DoD Breast Cancer, Clinical Research Extension Award | HT942524BCRPCREA2

Opportunity Information: Apply for HT942524BCRPCREA2

The FY24 DoD Breast Cancer Research Program (BCRP) Clinical Research Extension Award is a grant opportunity designed to get more value and more clinically useful insight out of breast cancer clinical studies that have already been conducted or are still underway. Instead of funding brand-new interventional trials, this mechanism focuses on extending, expanding, and strengthening what is learned from prior clinical research by supporting additional data collection, longer patient follow-up, deeper analysis of existing samples, and improved interpretation of results. The overarching goal is to prevent important knowledge from being lost when trials end early, follow-up is too short, or sample and data collection were not as complete as needed. A major theme is respect for patient participation: since patients contribute tissue, blood, other biospecimens, and personal health data, the program aims to ensure those contributions lead to the strongest possible scientific and clinical impact.

In terms of what projects can actually do, the award supports clinical research activities that build on an existing clinical trial or clinical study rather than initiating a new clinical trial. Examples of supported work include deeper molecular profiling of banked clinical samples, launching new correlative science studies tied to the original study, validating biomarkers, and continuing long-term clinical follow-up for participants from an ongoing or completed study. Projects may be hypothesis-generating or hypothesis-testing, and they can also be aimed at creating high-value, clinically annotated research resources such as molecular datasets, patient-derived models, or tissue arrays, as long as these platforms are grounded in the clinical study context. Notably, innovation is not used as a review criterion here; the program is more concerned with whether the proposed extension work is important, clinically meaningful, and well-justified. What is explicitly not supported is conducting clinical trials, meaning the award cannot be used for studies where human subjects are prospectively assigned to an intervention to measure its effects on health outcomes (consistent with the 45 CFR 46.102 definition).

Applications are expected to be highly practical and well-supported. Preliminary data is required to show scientific rationale and feasibility, and applicants must demonstrate they truly have access to the needed samples, data, and/or patient populations to complete the proposed work. The opportunity places strong emphasis on sound study design and statistics: the proposed sample size should be sufficient to support valid conclusions or at least generate a meaningful, credible hypothesis, and the application needs to explain the statistical approach and key analytic considerations. Just as important, applicants must provide a data-sharing plan so that molecular data, associated datasets, and any experimental platforms created through the project can be made accessible to the broader scientific community.

The funding opportunity encourages team science and provides a formal Partnering PI Option that allows two Principal Investigators to apply together. Under this structure, one PI serves as the Initiating PI and handles most submission administration, while the Partnering PI brings distinct expertise and shares leadership. The application must make a clear case that the partnership is genuinely necessary, that both PIs have equal intellectual input into the project design, and that effort and funding are generally balanced unless there is a strong justification otherwise. If selected, each PI is expected to be named on a separate award to their organization, with separate reporting and administrative requirements. Regardless of whether the project uses the partnering option, the program expects a strong, appropriately staffed research team with breast cancer-relevant expertise.

A distinctive requirement is the mandatory inclusion of consumer advocates. Each application must include at least two breast cancer consumer advocates who have personally been diagnosed with breast cancer and are actively involved in a breast cancer advocacy organization. Their role must be clearly described and should meaningfully influence both the design and conduct of the work, with a focus on providing independent, patient-centered perspective on the study and its potential impact. These advocates cannot be employees of organizations participating in the application, and they are expected to have enough knowledge and training to contribute thoughtfully to the research process.

Programmatically, the DoD emphasizes relevance to active-duty Service Members, Veterans, military beneficiaries, and/or the general American public, and it strongly encourages collaborations between military or Veteran institutions and non-military institutions to combine infrastructure, expertise, and access to unique patient populations. The announcement also signals several areas of encouraged alignment: applicants are urged to consider recommendations from the congressionally mandated Metastatic Cancer Task Force, to incorporate research that improves understanding of health conditions affecting women uniquely or differently (including analysis of sex as a biological variable when appropriate), and to propose efforts involving nuclear medicine and related approaches that could improve early diagnosis, targeted treatment, and health outcomes for Service Members and their families.

From an administrative and budget standpoint, awards are made as grants. Direct costs for the full performance period are capped at $5 million for a single-PI application, or $6 million if using the Partnering PI Option. The Army contracting and assistance entity involved is the U.S. Army Medical Research Acquisition Activity (USAMRAA) under the Department of the Army, and eligibility is listed as unrestricted. For this specific FY24 opportunity, the program indicated it expects to allocate about $9.3 million total to fund approximately one award, making it highly competitive. The original closing date listed is September 26, 2024, and awards supported with FY24 funds are expected to be made no later than September 30, 2025. Funds are anticipated to be FY24 appropriations with an expiration for use on September 30, 2030, meaning the government has a limited window in which those obligated funds can be utilized under federal fiscal rules.

• The 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 2024-06-11.
• Applicants must submit their applications by 2024-09-26. (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.

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