News Release

Osteoporosis Drug Evista® (Raloxifene) Cuts Newly Diagnosed, Invasive Breast Cancer Risk By More Than 60 Percent

Peer-Reviewed Publication

Northwestern University

SAN ANTONIO --- New research findings show that the osteoporosis preventive drug raloxifene (Evista®) reduces risk for newly diagnosed, invasive breast cancer -- potentially the most serious type of the disease-- by more than 60 percent.

Noted breast cancer researcher V. Craig Jordan will discuss these findings, which are the latest results from Eli Lilly and Company's ongoing studies of raloxifene, at the 21st San Antonio Breast Cancer Symposium in San Antonio, Tex., on Saturday, Dec. 12.

Jordan, a professor of cancer pharmacology at Northwestern University Medical School, is also director of the Breast Cancer Research Program at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University.

Raloxifene is the first osteoporosis preventive drug to show reduction in the risk of breast cancer in clinical trials among women at average risk for developing breast cancer.

Over 10,000 postmenopausal women age 31 to 80 taking raloxifene for more than three years had a 63 percent reduction in the incidence of newly diagnosed, invasive breast cancers when compared to their counterparts taking placebo. These women also showed a 55 percent overall reduction in both newly diagnosed invasive and non-invasive breast cancer.

These data were gathered from 10 randomized, double-blind, placebo-controlled osteoporosis studies. The women were taking daily raloxifene therapy for a follow-up of 40 to 55 months. Mammograms were routinely performed on an annual or biannual basis in all placebo-controlled trials of at least 12-months' duration.

The data are an update from those Jordan presented earlier this year at the American Society of Clinical Oncology.

The cancer preventive potential of raloxifene will be further explored in the upcoming Study of Tamoxifen and Raloxifene (STAR) trial, a landmark breast cancer prevention trial comparing the ability of tamoxifen and raloxifene to prevent breast cancer. The STAR trial will determine the safety and effectiveness of raloxifene in reducing the occurrence of breast cancer in women at high risk. Enrollment for the trial is expected to begin in 1999.

Raloxifene is an antiestrogen, a drug that works by blocking the estrogen receptors in the breast, thereby preventing the hormone estrogen from contributing to the growth of cancer. Jordan and other breast cancer researchers believe that the estrogenic properties of drugs such as raloxifene prevent osteoporosis and may be target to prevent heart attacks in postmenopausal women.

Raloxifene is the only selective estrogen receptor modulator (SERM) available in the United States to protect postmenopausal women against the rapid loss of bone that occurs after menopause and often leads to thinning bones, osteoporosis and fractures. Besides its effects on the breast, raloxifene has been shown to protect postmenopausal women against bone loss and osteoporosis-related fractures and also lowers cholesterol.

Raloxifene is indicated for the prevention of postmenopausal osteoporosis in the United States and is currently approved for marketing in 36 countries worldwide, including the United States.

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CONTACT: Elizabeth Crown at 312-503-8928 or e-mail at e-crown@nwu.edu
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(Editor's note: Jordan can be reached on-site from Dec. 11 through 14 at the San Antonio Breast Cancer Symposium meeting at the Marriott Rivercenter, San Antonio, Suite 530, through Stacey Isaacs at 210-228-4395 (or 4397) or through Jessica DiSalle at Cohn & Wolfe Healthcare, New York, at 212-589-3696.)



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