DoD Breast Cancer, Breakthrough Award Levels 1 and 2 | HT942524BCRPBTA122

Opportunity Information: Apply for HT942524BCRPBTA122

The DoD Breast Cancer Research Program (BCRP) Breakthrough Award Levels 1 and 2 (Funding Opportunity Number HT942524BCRPBTA122; CFDA 12.420) is a discretionary research grant opportunity administered through the Department of the Army, USAMRAA. Its purpose is to fund breast cancer research projects that are genuinely positioned to produce major advances, not incremental progress. The program is built around the idea that supported work should have clear potential to accelerate progress toward ending breast cancer, either on a near-term path to translation or through longer-term, paradigm-shifting discoveries. Applicants are expected to be explicit about which breast cancer patients or at-risk groups would ultimately benefit if the research succeeds, and why the expected outcomes matter in the real clinical landscape.

A key feature of this mechanism is that applicants must choose the correct funding level based on the project stage and goals, not on the size of the budget they want. The Breakthrough Award is structured across four levels overall, but this particular announcement covers only Levels 1 and 2. The program strongly emphasizes fit: if an application does not match the intent and scope of the chosen level, it can be declined even if it would have fit better under a different level. In practical terms, investigators need to align their aims, maturity of evidence, and anticipated deliverables with the specific level definitions described in the announcement.

Funding Level 1 is meant for bold, innovative, high-risk/high-reward concepts that are still early in development, including untested theories aimed at important breast cancer problems. To encourage new directions, preliminary data are not required at this level. The expected output is proof of concept rather than a fully validated translational package. This level is designed for ideas that could open up new avenues of investigation and ultimately reshape how breast cancer is understood, detected, or treated, even if the work begins from a less proven starting point.

Funding Level 2 is designed for projects that already have substantial preliminary and/or published data and that provide strong validation for clinical translation in a clearly defined breast cancer context. In other words, Level 2 is for teams that can show their approach is already well supported and that the next steps are logically connected to eventual patient impact. Within Level 2, the program also highlights a specific track for Population Science and Prevention Studies. These projects should focus on understanding why certain human populations differ in breast cancer risk or clinical outcomes, relying on analyses of human data and biospecimens. Like other Level 2 projects, they should be supported by substantial existing evidence and should make a strong case for clinical relevance; with compelling justification, these studies may request a higher funding amount and an additional year of performance.

The opportunity also includes a Partnering PI Option intended to support genuinely collaborative, two-PI projects where both investigators contribute substantial and distinct intellectual leadership. One PI serves as the Initiating PI (handling most submission and administrative responsibilities) and the other as the Partnering PI, but the program expects both to have comparable scientific ownership, meaningful roles in shaping the project narrative and statement of work, and similar, appropriate effort levels. Funding is expected to be relatively balanced between the two PIs unless a clear justification is provided. The program is specifically trying to avoid arrangements that are collaborative in name only, so it discourages partnerships that are essentially mentor-trainee pairings (such as a mentor and their current postdoc) or situations where one PI simply supplies samples or tools while the other performs nearly all experiments and analyses. If funded, each PI is named on a separate award to their organization, and each award carries separate reporting and administrative obligations.

From a scientific and regulatory standpoint, the program allows research involving human subjects, human anatomical substances, and human data, but it does not allow clinical trials. The announcement uses the federal regulatory definition of a clinical trial (45 CFR 46.102), emphasizing that trials involve prospective assignment of human subjects to an intervention to evaluate effects on health-related outcomes. Observational clinical research is allowed, including studies of disease mechanisms in humans, diagnostic and detection research (such as biomarkers or imaging), health disparity work, technology development, epidemiology, behavioral research, outcomes research, and health services research, as long as the study is not evaluating an intervention’s safety or efficacy in a trial format. The program also clarifies that certain in vitro studies using de-identified human materials that cannot be linked to living individuals may fall outside the clinical research definition when they meet the applicable Common Rule exemption criteria.

Programmatically, the BCRP signals several areas of interest and context. Applicants are encouraged to consider the recommendations of the congressionally mandated Metastatic Cancer Task Force, particularly work that could accelerate translational and clinical progress for advanced-stage and recurrent disease, so long as it fits within the opportunity’s constraints and FY24 BCRP priorities. The announcement also encourages innovative research involving nuclear medicine and related techniques that could improve early diagnosis and treatment, including noninvasive precision imaging and targeted therapy approaches, with a stated relevance to active-duty Service Members and their families. In addition, the program encourages research that addresses health conditions affecting women uniquely, disproportionately, or differently than men, including work that thoughtfully analyzes sex as a biological variable and ties findings to improvements in women’s health outcomes. Across all topics, proposals must be relevant to active-duty Service Members, Veterans, military beneficiaries, and/or the broader American public, and collaborations between military/Veteran institutions and non-military organizations are strongly encouraged to leverage complementary expertise, infrastructure, and access to clinical populations.

The awards are issued as grants (under 31 USC 6304). For budgeting, the anticipated direct cost caps for the full period of performance are: Level 1 up to $450,000 for a single PI or up to $750,000 using the Partnering PI Option; Level 2 up to $1.0 million for a single PI or up to $1.5 million with a Partnering PI; and Level 2 Population Science and Prevention Studies up to $1.5 million for a single PI or up to $2.0 million with a Partnering PI (with the possibility of an additional year when well justified). The agency expects to allocate about $12.6 million total to fund roughly eight awards under Levels 1 and 2 combined, though actual selections depend on federal fund availability, application pressure, and peer and programmatic review outcomes. Awards supported with FY24 funds are expected to be made no later than September 30, 2025, and the FY24 funds are expected to expire for use on September 30, 2030. The original closing date listed for this opportunity is September 26, 2024, and eligibility is described as unrestricted.

• 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, Breakthrough Award Levels 1 and 2" 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 8 candidate(s).
• Eligible applicants include: Unrestricted.

Apply for HT942524BCRPBTA122

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