• 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 strategy or approach for preventing or ending breast cancer that is significantly more effective than current strategies or approaches.
• Different funding levels are available, based on the scope of research.
• Partnering PI Option: Supports meaningful and productive partnerships between two investigators (termed the Initiating PI and Partnering PI) collaborating on a single application.

The following are key features and 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. Proof of concept is the anticipated outcome. Preliminary data are not required. Clinical trials are not allowed. Each investigator may be named as a PI or Initiating PI on only one Funding Level 1 application. There is no limit on the number of applications for which an investigator may be named as a Partnering PI. Submission of a Letter of Intent is required prior to full application submission.
• Funding Level 2: Research that is already supported by substantial preliminary or published data in breast cancer and strongly validates clinical translation in a well-defined context within the breast cancer landscape. Clinical trials are not allowed. Each investigator may be named as a PI or Initiating PI on only one Level 2 application. There is no limit on the number of applications for which an investigator may be named as a Partnering PI. Submission of a Letter of Intent is required prior to full application submission.
  • Funding Level 2 - Population Science and Prevention Studies: Studies that focus on the analysis of human data and 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 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 may be appropriate. Applications must include two or more consumer advocates on the research team. There is no limit on the number of pre-applications for which an investigator may be named as a PI, Initiating PI, or Partnering PI. Submission of a preproposal is required; application submission is by invitation only.
• Funding Level 4: Large-scale projects, including comparative effectiveness trials, that will transform and revolutionize the clinical management and/or prevention of breast cancer. Clinical trials are required. PIs are expected to have experience in successfully leading large-scale projects and the demonstrated ability to implement a clinical project successfully. 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 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); and validated projections for patient recruitment. Applications must include two or more consumer advocates on the research team. There is no limit on the number of pre-applications for which an investigator may be named as a PI, Initiating PI, or Partnering PI. Submission of a preproposal is required; application submission is by invitation only.
  • *New for FY25* Funding Level 4 Options:
    (1) Clinical Trial - Provides support for clinical trials with an active Investigational New Drug (IND) or Investigational Device Exemption (IDE), if needed, in place and cleared by the FDA prior to the full application submission deadline.
    (2) Clinical Trial with Planning Phase Option - Provides support for the final phase of regulatory activities necessary to initiate the planned clinical trial, including preparation and submission of an IND/IDE application to the FDA if needed. FDA/regulatory approval or exemption to proceed must be obtained, if applicable, before the clinical trial may be funded.

• Maximum period of performance is 3 years
• Maximum allowable funding:
  • Single PI: $540,000 for direct costs
  • Partnering PI Option: $900,000 for direct costs
• Indirect costs may be proposed in accordance with the institution's negotiated rate agreement.

Funding Level 2

• Maximum period of performance is 3 years
• Maximum period of performance for Funding Level 2 - Population Science and Prevention Studies Option is 4 years
• Maximum allowable funding:
  • Single PI: $1.2 million (M) for direct costs
  • Partnering PI Option: $1.8M for direct costs
  • Population Science and Prevention Studies with Single PI: $1.8M for direct costs
  • Population Science and Prevention Studies - Partnering PI Option: $2.4M for direct costs
• Indirect costs may be proposed in accordance with the institution's negotiated rate agreement.

Funding Level 3

• Maximum period of performance is 4 years
• Maximum allowable funding:
  • Single PI: $4M for direct costs
  • Partnering PI Option: $5M for direct costs
• Indirect costs may be proposed in accordance with the institution's negotiated rate agreement.

Funding Level 4

• Maximum period of performance for the Clinical Trial is 4 years
  -or-
  1 year for the Planning Phase Option (additional 4 years for the clinical trial may be funded)
• Maximum allowable funding:
  • Clinical Trial: $15M for direct costs
  • Planning Phase Option (1 year only): $500,000 for direct costs
• Indirect costs may be proposed in accordance with the institution's negotiated rate agreement.

• 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.
• PIs are required to include two or more consumer advocates on their research team.
• Submission of a Letter of Intent is required prior to full application submission.

• Maximum period of performance is 4 years
• Maximum allowable funding of $3.5M for direct costs
• Indirect costs may be proposed in accordance with the institution's negotiated rate agreement

• Supports research that extends or expands the data collection, follow-up, and analysis of breast cancer clinical research studies.
• Intended 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 consumer advocates on their research team.
• The Partnering PI Option allows two PIs, termed the Initiating PI and Partnering PI, to partner on a single application.
• Submission of a Letter of Intent is required prior to full application submission.

• Maximum period of performance is 4 years
• Maximum allowable funding:
  • Single PI: $5M for direct costs
  • Partnering PI Option: $6M for direct costs
• Indirect costs may be proposed in accordance with the institution's negotiated rate agreement

• Supports collaborations and ideas that will transform 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 teams 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.
• 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.
• The consortium must include at least one consumer advocate per project team.
• Submission of a preproposal is required; application submission is by invitation only.

• Maximum period of performance is 4 years
• Maximum allowable funding of $25M for direct costs
• Indirect costs may be proposed in accordance with the institution's negotiated rate agreement

• 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 the 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; (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 consumer advocate(s) on the research team.
• Submission of a Letter of Intent is required prior to full application submission.

• Maximum period of performance is 1 years
• Maximum allowable funding of $100,000 for direct costs
• Indirect costs may be proposed in accordance with the institution's negotiated rate agreement