The Women’s Cancer Research Fund is committed to saving lives by raising funds and awareness for the millions of women and their families at risk for, or affected by cancer. The goal is to advance leading-edge science by supporting the efforts of the nation’s foremost investigators and advocates of women’s cancer research.

EIF’s Breast Cancer Biomarker Project is a multi-year effort led by world-class scientists to find a biomarker – a protein – that would reveal the presence of breast cancer in the blood to provide early detection, predict the potential for metastasis and guide therapeutic response.

EIF’s Breast Cancer Biomarker Project:

Detecting breast cancer early is the single most important thin we can do to save lives. Most women who die of breast cancer do so because the disease was detected when it was too advanced to cure. So how do we catch it early enough? It’s a question that EIF’s Breast Cancer Biomarker Discovery Consortium endeavors to answer. Our blood holds the key in molecules called biomarkers – unique proteins that may signal the presence of cancer. The goal of the consortium project, sponsored by the Entertainment Industry Foundation/Women’s Cancer Research Fund, is to discover which biomarkers are related to breast cancer.

The foundation program has assembled a group of scientists at the leading edge of technology to discover molecular signlas for breast cancer. The study brings together experts in the fields of proteomics, informatics and clinical breast cancer care. The group consists of Bobel Laureates, internationally recognized scientists and leaders of some of the best scientific inistutions. Never before has a group of this caliber collaborated on such an ambitious biomarker study – and this groundbreaking approach is made possible by the Women’s Cancer Research Fund’s leadership and vision.

Scientists conceptualize the project in three stages:

Stage One – apply leading proteomics and gene expression technologies to examin blood, tissue and breast fluids to identify hundreds of biomarker candidates. Close collaboration of the project’s clinical breas cancer experts and technology leaders is critical.

Stage Two – develop assays (tests) to measure the biomarkers at very low concentrations in the blood.

Stage Three – confirm the presence of the most promising biomarkers in hundreds of blood samples from healthy women and women with breast cancer.

The Breast Cancer Biomarker Discovery Consortium’s vision for progress is shared internationally by scientific leaders: support and momentum are growing for the development of biomarker discovery. The EIF is taking a crucial role in advancing the field of biomarker research by funding this important project.

Progress:

PHASE I (2005-2009)

Technological Advancements in Biomarker Discovery 

During its first three years, the Consortium detected and prioritized approximately 2000 breast cancer biomarker candidates through the analysis of high quality samples from breast cancer patients using cutting edge protein detection technologies, novel data processing and statistical methods, and DNA analyses.  Achievement of this major milestone was built on early successes of the Consortium in both technology development and biomarker discovery.

• Technology improvements by Consortium scientists resulted in 4-5 fold improvement in the detection of hard-to-find proteins in blood and up to 50-fold improvement in protein detection in other biological fluids.
• The Consortium demonstrated for the first time that uniform results between expert labs undertaking complex proteomics experiments could be achieved
• Development of a novel statistical process provided the means for incorporating a wealth of other types of information into the process of selecting candidates from the discovery phase for further evaluation.

Breakthroughs 

The Consortium made remarkable and unanticipated advances in technologies directly relevant to biomarker discovery and verification.  These advances included targeted analysis methods for specifically screening and measuring low level candidates in blood; novel applications of high-performance instruments to further increase sensitivity and specificity of candidate verification, and new methods for faster and potentially more sensitive protein measurements and blood tests.

PHASE II (2010-2012)

The critical second phase of the project, Verification, involves testing breast cancer biomarker candidates emerging from Discovery (Phase I) to determine which contribute to the ability to distinguish breast cancer patients from those without breast cancer.  In most biomarker programs this is done by using whatever small numbers of suitable antibodies happen to be available.  Testing is spotty at best, and only a few candidates are typically evaluated in any project – greatly reducing the chances of success.  By figuring out how to do candidate verification using the mass spectrometer, rather than only antibodies, Consortium investigators have completely changed the paradigm.

For the first time the approach can be systematic, and large numbers of candidates can be tested. In the first step of this process, called Qualification, the Consortium tested more than 1100 protein biomarker candidates in blood samples drawn from 25 patients with breast cancer and 25 cancer-free patients (“controls”) to determine which were reliably detected in blood. Almost 500 individual tests are now being finalized that will allow precise measurement of 250 of the 350 detectable candidates in blood samples of individual patients, the central goal of Verification. Measurement in samples from 100 patients with breast cancer and 100 controls are about to begin. The breadth and scale of this verification work is unprecedented in protein biomarker development.

We are accelerating measurement of approximately 75 high priority breast cancer biomarker candidates.  Verification on this scale is unprecedented, and represents a transformative paradigm shift in biomarker development. Candidates successful in these initial analyses will be measured in at least 70 additional sample pairs. Once these measurements have been completed we will be able to estimate the prospects of realizing the ultimate goal of delivering clinically useful biomarkers to the breast cancer community.

This research and discovery translates to the best chance to date to find diagnostic markers of breast cancer.

Click Here to View EIF Breast Cancer Biomarker Project Scientists