Purpose

Military Relevance

Breast cancer is the most common non-skin cancer in women. It is the single greatest cause of cancer deaths among women under 40, and is a significant cause of mortality for women in the United States Armed Forces. Breast cancer mortality among women under 50 years accounts for more than 40% of years of life lost due to this disease. The economic, social and emotional costs to families are far greater when a young woman dies than when an older woman dies of breast cancer. The more aggressive nature of the disease in young patients along with the attendant costs underscores the importance of early detection of breast cancer in young women. Breast cancer is a curable disease if it is detected early; as such early detection is related to survivorship, cost of treatment and quality of life for the affected woman.

The majority (over 90%) of women in active military service are below 40 years of age. The Department of Defense (DOD) with its high percentage (and increasing percentage, as all roles in the military are now open to all genders, including combat roles) of young women and its commitment to health care is particularly concerned about breast cancer. When discovered at a later stage, treatment of breast cancer is expensive, aggressive and results in considerable disruption to the woman’s ability to contribute to the military and society. Cost and disruption to life are considerably less when the carcinoma is discovered at an earlier stage and therefore treatable with less invasive methods and curable in up to 90% of cases for Stage I disease.

The active duty military force is approximately 20% female. Most of these service members are in the age range (30-40 years) where routine screening for breast cancer consists only of clinical breast examination. Both mammography and clinical breast examination have a very poor accuracy in the young active duty force in determining which breast abnormalities require treatment, and which are benign and can be left alone. The immense scale and impact of this problem for the military can be assessed by the fact that there were over 2,000 cases of breast cancer diagnosed in active duty service members over the last ten years (source: ACTURS DoD Tumor Registry data).

As indicated, approximately 20% of the active duty military force is female, most under the age of 50. Breast cancer strikes one in eight women in her lifetime, and there is a documented change in breast cancer incidence in recent years, such that breast cancer is being detected and diagnosed more often in younger women (under age 50), and the same is true in our military members. In the same way that diagnostic and therapeutic efforts through the military and US Army are carried out in infectious disease care and research, eg. Malaria, Typhoid, etc., so too must the military continue to address the effects of the scourge of breast cancer and breast diseases on the 20% of total active duty force who are women.

Moreover, CBCP developed and to this day maintains the only specialty breast cancer evaluation and treatment center in the US Army, which is at the CBCP Breast Care Center at Walter Reed National Military Medical Center.

Additionally, ours is the only Army facility that financially supports direct genetic testing of active duty (all Services) women who are identified in our Center as being in a high risk category of carrying a BRCA genetic mutation, which when present can signify an up to 90% increased risk of breast cancer development, and for which we then deploy individualized cancer preventive therapies.

The CBCP is the Army-recognized and Military-recognized specialty referral center for tri-service active duty personnel from around the globe with medical disorders related to all breast diseases and breast cancer. CBCP Breast Care Center routinely cares for women on active duty Army from places such as the Middle East, Southwest Asia, OEF, Korea, Europe, and the Far East. CBCP at WRNMMC annually cares for over 7,000 patients.

Public Purpose

The foundation of the CBCP has been in existence for over fourteen years. Its uniqueness and excellence is well known and has been attested to by numerous world-class cancer research experts, and from the large number of public and invited presentations we have given over the last 16 years. CBCP researchers also have an extensive peer-reviewed publication and scientific communication record, now numbering in the hundreds of scientifically-validated contributions. This proposal is an application that continues and refines/focuses this established, unique effort.

The CBCP has the world’s largest biorepository of highly-characterized and pristinely-collected specimens from breast patients made up of human breast tissues, lymph nodes, sentinel nodes, sera, bone marrow aspirates, cancers, benign tumors, and pre-malignant disease, which amounts in-total presently to 70,592 specimens as of March 2017. This unique DoD resource, stored, maintained, tracked, and kept under strict QA in the CBCP-contracted repository at the Windber Research Institute since 2001, is used by both internal genomic and proteomic researchers, as well as for targeted collaborations with extramural collaborators from academia, governmental organizations, and corporate entities.

This biorepository is also unique in that its specimens are tightly coupled to highly-accurate clinical, demographic, and pathologic data collected from its originating patients through robust IRB-approved and fully HIPAA (Health Insurance Portability and Accountability Act)- compliant protocols that exceed all existing regulatory requirements for patient consent, privacy, and oversight.

The CBCP has one of the few fully integrated genomic and proteomic molecular biology research programs in the nation devoted exclusively to research in breast diseases. We have an established track record of publication and scientific communication in this field.

The CBCP has deployed a unique biomedical informatics data warehouse system that integrates clinical, pathologic, and molecular data on breast research subjects, allowing for a novel in-silico biology discovery platform.

The CBCP is a true translational research-clinical care environment, where there actually exists an organizationally-driven and structured collaborative effort between basic scientists, clinical scientists, clinicians, nurses, patients, and multiple other personnel.

The CBCP has successfully expanded to other clinical sites and has established other research collaborations with world-renowned lab researchers.