Trial Information

QUANTIFICATION OF CIRCULATING ENDOTHELIAL CELLS (CEC) AND PLASMA ANGIOGENIC FACTORS IN PATIENTS WITH BREAST CANCER

OBJECTIVES:

Primary

- To compare peripheral blood (PB) concentrations of circulating endothelial cells (CEC)
in women with measurable, active breast cancer to PB concentrations of CEC in a control
population of women with a history of breast cancer who are currently without evidence
of active disease.

Secondary

- To compare in women with measurable breast cancer the relationship between PB
concentrations of CEC prior to and at 3 and 6 weeks following initiation of a new
chemotherapy or hormonal therapy, and correlate these values with clinical response to
treatment to determine if CEC can be used as a tumor marker or indicator of disease
burden.

- To compare PB concentrations of CEC to levels of plasma proteins associated with
angiogenesis, including vascular endothelial growth factor, in women with active or a
prior history of breast cancer.

OUTLINE: Peripheral blood and plasma samples are collected for analysis of circulating
endothelial cells (CEC) and angiogenic growth factor levels. Blood samples from patients
initiating a new chemotherapy or hormonal therapy for breast cancer are collected at
baseline and at 3 and 6 weeks following the start of treatment. CEC are quantified via flow
cytometry and plasma angiogenic markers are assessed via ELISA.

PROJECTED ACCRUAL: A total of 100 patients with active, measurable breast cancer and 100
patients with a prior history of breast cancer will be accrued for this study.