Node-Negative Early Stage Breast Cancer Patients Benefit from Taxotere(R)-Based Ch...( First Phase III study performed ...),Health

First Phase III study performed solely in high risk node-negative population to show significant improvement in Disease Free Survival (DFS)

BRIDGEWATER, N.J., May 27 /PRNewswire-FirstCall/ -- Sanofi-aventis and GEICAM (Grupo Espanol de Investigacion en Cancer de Mama) announced today that for women with high-risk node-negative early stage breast cancer adjuvant treatment (post surgery) with Taxotere(R) (docetaxel) Injection Concentrate as part of the TAC regimen (Taxotere(R), doxorubicin, cyclophosphamide) was associated with a significant improvement in Disease Free Survival (DFS) compared to a standard FAC regimen (5-Fluorouracil, doxorubicin, cyclophosphamide) in the GEICAM 9805/Target-0 study.

The results will be presented at the 2008 annual meeting of the American Society of Clinical Oncology, ASCO, in Chicago (Monday June 2, 2008, 2-6 pm, poster number 1D, abstract 542).

In Europe and North America, most breast cancer patients are diagnosed at an early stage, before the tumor has spread to the lymph nodes. However, few clinical trials in the past were dedicated exclusively to this population of patients. GEICAM 9805/Target-0 is the first taxane-based study to exclusively enroll women with node-negative early stage breast cancer considered to be at high risk for recurrence. High risk patients were defined as having at least one of the following St Gallen 1998 criteria: patient's age <35 years, tumor histological grade II/III, tumor size >2 cm, or hormone-receptor (estrogen and/or progesterone receptor) negative tumor.

The 1059 women enrolled in this multicenter, phase III study were randomized to receive either TAC (n=539) or FAC (n=520) after surgical resection of their tumor. Therapy was given every three weeks for a total of 6 cycles. The primary end point was Disease Free Survival (DFS) and secondary end points included overall survival (OS), safety, and quality of life.

Analysis of efficacy, determined by DFS, wa
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