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Congressionally Directed Medical Research Programs -- Breast Cancer Research Program -- Breakthrough Award -- Levels 1 and 2
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 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. An application that does not meet the intent of the funding level selected will not be recommended for funding, even if it might meet the intent of a different funding level.
The current program announcement discusses the Breakthrough Award Levels 1 and 2. Funding Levels 3 and 4 are available under other program announcements (W81XWH-21-BCRP-BTA3-2 and W81XWH-21-BCRP-BTA4-2, respectively). The PI is strongly encouraged to review the research scope defined under each funding level as described in the corresponding Breakthrough Award program announcement before submitting the pre-application. An application that does not meet the intent of the funding level selected will not be recommended for funding, even if it might meet the intent of a different funding level.
The following are general descriptions, although not all-inclusive, of the scope of research projects that would be appropriate to propose under the current Program Announcement:
• Funding Level 1: Innovative, high-risk/high-reward research that is in the earliest stages of idea development or is an untested theory that addresses an important problem. To foster research that yields new avenues of investigation, preliminary data are not required. Proof of concept is the anticipated outcome.
• Funding Level 2: Research that is already supported by substantial preliminary or published data and strongly validates clinical translation in a well-defined context within the breast cancer landscape.
• Funding Level 2: Population Science and Prevention Studies: Research that is already supported by substantial preliminary or published data and strongly validates clinical translation in a well-defined context within the breast cancer landscape. With compelling justification, population science and prevention studies may request higher levels of funding and an additional year in the period of performance. Such studies may require additional resources due to the participation of human subjects and/or use of human biospecimens.
• Required Pre-Application Deadline: Aug. 31, 2021
• Application Submission Deadline: Sep. 14, 2021
Areas of Interest
Considering the current breast cancer landscape and the BCRP’s mission, all FY21 BCRP Breakthrough Award Levels 1 and 2 applications must address at least one of the following overarching challenges unless adequate justification for exception is provided.* Simply identifying an overarching challenge is not sufficient. Applications must address the challenge in a way that can lead to or make a breakthrough and have a major impact. • Prevent breast cancer (primary prevention) • Identify determinants of breast cancer initiation, risk, or susceptibility • Distinguish deadly from non-deadly breast cancers • Conquer the problems of overdiagnosis and overtreatment • Identify what drives breast cancer growth; determine how to stop it • Identify why some breast cancers become metastatic • Determine why/how breast cancer cells lie dormant for years and then re-emerge; determine how to prevent lethal recurrence • Revolutionize treatment regimens by replacing them with ones that are more effective, less toxic, and impact survival • Eliminate mortality associated with metastatic breast cancer
Investigators at all academic levels (or equivalent) are eligible to be named as a PI, Initiating PI, or Partnering PI on an application. Applications are encouraged for postdoctoral fellows. A Mentorship Statement (see Attachment 9) is required for applications submitted with a PI who is a postdoctoral fellow.
Each investigator may be named as a PI or Initiating PI on only one application per funding level for this Breakthrough Award Levels 1 and 2 Program Announcement.
There are no limitations on the number of applications for which an investigator may be named as a Partnering PI. To meet the intent of the Partnering PI Option, investigators are discouraged from being named as a Partnering PI on multiple FY21 BCRP Breakthrough Award Levels 1 and 2 applications unless they are clearly unique, meaningful partnerships addressing distinct research questions. Applications will be required to include a brief description of all the applications in which the PI is named as a PI, Initiating PI, Partnering PI, collaborator, or mentor under this Breakthrough Award Levels 1 and 2 Program Announcement.
The anticipated direct costs budgeted for the entire period of performance for an FY21 BCRP Breakthrough Award Funding Level 1 will not exceed $450,000 for applications with a single PI or $750,000 if applying under the Partnering PI Option.
The anticipated direct costs budgeted for the entire period of performance for an FY21 BCRP Breakthrough Award Level 2 will not exceed $1.0M for applications with a single PI or $1.5M if applying under the Partnering PI Option.
The anticipated direct costs budgeted for the entire period of performance for an FY21 BCRP Breakthrough Award Funding Level 2, Population Science and Prevention Studies will not exceed $1.5M for applications with a single PI or $2.0M if applying under the Partnering PI Option. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.