Aventis announced that it has submitted registrational applications for the use of Taxotere (docetaxel) in treating women with early-stage operable breast cancer with involved axillary lymph nodes in the United States and the European Union.

The applications are based on data from a large Phase III study that found the combination of Taxotere, doxorubicin and cyclophosphamide (TAC) to significantly improve overall survival in women with early-stage breast cancer and reduce their risk of a relapse compared with the standard regimen of 5-fluorouracil, doxorubicin and cyclophosphamide (FAC).

These data, from the Breast Cancer International Research Group (BCIRG) 001/ TAX 316 study, were presented at the San Antonio Breast Cancer Symposium on December 5, 2003 and demonstrated that women with node-positive, early-stage breast cancer who received a Taxotere-based chemotherapy regimen after surgery experienced a 30 per cent reduction in the risk of death at a 55-month follow-up and a 28 per cent reduction in the chance of their cancer returning as compared to women treated with a commonly used, standard (post-surgery) adjuvant regimen. A similar benefit for TAC over FAC was observed regardless of nodal, hormone-receptor or HER-2/neu status.

"The extension of the use of Taxotere in patients with early-stage breast cancer may provide an important treatment option for women throughout the world," states Dr. Susan Arbuck, vice president and Global Head, Oncology Therapeutic Area at Aventis. "These data on which the submissions are based reflect nearly five years of follow-up that demonstrate Taxotere extends the lives of women with node positive disease."