Sunday, June 17, 2012

Studying Breast Cancer

Some types of breast cancer can be successfully treated with drugs but treatment for a type of breast cancer more commonly found in young African American women is still limited to radiation and general chemotherapy. Called triple negative breast cancer, this type of cancer is the focus of a 20 month $8.6 million research project that aims to find new diagnostic tools and options for drugs to treat this cancer.

The research project taking place at the Department of Energy’s Pacific Northwest National Laboratory (PNNL) and at DOEs Environmental Molecular Sciences Laboratory (EMSL) in Richland Washington will be led by proteomics researcher Richard D. Smith, and funded by DOD.

“Since triple negative cancers are more likely to hit young women and African American women this indicates that a health disparity issue exists.” According to Karin Rodland, a Cancer Biologist at PNNL, “What’s been holding up the research is trying to get enough samples to thoroughly examine how triple negative cancers operate.”

The researchers are looking at the large population of women in the Army since they have received healthcare for years, plus the fact that the Army has a higher percentage of African American woman, than the general U.S. population. By using the Army’s breast cancer repository, researchers will be able to take advantage of one of the most comprehensive collections of breast cancer clinical samples in the U.S to further their research at DOE.

The researchers will access the Walter Reed-Windber breast cancer repository which is part of the Clinical Breast Care Project (CBCP) located at the Walter Reed National Military Medical Center (WRNMMC) in Bethesda Maryland.

Today, CBCP is successfully working to create an integrated communications network for the flow of biomedical informatics into a master database/warehouse to provide information for researchers. CBCP houses the world’s largest biorepository of high-quality, human breast specimens numbering more than 42,000. The tissue-bank repository is used for internal genomic and proteomic research and is targeted for extramural collaborations with facilities such as NCI’s Cancer Genome Atlas Project.

In another development, FDA has drafted a regulatory guidance describing a new way of conducting breast cancer drug trials that promises to substantially reduce the time and cost of getting new treatments to patients.

The approach is based on a trial design being tested in the I-SPY-2 TRIAL, an innovative Phase II breast cancer trial being conducted under the auspices of the Biomarkers Consortium which is a public-private partnership led by the Foundation for NIH.

The l-SPY 2 TRIAL underway at 19 major cancer research centers combines personalized medicine with a novel investigational design to identify women at high risk of early breast cancer recurrence.

Traditionally, patients with early stage breast cancer must wait years to receive new cancer drugs, which are generally tested first in patients with later stage metastatic disease and approved for use in more curable early stage cancer only after additional clinical trials.

The trial led by Laura Esserman, MD, at the University of California at San Francisco and Dr. Donald Berry, PhD at MD Anderson Cancer Center in Houston, uses specific genetic signatures—biomarkers—in the tumors of patients selected who are most likely to benefit from testing using the new approaches. The trial can test new treatments with significantly fewer participants in half the time.