Opportunity Information: Apply for W81XWH 12 BCRP CTR

  • The Dept. of the Army USAMRAA in the science and technology and other research and development sector is offering a public funding opportunity titled "DOD Breast Cancer Clinical Translational Research Award" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 12.420 Military Medical Research and Development.
  • This funding opportunity was created on Feb 23, 2012 and posted on Feb 23, 2012.
  • Applicants must submit their applications by Aug 15, 2012. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • The funding agency has allocated a total of $9,000,000.00 to eligible and selected applicants.
  • The number of recipients for this funding is limited to 3 candidate(s).
  • Eligible applicants include: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled Additional Information on Eligibility.
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Opportunity Summary:

The DOD Breast Cancer Clinical Translational Research (CTR) Award, offered through the Department of the Army and administered under the Breast Cancer Research Program (BCRP), is designed to push breast cancer research beyond promising laboratory findings and into real-world patient testing. The main goal is to produce meaningful improvements over current prevention and treatment approaches, especially projects aimed at preventing primary breast cancer, reducing recurrence, or stopping progression to metastatic disease. In practical terms, the program is looking for studies that are ready to translate strong preclinical results into clinical settings where they can begin to influence how breast cancer is managed.

This opportunity specifically targets advanced translational research that directly leads into a prospective clinical trial that will actually occur during the award period. Applicants are expected to be close to the clinic already, not at the early discovery stage. Proposed projects can come from a research team that has developed a therapy, diagnostic, or intervention internally, or they can be built around partnerships with industry, such as using an existing company platform or candidate drug that is ready for clinical evaluation. Either way, the application has to show that the team can realistically complete both the remaining translational steps and an early phase clinical trial within the proposed timeline.

A key feature of the CTR Award is how strongly it emphasizes readiness and feasibility. Applications must include preliminary data along with a clear scientific and clinical rationale showing why the approach is likely to work and why it should be tested in people now. Because the translational phase is relatively short, applicants are expected to already have proof of concept and demonstrated efficacy in an in vivo model at the time they apply. This requirement makes it clear that the award is meant for projects that have moved past basic plausibility and have generated credible preclinical evidence suggesting potential benefit.

The clinical trial component must be well planned and statistically sound. Proposals need a clear experimental design and a properly powered statistical plan, meaning the trial should enroll an adequate number of participants to answer its primary questions in a meaningful way. Reviewers will also expect applicants to show that they have access to the necessary patient population to complete enrollment and generate interpretable outcomes. In other words, the proposal must demonstrate that the clinical environment, recruitment pathways, and infrastructure are in place so the trial can be executed successfully rather than remaining aspirational.

In terms of award mechanics, this funding opportunity (W81XWH-12-BCRP-CTR) was posted on February 23, 2012, with an application closing date of August 15, 2012, and it was later archived on September 14, 2012. The funding instrument is listed as a cooperative agreement and grant, within the federal research and development category. The program anticipated making about three awards, with an estimated total funding amount of $9,000,000, and it did not require cost sharing or matching. Eligibility was described as unrestricted, meaning a wide range of organizations could apply as long as they met any additional requirements stated in the full announcement.

Overall, the CTR Award is best understood as a bridge between strong preclinical success and early clinical validation. It is aimed at teams that can show they already have convincing in vivo results, have a credible plan to complete the remaining translational work quickly, and are prepared to run a prospective early phase clinical trial with appropriate statistical power and access to participants. For applicants, the central challenge is proving that the project is not only scientifically compelling, but also operationally ready to deliver clinical results within the award period. For questions or access issues related to the full announcement, the listing provides the CDMRP Help Desk contact information at 301-682-5507 and help@cdmrp.org.

FAQs: DOD Breast Cancer Clinical Translational Research (CTR) Award (BCRP)

What is the DOD Breast Cancer Clinical Translational Research (CTR) Award?

The CTR Award is a Department of Defense breast cancer funding opportunity offered through the Department of the Army and administered under the Breast Cancer Research Program (BCRP). It is intended to move breast cancer research beyond promising laboratory findings and into real-world patient testing by supporting advanced translational work that leads directly into a prospective clinical trial during the award period.

What is the main purpose of this award?

The main purpose is to produce meaningful improvements over current breast cancer prevention and treatment approaches by advancing strong preclinical results into clinical settings. Priority aims include preventing primary breast cancer, reducing recurrence, and stopping progression to metastatic disease.

What kinds of projects are a good fit for the CTR Award?

Projects that are already close to the clinic and are ready to translate strong preclinical findings into human testing are a good fit. The award targets advanced translational research that directly leads into a prospective clinical trial that will actually occur during the award period, rather than early discovery or exploratory laboratory work.

Does the award require a clinical trial?

Yes. A defining requirement is that the proposed effort leads into a prospective clinical trial and that the clinical trial will occur during the award period. The application must show the team can complete the remaining translational steps and run an early phase clinical trial within the proposed timeline.

What stage of research is expected at the time of application?

Applicants are expected to be beyond early discovery and basic plausibility. The opportunity emphasizes readiness and feasibility, expecting teams to already have proof of concept and demonstrated efficacy in an in vivo model at the time they apply.

Is preliminary data required?

Yes. Applications must include preliminary data and provide a clear scientific and clinical rationale for why the approach is likely to work and why it is ready to be tested in people now.

What preclinical evidence is expected to demonstrate readiness?

The award expects proof of concept and demonstrated efficacy in an in vivo model at the time of application. This reflects the program focus on credible preclinical evidence suggesting potential benefit before moving into clinical evaluation.

Can projects be based on industry partnerships or company platforms?

Yes. Projects may come from a research team developing a therapy, diagnostic, or intervention internally, or they may be built around partnerships with industry, such as leveraging an existing company platform or candidate drug that is ready for clinical evaluation.

What does the program mean by "advanced translational research"?

In this context, advanced translational research means work that is ready to move from strong preclinical success into clinical testing and that directly enables a prospective early phase clinical trial to be conducted during the award period. It is described as a bridge between preclinical success and early clinical validation.

What are the expectations for the clinical trial design?

The clinical trial component must be well planned and statistically sound. Proposals need a clear experimental design and a properly powered statistical plan, meaning the trial should enroll an adequate number of participants to answer its primary questions in a meaningful way.

What does "properly powered" mean in the context of this opportunity?

Based on the opportunity description, "properly powered" means the clinical trial includes a statistical plan and enrolls an adequate number of participants to answer the primary questions in a meaningful way, rather than being too small to produce interpretable conclusions.

Do applicants need to demonstrate access to patients for enrollment?

Yes. Reviewers will expect evidence that the team has access to the necessary patient population to complete enrollment and generate interpretable outcomes. The proposal should demonstrate the clinical environment, recruitment pathways, and infrastructure are in place to execute the trial successfully.

How many awards were anticipated, and what was the estimated total funding amount?

The program anticipated making about three awards, with an estimated total funding amount of $9,000,000.

Is cost sharing or matching required?

No. The listing states that cost sharing or matching was not required.

What is the funding instrument for this opportunity?

The funding instrument is listed as a cooperative agreement and grant, within the federal research and development category.

Who could apply (what was the eligibility)?

Eligibility was described as unrestricted, meaning a wide range of organizations could apply as long as they met any additional requirements stated in the full announcement.

What is the opportunity identifier?

The opportunity is identified as W81XWH-12-BCRP-CTR.

When was this funding opportunity posted and when did it close?

It was posted on February 23, 2012, and the application closing date was August 15, 2012.

Is this opportunity still active?

No. The listing indicates it was archived on September 14, 2012.

What is the overarching theme of what reviewers are looking for?

The opportunity strongly emphasizes readiness and feasibility. Applicants are expected to show convincing in vivo results, a credible plan to complete remaining translational work quickly, and operational readiness to run a prospective early phase clinical trial with appropriate statistical power and access to participants within the award period.

Who can be contacted for help with questions or access issues related to the full announcement?

The listing provides the CDMRP Help Desk contact information: 301-682-5507 and help@cdmrp.org.

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