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 Level 3. Funding Levels 1, 2, and 4 are available under other program announcements (HT9425-23-BCRP-BTA12-2 for Levels 1 and 2 and HT9425-23-BCRP-BTA4-2 for Level 4). 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 the funding level selected will not be recommended for funding, even if it might meet the intent of a different funding level.
Funding Level 3: Advanced translational studies with a high degree of project readiness. Where relevant, proof of availability of and access to necessary data, human samples, cohort(s) and/or critical reagents must be provided. If the proposed research would ultimately require U.S. Food and Drug Administration (FDA) involvement, applications must demonstrate availability of, and access to, clinical reagents (e.g., therapeutic molecules) and patient population(s). Applications must state a realistic timeline for near-term clinical investigation. Small-scale clinical trials (e.g., first in human, phase 1/1b) may be appropriate.
Deadlines:
• Pre-Application Deadline: June 29, 2023
• Invitation to Submit an Application: Aug. 2023
• Application Submission Deadline: Sep. 26, 2023
Considering the current breast cancer landscape and the BCRP’s mission, all FY23 BCRP Breakthrough Award Level 3 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 the mortality associated with metastatic breast cancer
Independent investigators at all academic levels (or equivalent) are eligible to be named as a PI, Initiating PI, or Partnering PI on an application.
There are no limits on the number of pre-applications for which an investigator may be named as a PI, Initiating PI, or Partnering PI for this Breakthrough Award Level 3 program announcement.
Investigators who were invited to be named on an application submitted under funding opportunity HT9425-23-BCRP-BTA3 are not eligible to submit a pre-application for the same research project under the current funding opportunity.
Investigators are discouraged from being named on multiple pre-applications unless they are clearly addressing distinct research questions. Invited 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, or collaborator under this Breakthrough Award Level 3 program announcement.
The anticipated direct costs budgeted for the entire period of performance for an FY23 BCRP Breakthrough Award Funding Level 3 should not exceed $4M for applications with a single PI or $5M if applying under the Partnering PI Option. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.
