This program announcement must be read in conjunction with the General Application Instructions, version CD26_01.

Program Announcement for the Defense Health Agency

Breast Cancer Research Program

Transformative Breast Cancer Consortium Award

Funding Opportunity Number: HT942526BCRPTBCCA

Pre-Application Due: June 12, 2026

Application Due: September 30, 2026 https://ebrap.org/eBRAP/public/gai.htm?version=CD25_01

FY26 Transformative Breast Cancer Consortium Award 2

Content

Before You Begin 3

Basic Information Summarizes the funding opportunity, funding details, submission deadlines and review dates

Eligibility Details eligibility factors for the applicant organization and Principal Investigator

Program Description Describes the program mission and intent of the Transformative Breast Cancer Consortium Award; provides key award information and considerations; and outlines funding details

Application Contents Presents the two-step application process and instructions for preparing a pre-application and full application

Submission Requirements Provides locations for application packages, instructions for submitting pre-applications and full applications, and describes application verification

Application Review Information Outlines the processes for application compliance review, pre-application and full application selection/notification, and risk assessment. Also, details the review criteria for pre-application screening and both tiers of the CDMRP application review process – Peer Review and Programmatic Review

Federal Award Notices Outlines what a successful applicant can expect if recommended for funding

Post-Award Requirements References policy requirements for funded research; outlines reporting requirements and restrictions related to Principal Investigator changes and institutional award transfers

Other Information Outlines criteria for administrative actions including application rejection, modification, withdrawal and withhold

Appendix 1 Includes a checklist for all full application components to facilitate application submission

Appendix 2 Acronym List

FY26 Transformative Breast Cancer Consortium Award 3

Before You Begin

• Active SAM.gov, eBRAP.org and Grants.gov registrations are required for application submission. User registration for each of these websites can take several weeks or longer.

Each applicant must ensure their registrations are active and up to date prior to application preparation.

• Read this funding opportunity announcement in the order it is written before beginning to prepare application materials. It is the responsibility of the applicant to determine whether the proposed research meets the intent of this funding opportunity and that all parties meet eligibility requirements.

• To support application preparation, additional resources are available including an application process FAQ, a Guide for Intragovernmental & Intramural Applicants and a CDMRP Video Series detailing the application process.

Who to Contact for Support

This document uses internal links; you can go back to where you were by pressing the Alt + left arrow keys (Windows) or command + left arrow keys (Macintosh) on your keyboard.

Click to be taken to additional guidance and instructions within the General Application Instructions (GAI).

eBRAP Help Desk

301-682-5507 help@eBRAP.org

Questions regarding funding opportunity submission requirements, as well as technical assistance related to pre-application or intramural application submission.

Grants.gov Support Center

800-518-4726 International: 1-606-545-5035 support@grants.gov

Questions regarding Grants.gov registration and Workspace.

https://sam.gov/ https://ebrap.org/eBRAP/public/index.htm https://grants.gov/register https://cdmrp.health.mil/#:~:text=Frequently%20Asked%20Questions%20%C2%BB https://cdmrp.health.mil/#:~:text=Guide%20for%20Intragovernmental%20%26%20Intramural%20Applicants https://ebrap.org/eBRAP/public/Program.htm#:~:text=Journey%20of%20an,Tier%20Review%20Process mailto:help@eBRAP.org mailto:support@grants.gov https://ebrap.org/eBRAP/public/gai.htm?version=CD25_01 https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01

Section Shortcuts Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements

Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

FY26 Transformative Breast Cancer Consortium Award 4

1. Basic Information About the Funding Opportunity

Summary: The fiscal year 2026 (FY26) Breast Cancer Research Program (BCRP) Transformative Breast Cancer Consortium Award 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. Applications must propose a synergistic, highly integrated, multidisciplinary and multi-institutional consortium of leading scientists, clinicians and breast cancer consumer advocates that will address a major problem in a way that a single investigator or group could not accomplish. The consortium’s collaborative efforts must make a transformative impact in breast cancer. All applications must address at least one of the FY26 BCRP overarching challenges or provide adequate justification for exception. If the application addresses a different fundamental issue, the application must couple it with at least one of the overarching challenges.

Distinctive Features: This funding mechanism allows for up to five Principal Investigators (PIs) which includes the Consortium Director and three or four Project Team PIs. Applications must include at least one breast cancer consumer advocate per project team. Only the Consortium Director will submit a pre-application, but all PIs will need to submit at the full application stage. Be advised, failure to submit all associated (Consortium Director and Project Team PIs) applications by the full application deadline may result in administrative withdrawal.

Funding Details: The Congressionally Directed Medical Research Programs (CDMRP) expects to allot roughly $35 million (M) to fund approximately one Transformative Breast Cancer Consortium Award application with a total cost cap of $35M. The maximum period of performance is four years. It is anticipated that the award made from this FY26 funding opportunity will be funded with FY26 funds, which will expire for use on September 30, 2032.

The award supported with FY26 funds will be made no later than September 30, 2027.

Submission and Review Dates and Times

• Pre-Application (Preproposal) Submission Deadline: 5:00 p.m. Eastern Time (ET), June 12, 2026

• Invitation to Submit an Application: July 16, 2026

• Application Submission Deadline: 11:59 p.m. ET, September 30, 2026

• End of Application Verification Period: 5:00 p.m. ET, October 5, 2026

• Peer Review: December 2026

• Programmatic Review: January 2027

• Invitation for Oral Presentation: February 2027

• Programmatic Review, Stage 2: March 2027

Announcement Type: Initial

Funding Opportunity Number: HT942526BCRPTBCCA

Assistance Listing Number: 12.420

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FY26 Transformative Breast Cancer Consortium Award 5

2. Eligibility Information

2.1. Eligible Applicants

2.1.1. Organization

Extramural and intramural U.S. Department of War (DOW) organizations are eligible to apply, including foreign and domestic organizations, for-profit and nonprofit organizations, and public or private entities.

2.1.2. Principal Investigator

Independent investigators affiliated with an eligible organization are eligible to be named PI, also referred to as the Consortium Director, or Project Team PI on the application, regardless of ethnicity, nationality or citizenship status.

The Consortium Director must commit and maintain a minimum level of time and effort of 25% during the period of performance to direct and manage the consortium and to lead their own project team.

An investigator may be named as Consortium Director on only one pre-application or full application under this funding opportunity.

There are no limits on the number of pre-applications for which an investigator may apply as a Project Team PI for this funding opportunity.

Investigators named as Consortium Director on a pre-application or full application submitted under funding opportunity HT942526BCRPTBCCDA are not eligible to be named as the Consortium Director on an application submitted under the current funding opportunity.

2.2. Cost Sharing

Cost sharing is not an eligibility requirement.

2.3. Other

Awards are made to eligible organizations, not to individuals. Refer to the GAI for additional recipient qualification requirements.

https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Content_Form_Full_App_Submission:~:text=pre%2Dapplication%20submission.-,Extramural%20Organization%3A,-A%20foreign%20or https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=Intramural%20DOW%20Organization%3A%20A%20subset%20of%20intragovernmental%20organizations%3B%20refers%20specifically%20to%20DOW%20organizations%2C%20including%20DOW%20laboratories%2C%20DOW%20military%20treatment%20facilities%2C%20and/or%20DOW%20activities%20embedded%20within%20a%20civilian%20medical%20center.

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3. Program Description

The Defense Health Agency Contracting Activity (DHACA) is soliciting applications to this funding opportunity using delegated authority provided by United States Code, Title 10, Section 4001 (10 USC 4001). The CDMRP is the program office managing this FY26 funding opportunity as part of the BCRP. The CDMRP is located within the Defense Health Agency Research and Development (DHA R&D), which is a part of the Department of Defense, DOD, herein referred to using the secondary title Department of War, DOW. Congress initiated the BCRP in FY92 to support innovative, high-impact research, with a mission of ending breast cancer for Service Members and their Families, Veterans, and the general public. Appropriations for the BCRP from FY92 through FY25 totaled $4.52 billion. The FY26 appropriation is $145M.

The BCRP challenges the scientific community to design research that will address the urgency of ending breast cancer. Specifically, the BCRP seeks to accelerate high-impact research with clinical relevance, encourage innovation and stimulate creativity, and facilitate productive collaborations.

The BCRP brief overview called The Breast Cancer Landscape describes what is currently known about the most pertinent topics that are consistent with the BCRP’s mission of ending breast cancer. Considering the current breast cancer landscape and the program’s mission, the BCRP seeks to invest in research that addresses the following FY26 BCRP overarching challenges:

• 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 do all of the following:

improve survival, are more effective, and are less toxic

• Eliminate the mortality associated with metastatic breast cancer

3.1. Intent of the Transformative Breast Cancer Consortium Award

The intent of the FY26 BCRP Transformative Breast Cancer Consortium Award (TBCCA) is to support 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.

Applicants must bring together different perspectives to develop new paradigms that will solve fundamental yet overarching problems in breast cancer. This award requires a team-based approach with a consortium of exceptional researchers and breast cancer consumer advocates, whose collaborative efforts will make a transformative impact in breast cancer. The consortium’s intended transformation must occur in people’s lives, and not in the health care or research system.

https://cdmrp.health.mil/bcrp/pdfs/BreastCancerLandscape2025.pdf

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FY26 Transformative Breast Cancer Consortium Award 7

This is a separate award mechanism from the FY26 BCRP Transformative Breast Cancer Consortium Development Award (TBCCDA) which provides successful applicants with the time and resources needed to bring investigators and breast cancer consumer advocates together to establish a consortium framework and conduct preliminary research in support of an application to a future, full BCRP TBCCA (pending availability of funds). For FY26, investigators may be named as Consortium Director on an application submitted to either (but not both) of these award mechanisms. It is not necessary to receive a development award in order to apply for the current funding opportunity or anticipated full consortium awards in the future.

Detailed information on the FY26 BCRP TBCCDA is available under a separate program announcement (HT942526BCRPTBCCDA).

The FY26 BCRP TBCCA supports a consortium composed of 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. The consortium must integrate each team’s work so that every component is working toward the consortium’s central hypothesis.

Note: The BCRP does not intend this award to replace, supplement, duplicate or compete with other collaborative research efforts, such as the National Cancer Institute (NCI) Specialized Programs of Research Excellence (SPORE), and it should not represent a collection of related Program Project grants or subprojects.

The consortium must propose work that is innovative. In addition, the FY26 BCRP TBCCA will include funds for “seed projects” to pursue brand-new, high-risk/high-reward concepts that arise from the work during the award period.

The Breast Cancer Landscape describes the reality of breast cancer and identifies overarching challenges to progress the field. Research funded under this award mechanism should result in answers that will fundamentally and significantly transform and disrupt the present landscape.

Although not all-inclusive, applications that propose the following as the primary effort(s) or central hypothesis of the consortium will not meet the intent of this award mechanism:

• NCI Program Project or SPORE grants or applications.

• Conducting drug screens or testing a “cocktail” of therapeutics.

• Targeting a single gene or protein.

• Developing a new derivative or formulation of an old drug.

• Conducting genomic landscape mapping analyses.

• Seeking to improve existing technologies (e.g., mammography or magnetic resonance imaging screening).

3.1.1. Key Elements for the TBCCA

Applications must include the following:

• Research that includes truly innovative and brand-new, paradigm-shifting work in breast cancer that will address vital issues in a unique way. The research must address one (or more) of the above overarching challenges or, with adequate justification, address a different issue that meets the intent of the award mechanism and addresses the BCRP’s mission of ending breast cancer. If the application addresses a different fundamental issue, the application must couple it with at least one of the overarching challenges and provide justification.

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FY26 Transformative Breast Cancer Consortium Award 8

• Research that includes different disciplines that come together to address ending breast cancer with an ecologic approach. The consortium’s proposed research must look at all aspects of the disease and bring together these different perspectives into one overarching plan for a deep, definitive dive into the overarching challenge(s) or other fundamental issue(s) identified in the application. The plan should also include previously unaddressed or unanswered issues related to the hypothesis.

• A plan that describes in detail the integration across the consortium in all aspects, including administration, logistics, and substance. Applications must describe the substantive integration across and among teams that are necessary for the work. The required communication plan and administrative management plan will not suffice to show integration, nor will identifying individual team members who will cross teams. The application must provide a detailed explanation of the substantive research processes that will be integrated.

The application must propose a synergistic, highly integrated, multidisciplinary and multi-institutional consortium of leading scientists, clinicians, and breast cancer consumer advocates that will address a major problem in a way that a single investigator or group could not accomplish. While the project teams are made up of different groups, each with its own PI, the teams must all work on the major problem identified in the application and under the leadership of the Consortium Director. Proposed research may include phase 1 clinical trials and collaborations with pharmaceutical or biotechnology industry scientists and/or companies, as appropriate. However, clinical trials are not required, and the primary thrust of the application should not be a clinical trial.

All applications must address the following key features:

1. IMPACT

Demonstrate potential to transform or improve the lives of individuals with, and/or at risk for, breast cancer. The time to the final impact may vary, but the application must demonstrate potential for transformative outcomes that will significantly advance the BCRP’s mission of ending breast cancer. The application must provide a clear and compelling explanation of how the effort will be transformative for individuals with, and/or at risk for, breast cancer. Applications proposing research that represents an incremental advance in breast cancer do not meet the intent of this award mechanism.

2. INNOVATION

Pursue innovative, high-risk/high-reward research with the potential to change existing paradigms, or develop new paradigms. Innovative research may introduce a new paradigm, look at existing problems from new perspectives, or exhibit other highly creative qualities. In addition to the requirement that the consortium’s overall research be innovative, applications must describe a plan to support the pursuit of innovative concepts through “seed projects,” i.e., the development of new concepts that emerge during the course of the award. These “seed projects” should enable the research team to explore new avenues of high-risk/high-reward ideas that were not part of the original application, but that develop during the project and are within the scope of the overall vision of the research. The consortium must reserve a portion of the total direct budget costs (no more than 5%) to support the “seed projects.” The consortium may not use these funds for equipment or travel.

3. CONSORTIUM

Integrate project teams consisting of preeminent investigators and consumer advocates from appropriate disciplines and institutions. Applications should include a robust https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=or%20hardware%20procurement.-,Clinical%20Trial%3A,-As%20defined%20in

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FY26 Transformative Breast Cancer Consortium Award 9 consortium of researchers with the combined backgrounds and breast cancer-related expertise to enable successful conduct of the proposed research. The application should emphasize integrating the most highly qualified investigators and consumer advocates to focus on the research problem, regardless of their location. These investigators must include highly accomplished scientists, clinicians and promising young investigators in the targeted areas of research who collectively represent the best team to solve the problem(s) identified. The consortium should propose a research effort broad enough to require a multidisciplinary approach that is reflected in the composition of the consortium team. The BCRP encourages applications to include scientists from nontraditional disciplines.

The award mechanism is structured with a Consortium Director and at least three, but no more than four, Project Team PIs representing at least two institutions. The Consortium Director is responsible for the day-to-day management of the consortium, as well as for leading their own project team. The Consortium Director, together with the Project Team PIs, are jointly responsible for leading and executing the proposed research projects. A central hypothesis must integrate all research projects to result in answers that will fundamentally and significantly transform and disrupt the present breast cancer landscape.

Incorporate breast cancer consumer advocates into every aspect of the proposed consortium’s activities. The consortium must include at least one breast cancer consumer advocate per project team. The consumer advocates should represent the perspective of the patient population(s) that are most relevant to the consortium’s proposed research. The consumer advocates must have an active role in every aspect of the proposed consortium’s work, including consortium conception and design, ongoing discussion, decisions and oversight, program evaluation, and dissemination of information to the public. The consortium must integrate consumer advocates from each project team as active participants in leadership and decision-making committees for the consortium. Examples of appropriate integration include membership on the advisory board(s) and steering committee(s), participation in each project team and attendance at all consortium-related meetings. As lay representatives, the consumer advocates must be individuals who have been diagnosed with breast cancer and are actively involved in breast cancer advocacy organization. They must perform their role in the project independently of their employment and cannot be employees of any of the organizations participating in the application. The consumer advocates must have a high level of familiarity and training involving science and current issues in breast cancer research.

4. INTEGRATION

Provide a plan that describes in detail the integration across the consortium in all aspects, including administration, logistics and substance. Applications must demonstrate the substantive integration across and among teams that are necessary for the work. The integration plan must provide a detailed explanation of the substantive research processes that will be integrated.

5. IMPLEMENTATION

Provide a strategy for implementation. Projects must demonstrate solid scientific rationale, and applications must include published and/or preliminary data that support the feasibility of their hypotheses and/or approaches. The application must include a detailed research management plan that identifies critical milestones, outlines the innovations and technical solutions to accomplish the milestones, and explains the plan for translation of these solutions to individuals with, and/or at risk for, breast cancer. The proposed plan must present an exceptional level of innovation and creativity.

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FY26 Transformative Breast Cancer Consortium Award 10

Accelerate research progress through communication. Communication between and among consortium team members is essential to the success of the consortium. Applications must include a strategy for sharing data in real time and using information technologies to facilitate timely and effective communication and cooperation. The communication plan should specify the processes and tools for utilization in regular and structured communication. The consortium should take full advantage of state-of-the-art communication and data sharing tools in addition to formal and informal meetings. The application must include the framework for the communication plan and identify the individual(s) who will maintain the data sharing and communications technologies.

Provide an effective, coordinated administrative management plan that integrates and optimizes the research and collaborations. The Consortium Director must commit a minimum level of time and effort of 25% to direct and manage an initiative of this magnitude, as well as lead their own project team. The Consortium Director must have the scientific ability and proven administrative ability to oversee large research programs and a proven record of leadership, including experience in the effective use of communication tools and the management of multifaceted and multidisciplinary projects. The administrative management plan must explain the organization and management of the consortium. The plan should specify the processes and tools for utilization in project meeting scheduling, reviews of research findings, ensuring multidisciplinary authorship of all publications arising from the consortium’s work, and other issues of common concern to the consortium and its investigators. The administrative management plan also must describe procedures and processes for maximizing the resources (e.g., databases, animal models) and products (e.g., antibodies) generated by the consortium and how the scientific community will gain access to these resources and products.

The consortium must reserve a portion of the total direct budget costs for a program manager.

3.1.2. Other Important Considerations for the TBCCA

The FY26 BCRP Transformative Breast Cancer Consortium Award application review requires an invited oral presentation, as described in Section 4.4.

Award Structure: The FY26 BCRP TBCCA allows for up to five PIs (the Consortium Director and three or four Project Team PIs). The Consortium Director is responsible for the majority of the administrative tasks associated with application submission and the day-to-day management of the consortium. In addition, the Consortium Director is responsible for leading their own project team. The Consortium Director and Project Team PIs each have different submission requirements; however, all PIs should contribute significantly to the development of the proposed research project, including the Project Narrative, Statement of Work (SOW) and other required components. If recommended for funding, each PI will be named on separate awards to the recipient organization(s). Each award will be subject to separate reporting, regulatory, and administrative requirements. For individual submission requirements for the Consortium Director and Project Team PIs, refer to Section 5.3, Submission Instructions.

In-Progress Reviews: The FY26 BCRP TBCCA requires the Consortium Director, Project Team PIs and consumer advocates to present an update on progress toward accomplishing research milestones and goals of the consortium and each project at an annual In-Progress Review (IPR) Meeting. The intent of the IPR Meeting is to assess research progress, address problems and define future directions. TBCCA awardees must attend annual IPR meetings at the conclusion of year 1 and every subsequent year in the period of performance. Members of the BCRP Programmatic Panel, CDMRP staff, and the DHACA Grants Officer will attend the IPR to facilitate oversight and provide feedback to the consortium. IPR meetings will either be held in

Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements

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FY26 Transformative Breast Cancer Consortium Award 11 person in the National Capital Area or virtually, at the discretion of the government. Continued funding may be contingent upon the successful completion of specific research milestones and goals.

In addition to IPR meetings, the consortium must hold biannual workshops, at the PIs’ institutions or virtually, to facilitate ongoing communication and exchange of information within the consortium, as well as with advisory board(s) and/or steering committee(s).

In accordance with the National Defense Authorization Act for Fiscal Year 2026, Section 732, CDMRP does not support the conduct of painful research (U.S. Department of Agriculture pain category D or E) involving domestic cats or dogs, except for studies relating to military or service animals.

Clinical research including projects involving human data, human anatomical substances, and/or interaction with human subjects is permitted. Clinical trials (e.g., up to and including phase 1 or equivalent) are allowed, but not required, within this funding opportunity.

All projects should adhere to a core set of standards for rigorous study design and reporting to maximize the reproducibility and translational potential of clinical and preclinical research, such as those described in the STROBE, CONSORT, SPIRIT and ARRIVE 2.0 guidelines.

The proposed research must be relevant to Service Members, Veterans, their Families and/or the American Public. PIs are encouraged to integrate and/or align their research projects with DOW and/or VA research laboratories and programs. Collaboration with the DOW and/or VA is also encouraged. A list of websites that may be useful in identifying additional information about ongoing DOW and VA areas of research interest or potential opportunities for collaboration can be found in Appendix 10 of the GAI.

A congressionally mandated Metastatic Cancer Task Force was formed with the purpose of identifying ways to help accelerate clinical and translational research aimed at extending the lives of advanced state and recurrent patients. As a member of the Metastatic Cancer Task Force, the CDMRP encourages applicants to review the task force recommendations and submit research ideas to address these recommendations, provided they are within the limitations of this funding opportunity and align with the FY26 BCRP priorities.

3.2. Funding Instrument

The funding instrument for awards made under the program announcement will be cooperative agreements (31 USC 6305) based on anticipated “substantial involvement” on the part of CDMRP. Substantial involvement means that, after award, CDMRP staff will assist, guide, coordinate and/or participate in project activities including but not limited to IPR meetings wherein recommendations for continued funding will be made based on overall study progress.

3.3. Funding Details

Period of Performance: The maximum period of performance is four years.

Cost Cap: The combined total costs budgeted for the entire period of performance in the applications of the Consortium Director and the Project Team PIs performance should not exceed $35M. If indirect cost rates have been negotiated, indirect costs are to be budgeted in accordance with the organization’s negotiated rate. Collaborating organizations should budget associated indirect costs in accordance with each organization’s negotiated rate.

All direct and indirect costs of any subaward or contract must be included in the direct costs of the primary award.

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FY26 Transformative Breast Cancer Consortium Award 12

The applicant may request the entire maximum funding amount for a project that may have a period of performance less than the maximum four years.

The appropriateness of the budget for the proposed research will be assessed during peer review.

A separate award will be made to each PI’s organization.

Direct Cost Restrictions: For this award mechanism, direct costs:

Must be requested for:

• Costs associated with meetings described in Section 8.3.

• Costs for the PIs and consumer advocates to present project information or disseminate project results at biannual consortium workshops to facilitate ongoing communication and exchange of information within the consortium, as well as with advisory board(s) and/or steering committee(s). The biannual workshops are in addition to IPR meetings described in Section 8.3. The consortium may hold the biannual workshops at the PIs’ institutions or virtually. For planning purposes, PIs should assume that they will hold the workshops at one of the PIs’ institutions.

• Costs (no more than 5% of the total direct costs) for “seed projects” to support the pursuit of innovative ideas. The PIs should develop “seed projects” during the project and they must align with the scope of the overall vision of the research. Applicants should allocate direct costs for these “seed projects” into the “other direct cost” category of the year 1 budget. The consortium may not use funds for “seed projects” for equipment or travel.

May be requested for (not all-inclusive):

• Consortium-related meetings, teleconferences and travel between/among participating investigators and consumer advocates.

• Costs related to identifying and acquiring research resources.

• Computers and software required to participate in the consortium.

• Other costs associated with planning and developing the consortium collaborations, communications and resources.

• Research subject compensation and reimbursement for study-related out-of-pocket costs (e.g., travel, lodging, parking, costs associated with caregiving, and resources/equipment to enable participation), if applicable.

• Costs for two investigators per project to travel to one scientific/technical meeting per year in addition to the required meetings described in Section 8.3. The intent of travel costs to scientific/technical meetings should be to present project information or disseminate project results from the FY26 BCRP Transformative Breast Cancer Consortium Award.

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FY26 Transformative Breast Cancer Consortium Award 13

4. Application Contents and Format

4.1. Application Overview

Application submission is a two-step process requiring both a pre-application submitted via the Electronic Biomedical Research Application Portal (eBRAP) and a full application submitted through eBRAP or Grants.gov. Depending on the submission portal, certain aspects of the application will differ.

Intramural DOW organizations submitting a full application should follow instructions for submission through eBRAP.

Extramural organizations submitting a full application must follow instructions for submission through Grants.gov.

4.2. Pre-Application Components

The Initiating PI must submit the following pre-application components.

Upload documents as individual PDF files unless otherwise noted. Files must comply with the formatting guidelines listed in the GAI.

• Preproposal Narrative (three-page limit): The Preproposal Narrative page limit applies to text and non-text elements (e.g., figures, tables, graphs, photographs, diagrams, chemical structures, drawings) used to describe the project. Inclusion of URLs that provide additional information to expand the Preproposal Narrative and could confer an unfair competitive advantage is prohibited and may result in administrative withdrawal of the pre-application.

The Preproposal Narrative should include the following:

○ How will the proposed research fundamentally and significantly transform and disrupt the present breast cancer landscape?

○ How does the consortium bring different disciplines together with one overarching plan to address breast cancer with an ecologic approach?

○ How will the proposed research be innovative and introduce brand-new paradigms in breast cancer?

○ How will the consortium’s proposed deep, definitive dive into one (or more) of the overarching challenge(s) or fundamental issue(s) in breast cancer explore or address the challenge or issue in a manner not yet attempted. Explain how and/or why this challenge or issue has not yet been explored using the proposed research.

○ How will the proposed research make a transformative impact on the lives of the individuals with, and/or at risk for, breast cancer? How will the outcomes of the proposed research significantly accelerate progress towards ending breast cancer?

○ What is the overall organization of key personnel, including consumer advocates, and what will each team member’s role be in the consortium? How will the consortium team be integrated to address an overarching problem in breast cancer in a way that could not be accomplished by a single investigator or group?

○ How will the consortium be integrated in all aspects, including administration, logistics and substance?

https://ebrap.org/eBRAP/public/index.htm https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=APPENDIX%202.%0AFORMATTING%20GUIDELINES https://cdmrp.health.mil/bcrp/pdfs/BreastCancerLandscape2025.pdf https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Full_App_Submission_Grants:~:text=IV.%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%20FULL%20APPLICATION%20SUBMISSION%20THROUGH%20GRANTS.GOV https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Full_App_Submission_eBRAP:~:text=V.%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%20FULL%20APPLICATION%20SUBMISSION%20THROUGH%20eBRAP

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FY26 Transformative Breast Cancer Consortium Award 14

• Pre-Application Supporting Documentation: The items to be included as supporting documentation for the pre-application must be uploaded as individual files and are limited to the following:

○ References Cited (one-page limit): List the references cited (including URLs if available) in the Preproposal Narrative using a standard reference format that includes the full citation (i.e., author[s], year published, reference title, and reference source, including volume, chapter, page numbers, and publisher, as appropriate).

○ List of Abbreviations, Acronyms, and Symbols: Provide a list of abbreviations, acronyms and symbols used in the Preproposal Narrative.

○ Key Personnel Biographical Sketches: All biographical sketches should be uploaded as a single combined file. Biographical sketches should be used to demonstrate background and expertise through education, positions, publications and previous work accomplished.

○ Additional Information: One page for additional information that the PIs can use, at their discretion, to provide supporting data or rationale for the pre-application.

4.3. Full Application Components

Applicants must receive an invitation to submit a full application. Uninvited full application submissions will be rejected.

The CDMRP requires separate full application package submissions for the Consortium Director and each Project Team PI, even if the PIs are located within the same organization. The application submission process for Project Team PIs uses an abbreviated full application package.

4.3.1. Full Application Components for the Consortium Director

Each application submission must include the completed full application package for this program announcement. See Appendix 1 for a checklist of the full application components.

(a) SF424 Research & Related Application for Federal Assistance Form (Grants.gov submissions only):

IMPORTANT: When completing the SF424 R&R, enter the eBRAP log number assigned during pre-application submission into Block 4a – Federal Identifier.

(b) Attachments:

Each attachment of the full application components must be uploaded as an individual file in the format specified and in accordance with the formatting guidelines in the GAI.

○ Attachment 1: Project Narrative (45-page limit): Upload as “ProjectNarrative.pdf”.

Describe the proposed consortium in detail using the outline below.

– Overarching Challenge(s): State explicitly which overarching challenge(s) in breast cancer the proposed research will address. Describe how a deep, definitive dive into the overarching challenge(s) or fundamental issue(s) in breast cancer will explore or address the issue in a manner not yet attempted and will fundamentally and significantly transform and disrupt the current breast cancer landscape.

https://ebrap.org/eBRAP/public/gai.htm?version=CD25_01#_Recipient_Qualification_Restriction_Info:~:text=APPENDIX%202%0AFORMATTING%20GUIDELINES https://cdmrp.health.mil/bcrp/pdfs/BreastCancerLandscape2025.pdf https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=(a)%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%20SF424%20(R%26R)%20%E2%80%93%20Application%20for%20Federal%20Assistance%20Form https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=Full%20Application%20Files.-,Biographical%20Sketch%3A%20This%20file,-must%20be%20titled https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=%C2%B7-,Project%20Narrative%3A,-Attach%20as%20%E2%80%9CProjectNarrative

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FY26 Transformative Breast Cancer Consortium Award 15

– Central Hypothesis: State the consortium’s central hypothesis to be tested.

– Projects and Objectives: Briefly explain the consortium’s proposed projects that the Consortium Director and each Project Team PIs will lead, and explain the objective(s) to be reached by each project. Explain how the projects form a coherent plan to address the consortium’s central hypothesis. Identify the key points of interaction between the projects and how such interaction will create synergy to address the overarching challenge(s) more effectively than projects conducted independently.

Consortia should have at least four, but no more than five, project teams, each investigating different projects. The Consortium Director will lead one project, and the Project Team PIs will lead the remaining three or four projects. For each proposed project (either four or five total with one led by the Consortium Director), provide the following details using this outline. Start each project on a separate page:

– Title: Provide a title for each project.

– Project Leader: Identify the project leader (either the Consortium Director or one of the Project Team PIs) and any key personnel, as appropriate.

– Background: Describe in detail the ideas and reasoning on which the proposed research is based. Provide sufficient preliminary data to support the feasibility of the work proposed. The application must demonstrate logical reasoning and provide a sound scientific rationale, as established through a critical review and analysis of published literature. If proposing translational or clinical research, describe the studies showing proof of concept and, if applicable, efficacy in an in vivo system.

– Hypothesis/Objective: State the hypothesis to be tested and/or the objective(s) to be reached.

– Specific Aims: Concisely explain the project’s specific aims.

– Research Strategy: Describe the experimental design, methods, and analyses, including appropriate controls, in sufficient detail for evaluation. Explain how this research strategy will meet the research goals and milestones. Address potential pitfalls and problem areas, and present alternative methods and approaches.

Applications proposing translational research should provide a well-developed, well-integrated, and detailed research plan that supports the translational feasibility and promise of the approach. If the methodology is new or unusual, provide sufficient details for evaluation. If using human subjects or human biological samples, describe the study population and provide a detailed plan for the recruitment of human subjects or the acquisition of samples. Where relevant, describe the availability of, and access, to the data, human samples, cohort(s), and/or critical reagents (e.g., therapeutic molecules) necessary for the project, and provide appropriate letters of support in Attachment 2: Supporting Documentation. If applicable, describe resources available for the development of sufficient quantities of critical reagents under Good Manufacturing Practices (GMP) guidelines. Describe data reporting procedures and plans to assure that the documentation will support a regulatory filing with the U.S. Food and Drug Administration (FDA) or an equivalent international regulatory agency, if applicable. Consult appropriate guidelines to ensure relevant aspects of rigorous and reproducible research are adequately planned for and, ultimately, reported.

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FY26 Transformative Breast Cancer Consortium Award 16

For clinical research, see Attachment 12 for the required strategy for the inclusion of women and minorities appropriate to the objectives of the study.

– Clinical Strategy (if applicable): Only small-scale (e.g., up to and including phase 1 or equivalent) clinical trials are allowed. Describe the rationale for the proposed clinical trial. Provide detailed plans for initiating, conducting, and completing the clinical trial during the period of performance. As appropriate, outline a plan for obtaining regulatory approvals necessary to initiate the clinical trial (e.g., active Investigational New Drug (IND), Investigational Device Exemption (IDE), or equivalent status). If an IND or IDE (or other international equivalent) is required, the PI must submit the IND/IDE (or other international equivalent) application to the applicable regulatory agency within 12 months of the award start date. Describe the type of clinical trial the team will perform (e.g., prospective, randomized, controlled), the study phase, and the study model (e.g., single group, parallel, crossover). Outline the proposed clinical trial methodology in sufficient detail to show a clear course of action. Describe potential challenges and alternative strategies where appropriate.

Consult appropriate guidelines to ensure relevant aspects of rigorous and reproducible research are adequately planned for and, ultimately, reported.

▪ Identify the intervention the clinical trial will test and describe the projected outcomes.

▪ Define the study variables and describe how the study team will measure them.

Include a description of appropriate controls and the endpoints to be tested.

▪ Describe the availability of, and access to, critical reagents (e.g., therapeutic molecules) necessary for the clinical trial, and provide appropriate letters of support in Attachment 2: Supporting Documentation.

▪ Identify the study population and specify the number of human subjects the trial will enroll. Describe the access to the study population, recruitment plans and inclusion/exclusion criteria. Provide appropriate letters of support demonstrating access to the study population in Attachment 2: Supporting Documentation.

Define each arm/study group of…