DoW Breast Cancer, Breakthrough Award Level 3

The Breast Cancer Research Program Breakthrough Award Level 3 is a federal funding opportunity administered by the Defense Health Agency Contracting Activity through the Congressionally Directed Medical Research Programs as part of the Breast Cancer Research Program. The funding opportunity is designed to support advanced translational breast cancer research projects with high potential to lead to or make significant breakthroughs in the prevention, treatment, diagnosis, or understanding of breast cancer. The program originates from a long-standing congressional investment in breast cancer research beginning in fiscal year 1992 and reflects the mission of ending breast cancer for Service Members, Veterans, their Families, and the general public. The funding opportunity specifically emphasizes projects that can produce major impact and substantially accelerate progress beyond incremental advances in the field. Applications submitted to this opportunity must address at least one of the fiscal year Breast Cancer Research Program overarching challenges unless a compelling justification for an alternative challenge is provided. These challenges include prevention of breast cancer, understanding determinants of initiation and susceptibility, distinguishing deadly from non-deadly disease, reducing overdiagnosis and overtreatment, identifying drivers of breast cancer growth and metastasis, understanding recurrence and dormancy, revolutionizing treatment regimens, and eliminating mortality associated with metastatic disease. Applicants are strongly encouraged to align projects with the published Breast Cancer Landscape document and demonstrate how the proposed research could lead to fundamentally new strategies or approaches that are substantially more effective than current standards of care or prevention. The Breakthrough Award Level 3 mechanism specifically supports advanced translational studies and may include small-scale clinical trials such as first-in-human or phase 1/1b studies, although clinical trials are not required. Projects involving clinical translation must demonstrate access to required cohorts, biospecimens, therapeutic agents, datasets, or clinical reagents and provide realistic timelines for near-term clinical application. Applications involving regulatory oversight must describe plans for interaction with the U.S. Food and Drug Administration or equivalent international agencies. The mechanism allows either a single Principal Investigator model or a Partnering PI Option involving two investigators who contribute equally to the intellectual design and execution of the project. Partnering PI applications require separate but coordinated submissions and balanced effort across investigators. Funding for this opportunity is substantial. The program expects to allocate approximately 12.6 million dollars to support approximately two awards. Single Principal Investigator applications may request up to 5.6 million dollars in total costs over a maximum four-year performance period, while Partnering PI Option applications may request up to 7 million dollars in combined total costs. Cost sharing is not required. Allowable costs may include travel for collaborative meetings, attendance at scientific conferences, research subject reimbursement expenses, and costs related to advanced preclinical or regulatory preparation activities. For projects proposing clinical trials, funding may support both preparatory work and optional clinical trial activities within the same award structure. Indirect costs are permitted according to negotiated institutional rates. Eligibility is broad and includes both domestic and international organizations, for-profit and nonprofit institutions, public and private entities, and intramural or extramural organizations affiliated with the Department of War. Independent investigators affiliated with eligible organizations may apply regardless of nationality or citizenship status. Applications are required to include at least two breast cancer consumer advocates as active members of the research team throughout project planning, implementation, and evaluation. These advocates must be individuals diagnosed with breast cancer who are actively involved in advocacy organizations and able to provide independent patient-centered perspectives. The program strongly emphasizes interdisciplinary collaboration, scientific rigor, reproducibility, and translational feasibility. The application process consists of a mandatory two-step submission system beginning with a pre-application submitted through the Electronic Biomedical Research Application Portal. The pre-application deadline is June 12, 2026, and invited applicants will be notified by July 16, 2026. Full applications are due September 30, 2026, followed by an application verification period ending October 5, 2026. Peer review is expected in December 2026 and programmatic review in January 2027, with awards anticipated no later than September 30, 2027. The application package contains numerous required components including a project narrative, technical abstract, lay abstract, statement of work, impact statement, consumer advocate statement, post-award transition plan, budget documentation, and additional regulatory or inclusion materials if clinical research is proposed. Review criteria focus on impact, innovation, scientific rationale, feasibility, statistical rigor, personnel qualifications, consumer advocate integration, translational strategy, and military relevance. Applicants are required to maintain active registrations in SAM.gov, Grants.gov, and eBRAP before submission. Technical assistance is available through the eBRAP Help Desk at help@eBRAP.org and 301-682-5507, while Grants.gov support can be reached at support@grants.gov and 800-518-4726. The funding opportunity uses a rigorous two-tier review process consisting of scientific peer review followed by programmatic review. Applications must comply with strict formatting, eligibility, and submission requirements, and the program may administratively reject or withdraw applications that fail to meet requirements such as inclusion of consumer advocates, submission of complete application components, or alignment with overarching breast cancer challenges. The opportunity is part of a recurring annual federal research funding program and is expected to continue in future cycles subject to congressional appropriations.

Demonstrate strong translational feasibility and major impact beyond incremental advances. Clearly align the project with at least one Breast Cancer Research Program overarching challenge. Integrate consumer advocates meaningfully throughout project design and implementation. Provide strong preliminary data, rigorous statistical plans, and realistic clinical translation timelines.