DoD Breast Cancer, Clinical Research Extension Award | HT9425 23 BCRP CREA2

Opportunity Information: Apply for HT9425 23 BCRP CREA2

The DoD Breast Cancer, Clinical Research Extension Award (FY23 BCRP CREA; Funding Opportunity Number HT9425 23 BCRP CREA2) is a Department of Defense Breast Cancer Research Program funding mechanism designed to extend the value of existing breast cancer clinical research by supporting additional data collection, patient follow-up, and deeper analysis of already collected clinical samples and datasets. The central idea is to prevent the loss of clinically meaningful knowledge that can happen when follow-up ends too early or when samples are not fully analyzed, and to turn prior patient participation into clearer, more actionable insights that can move the field closer to improved outcomes and, ultimately, ending breast cancer.

A defining expectation of this award is impact. Proposed work should be positioned to make a major, clinically relevant difference rather than incremental progress. Applications are expected to clearly identify which breast cancer patient groups, or which at-risk individuals, stand to benefit from the findings. In practice, that means a strong application will connect the extension work to a tangible clinical need, such as improving risk stratification, refining prognosis, predicting therapy response, understanding recurrence, or informing future standards of care. Even though the project builds on existing studies, the extension should push the science toward conclusions that matter for patients and clinicians.

The research scope is intentionally broad but focused on extension activities rather than launching new trials. Appropriate projects may include deeper molecular profiling of existing clinical specimens, new or expanded correlative studies linked to clinical outcomes, validation of candidate biomarkers, or continued follow-up of participants from an open/ongoing trial or a completed trial. The mechanism also supports work that may be hypothesis-driven (testing or generating hypotheses) and work that creates clinically annotated and molecularly characterized resources, such as patient-derived models or tissue arrays, that can serve as experimental platforms for the wider research community. A key boundary is that the award cannot be used to directly support a clinical trial itself; instead, it funds the added analyses, follow-up, and translational work that build on trials and clinical studies that already exist.

Feasibility is treated as a must-have rather than a nice-to-have. Applicants are required to present preliminary data that supports both the scientific rationale and the practicality of the approach, and they must show that they have access to the needed samples, datasets, patient populations, and any other resources required to complete the work. Because this mechanism is about extending and completing what prior clinical research started, reviewers will expect clear evidence that the necessary materials are available now and that there is a realistic path to executing the analyses and follow-up within the award period.

The opportunity also places weight on rigorous data evaluation and on sharing outputs beyond the immediate project team. Applicants need to justify study sample size so that the results can support valid conclusions and credibly move toward clinical application. The burden is on the applicant to demonstrate that the proposed cohort size, statistical plan, and endpoints match the objectives and will not lead to underpowered or ambiguous findings. In addition, applicants must provide a plan for sharing experimental platforms and molecular data generated through the project with the broader scientific community, reinforcing the goal that these extensions should multiply the impact of past patient participation and accelerate progress across the field.

A notable feature is the Partnering PI Option, which is meant to encourage genuine, productive collaborations, especially between basic scientists and clinical researchers. Under this structure, two principal investigators can lead together: an Initiating PI (handling most submission and administrative responsibilities) and a Partnering PI. The announcement emphasizes that this is not a token arrangement; both PIs are expected to contribute substantial and distinct expertise, share meaningful intellectual ownership of the project design, and commit comparable and appropriate effort. Budgets are generally expected to be balanced between the two PIs unless there is a clear justification otherwise. The application should also explain why the partnership is necessary and why the work cannot be effectively accomplished through separate, disconnected efforts. If recommended for funding, each PI is named on an individual award within the recipient organization.

Team strength and patient-centered perspective are emphasized throughout. Applications are expected to assemble a robust research team with the combined expertise needed to deliver the proposed extension work. Additionally, consumer advocate involvement is required, not optional. The team must include at least two breast cancer consumer advocates who are breast cancer survivors and active members of a breast cancer advocacy organization. Their role must be independent (they cannot be employees of the participating organizations) and should be clearly described in both study design and execution. The intent is for advocates to provide objective, informed input that keeps the project aligned with patient priorities and real-world impact for people living with breast cancer or those at increased risk.

From an administrative standpoint, this opportunity is offered by the Department of Defense, Department of the Army, via USAMRAA. It is listed under CFDA 12.420 and supports research and development activities. The funding instrument types include grants and cooperative agreements. Eligibility is described as unrestricted (open to any type of entity, subject to any additional eligibility language in the full notice). For the FY23 cycle referenced in the source text, the opportunity was posted on February 6, 2023, with an original closing date of April 11, 2023. The listing anticipated approximately two awards, and the posted award ceiling is shown as 0, which typically indicates applicants must consult the full program announcement for budget limits or that ceilings may be determined by other guidance rather than a single fixed cap in the listing.

In summary, the Clinical Research Extension Award is essentially a mechanism for finishing strong: it funds the extra follow-up, analyses, and translational validation steps that can turn existing clinical research participation and biospecimens into more definitive, clinically useful knowledge, while requiring solid feasibility evidence, statistical rigor, meaningful collaboration options, clear data-sharing plans, and direct involvement of informed consumer advocates.

• 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 Feb 06, 2023.
• Applicants must submit their applications by Apr 11, 2023. (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.

Apply for HT9425 23 BCRP CREA2

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