DoD Breast Cancer, Breakthrough Award Level 4 | W81XWH 22 BCRP BTA4 2

Opportunity Information: Apply for W81XWH 22 BCRP BTA4 2

The DoD Breast Cancer Research Program (BCRP) Breakthrough Award Level 4 (Funding Opportunity Number W81XWH-22-BCRP-BTA4-2) is designed to back ambitious, high-stakes breast cancer research that can realistically change the field rather than incrementally improve it. The core expectation is impact: proposed work should have a strong chance of accelerating progress toward ending breast cancer by enabling a new approach that is fundamentally better than what is already approved or currently in clinical development. Applicants are expected to be explicit about who will benefit from the research, identifying the patient populations or at-risk individuals who are the intended end users of the eventual clinical application, and describing how the results could translate into real changes in prevention and/or clinical management.

Level 4 is the most advanced of four Breakthrough Award funding levels, each aimed at different stages on the path to clinical application. Applicants must choose the level that fits the defined scope rather than trying to match a preferred budget number to a level. Level 4 specifically targets large-scale projects intended to transform and potentially revolutionize breast cancer prevention and/or clinical management, and it requires human clinical trials as a non-negotiable component. This means the program is not looking for preclinical-only packages at this level; it is looking for trials that are ready to be executed and that are positioned to generate clinically meaningful evidence.

Because the mechanism is meant for complex, high-visibility clinical work, the program places a heavy emphasis on demonstrated leadership and operational readiness. Principal Investigators are expected to have experience leading large-scale efforts and to show they can successfully implement a clinical project, either through their own track record or through a committed collaborating clinical investigator. Applications should also show that the project has practical access to what it needs to run: relevant datasets, human samples, cohorts, and any critical reagents. In other words, reviewers are being asked to judge not only the scientific promise, but whether the team is actually positioned to carry out the trial at the necessary scale without unrealistic assumptions.

If the project will involve the U.S. Food and Drug Administration, the readiness bar is even higher at the time of submission. The announcement calls for proof that the team has access to clinical-grade reagents (such as therapeutics) that meet regulatory compliance expectations, proof that appropriate subject populations are available, and validated projections that patient recruitment is feasible. When applicable, the program expects that an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application has already been submitted to the FDA. Collectively, these requirements signal that Level 4 is aimed at trials that are not just conceptually attractive, but operationally mature and capable of starting and progressing on a realistic timeline.

The opportunity also encourages real collaboration through an optional Partnering PI structure, allowing two Principal Investigators to apply together in a way that is meant to be genuinely co-led. One PI serves as the Initiating PI and handles most administrative submission tasks, while the Partnering PI shares equal intellectual ownership of the science. The application needs to make a clear case that both PIs have distinct, essential contributions, comparable engagement, and appropriate effort, and that the work is stronger because it is being done together rather than split into separate projects. Funding is generally expected to be balanced between the two awards unless there is a strong justification. The program discourages superficial pairings, such as one PI merely supplying samples or an investigational agent while the other conducts nearly all the research, and it also discourages the same person serving as Partnering PI on multiple Level 4 applications unless the projects clearly address different research questions. If funded, each PI is named on an individual award within the recipient organization.

Another defining feature of this mechanism is the required involvement of breast cancer consumer advocates, with at least two advocates integrated into the research team. These are not symbolic roles: advocates are expected to be involved throughout planning and implementation, including shaping the research question, contributing to project design, providing oversight, supporting recruitment and evaluation strategies, and participating in other major project activities. The advocates must be individuals diagnosed with breast cancer who are active in advocacy organizations, and they cannot be employees of any participating organization. Their contributions are intended to provide independent, patient-centered input focused on real-world relevance and potential impact for people living with breast cancer or those at risk, and they are expected to have sufficient knowledge of current breast cancer issues and enough background or training to participate meaningfully in research discussions.

Administratively, this is a discretionary Department of Defense grant/cooperative agreement opportunity administered by the Department of Defense, Department of the Army, U.S. Army Medical Research Acquisition Activity (USAMRAA), under CFDA 12.420. Eligibility is listed as unrestricted (open broadly to entity types, subject to any additional constraints described in the full announcement). The posting indicates an expected number of awards of one, and while an award ceiling is not specified in the provided summary (listed as 0), the program makes clear that applicants should select Level 4 because their project fits the Level 4 scope, not because of a target budget. The opportunity was created June 9, 2022, with an original closing date of November 2, 2022.

• 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 Jun 09, 2022.
• Applicants must submit their applications by Nov 02, 2022. (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 22 BCRP BTA4 2

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