SEDE Study

CENTER FOR ADVANCED BREAST CARE TO PARTICIPATE IN NATIONAL
STUDY OF WOMEN AT HIGH-RISK FOR BREAST CANCER

Study to Determine Relationship between Early Cellular Changes in the Breast
and Long-Term Breast Health Using Ductal Lavage Procedure

Arlington Heights, Ill.—October, 2005—The Center for Advanced Breast Care today announced that it is one of sixteen medical centers nationally to participate in a three-year study of women at high-risk for developing breast cancer. Physicians at the Center for Advanced Breast Care are among a select, national group of breast cancer specialists who will evaluate and monitor early cellular changes in the breast milk ducts of high-risk women using ductal lavage, a minimally-invasive procedure of collecting cells from the breast milk ducts—where more than 95 percent of breast cancers originate. The objective of the study, called “SEDE” (Serial Evaluation of Ductal Epithelium), is to define the relationship between early cellular changes in the breast as identified by the ductal lavage procedure and long-term breast health. The results of the study will establish the role that breast duct cell changes, as obtained by ductal lavage, plays in gauging a high-risk woman’s individual risk for developing breast cancer.

At-risk women may be eligible to participate in the study if they meet the following conditions:

  • Are between the ages of 35-70
  • Have a family history of breast cancer (multiple family members) or other known risk factors
  • Have no personal history of breast cancer

“At The Center for Advanced Breast Care we are committed to providing women with the most advanced technology to manage their health,” said Michael Kinney, MD. “Our goal is to help determine if the analysis of a woman’s breast duct cells can provide additional information about her near-term risk of developing breast cancer when she is already at an elevated lifetime risk for breast cancer. It is our hope that women at-risk for breast cancer in the Chicago area will benefit from our participation in this important national study that may ultimately benefit the millions of women who are at risk for developing this serious disease.”

Study participants will undergo ductal lavage every six months for three years in conjunction with a clinical breast exam every six months and a mammogram every twelve months. Physicians at The Center for Advanced Breast Care will monitor participants’ breast health for an additional two years. The ductal lavage procedure and ongoing physician monitoring is available free of charge to women who quality for the study.

For more information about the SEDE study at the The Center for Advanced Breast Care, please contact 1-888-KNOW-RISK (1-888-566-9747) or call The Center for Advanced Breast Care at 847-797-9000.

About the Ductal Lavage Procedure
Commercially available as the FirstCyte Breast Test, the ductal lavage procedure begins with the application of an anesthetic cream to the nipple to numb the area. Next, a small suction cup is used to help draw tiny amounts of ductal fluid up to the nipple surface, to determine the duct’s natural opening. A tiny plastic tube is inserted into the ductal opening and an anesthetic is delivered to numb the inside of the duct, and then the duct is rinsed with a balanced electrolyte solution to collect cells. The cell specimen is then sent to a laboratory to determine whether the cells are normal or atypical. The devices used in the ductal lavage procedure are cleared by the U.S. Food and Drug Administration (FDA) for obtaining breast duct cells.