HT942526BCRPBTA122_GG.pdf

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

Breakthrough Award Levels 1 and 2

Funding Opportunity Number: HT942526BCRPBTA122

Pre-Application Due: November 4, 2026

Application Due: November 18, 2026 https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01

FY26 Breast Cancer Breakthrough Award Levels 1 and 2 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 Breakthrough Award Levels 1 and 2; 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 Breast Cancer Breakthrough Award Levels 1 and 2 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=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 Breast Cancer Breakthrough Award Levels 1 and 2 4

1. Basic Information About the Funding Opportunity

Summary: The fiscal year 2026 (FY26) Breast Cancer Research Program (BCRP) Breakthrough Award mechanism supports promising research with high potential to lead to or make breakthroughs in breast cancer. All applications must address at least one of the FY26 BCRP overarching challenges or provide adequate justification for exception. Applications must address the challenge in a way that can lead to a breakthrough and have major impact. The FY26 Breakthrough Award mechanism contains four different funding levels designed to support major (but not all) stages of research that will lead to clinical application. Each level specifies a distinct research scope. This program announcement discusses the Breakthrough Award Levels 1 and 2.

Distinctive Features:

• This funding mechanism allows for applications submitted under Funding Level 1 or Funding Level 2. Funding Level 2 also includes a Population Science Studies option.

With compelling justification, population science studies may request higher levels of funding and an additional year in the period of performance.

• This funding mechanism allows for a single Principal Investigator (PI), or two partnering PIs referred to as the Initiating PI and the Partnering PI. For the Partnering PI Option (PPIO), only the Initiating PI will submit a pre-application, but both PIs will need to submit at the full application stage. Be advised, failure to submit all associated (Initiating and Partnering PI) applications by the deadline may result in administrative withdrawal.

Funding Details: The Congressionally Directed Medical Research Programs (CDMRP) expects to allot roughly $10.6 million (M) to fund approximately 6 Breakthrough Award Levels 1 and 2 applications with total cost caps of $0.75M (single PI) or $1.25M (PPIO) for Level 1; $1.65M (single PI) or $2.5M (PPIO) for Level 2; and $2.5M (single PI) or $3.35M (PPIO) for Level 2 – Population Science Studies. The maximum period of performance is three years for Breakthrough Award Levels 1 and 2 and four years for Breakthrough Award Level 2 – Population Science Studies. It is anticipated that awards made from this FY26 funding opportunity will be funded with FY26 funds, which will expire for use on September 30, 2032.

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

Submission and Review Dates and Times

• Pre-Application (Letter of Intent) Submission Deadline: 5:00 p.m. Eastern Time (ET), November 4, 2026

• Application Submission Deadline: 11:59 p.m. ET, November 18, 2026

• End of Application Verification Period: 5:00 p.m. ET, November 25, 2026

• Peer Review: January 2027

• Programmatic Review: March 2027

Announcement Type: Initial

Funding Opportunity Number: HT942526BCRPBTA122

Assistance Listing Number: 12.420

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

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FY26 Breast Cancer Breakthrough Award Levels 1 and 2 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

Investigators affiliated with an eligible organization are eligible to be named PI, Initiating PI or Partnering PI on the application, regardless of ethnicity, nationality or citizenship status.

Applications naming post-doctoral fellows as PI are encouraged. A Mentorship Statement (Attachment 8) is required for all applications submitted with a PI who is a postdoctoral fellow.

An investigator may only be named on one application as PI or Initiating PI and one additional application as a Partnering PI for the Breakthrough Award Levels 1 and 2 mechanism.

Investigators named as PI, Initiating PI or Partnering PI on an application submitted under funding opportunity HT942526BCRPBTA12 are not eligible to submit a pre-application or full application for the same research project under this 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 https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=APPENDIX%201-,RECIPIENT%20QUALIFICATION%20AND%20RESTRICTION%20INFORMATION,-A.%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0

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FY26 Breast Cancer Breakthrough Award Levels 1 and 2 6

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 Breakthrough Award Levels 1 and 2

The intent of the FY26 BCRP Breakthrough Award is to support promising research with high potential to lead to or make breakthroughs in breast cancer.

The FY26 BCRP Breakthrough Award contains four different funding levels, each intended to support a defined research scope. It is the responsibility of the PI to select the level that aligns with the scope of the proposed research. The PI should select the funding level based on the research scope defined in the program announcement, and not on the amount of the budget.

The BCRP will not recommend for funding an application that does not meet the intent of the funding level selected, even if it might meet the intent of a different funding level.

This program announcement discusses the FY26 BCRP Breakthrough Award Levels 1 and 2 (BTA12).

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

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FY26 Breast Cancer Breakthrough Award Levels 1 and 2 7

• Funding Level 1: This funding level supports innovative, high-risk/high-reward research that is in the earliest stages of idea development or is an untested theory that addresses an important problem. To foster research that yields new avenues of investigation, this level does not require preliminary data. Proof of concept is the anticipated outcome.

• Funding Level 2: This funding level supports research 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.

• Funding Level 2: Population Science Studies: The studies should focus on the analysis of human data and biospecimens. Research 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. With compelling justification, population science studies may request higher levels of funding and an additional year in the period of performance.

3.1.1. Key Elements for the BTA12

Impact: Proposed research must have the potential for a major impact and accelerate progress toward ending breast cancer. The near-term and/or long-term impact must move beyond a minor advancement and have the potential to lead to a fundamentally new strategy or approach to preventing or ending breast cancer that is significantly more effective than current strategies or approaches. Applications must identify the breast cancer patients or at-risk individuals who would ultimately benefit from the proposed research.

Overarching Challenges: Considering the current breast cancer landscape and the BCRP’s mission, all applications must address at least one of the above overarching challenges or provide adequate justification for exception.1 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. The BCRP strongly urges applicants to read and consider The Breast Cancer Landscape before preparing their applications.

Personnel: Applications must include an appropriate and robust research team with the combined backgrounds and breast cancer-related expertise to enable successful conduct of the project.

Partnering PI Option: The BTA12 PPIO encourages applications that include meaningful and productive partnerships between two PIs. One PI will be identified as the Initiating PI and will be responsible for the majority of the administrative tasks associated with application submission.

The other PI will be identified as the Partnering PI. Both PIs should contribute significantly to the development and execution of the proposed research project. The PIs may have expertise in similar or disparate scientific disciplines, but each PI must bring distinct contributions to the application. The application should clearly demonstrate that both PIs have equal intellectual input into the design of the project and will devote similar levels of effort to the conduct of the project. The application should balance funding between both PIs unless appropriately justified.

The PPIO encourages, but does not require, new partnerships. The application should describe how the PIs’ unique expertise combined as a partnership will better address the research question, how the unique expertise that each individual brings to the application is critical for the research strategy and completion of the proposed project, and why the work should be done together rather than through separate efforts. Applications do not meet the intent of the PPIO if a mentor and their current postdoctoral fellow or junior investigator are named as

1 With adequate justification, applications may identify and address another overarching challenge related to The Breast Cancer Landscape. Investigators must provide justification in the application.

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

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Initiating and Partnering PIs. Applications where one PI is providing samples, animal models, or investigational agents, while the other PI is conducting most or all of the experiments and analyses, do not meet the intent of the PPIO. 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 Initiating and Partnering PIs, refer to Section 5.3, Submission Instructions.

3.1.2. Other Important Considerations for the BTA12

Clinical research including projects involving human data, human anatomical substances, and/or interaction with human subjects is permitted. However, clinical trials are not allowed within this funding opportunity.

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.

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 grants

(31 USC 6304).

3.3. Funding Details

The requested funding level should be aligned with the scope of the research proposed and the funding level description.

Funding Level 1 (Single PI or Partnering PI Option):

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

Cost Cap: For applications with a single PI, the application’s total costs budgeted for the entire period of performance should not exceed $750,000. For PPIO Applications, the application’s total costs budgeted for the entire period of performance should not exceed $1.25M.

Funding Level 2 (Single PI or Partnering PI Option):

https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Content_Form_Full_App_Submission:~:text=Clinical%20Research%3A,-For%20the https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=or%20hardware%20procurement.-,Clinical%20Trial%3A,-As%20defined%20in https://www.strobe-statement.org/ https://www.nature.com/articles/s41591-025-03635-5#:~:text=SPIRIT%20and%20CONSORT%20are%20evidence,relevant%20empirical%20evidence%20where%20possible https://www.nature.com/articles/s41591-025-03668-w?fromPaywallRec=false https://arriveguidelines.org/arrive-guidelines https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#DOW_AND_VA_WEBSITES https://health.mil/Reference-Center/Congressional-Testimonies/2018/05/03/Metastatic-Cancer-Research https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=Period%20of%20Performance%3A%20The%20time%20interval%20between%20the%20start%20of%20a%20federal%20award%20and%20the%20planned%20end%20date.

https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=in%20project%20activities.-,Cost%20Cap%3A,-The%20maximum%20cost

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FY26 Breast Cancer Breakthrough Award Levels 1 and 2 9

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

Cost Cap: For applications with a single PI, the application’s total costs budgeted for the entire period of performance should not exceed $1.65M. For PPIO Applications, the application’s total costs budgeted for the entire period of performance should not exceed $2.5M.

Funding Level 2 – Population Science Studies (Single PI or Partnering PI Option):

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

Cost Cap: For applications with a single PI, the application’s total costs budgeted for the entire period of performance should not exceed $2.5M. For PPIO Applications, the application’s total costs budgeted for the entire period of performance should not exceed $3.35M.

For All Funding Level 1 and 2 Applications:

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.

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

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

For Partnering PI Option Applications: A separate award will be made to each PI’s organization.

Applications Submitted With a PI Who is a Postdoctoral Fellow: The PI of the award is expected to manage the budget during the award period, not their mentor.

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

May be requested for (not all-inclusive):

• Costs for one investigator to travel to one scientific/technical meeting per year. The intent of travel to scientific/technical meetings should be to present project information or disseminate project results from the FY26 BCRP Breakthrough Award Levels 1 and 2.

Must not be requested for:

• Clinical trial costs.

https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=Period%20of%20Performance%3A%20The%20time%20interval%20between%20the%20start%20of%20a%20federal%20award%20and%20the%20planned%20end%20date.

https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=in%20project%20activities.-,Cost%20Cap%3A,-The%20maximum%20cost https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=Period%20of%20Performance%3A%20The%20time%20interval%20between%20the%20start%20of%20a%20federal%20award%20and%20the%20planned%20end%20date.

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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 PI or Initiating PI must submit the following pre-application component.

Letter of Intent (LOI) (one-page limit): Provide a brief description of the research to be conducted. Include the overarching challenge(s) under which the application will be submitted.

4.3. Full Application Components

PPIO: The CDMRP requires separate full application package submissions for the Initiating PI and each Partnering PI, even if the PIs are located within the same organization. The application submission process for the Partnering PI uses an abbreviated full application package.

4.3.1 Full Application Components for the PI or Initiating PI

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: Upload as “ProjectNarrative.pdf”.

Page Limit: The page limits for the Project Narrative are dependent upon the funding level of the application:

Funding Level 1: Seven-page limit

Funding Level 2: 14-page limit

Funding Level 2 – Population Science Studies: 14-page limit 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://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 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#_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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Outline for Project Narrative: Describe the proposed project in detail using the outline below.

Background: Briefly describe the ideas and reasoning on which the proposed work is based. For Funding Level 1 applications, preliminary data are not required, but may be included. For Funding Level 2 applications, provide sufficient preliminary data in breast cancer to support the feasibility of the work proposed. Whether or not preliminary data are available, the application must demonstrate logical reasoning and provide a sound scientific rationale for the proposed project 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 or the objective to be reached.

Specific Aims: Concisely explain the specific aims of the study.

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 accessibility to the data, samples, and/or cohort(s) necessary for the project, and provide appropriate letters of support in Attachment 2: Supporting Documentation. 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.

For all applications proposing clinical research, describe the strategy for the inclusion of women and minorities appropriate to the objectives of the study, including a description of the composition of the proposed study population in terms of sex, racial, and ethnic group, and an accompanying rationale for the selection of subjects.

Studies utilizing human biospecimens or datasets that cannot be linked to a specific individual, ethnicity or race (typically classified as exempt from Institutional Review Board [IRB] review) are exempt from this requirement. Anticipated enrollment table(s) with the proposed enrollment distributed on the basis of sex, race and ethnicity should be provided as part of the application’s Supporting Documentation (Attachment 2).

Statistical Plan: Describe the statistical plan including power analysis, as appropriate, for the research project.

Research Team: Describe how the combined backgrounds and breast cancer-related expertise of the research team will enable successful conduct of the project.

https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Content_Form_Full_App_Submission:~:text=Clinical%20Research%3A,-For%20the

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○ Attachment 2: Supporting Documentation: Combine and upload as a single file named “Support.pdf”.

There are no page limits for these components unless otherwise noted. Include only components described below; inclusion of items not requested or viewed as an extension of the Project Narrative will result in the removal of those items or may result in administrative withdrawal of the application.

References Cited: List the references cited in the Project Narrative using a standard reference format (include URLs, if available).

List of Abbreviations, Acronyms and Symbols: Provide a list of abbreviations, acronyms and symbols.

Facilities, Existing Equipment and Other Resources: Describe the facilities and equipment available for performance of the proposed project; include any additional facilities or equipment proposed for acquisition at no cost to the award. Indicate whether government-furnished facilities or equipment are proposed for use. If so, reference the original or present government award under which the facilities or equipment items are now accountable. There is not a standardized form for this information.

Publications and/or Patents: Include a list of relevant publication URLs and/or patent abstracts. If articles are not publicly available, then copies of up to five published manuscripts may be included in Attachment 2. Extra items will not be reviewed.

Letters of Support: Provide individual letters signed by collaborating individuals and/or organizational officials demonstrating that the PI has the support and resources necessary for the proposed work. Letters from the PI’s Department Chair, or appropriate organization official, should also confirm that the PI(s) meet eligibility criteria. If applicable, provide a letter of support, signed by the lowest-ranking person with approval authority, confirming participation of intramural DOW collaborator(s) and/or access to military populations, databases or DOW resources. If applicable, provide a letter of support signed by the VA Facility Director(s), or an individual designated by the VA Facility Director(s), confirming access to VA patients, resources and/or VA research space.

Letters of Recommendation (only applicable and required for applications submitted with a PI who is a postdoctoral fellow; one-page limit is recommended): The mentor(s) should provide a letter of recommendation on organizational letterhead describing:

▪ The degree to which the PI participated in the development of the research idea.

▪ How well the PI can manage the technical and administrative aspects of the award.

▪ How well the PI can successfully accomplish the proposed research.

Intellectual and Material Property Plan (if applicable): Provide a plan for resolving intellectual and material property issues among participating organizations.

Research Sharing Plan: Describe the type of data or research resources to be made publicly available as a result of the proposed work. Describe the mechanism (e.g., direct sharing, repository, mixed mode) by which data and resources generated during the period of performance will be shared with the research community and https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=%C2%B7-,Supporting%20Documentation%3A,-Combine%20and%20attach

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FY26 Breast Cancer Breakthrough Award Levels 1 and 2 13 other affected communities, including clinical research participants. If applicable, include the name of the repository(ies) where scientific data and resources arising from the proposed study will be archived. Identify and provide the rationale for any data or resources that will not be shared (e.g., for intellectual property, feasibility, cost, or other considerations). The plan should also protect participant privacy, confidential and proprietary data, and performer/third-party intellectual property.

Provide a milestone plan for disseminating data/results including when data and resources will be made available to other users. In cases where the study participant could potentially derive medical or other benefit from the information, explain whether the results of screening and/or study participation will be shared with the participant or their primary care provider, including results from any screening or diagnostic tests performed as part of the study.

Do not submit a copy of the National Institutes of Health (NIH) Data Management and Sharing Plan or duplicate the Data Management Plan which will be requested only after a recommendation for funding is made.

Refer to the CDMRP Directive on Sharing Data and Research Resources for more information about the CDMRP’s expectations for making data and research resources publicly available.

Inclusion Enrollment Report (only required if clinical research is proposed):

Provide an anticipated enrollment table(s) for the inclusion of women and minorities using the “Public Health Service (PHS) Inclusion Enrollment Report”, a three-page fillable PDF form, that can be downloaded from eBRAP. The enrollment table(s) should be appropriate to the objectives of the study with the proposed enrollment distributed on the basis of sex, race, and ethnicity. Studies utilizing human biospecimens or datasets that cannot be linked to a specific individual, ethnicity, or race (typically classified as exempt from IRB review) are exempt from this requirement.

Sex as a Biological Variable (SABV) Strategy (two-page limit is recommended):

Describe the strategy for how sex will be considered as a biological variable. This strategy should include a brief discussion of what is currently known regarding sex differences in the applicable research area. Clearly articulate how sex as a biological variable will be factored into the data analysis plan and how data will be collected and disaggregated by sex. If needed, provide a strong rationale for proposing a single-sex study, based on justification from scientific literature, preliminary data or other relevant considerations. Refer to the CDMRP Directive on Sex as a Biological Variable in Research for additional information.

○ Attachment 3: Technical Abstract (one-page limit): Upload as “TechAbs.pdf”.

Write the technical abstract using the outline below. Clarity and completeness within the space limits are highly important.

Background: Present the scientific rationale behind the proposed research project.

Overarching Challenge(s): State the overarching challenge(s) that the proposed research will test and briefly state how the project will address the challenge in a way that can lead to or make a breakthrough and have a major impact. Simply identifying an overarching challenge is not sufficient.

Hypothesis/Objective(s): State the hypothesis to be tested and/or objective(s) to be reached. Provide evidence or rationale that supports hypothesis/objective.

https://ebrap.org/eBRAP/public/Program.htm#:~:text=Directive%20on%20Sharing%20Data%20and%20Research%20Resources https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Content_Form_Full_App_Submission:~:text=Clinical%20Research%3A,-For%20the https://ebrap.org/eBRAP/public/Program.htm#:~:text=Statement%20of%20Work-,Public%20Health%20Service%20Inclusion%20Enrollment%20Report,-n/a https://cdmrp.health.mil/pubs/pdf/CDMRP%20SABV%20Directive_Revised_MAR2025_signed.pdf https://cdmrp.health.mil/pubs/pdf/CDMRP%20SABV%20Directive_Revised_MAR2025_signed.pdf https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=%C2%B7-,Technical%20Abstract%3A,-Attach%20as%20%E2%80%9CTechAbs

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FY26 Breast Cancer Breakthrough Award Levels 1 and 2 14

Specific Aims: State the specific aims of the study.

Study Design: Describe the study design, including appropriate controls.

Impact: Describe how the proposed project will lead to a major impact for the overarching challenge(s). Explain how the research meets the requirements for high potential to lead to or make a breakthrough and accelerate progress toward ending breast cancer.

Military Relevance: Describe how the study is relevant to military health.

Innovation (required for Level 1 applications only): Explain how the proposed research is innovative and will investigate a novel idea or research question that introduces a new paradigm or challenges existing paradigms.

○ Attachment 4: Lay Abstract (one-page limit): Upload as “LayAbs.pdf”.

The lay abstract should address the points outlined below in a manner that is readily understood by readers without a background in science or medicine. Avoid overuse of scientific jargon, acronyms and abbreviations. Do not duplicate the technical abstract.

– Clearly describe the scientific rationale, objective and aims of the application.

– Describe the ultimate applicability of the research.

▪ Which overarching challenge(s) does this research address?

▪ What types of patients or at-risk individuals will the research help and how will it help them?

▪ What are the potential clinical applications, benefits and risks?

▪ What is the projected timeline for achieving a patient-related outcome?

▪ How will the proposed project lead to or make a breakthrough in breast cancer and accelerate progress toward the BCRP’s mission of ending breast cancer?

▪ If the research is too basic for clinical applicability, describe the interim outcomes.

▪ What is the potential benefit of the proposed study and the anticipated outcomes to Service Members, Veterans and/or their Families?

○ Attachment 5: Statement of Work (three-page limit): Upload as “SOW.pdf”.

Refer to eBRAP for the Suggested SOW Format.

For guidance on preparing the SOW, refer to the Example: Assembling a Generic Statement of Work. Include milestones for data or research resource(s) sharing.

Partnering PI Option: Each PI must submit an identical copy of a jointly created SOW. The specific contributions of the Initiating PI and the Partnering PI should be clearly noted for each task.

○ Attachment 6: Impact Statement (300 words or less recommended; one-page limit): Upload as “Impact.pdf”.

The statement should address the points outlined below written in a manner that is readily understood by readers without a background in science or medicine. DO NOT restate the research strategy as part of the Impact Statement.

– Articulate concisely how the proposed project will have a major impact on at least one of the overarching challenges.

https://ebrap.org/eBRAP/public/Program.htm#:~:text=Suggested%20SOW%20Format https://ebrap.org/eBRAP/public/Program.htm#:~:text=Example%3A%20Assembling%20a%20Generic%20Statement%20of%20Work https://ebrap.org/eBRAP/public/Program.htm#:~:text=Example%3A%20Assembling%20a%20Generic%20Statement%20of%20Work https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=%C2%B7-,Lay%20Abstract%3A,-Attach%20as%20%E2%80%9CLayAbs https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=%C2%B7-,Statement%20of%20Work%3A,-Attach%20as%20%E2%80%9CSOW

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FY26 Breast Cancer Breakthrough Award Levels 1 and 2 15

– Explain how the project meets the requirement for high potential to accelerate progress toward ending breast cancer substantially beyond an incremental advance.

– Explain briefly how the proposed research will lead to a fundamentally new strategy or approach to preventing or ending breast cancer that is significantly more effective than current strategies or approaches.

– Identify the breast cancer patients or at-risk individuals who would ultimately benefit from the proposed research. Justify how these individuals would benefit from the project.

– Explain briefly how the proposed research is relevant to Service Members, Veterans, and their Families.

○ Attachment 7: Partnership Statement (one-page limit): Upload as “Partnership.pdf”. (Attachment 7 is only applicable and required for applications submitted under the Partnering PI Option.)

Describe the partnership and combined expertise of the Initiating and Partnering PIs that are critical for the research strategy and completion of the proposed work. Explain how the partnership will better address the research question and why the work should be done together rather than through separate efforts. Explain how both PIs have equal intellectual input into the design of the project and will devote similar levels of effort to the conduct of the project. Explain the plan to balance funding between both PIs or otherwise provide appropriate justification.

○ Attachment 8: Mentorship Statement (one-page limit): Upload as “Mentorship.pdf”. (Attachment 8 is only applicable and required for applications in which the PI is a postdoctoral fellow.)

Identify the PI’s mentor(s) and provide a description of their qualifications to mentor the PI in the successful execution and completion of the proposed work. Describe the mentor’s experience in breast cancer research and their success in research projects relevant to the current application. Describe the mentor’s commitment to the PI’s project, including details of their proposed interactions with the PI and how they will support the PI’s research endeavors.

o Attachment 9: Innovation Statement (one-page limit): Upload as “Innovation.pdf”.

(Attachment 9 is only applicable and required for applications submitted under Funding Level 1.)

Explain how the proposed research addresses breast cancer in a fundamentally new way. Innovation requires a novel idea or approach that either introduces an entirely new paradigm or challenges existing paradigms in unprecedented ways. It will result in a creative, but scientifically sound, transformation from existing approaches, methods or strategies. The next step in an established process or targeting strategy, or building on significant preliminary data, does not meet the criteria for innovation.

○ Attachment 10: Representations (Grants.gov submissions only): Upload as “RequiredReps.pdf”. All extramural applicants must complete and submit the Required Representations document available on eBRAP.

○ Attachment 11: Suggested Intragovernmental/Intramural Budget Form (if applicable): Upload as “IGBudget.pdf”. If an intramural DOW organization will be a collaborator in the performance of the project, complete a separate budget for that organization using the Suggested Intragovernmental/Intramural Budget form available on eBRAP.

https://ebrap.org/eBRAP/public/Program.htm#:~:text=Required%20Representations 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 https://ebrap.org/eBRAP/public/Program.htm#:~:text=Suggested%20Intragovernmental/Intramural%20Budget https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=B.%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%20Representations https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=Suggested%20Intragovernmental/Intramural%20Budget%20Form%2C%20if%20applicable%3A

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FY26 Breast Cancer Breakthrough Award Levels 1 and 2 16

(c) Additional Application Materials:

The following are additional forms for application submission. Follow the instructions specific to the submission portal, as found within the GAI.

i. Research & Related Senior/Key Person Profile (Expanded)

○ Biographical Sketch

○ Current/Pending Support

Intragovernmental applicants must include their internally supported research and development programs.

ii. Research & Related Budget

Partnering PI Option: Initiating and Partnering PIs must have a separate budget and justification specific to their distinct portions of the effort that the applicant organization will submit as separate Grants.gov or eBRAP application packages. The Initiating PI should not include budget information for Partnering PI(s), or vice versa, even if they are located within the same organization. Refer to Section 3.3, Funding Details, for detailed budget information.

iii. Project/Performance Site Location(s)

iv. Research & Related Subaward Budget Attachment(s) (if applicable, Grants.gov submissions only)

4.3.2. Full Application Components for the Partnering PI

Refer to the equivalent attachment above for details specific to each of the following application components. See Appendix 1 for a checklist of the full application components required for the Partnering PI.

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

(b) Attachments:

○ Attachment 5: Statement of Work (three-page limit): Upload as “SOW.pdf”.