January 21, 2000

Researchers test new technique to detect breast cancer earlier

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Dr. Mark Kelley

Researchers test new technique to detect breast cancer earlier

A new technique, likened to a "Pap smear for the breast," may someday enable doctors to get to the source of breast cancer and detect it before a lump develops.

Called ductal lavage, the technique is being tested at the Vanderbilt-Ingram Cancer Center and more than 10 other centers to determine whether it can offer a microscopic peek at the early cellular changes inside the milk ducts.

This study is aimed at identifying atypical and malignant cells in women whose mammograms and physical examinations are normal. The ultimate goal is to develop a minimally invasive test that could be used along with mammography and physical examination for breast cancer screening.

"The concept is very simple in that most breast cancers start out in the duct," said Dr. Mark Kelley, assistant professor of Surgery and director of the Vanderbilt Breast Center. "With standard diagnostic techniques, we cannot detect breast cancer until a lump forms or an abnormality appears on the mammogram. This new approach may allow us to identify the earliest malignant changes that occur in the breast ducts before breast cancer develops."

The technique involves a two-step process to first identify ducts in the breast that produce fluid and then to "lavage," or wash, these ducts with saline to obtain thousands of cells that line the duct for examination under a microscope.

A three-member team of pathologists, including Dr. David Page, professor of Pathology and Preventive Medicine, will examine the samples. They will determine whether the samples are normal, reflective of atypical though not yet malignant changes, or clearly malignant.

"This is a logical extension of our realization that many early cancers are confined to one duct system," Page said. "Reaching into the ducts gets our detection capability closer to these lesions. We should be able to detect lesions of high concern with cancer risk implications as well as some lesions confined to a part of a duct system, particularly some types of carcinoma in situ."

The concept behind the technique is very similar to the Pap smear, the gold standard for screening women for cervical cancer. In a Pap smear, cells are removed directly from the cervix and examined for pathological changes ranging from normal through malignancy.

"Like a Pap smear, this technique takes cells from where the cancer begins, looks for atypical or early malignant changes that determine which therapies should be used and may help spare the organ," Kelley said.

In women who are diagnosed with malignant cells that suggest an occult cancer, Kelley said his recommendation will be to target that duct for removal along with some surrounding tissue to determine the diagnosis.

In women with atypical changes, treatment decisions will be based on guidelines that already exist for dealing with those specific changes diagnosed through other means, such as fine-needle biopsy, Kelley said.

Such steps might include more frequent examinations or use of preventive agents like tamoxifen, already approved for breast cancer prevention in high-risk women, or participation in the STAR trial for breast cancer prevention, which compares tamoxifen with another similar drug, raloxifene.

The procedure is done under local anesthetic. The fluid-producing ducts are identified using a modified breast pump, while the lavage is done using a specially made, very fine catheter.

A map is made of the duct openings so that any suspicious finding can be traced to the source duct.

"There are eight to 10 ductal openings in each nipple and only a few will produce fluid," explained Kelley.

"We know from previous studies that women who produce fluid and have atypical cells in this fluid are at an increased risk for developing breast cancer."

Pro-Duct Health Inc., the Menlo Park, Calif.-based company that has developed the technology, is sponsoring the national trial, which will test the technique in 300 women considered at high-risk for breast cancer.

"There is a lot of potential application for this technique," Kelley said. "It's exciting to be involved at the beginning of something that could make a tremendous difference in the management of women at high-risk of developing breast cancer."

The technique also holds promise for providing new information about how breast cancer develops at its earliest stages, he said.

Women are eligible for the study if they are over age 18, are at considered a high risk for breast cancer and have had normal mammograms and clinical breast examinations within the past 12 months.

For more information about the study, contact Caroline Gilmore, RN, at 615-343-8761 or the Vanderbilt-Ingram Cancer Center's Cancer Information Program at 1-800-811-8480.