DoD Breast Cancer, Breakthrough Award Level 4 | W81XWH 22 BCRP BTA4 2

FAQs: DoD Breast Cancer Research Program (BCRP) Breakthrough Award Level 4 (W81XWH-22-BCRP-BTA4-2)

What is the Breakthrough Award Level 4 designed to fund?

Level 4 is designed to support ambitious, high-stakes breast cancer research that can realistically change the field rather than incrementally improve it. The core expectation is impact: the proposed work should have a strong chance of accelerating progress toward ending breast cancer by enabling a new approach that is fundamentally better than what is already approved or currently in clinical development.

What type of outcomes does the program expect from a Level 4 project?

The program expects outcomes that can translate into real changes in breast cancer prevention and/or clinical management. Applicants are expected to describe how results could lead to clinically meaningful impact and not just advance knowledge in small steps.

Is a human clinical trial required for Level 4?

Yes. Human clinical trials are a non-negotiable component of Breakthrough Award Level 4. This level is not intended for preclinical-only packages; it is intended for trials that are ready to be executed and positioned to generate clinically meaningful evidence.

Can a preclinical-only proposal be competitive under Level 4?

Based on the opportunity description, Level 4 is specifically seeking projects that include human clinical trials. A preclinical-only proposal would not meet the stated requirement that clinical trials be included.

How is Level 4 different from other Breakthrough Award levels?

Level 4 is described as the most advanced of four Breakthrough Award levels, each targeting different stages on the path to clinical application. Level 4 targets large-scale projects intended to transform and potentially revolutionize breast cancer prevention and/or clinical management, with required human clinical trials.

Should applicants choose Level 4 based on the budget they want?

No. Applicants are instructed to choose the funding level that fits the defined scope rather than trying to match a preferred budget number to a level. Level 4 should be selected because the project fits Level 4 expectations, including large-scale, transformative goals and required clinical trials.

Who is expected to benefit from the research?

Applicants are expected to be explicit about who will benefit by identifying the patient populations or at-risk individuals who are the intended end users of the eventual clinical application.

What must applicants include about translation to practice?

Applicants should explain how the results could translate into real changes in prevention and/or clinical management. The opportunity emphasizes impact and practical relevance to patients and those at risk.

What does the program mean by "operational readiness"?

The program emphasizes that reviewers will assess not only scientific promise, but whether the team is positioned to carry out the clinical trial at the necessary scale without unrealistic assumptions. Applications are expected to show practical access to what is needed to run the project, such as relevant datasets, human samples, cohorts, and critical reagents.

What leadership experience is expected of the Principal Investigator (PI)?

Because Level 4 is intended for complex, high-visibility clinical work, PIs are expected to have experience leading large-scale efforts and to demonstrate the ability to successfully implement a clinical project. This can be shown through the PI's own track record or through a committed collaborating clinical investigator.

What resources should the application demonstrate access to?

Applications should show practical access to relevant datasets, human samples, cohorts, and any critical reagents needed to execute the trial at the required scale.

What additional readiness requirements apply if the project involves the FDA?

If the project will involve the U.S. Food and Drug Administration, the opportunity calls for proof at the time of submission that the team has access to clinical-grade reagents that meet regulatory compliance expectations, proof that appropriate subject populations are available, and validated projections that patient recruitment is feasible.

Is an IND or IDE expected to be submitted before applying?

When applicable, the program expects that an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application has already been submitted to the FDA.

What does "clinical-grade reagents" mean in this context?

The opportunity describes clinical-grade reagents as items such as therapeutics that meet regulatory compliance expectations, especially in projects involving FDA oversight.

What does the program require regarding recruitment feasibility?

For projects involving the FDA, the announcement calls for validated projections that patient recruitment is feasible, along with proof that appropriate subject populations are available.

What is the optional Partnering PI structure?

The opportunity allows an optional Partnering PI structure intended to support genuinely co-led collaborations. Two PIs may apply together: one serves as the Initiating PI and handles most administrative submission tasks, while the Partnering PI shares equal intellectual ownership of the science.

How should responsibilities be shared between the Initiating PI and Partnering PI?

The application needs to make a clear case that both PIs have distinct, essential contributions, comparable engagement, and appropriate effort. The collaboration should make the work stronger because it is being done together rather than split into separate projects.

How is funding expected to be split in a Partnering PI application?

Funding is generally expected to be balanced between the two awards unless there is a strong justification for a different distribution.

What types of Partnering PI arrangements are discouraged?

The program discourages superficial pairings, such as one PI merely supplying samples or an investigational agent while the other conducts nearly all the research.

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

The program discourages the same person serving as Partnering PI on multiple Level 4 applications unless the projects clearly address different research questions.

If funded, how are awards issued under the Partnering PI structure?

If funded, each PI is named on an individual award within the recipient organization.

Are breast cancer consumer advocates required on the research team?

Yes. The opportunity requires the involvement of breast cancer consumer advocates, with at least two advocates integrated into the research team.

What roles are consumer advocates expected to play?

Advocates are expected to be involved throughout planning and implementation. This includes shaping the research question, contributing to project design, providing oversight, supporting recruitment and evaluation strategies, and participating in other major project activities. These roles are not intended to be symbolic.

Who qualifies as a consumer advocate for this opportunity?

Advocates must be individuals diagnosed with breast cancer who are active in advocacy organizations. They are expected to have sufficient knowledge of current breast cancer issues and enough background or training to participate meaningfully in research discussions.

Can consumer advocates be employees of participating organizations?

No. The opportunity states that advocates cannot be employees of any participating organization.

What is the administering organization for this grant opportunity?

This is a discretionary Department of Defense grant/cooperative agreement opportunity administered by the Department of Defense, Department of the Army, U.S. Army Medical Research Acquisition Activity (USAMRAA).

What is the CFDA number associated with this opportunity?

The opportunity is listed under CFDA 12.420.

What is the Funding Opportunity Number (FON)?

The Funding Opportunity Number is W81XWH-22-BCRP-BTA4-2.

Who is eligible to apply?

Eligibility is listed as unrestricted, meaning it is open broadly to entity types, subject to any additional constraints described in the full announcement.

How many awards does the posting expect to make?

The posting indicates an expected number of awards of one.

Is there an award ceiling listed in the provided summary?

An award ceiling is not specified in the provided summary (it is listed as 0). The program also emphasizes selecting Level 4 based on scope fit rather than targeting a budget.

When was this opportunity created and when did it close?

The opportunity was created on June 9, 2022, with an original closing date of November 2, 2022.