Opportunity Information: Apply for HT9425 23 BCRP BTA4
The DoD Breast Cancer Research Program (BCRP) Breakthrough Award Level 4 (Funding Opportunity Number HT9425-23-BCRP-BTA4) is designed to back large, high-impact breast cancer projects that have a real chance of changing the field rather than adding another incremental improvement. The central idea is impact: proposed work needs the potential to produce a major shift in how breast cancer is prevented and/or clinically managed. The program is looking for research that could plausibly lead to a fundamentally new and more effective approach than what is already approved or currently being tested in clinical development. Applicants are also expected to be explicit about who benefits, meaning they should clearly identify the breast cancer patient populations or at-risk groups the intervention is ultimately intended to help.
Level 4 is specifically positioned as the most advanced and clinically grounded of the Breakthrough Award levels, and it has a clear boundary: a human clinical trial is required. This is not a mechanism for exploratory lab studies, retrospective analyses, or observational work that does not test an intervention. Under the definition used here, a clinical trial means one or more human subjects are prospectively assigned to one or more interventions (including placebo or control, as appropriate) so the study can evaluate biomedical or behavioral health-related outcomes, such as safety, effectiveness, and/or efficacy. Projects that do not actually evaluate an intervention with these kinds of outcomes are not considered clinical trials for this opportunity and would be better aligned with other BCRP announcements.
Because Level 4 aims to support large-scale projects intended to be transformative, the solicitation sets expectations around project leadership and readiness. Principal Investigators are expected to have a track record of successfully leading large, complex efforts, and they must show they can realistically implement a clinical project, either through their own experience or through a committed collaborating clinical investigator. Applications also need to demonstrate that the team has access to what is required to execute the trial at scale, such as necessary datasets, human samples, patient cohorts, and critical reagents. In other words, the review standard is not just whether the science is exciting, but whether the project is truly ready to run as proposed.
Regulatory readiness is a major emphasis when FDA (or an equivalent international regulatory agency) involvement is relevant. At the time of application submission, projects that require regulatory engagement are expected to show concrete proof that key clinical reagents or products (for example, therapeutics or devices) are available and meet regulatory compliance guidelines, that appropriate subject populations are accessible, and that patient recruitment projections are validated and credible. If applicable, the program expects that an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application has been submitted to the FDA. This requirement signals that Level 4 is meant for trials that are not just conceptual, but positioned to move forward without major avoidable delays.
The opportunity also encourages a two-PI structure through a Partnering PI Option, aimed at supporting genuine, balanced scientific partnerships rather than nominal collaborations. One PI serves as the Initiating PI and handles most administrative submission duties, while the Partnering PI is expected to share equal intellectual ownership of the project design and make distinct, essential contributions to the research strategy and statement of work. The program expects comparable and appropriate levels of effort from both PIs and generally expects funding to be balanced between them unless there is a strong justification. Importantly, the partnership must be meaningful: arrangements where one PI merely supplies samples or an investigational agent while the other PI conducts nearly all the research and analyses are discouraged and may not meet the intent of the mechanism. If funded, each PI is named on an individual award within the recipient organization, reflecting the program's intent to support two leaders driving one integrated project.
A notable structural feature of Level 4 is that it includes an invited oral presentation as part of the application review process. That requirement underscores how selective and high-stakes this mechanism is, and it indicates that finalists should be prepared to defend feasibility, readiness, and potential impact in a live setting beyond the written application.
The solicitation also mandates robust stakeholder engagement through consumer advocate participation. Every application must include at least two breast cancer consumer advocates who are integrated throughout planning and execution, not simply consulted occasionally. These advocates are expected to contribute to shaping the research question, advising on study design, helping with oversight, informing recruitment strategies, and participating in evaluation and other key project components. They must be breast cancer survivors (diagnosed with breast cancer), active in a breast cancer advocacy organization, and independent in their role: they cannot be employees of the participating organizations, and their involvement should be focused on objective input about patient-centered impact. The program also expects advocates to have enough familiarity with breast cancer issues and research to engage substantively with the team.
Administratively, this is a discretionary Department of Defense opportunity managed through the U.S. Army Medical Research Acquisition Activity (USAMRAA). The instrument type includes grants and cooperative agreements, and it falls under CFDA 12.420 for science and technology research and development. Eligibility is described as unrestricted (open to any entity type, subject to any additional eligibility clarifications in the full announcement). The opportunity was originally posted February 6, 2023, with an original closing date of June 28, 2023, and it anticipated a very limited number of awards (listed as 1). While the notice lists an award ceiling as 0, that typically indicates that applicants must rely on the program announcement for the specific budget guidance rather than treating the listing field as the true cap; the key point in the narrative is that Level selection should be based on scope and intent, not on how much budget is being requested.
Taken together, Breakthrough Award Level 4 is essentially a clinical-trial-driven mechanism for teams that are ready to run a large, practice-changing intervention study in breast cancer, can demonstrate regulatory and operational readiness (including recruitment realism and access to required materials), and can show that the work is aimed at a clear patient population with the potential to deliver a step-change improvement over existing or emerging approaches.Apply for HT9425 23 BCRP BTA4
- 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, Breakthrough Award Level 4" 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 Jun 28, 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 1 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.
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FAQs: DoD BCRP Breakthrough Award Level 4 (HT9425-23-BCRP-BTA4)
What is the Breakthrough Award Level 4 trying to fund?
Breakthrough Award Level 4 (BTA4) is designed to support large, high-impact breast cancer projects that have a real chance of changing the field. The focus is on work that could drive a major shift in how breast cancer is prevented and/or clinically managed, rather than producing incremental improvements.
What kind of impact is expected for a Level 4 project?
The solicitation emphasizes transformative impact. Proposed research should plausibly lead to a fundamentally new and more effective approach than what is already approved or currently being tested in clinical development. Applications are expected to clearly explain why the approach could be practice-changing.
Is a human clinical trial required for Level 4?
Yes. A human clinical trial is required for Breakthrough Award Level 4, and it is presented as a clear boundary of the mechanism.
How does this opportunity define a "clinical trial"?
Under this opportunity, a clinical trial means one or more human subjects are prospectively assigned to one or more interventions (including placebo or control, as appropriate) in order to evaluate biomedical or behavioral health-related outcomes, such as safety, effectiveness, and/or efficacy.
Are exploratory lab studies eligible under Level 4?
No. Level 4 is not intended for exploratory laboratory studies.
Are retrospective analyses or observational studies eligible under Level 4?
No. The opportunity states that Level 4 is not a mechanism for retrospective analyses or observational work that does not test an intervention by evaluating outcomes like safety, effectiveness, and/or efficacy in a prospectively assigned human intervention setting.
What types of projects are considered out of scope for Level 4?
Projects that do not actually evaluate an intervention in humans using biomedical or behavioral outcomes (for example, safety or effectiveness) are not considered clinical trials for this opportunity and would be better aligned with other BCRP announcements.
Do applicants need to identify who benefits from the proposed intervention?
Yes. Applicants are expected to be explicit about who benefits by clearly identifying the breast cancer patient populations or at-risk groups the intervention is ultimately intended to help.
How advanced is Level 4 compared to other Breakthrough Award levels?
Level 4 is described as the most advanced and clinically grounded of the Breakthrough Award levels, with the requirement to conduct a human clinical trial.
What leadership experience is expected from the Principal Investigator (PI)?
PIs are expected to have a track record of successfully leading large, complex efforts. They must also show they can realistically implement a clinical project, either through their own experience or through a committed collaborating clinical investigator.
Does the application need to demonstrate operational readiness to run a trial at scale?
Yes. Applications are expected to demonstrate the team has access to what is needed to execute the trial at scale, such as necessary datasets, human samples, patient cohorts, and critical reagents.
How important is feasibility and readiness in the review standard?
Feasibility and readiness are central. The review standard described is not only whether the science is exciting, but whether the project is truly ready to run as proposed.
What does the opportunity expect regarding regulatory readiness?
When FDA (or an equivalent international regulatory agency) involvement is relevant, the application is expected (at submission) to show concrete proof that key clinical reagents or products (for example, therapeutics or devices) are available and meet regulatory compliance guidelines, that appropriate subject populations are accessible, and that patient recruitment projections are validated and credible.
Is an IND or IDE submission expected?
If applicable, the program expects that an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application has been submitted to the FDA. This signals the intent to support trials positioned to move forward without major avoidable delays.
What is the Partnering PI Option?
The solicitation encourages a two-PI structure through a Partnering PI Option to support genuine, balanced scientific partnerships. One PI serves as the Initiating PI and typically handles most administrative submission duties, while the Partnering PI is expected to share equal intellectual ownership of the project design and make distinct, essential contributions to the research strategy and statement of work.
How balanced should the two-PI partnership be?
The program expects comparable and appropriate levels of effort from both PIs and generally expects funding to be balanced between them unless there is a strong justification for an imbalance.
What types of two-PI arrangements are discouraged?
The solicitation discourages arrangements where one PI merely supplies samples or an investigational agent while the other PI conducts nearly all the research and analyses, because that may not meet the intent of a meaningful partnership.
If funded under the Partnering PI Option, how are awards issued?
If funded, each PI is named on an individual award within the recipient organization, reflecting the program intent to support two leaders driving one integrated project.
Is there an oral presentation as part of the review process?
Yes. A notable feature of Level 4 is an invited oral presentation as part of the application review process. This suggests a selective process where finalists should be prepared to defend feasibility, readiness, and potential impact beyond the written application.
Are breast cancer consumer advocates required?
Yes. Every application must include at least two breast cancer consumer advocates.
How are consumer advocates expected to participate?
Consumer advocates must be integrated throughout planning and execution, not simply consulted occasionally. Their expected roles include helping shape the research question, advising on study design, helping with oversight, informing recruitment strategies, and participating in evaluation and other key project components.
Who qualifies as a consumer advocate for this opportunity?
Consumer advocates must be breast cancer survivors (diagnosed with breast cancer), active in a breast cancer advocacy organization, and sufficiently familiar with breast cancer issues and research to engage substantively with the team.
Can consumer advocates be employees of the participating organizations?
No. The solicitation states that advocates must be independent in their role and cannot be employees of the participating organizations.
Which agency manages this funding opportunity?
This is a discretionary Department of Defense opportunity managed through the U.S. Army Medical Research Acquisition Activity (USAMRAA).
What funding instruments are used for awards?
The instrument type includes grants and cooperative agreements.
What is the CFDA number associated with this opportunity?
The opportunity is listed under CFDA 12.420 (science and technology research and development).
Who is eligible to apply?
Eligibility is described as unrestricted (open to any entity type), subject to any additional eligibility clarifications in the full announcement.
When was the opportunity posted and when was it originally due?
The opportunity was originally posted on February 6, 2023, with an original closing date of June 28, 2023.
How many awards were anticipated?
The notice anticipated a very limited number of awards (listed as 1).
Why does the notice show an award ceiling of 0?
The notice lists an award ceiling as 0, which is described as typically indicating that applicants should rely on the program announcement for specific budget guidance rather than treating the listing field as a true cap.
Should Level 4 be chosen based on budget size?
No. The narrative emphasizes that Level selection should be based on scope and intent, not on how much budget is being requested.
What is the overall theme of a competitive Level 4 application?
Based on the solicitation description, a competitive Level 4 application is clinical-trial-driven and shows readiness to run a large, practice-changing intervention study in breast cancer, including operational access (cohorts/materials) and regulatory readiness (when applicable), with a clearly defined patient or at-risk population and a strong case for step-change improvement over existing or emerging approaches.
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