• 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 fundamentally new approach that is significantly more effective than interventions already approved or in clinical development.
• Partnering Principal Investigator (PI) Option allows two PIs, termed Initiating and Partnering PIs, to partner 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: Studies that investigate why certain human patient populations differ in cancer risk or clinical prognosis. The studies should focus on the analysis of human data and biospecimens and, with compelling justification, may request higher levels of funding and an additional year in the period of performance.
• 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 the availability of and access to clinical reagents 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 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 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 partnerships addressing distinct research questions.
• 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.
• 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 $15M 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 $3.5M for direct costs (plus indirect costs)
• Maximum period of performance is 4 years

• Supports research that extends or expands the data collection, follow-up, and analysis of breast cancer clinical research studies.
• The intent of this mechanism is to increase the clinically relevant impact of breast cancer patient participation in clinical research by addressing the knowledge lost due to early termination, limited patient follow-up, or suboptimal sample and/or data collection and analysis.
• Although not all-inclusive, research proposed under this mechanism may entail a deeper molecular analysis of clinical samples, initiation of new correlative studies, biomarker validation, or continuing clinical follow-up of patients enrolled in an open/ongoing or completed clinical trial. The proposed research may be hypothesis-testing or -generating or may be designed to generate clinically annotated and molecularly characterized experimental platforms, including patient-derived models or tissue arrays. Projects proposing to conduct clinical trials will not be supported.
• PIs are required to include two or more breast cancer advocates on their research team.
• The Partnering PI Option allows two PIs, termed Initiating and Partnering PIs, to partner on a single application.
• Submission of a Letter of Intent is required prior to full application submission.

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

      Partnering PI Option:

• Maximum funding of $6M for direct costs (plus indirect costs)
• Maximum period of performance is 4 years

• Supports collaborations and ideas that will transform or improve the lives of individuals with, and/or at risk for, breast cancer and will significantly accelerate progress toward ending breast cancer.
• Requires synergistic, highly integrated, multidisciplinary, and multi-institutional research team of leading scientists, clinicians, and consumer advocates who will be assembled into a consortium to address a major problem in a way that could not be accomplished by a single investigator or group.
• The consortium should have at least four, but no more than five, project teams, each investigating different projects under a central hypothesis. No more than two project teams may be based at one institution. Each team’s work must be integrated within the consortium so that every component is working toward the consortium’s central hypothesis.
• The consortium must include at least one breast cancer consumer advocate per project team.
• May include clinical trials up to and including phase 1 or equivalent; however, clinical trials are not required, and the primary thrust of the application should not be a clinical trial.
• Submission of a preproposal is required; application submission is by invitation only.

• Maximum funding of $25M for direct costs (plus indirect costs)
• Maximum period of performance is 4 years

• Provides the time and resources needed to bring investigators and breast cancer advocates together to establish a consortium framework and conduct preliminary research to support application to a future, full Transformative Breast Cancer Consortium Award (pending availability of funds).
• Supports the following: (1) development of the infrastructure of a multi-institutional research team inclusive of scientists, clinicians, and breast cancer advocates (e.g., building appropriate collaborations, outlining integration, research management, administrative management, and communication plans, and devising an intellectual property plan), (2) generation of necessary preliminary data to serve as proof of concept or for project integration, (3) acquisition of research resources, and (4) development of a framework of necessary statistical analyses.
• PIs are required to include breast cancer advocate(s) on the research team.
• Submission of a Letter of Intent is required prior to full application submission.

• Maximum funding of $100,000 for direct costs (plus indirect costs)
• Maximum period of performance is 1 year