DoD Breast Cancer, Breakthrough Award Level 4 | W81XWH 22 BCRP BTA4

FAQs: DoD BCRP Breakthrough Award Level 4 (W81XWH-22-BCRP-BTA4)

1) What is this funding opportunity?

This is the Department of Defense (DoD) Breast Cancer Research Program (BCRP) Breakthrough Award Level 4 funding opportunity (Funding Opportunity Number W81XWH-22-BCRP-BTA4). It is designed to support breast cancer research efforts that are positioned to produce a major, practice-changing impact rather than incremental progress.

2) What is the main purpose of the Breakthrough Award Level 4 mechanism?

The purpose is to fund large-scale efforts intended to transform and potentially revolutionize clinical management and/or prevention of breast cancer. The emphasis is on clear potential to accelerate progress toward ending breast cancer by enabling a fundamentally better approach than what is already approved or currently in clinical development.

3) Is a human clinical trial required under Level 4?

Yes. A human clinical trial is required, and the award funds must support that clinical trial. This requirement is described as non-negotiable for Level 4.

4) What happens if a proposed project does not truly fit Level 4?

Applications that do not match the Level 4 intent will not be recommended for funding, even if the project might have been a better fit for Levels 1 through 3. Levels 1 to 3 are offered under separate announcements.

5) How is Level 4 positioned within the overall Breakthrough Award structure?

The Breakthrough Award structure is organized into four funding levels, each aligned to a different stage on the path to clinical application. Level 4 is the most advanced level and is reserved for large-scale, potentially practice-changing clinical efforts.

6) What kind of impact is the program looking for?

The program is focused on impact: projects should be genuinely poised to change the game by enabling a fundamentally better approach than existing approved options or approaches already in clinical development.

7) Do applicants need to identify who will benefit from the research?

Yes. Applicants are expected to clearly specify the intended beneficiaries by identifying the breast cancer patient populations or at-risk groups that would ultimately benefit if the research is successful.

8) What expectations are there for the Principal Investigator (PI) for Level 4?

The sponsor expects substantial readiness and execution capability. The PI is expected to demonstrate the ability to lead a large-scale project successfully, either through their own track record or through a committed collaborating clinical investigator with the appropriate experience.

9) What does the program expect regarding access to infrastructure and materials?

If the project depends on specific infrastructure or materials, the application needs to demonstrate access to essentials such as data, human samples, cohorts, and critical reagents.

10) What if the project involves U.S. Food and Drug Administration (FDA) involvement?

If the work triggers FDA involvement, the opportunity describes explicit readiness expectations at the time of application submission, including availability and regulatory compliance of clinical reagents (such as therapeutics), access to an appropriate subject population, credible and validated recruitment projections, and submission of an IND or IDE when applicable.

11) Are investigators expected to have clinical reagents available at the time of application?

Yes, when FDA involvement applies. The application is expected to show that clinical reagents (for example, therapeutics) are available and meet regulatory compliance requirements at the time of submission.

12) What does the opportunity say about patient recruitment planning?

Recruitment planning must be credible and validated. The application should demonstrate that the subject population is accessible and that patient recruitment projections are realistic and supported.

13) Is IND or IDE submission required as part of readiness when applicable?

Yes. When applicable, the opportunity expects that an IND (Investigational New Drug) or IDE (Investigational Device Exemption) application has been submitted to the FDA by the time of application submission.

14) Is there an option for two PIs to co-lead the project?

Yes. The opportunity includes an optional Partnering PI approach intended for genuine, balanced co-leadership.

15) How does the Partnering PI structure work?

Two PIs may apply together: an Initiating PI who handles most submission administration and a Partnering PI who shares major intellectual responsibility. Both are expected to contribute meaningfully to the project narrative and statement of work, bring distinct and necessary expertise, and commit comparable and appropriate effort.

16) Are budgets expected to be balanced across the Initiating PI and Partnering PI?

Budgets are generally expected to be balanced across the two PIs unless there is a strong justification for an imbalance.

17) What types of PI partnerships does the program discourage?

The program discourages arrangements where one PI mainly provides samples, models, or an investigational agent while the other does nearly all the research work. The intent is that the partnership adds real value through integrated expertise that is better than two separate efforts.

18) If funded, how are awards handled for the Initiating PI and Partnering PI?

If funded, each PI is typically named on an individual award within their organization, reinforcing that this is true co-leadership rather than a subcontract-style relationship.

19) What are the expectations for the overall research team?

The opportunity expects a robust, well-rounded research team with the appropriate breast cancer-related expertise to execute a demanding clinical trial.

20) Are consumer advocates required on the project?

Yes. Embedded consumer advocate participation is a distinctive and required feature. Every application must include at least two breast cancer consumer advocates who are integrated into the project throughout planning and implementation.

21) Who qualifies as a breast cancer consumer advocate for this opportunity?

Consumer advocates must be individuals diagnosed with breast cancer who are active in advocacy organizations.

22) Can consumer advocates be employees of a participating organization?

No. Their role must be independent of employment relationships, meaning they cannot be employees of any participating organization.

23) What does it mean for consumer advocates to be "embedded" in the project?

It means they are not passive or occasional advisors. They should be actively involved throughout planning and implementation, including shaping the research question, refining study design, providing oversight input, supporting recruitment considerations, contributing to evaluation, and participating in other key project activities.

24) Why does the program require consumer advocates?

The stated intention is to keep the clinical trial grounded in patient realities and priorities, with advocates providing objective feedback on the project and its potential real-world impact for people living with breast cancer or at risk of developing it.

25) What agency administers this opportunity?

This is a discretionary DoD opportunity managed through the Department of Defense, Department of the Army, U.S. Army Medical Research Acquisition Activity (USAMRAA).

26) What assistance instruments are associated with this opportunity?

The assistance instruments listed include grants and cooperative agreements.

27) What is the CFDA number listed for this opportunity?

The CFDA number listed is 12.420.

28) Who is eligible to apply based on the provided information?

Eligibility is described as unrestricted, meaning it is open to any entity type, subject to any additional eligibility clarifications in the full announcement.

29) What are the posting and closing dates shown in the source information?

The source information shows a creation date of March 16, 2022, and an original closing date of July 27, 2022.

30) How many awards are expected?

The provided record lists an expected number of awards as 1.

31) Is there an award ceiling listed, and what does it mean?

The provided record shows an award ceiling of 0. In this context, that typically signals that applicants should rely on the program announcement for the actual funding limits and structure rather than treating that field as a practical cap.

32) What is the key theme applicants should demonstrate across the application?

The theme is readiness and credibility for executing a high-stakes breast cancer clinical trial: strong leadership capability, real access to needed resources, realistic recruitment plans, regulatory preparedness when applicable, meaningful co-leadership if using a Partnering PI, and deep integration of at least two independent breast cancer consumer advocates.