Department of Defense(DoD) Breast Cancer Research Program(BCRP) Clinical Translational Research Award(CTR)

The summary for the Department of Defense(DoD) Breast Cancer Research Program(BCRP) Clinical Translational Research Award(CTR) grant is detailed below. This summary states who is eligible for the grant, how much grant money will be awarded, current and past deadlines, Catalog of Federal Domestic Assistance (CFDA) numbers, and a sampling of similar government grants. Verify the accuracy of the data FederalGrants.com provides by visiting the webpage noted in the Link to Full Announcement section or by contacting the appropriate person listed as the Grant Announcement Contact. If any section is incomplete, please visit the website for the Department of Defense, which is the U.S. government agency offering this grant.

Department of Defense(DoD) Breast Cancer Research Program(BCRP) Clinical Translational Research Award(CTR): The overall goal of the FY06 BCRP is to promote research focused on eradicating breast cancer. Therefore, the BCRP challenges the scientific community to design innovative research that will foster new directions for, address neglected issues in, and bring new investigators to the field of breast cancer research. The BCRP focuses its funding on innovative projects, particularly those involving multidisciplinary and/or multi-institutional collaborations and alliances that have the potential to make a significant impact on breast cancer. Projects that address underinvestigated avenues of research or novel applications of existing technologies are strongly encouraged. The BCRP encourages risk-taking research; however, all projects must demonstrate solid scientific judgment and rationale. The BCRPs objective within this context is to fund a balanced portfolio of scientifically meritorious research related to all aspects of breast cancer. The BCRP seeks proposals from all areas of laboratory, clinical, behavioral, and epidemiologic research, including all disciplines within the basic, clinical, psychosocial, behavioral, sociocultural, and environmental sciences, nursing; occupational health, alternative therapies, public health and policy, ethics, and economics. Proposals that address the needs of minority, low-income, rural, and other underrepresented and/or medically underserved populations are strongly encouraged. The Clinical Translational Research (CTR) award mechanism is designed to sponsor innovative preclinical and clinical/translational research that will result in substantial improvements over current approaches to breast cancer chemoprevention and therapy, including predictive biomarker studies that would better align treatment options with more specific breast cancer subtypes and/or may identify a new way to treat breast cancer patients. These awards are intended to support both new and established scientists across a broad spectrum of disciplines in research projects that are likely to have a major impact on breast cancer chemoprevention and/or therapy by applying promising and well-founded laboratory or other preclinical or clinical research findings to the treatment of patients with, or populations at risk for, breast cancer. Applicants may have already originated projects in their laboratories that will form the basis for clinical trials to be conducted during this award period. Alternatively, they may leverage chemopreventive or therapeutic technologies from partnerships with industry (if they can demonstrate the ability to conduct the required preclinical and Phase I or II clinical trial). In exceptional cases, projects may capitalize on independently published research. Applicants must include preliminary data or exceptional rationale to support the feasibility of their hypotheses and approaches, along with a plan to conduct a prospective clinical trial or study during the course of the award. Proposals must also include a clear experimental plan and, as appropriate, a properly powered statistical plan to perform a prospective clinical trial, as well as information demonstrating that participants will be accrued to the proposed clinical trial for a minimum of 1 year during the award period. Proposals addressing predictive biomarker studies must be supported by a previously-conducted retrospective study and must include data validating the methods for the collection, storage, annotation and analysis of human biological substances. When appropriate, all chemoprevention or therapeutic interventions developed through the CTR award should meet the requirements for obtaining Investigational New Drug (IND) or Investigational Device Exemption (IDE) status (or other approvals required by the US Food and Drug Administration [FDA]) during the lifetime of the award. Participating institutions must be willing to resolve potential intellectual and material property issues and remove institutional barriers to achieving high levels of cooperation. An intellectual and material property plan agreed to by all participating institutions is required in the proposals administrative documentation. For FY06, CTR proposals are only being sought in the areas of chemoprevention and therapeutics. The proposed study could begin the clinical evaluation of a predictive biomarker concept for customized treatment that would better align treatment options with more specific breast cancer subtypes. This award is not intended to support the study of new combinations of conventional breast cancer therapies, target discovery, drug screens, lead agent optimization, or the late stages of drug development. All investigators interested in applying for a CTR Award must submit a preproposal. Full proposals will be submitted based upon invitation. Do not submit a full Clinical Translational Research Award proposal unless you receive a letter of invitation. The CDMRP expects to allot approximately $8 M of the $127.5M FY06 BCRP appropriation to fund approximately 4 CTR Awards, depending on the quality and number of proposals received. These awards have no dollar amount restrictions but research should be completed within 5 years. No more than $5M will be granted in any single year during the lifetime of the award. Funding will be disbursed in installments. The first installment will be made at the time of the award; subsequent installments will be contingent upon the successful completion of specific milestones. Milestones from the approved Statement of Work will be determined during the award negotiation process. Failure to complete each milestone may result in forfeiture of the subsequent installment of Breast Cancer CTR Award funding. The nature of the BCRP does not allow for renewal of grants or supplementation of existing grants. Estimated timelines for the FY06 BCRP Clinical Translational Research Award are as follows: Preproposals are due by, April 11, 2006, 5:00 p.m. Eastern time and Proposal Submission is due July 25, 2006, 5:00 p.m. Eastern time. Electronic submission is required. Proposal will be accepted only as PDF files submitted through the CDMRP eReceipt system. The CDMRP uses a two tier review process for proposals: scientific peer review, followed by programmatic review. Details of both tiers of review can be found in the full text of the Program Announcement. Applicants should submit questions as early as possible. Every effort will be made to answer questions within 5 working days. Phone: 301-619-7079, Fax: 301-619-7792, e-mail : [email protected], Mail: Commander U.S. Army Medical Research and Materiel Command, ATN: MCMR-ZB-C (W871XWH-06-BCRP-CTR), 1077 Patchel Street(Building 1077), Fort Detrick, MD 21702-5024.