Aventis submitted US and EU regulatory applications for the use of Taxotere(R) in patients with early-stage breast cancer involving axillary lymph nodes.

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).

The data from the Breast Cancer International Research Group (BCIRG) 001/ TAX 316 study was 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 percent reduction in the risk of death at a 55-month follow-up and a 28 percent 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.