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INTERIM ANALYSIS OF STUDY SHOWS POSITIVE BREAST CANCER RESULTS

September 16, 2005

The Breast Cancer International Research Group (BCIRG) and sanofi-aventis have announced results from an interim efficacy analysis of a Phase III trial, which shows that two Taxotere-based chemotherapy regimens, in combination with monoclonal antibody therapy Herceptin, significantly improved disease-free survival in women with early-stage human epidermal growth factor Receptor 2 positive breast cancer.

The BCIRG trial compared a standard treatment arm of four cycles of doxorubicin and cyclophosphamide, followed by Taxotere for six cycles, to two Herceptin-containing regimens following initial surgery. One arm included the above regimen with one year of Herceptin, and the other was a non-anthracycline regimen of Taxotere plus carboplatin plus one year of Herceptin. In the latter arm, the Herceptin was started concomitantly with chemotherapy.