San Antonio, TX December 5, 2003 A Docetaxel (Taxotere)-based regimen reduced the relative risk of death in women with early stage breast cancer by 30 percent and lowered the relative risk of the cancer returning by 28 percent when compared to a standard adjuvant (post-surgery) regimen after 55-month follow-up. The results of BCIRG 001, the first phase III study evaluating Taxotere after breast surgery, were presented at the San Antonio Breast Cancer Symposium (SABCS) by the Breast Cancer International Research Group (BCIRG) today.

"Taxotere continues to demonstrate its effectiveness across various stages of breast cancer, and this study indicates that women with early stage breast cancer and their physicians should seriously consider a Taxotere-based treatment, like the TAC regimen tested in the BCIRG 001 trial, to significantly prolong disease-free survival and survival," said Miguel Martin M.D. from the Medical Oncology Department, Hospital Universitario San Carlos, Madrid, Spain, chairman of GEICAM.

Study Design
The BCIRG 001 study was designed to determine if Taxotere, one of the most active agents in advanced breast cancer, would also have benefits for women with early stage disease. Study participants received either a post-surgery regimen of Taxotere, doxorubicin (Adriamycin), and cyclophosphamide (Cytoxan), known as TAC, or the widely used standard regimen of 5-fluorouracil, doxorubicin and cyclophosphamide, known as FAC. BCIRG 001 enrolled 1,491 pre- and post-menopausal women with early breast cancer at 111 sites in 20 countries; 745 patients were randomized to receive TAC and 746 to receive FAC. The study was designed to perform analyses on subgroups of women based on hormonal receptor status (hormone-receptor-positive or hormone-receptor-negative tumors) and nodal involvement (one-to-three or four-plus axillary lymph nodes). Tumor samples were prospectively collected for 95 percent of the patients. Hormonal receptor s
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Contact: Arleen Goldenberg
arleen_goldenberg@nyc.cohnwolfe.com
212-798-9749
Cohn & Wolfe
5-Dec-2003

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