Circulating Tumor Cells (CTCs): A Potential Screening Test for Clinically Undetectable Breast Carcinoma

With an estimated > 2 million women with undetected breast cancer in the United States, the
need for improved early detection is imperative. Early diagnosis for these women is key to
minimizing quality life-years lost to disease and optimizing success of treatment. Evidence
now exists supporting the finding that systemic spread is an early event in the natural
history of breast cancer, manifested as a release of single cancer cells from the incident,
clinically undetectable tumor, which circulate through the bloodstream and deposit within
remote tissues. Reliable and accurate detection of these circulating tumor cells (CTCs) is
now possible with a simple peripheral venous blood draw. This study hypothesizes that women
with CTCs and no other signs of malignancy have clinically undetectable disease.

This study will attempt to validate this technology as a breast cancer screening test and
acquire data to determine the clinical validity and utility of this proposed screening
methodology on a relatively young, ethnically diverse population who are eligible military
health care beneficiaries. Furthermore, this study will attempt to bank identified CTCs in
order to perform additional molecular analyses in the future. The specific aims are to
develop a simple, reliable, cost-effective, and clinically relevant breast cancer screening
test in order to identify subclinical disease early in its natural history in subjects at
risk of progression to clinically apparent disease over the ensuing decade. The ultimate
goal is to decrease the treatment-related morbidity and cause-specific mortality of breast
cancer. An experienced team devoted to the care of patients with breast disease has been
assembled to achieve this goal.