DoD Breast Cancer, Breakthrough Award Level 4 | W81XWH 21 BCRP BTA4 2

Frequently Asked Questions (FAQs)

What is the DoD BCRP Breakthrough Award Level 4 (BTA4)?

The Breast Cancer Research Program (BCRP) Breakthrough Award Level 4 is a Department of Defense funding mechanism intended to support ambitious breast cancer research that has a realistic chance to deliver a true breakthrough rather than an incremental advance. The core expectation is strong, practice-changing impact on how breast cancer is prevented and/or clinically managed.

What is the Funding Opportunity Number (FON) for this opportunity?

The Funding Opportunity Number listed is W81XWH-21-BCRP-BTA4-2.

What is the central goal or expectation of Level 4 projects?

Level 4 projects are expected to plausibly transform or revolutionize clinical management and/or prevention of breast cancer. The approach should be fundamentally better than what is already approved or what is currently progressing through clinical development.

Is a human clinical trial required for Level 4?

Yes. Level 4 requires that the project include a human clinical trial as a mandatory component.

Is Level 4 simply a larger-budget version of Levels 1 to 3?

No. Level 4 is a distinct category focused on large, practice-changing clinical efforts. It is not described as simply a bigger project. Investigators are expected to select the correct level based on the project scope and intent, not on budget size.

What happens if a proposal does not match Level 4 intent?

Proposals that do not meet Level 4 intent will not be recommended for funding even if they might have fit Breakthrough Award Levels 1 through 3. Those other levels are offered under separate announcements.

How should applicants tie their research to patient needs?

Applicants are expected to explicitly identify which breast cancer patient groups, or which at-risk populations, would ultimately benefit if the project succeeds. The research is expected to stay anchored to real-world clinical need and potential patient impact.

What does the program expect regarding the Principal Investigator (PI) and trial leadership capacity?

The PI is expected to demonstrate the capacity to run a complex clinical project. This can be shown through direct experience leading large initiatives or through a firm, credible partnership with a clinical investigator who can ensure successful clinical trial implementation.

What kind of readiness and feasibility information is expected in the application?

Applications are expected to demonstrate practical readiness and feasibility, including access to necessary datasets, human samples, cohorts, and other critical reagents needed to execute the clinical effort.

What is expected when FDA involvement is relevant (e.g., IND/IDE)?

When FDA involvement is relevant, the application must demonstrate clinical-trial readiness at the time of submission. This includes access to regulatory-compliant clinical reagents (such as therapeutics manufactured or handled under appropriate standards), access to an appropriate participant population, realistic and validated recruitment projections, and submission of an IND or IDE to the FDA when applicable.

Is this mechanism intended for planning studies or for teams ready to execute?

This mechanism is positioned for teams that are ready to execute a large, transformative clinical project, not teams proposing work that is primarily at the planning stage.

What are the recruitment planning requirements?

Applicants must provide quarterly enrollment targets across all sites in the Statement of Work (Attachment 4). After selection, awardees will work with USAMRAA to finalize recruitment milestones.

Is continued funding tied to recruitment performance?

Yes. Continued funding support is tied to satisfactory progress toward human subjects recruitment milestones, making enrollment performance a formal condition for staying on track during the project period.

Are there any additional review steps unique to Level 4?

Yes. Level 4 applications have an additional review requirement: an invited oral presentation is required as part of the application review process.

Is there an option to apply with two Principal Investigators?

Yes. The opportunity includes an optional Partnering PI model intended to support two PIs working together in a genuinely integrated way.

What is the difference between the Initiating PI and the Partnering PI?

Under the Partnering PI model, one PI serves as the Initiating PI and handles most submission-related administration, while the other serves as the Partnering PI. Both are expected to contribute substantially to the intellectual development of the project, including the project narrative and the statement of work.

How balanced does the Partnering PI collaboration need to be?

The intent is balanced, co-led science where each PI brings distinct, essential expertise and commits an appropriate and roughly comparable level of effort. Funding is generally expected to be balanced unless a clear justification is provided.

What types of collaborations are considered non-responsive under the Partnering PI model?

Superficial collaborations do not qualify. For example, arrangements where one PI mainly supplies materials while the other carries out nearly all experiments and analyses are not considered responsive to the intent of an integrated, co-led project.

Are new Partnering PI partnerships required?

No. New PI partnerships are encouraged but not mandatory.

Can the same person be listed as a Partnering PI on multiple Level 4 applications?

Applicants are discouraged from listing the same individual as a Partnering PI on multiple Level 4 applications unless the projects clearly address different research questions.

If funded, how are awards handled under the Partnering PI model?

If funded, each PI is named on an individual award within the recipient organization, reinforcing shared leadership and responsibility.

What kind of team expertise is expected for a Level 4 project?

Applications are expected to include the breadth of breast cancer-relevant expertise needed to carry out a large clinical trial and its associated scientific and operational work. Depending on the design, this may include clinical operations, biostatistics, regulatory affairs, data management, and recruitment/retention infrastructure.

Are breast cancer consumer advocates required?

Yes. Each application must include at least two breast cancer consumer advocates who are integrated into the project from planning through execution.

What does "integrated" consumer advocate involvement mean in this program?

Consumer advocate involvement is expected to be continuous and substantive. Examples described include shaping the research question, reviewing study design, providing oversight, informing recruitment approaches, and helping evaluate project relevance and impact. Limited involvement (such as occasional meeting attendance) is not aligned with the stated expectation.

Who qualifies as a consumer advocate for this opportunity?

Consumer advocates must be individuals diagnosed with breast cancer who are active in advocacy organizations. They must be independent lay representatives and not employees of any participating organization included in the application.

Why does the program require consumer advocate participation?

The requirement is meant to bring an objective perspective grounded in lived experience, ensuring the proposed work remains relevant to patient priorities and real-world clinical adoption, in addition to being scientifically compelling.

Which agency is offering this funding opportunity?

The opportunity is offered by the Department of Defense, Department of the Army, through USAMRAA (U.S. Army Medical Research Acquisition Activity).

What CFDA number is associated with this opportunity?

The listing references CFDA 12.420.

What types of funding instruments are mentioned?

The opportunity lists grants and cooperative agreements as the funding instruments.

What does the listing say about eligibility?

Eligibility is described as unrestricted, with any specific clarifications indicated as being contained in the full announcement.

How many awards were expected under this listing?

The listing indicates an expected single award.

What were the posted dates for this specific solicitation record?

The record includes a creation date of April 26, 2021 and an original closing date of October 5, 2021. These dates apply to that particular solicitation record, even if similar opportunities may reappear in future cycles under updated announcements.