• Supports promising research that has high potential to lead to or make breakthroughs in breast cancer.
• Potential impact of the research may be near-term or long-term, but it 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.
• Partnering PI Option allows two Principal Investigators (PIs), termed Initiating and Partnering PIs, to collaborate on a single application.
• Different funding levels, based on the scope of research, are available. It is the responsibility of the PI to select the funding level that is most appropriate for the research proposed. The funding level should be selected based on the scope of the research project, rather than the amount of the budget.

The following are general descriptions, although not all-inclusive, of the scope of research projects that would be appropriate to propose under each funding level:

• Funding Level 1: Innovative, high-risk/high-reward research that is in the earliest stages of idea development or 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: 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.
• 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 subject 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.
• 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 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 or Investigational Device Exemption application to the FDA, if applicable.

Funding Levels 1 and 2

• Each investigator may be named as a PI or Initiating PI on only one application per funding level. There are no limitations on the number of applications for which an investigator may be named as a Partnering PI. However, investigators are discouraged from being named as a Partnering PI on multiple applications unless they are clearly unique, meaningful collaborations addressing distinct research questions.
• Additional funds are available for applications submitted under the Partnering PI Option.
• Clinical trials are not allowed.
• Submission of a Letter of Intent is required prior to full application submission.

Funding Levels 3 and 4

• 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
• Investigators are discouraged from being named on multiple pre-applications unless they are clearly addressing distinct research questions.
• Additional funds are available for Funding Level 3 applications submitted under the Partnering PI Option.
• PIs must include two or more breast cancer advocates on their research team.
• Clinical trials are allowed (Funding Level 3) or required (Funding Level 4).
• Submission of a preproposal is required; application submission is by invitation only.

• Maximum funding of $450,000 for direct costs (plus indirect costs).
• Maximum period of performance is 3 years.

Funding Level 1 – Partnering PI Option

• Maximum funding of $750,000 for direct costs (plus indirect costs).
• Maximum period of performance is 3 years.

Funding Level 2

• Maximum funding of $1 million (M) for direct costs (plus indirect costs).
• Maximum period of performance is 3 years.

Funding Level 2 – Partnering PI Option

• Maximum funding of $1.5M for direct costs (plus indirect costs).
• Maximum period of performance is 3 years.

Funding Level 2 – Population Science and Prevention Studies

• Maximum funding of $1.5M for direct costs (plus indirect costs).
• Maximum period of performance is 4 years.

Funding Level 2 – Population Science and Prevention Studies – Partnering PI Option

• Maximum funding of $2M for direct costs (plus indirect costs).
• Maximum period of performance is 4 years.

Funding Level 3

• Maximum funding of $4M in direct costs (plus indirect costs).
• Maximum period of performance is 4 years.

Funding Level 3 – Partnering PI Option

• Maximum funding of $5M for direct costs (plus indirect costs).
• Maximum period of performance is 4 years.

Funding Level 4 and Funding Level 4 – Partnering PI Option

• Maximum funding of $10M for direct costs (plus indirect costs).
• Maximum period of performance is 4 years.

• Supports exceptionally talented, early-career scientists who have demonstrated that they are the “best and brightest” in their fields through extraordinary creativity, vision, innovation, and productivity.
• PIs should articulate a vision that challenges current dogma and demonstrates an ability to look beyond tradition and convention.
• PIs must demonstrate experience in forming effective partnerships and collaborations and exhibit strong potential for future leadership in breast cancer research.
• PIs are required to include two or more breast cancer advocates on their research team.
• Submission of a Letter of Intent is required prior to full application submission.

• Maximum funding of $3M for direct costs (plus indirect costs).
• Maximum period of performance is 4 years.

• Supports visionary individuals who have demonstrated exceptional creativity, innovative work, and paradigm-shifting leadership in any field.
• Provides opportunity to pursue novel, visionary, high-risk ideas that will accelerate progress toward ending breast cancer.
• PIs must include two or more breast cancer advocates on their research team.
• Submission of a preproposal is required; application submission is by invitation only.

• Maximum funding of $7M for direct costs (plus indirect costs).
• Maximum period of performance is 4 years.