The intent of the Breakthrough Award is to support promising research that has high potential to lead to or make breakthroughs in breast cancer.

The critical components of this award mechanism are:Impact:
Research supported by the Breakthrough Award will have the potential for a major impact

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and accelerate progress toward ending breast cancer.

The impact may be near-term or long-term, but must move beyond a minor advancement and have the potential to lead to a new approach that is fundamentally better than interventions already approved or in clinical development.

Applications are expected to identify the breast cancer patients or at-risk individuals who would ultimately benefit from the proposed research.Research Scope:
The Breakthrough Award is structured with four different funding levels.

The levels are designed to support major (but not all) stages of research that will lead to clinical application.

Each level has a defined research scope.

It is the responsibility of the Principal Investigator (PI) to select the level that aligns with the scope of the proposed research.

The funding level should be selected based on the research scope defined in the Program Announcement, and not on the amount of the budget.The current Program Announcement discusses the Breakthrough Award Level 4.

Funding Levels 1, 2, and 3 are available under other Program Announcements (W81XWH-20-BCRP- BTA12-2 for Levels 1 and 2 and W81XWH-20-BCRP-BTA3-2 for Level 3).

The PI is strongly encouraged to review the research scope defined under each funding level as described in the corresponding Breakthrough Award Program Announcements before submitting the pre- application.

An application that does not meet the intent of Funding Level 4 will not be recommended for funding, even if it might meet the intent of a different funding level.The following is a general description, although not all-inclusive, of the scope of research projects that would be appropriate to propose under the current Program Announcement:Funding Level 4:
Large-scale projects that will transform and revolutionize the clinical management and/or prevention of breast cancer.

Human clinical trials are required.

PIs are expected to have experience in successfully leading large-scale projects and demonstrated ability (through personal experience or via a commitment from a collaborating clinical investigator) to implement a clinical project successfully.

Where relevant, applications must demonstrate availability of and access to necessary data, human samples, cohort(s), and/or critical reagents.

For proposed research that will require U.

S.

Food and Drug Administration (FDA) involvement, project readiness requirements at the time of application submission include:
proof of availability of and access to clinical reagents (e.g., therapeutics) that meet regulatory compliance guidelines, proof of availability of and access to appropriate subject population(s), validated projections for patient recruitment, and submission of an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application to the FDA, if applicable.