DoD Breast Cancer, Clinical Research Extension Award | HT9425 23 BCRP CREA

Opportunity Information: Apply for HT9425 23 BCRP CREA

The DoD Breast Cancer, Clinical Research Extension Award (FY22 BCRP; Funding Opportunity Number HT9425 23 BCRP CREA) is designed to get more value and real-world impact out of breast cancer clinical research that has already been conducted or is currently underway. Instead of paying for a brand-new clinical trial, this program focuses on extending and strengthening existing clinical research by supporting additional data collection, longer patient follow-up, and deeper analysis of samples that may have been underused because a study ended early or because long-term tracking and lab work were limited by time and money. The central idea is simple: breast cancer patients and at-risk participants have already contributed time, biospecimens, and personal data to research, and this award aims to make sure that contribution translates into clinically meaningful knowledge rather than being partially lost due to incomplete follow-up or unfinished correlative work.

A core expectation of the award is clinical impact. Proposed projects are expected to have a strong chance of making a major difference in breast cancer outcomes and accelerating progress toward ending breast cancer. Applicants are expected to clearly identify which breast cancer patients or at-risk groups are most likely to benefit from the work and to keep the project grounded in clinical relevance, not just academic curiosity. While the scope is flexible, the program description highlights several types of projects that fit well: performing deeper molecular analyses on existing clinical samples, launching new correlative studies tied to clinical outcomes, validating biomarkers, and continuing clinical follow-up on patients enrolled in an open/ongoing trial or a completed clinical trial. The mechanism can support both hypothesis-driven and hypothesis-generating research, and it can also support creation of clinically annotated resources and experimental platforms, such as molecularly characterized tissue arrays or patient-derived models, as long as these are firmly connected back to human clinical data.

There are also clear boundaries. This award cannot be used to directly support a clinical trial itself, meaning it is not intended to pay for trial operations such as enrollment for a new interventional study. Instead, it funds the extension activities around clinical research, such as additional follow-up timepoints, expanded sample analyses, and studies that connect molecular findings to outcomes. Because the program is meant to produce results that can stand up to scrutiny and move toward translation, applicants must provide preliminary data that supports both the scientific rationale and feasibility of the approach. They also need to show they can actually execute the work by demonstrating access to the necessary resources, including the relevant patient populations, existing datasets, and biospecimen collections.

Strong attention to study design is emphasized, particularly around sample size and the strength of conclusions. Applicants are expected to justify that the study has an appropriate sample size to answer the stated objectives and to support valid, interpretable conclusions that can be translated toward clinical application. In addition, the award expects a clear plan for data and resource sharing. If the project generates molecular datasets or experimental platforms, the applicant must describe how those outputs will be shared with the broader scientific community, reinforcing the goal of maximizing the downstream value of patient participation and accelerating progress across the field rather than keeping the results siloed.

The opportunity also encourages meaningful collaboration through a Partnering PI option. Under this structure, two Principal Investigators can apply together: one serves as the Initiating PI and handles most submission and administrative responsibilities, while the other is listed as the Partnering PI. The program expects true intellectual partnership, not a token collaboration. The application should show that both investigators contribute substantially to the project design and execution, devote similar and appropriate levels of effort, and bring distinct expertise that is critical to the work. Collaborations that bridge basic science and clinical research are especially encouraged. Funding is generally expected to be balanced across the two PIs unless there is a strong justification otherwise, and if funded, each PI would be named on an individual award within the recipient organization.

Team composition and patient voice are treated as essential, not optional. Applications are expected to assemble a robust research team with the expertise needed to complete the project successfully, and consumer advocate participation is required. Specifically, the research team must include at least two breast cancer consumer advocates who have been diagnosed with breast cancer and are actively involved in a breast cancer advocacy organization. These advocates must be independent lay representatives: they cannot be employees of any organization participating in the application, and their role should not be tied to employment. They should also have enough knowledge of current breast cancer issues and sufficient background or training in research to contribute meaningfully. The application must spell out what they will do throughout the project, with their role focused on providing objective input into study design, execution, and the likely impact for people living with breast cancer or those at risk.

Administratively, this is a Department of Defense program managed through the U.S. Army Medical Research Acquisition Activity (USAMRAA). The funding instrument type may be a grant or cooperative agreement, and eligibility is described as unrestricted (open to any type of entity), subject to any clarifications in the full announcement. The posted opportunity information lists an estimated three awards and shows an award ceiling of 0, which typically signals that applicants should rely on the full announcement for budget limits or that the ceiling is not specified in that summary field. The opportunity was created on October 13, 2022, with an original closing date of December 13, 2022, and it is associated with CFDA 12.420 for DoD research and development assistance.

Overall, this award is best understood as a way to extend the scientific and clinical return on investment of existing breast cancer clinical research. It is meant for teams that already have access to patient cohorts and samples, have enough preliminary evidence to justify deeper or longer follow-up work, and can convert those assets into validated biomarkers, stronger clinical correlations, and shared datasets or platforms that push the field closer to practical clinical benefit.

• 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, Clinical Research Extension Award" 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 Oct 13, 2022.
• Applicants must submit their applications by Dec 13, 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 3 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 CREA

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