Postmenopausal women at high risk for breast cancer needed for new prevention study

09/09/04

Study will test new drug as a way to prevent breast cancer

(SACRAMENTO, Calif.) -- Healthy, post-menopausal women at high risk for breast cancer may be eligible to participate in a major new international study to determine whether the drug exemestane can prevent the disease. UC Davis Medical Center is the first center in the United States chosen to participate in the study, funded by the Canadian National Cancer Institute. Ultimately more than 5,000 women will be enrolled in the trial, which will last five years.

"Exemestane may present a new breakthrough in the prevention of breast cancer, and has the potential to greatly decrease the risk of this deadly disease, with fewer side effects than currently available preventive medications," said John Robbins, professor of general medicine at UC Davis School of Medicine and Medical Center and principal investigator of the study.

Exemestane is one of a new class of anti-cancer medications known as aromatase inhibitors. Aromatase inhibitors have shown promise in preventing breast cancer recurrences in women previously treated for the disease, but have not yet been clinically studied as a way to prevent breast cancer in high-risk women. The new study is the first designed to answer this question. In addition, the new study will determine whether exemestane plus an anti-inflammatory drug is more effective at preventing breast cancer than exemestane alone.

The drug tamoxifen has already been shown to prevent breast cancer in high-risk women, but many women have found its side effects, including hot flashes, unacceptable. Preliminary research suggests that exemestane will have fewer side effects than tamoxifen.

For the purposes of the study, women are considered at high risk of developing breast cancer if they have had a prior breast biopsy that yielded atypical findings, have had a previous ductal carcinoma (localized breast cancer), have a strong family history of breast cancer or are age 60 or older, among other factors. All participants must be between the ages of 40 and 75, with no history of invasive breast cancer, and in general good health.

Study volunteers will be randomized into one of three groups. In the first group, participants will receive oral exemestane daily for five years along with an oral placebo for the first three years. In the second group, participants will receive oral exemestane daily for five years along with oral celecoxib, an anti-inflammatory agent, for the first three years. In the third group, patients will receive an oral placebo daily for five years. The study will be "double-blind," meaning that neither the participants nor the study investigators will know who is taking the placebo until after the study is over.

According to the American Cancer Society, a woman in the United States has a 1-in-7 lifetime chance of developing invasive breast cancer, up from 1-in-11 odds in 1975.

For more information about the exemestane study at UC Davis Medical Center, please contact Elizabeth Winward at 916-734-5562, or e-mail Robbins directly at jarobbins@ucdavis.edu.

Source: Eurekalert & others

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