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: