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Xeloda(R), Taxotere(R) and Herceptin(R) Combination Study Suggests Clinical Benefit in Invasive Breast Cancer with Shortened Treatment Cycle
Date:12/15/2007

hich is the absence of histological evidence of cancer cells in the tissue specimen, plus near pathological complete response, which is less than or equal to 5 millimeters of residual cancer). Additionally, HER2-negative patients experienced a clinical response rate of 76 percent and 15 percent pathological response with the combination of solely Xeloda and Taxotere. In patients with HER2-negative tumors, a decrease from 6.1 to 2.8 centimeters was observed; in HER2-positive patients, the reduction was from 5.6 to 1.6 centimeters.

"The XeNA results demonstrate the potential for oral Xeloda to serve as the cornerstone of combination chemotherapy in the treatment of early invasive breast cancer," said Lars Birgerson, M.D., PhD, Vice President of Global Head Medical Affairs at Roche.

Invasive breast cancer, also known as infiltrating breast cancer, is cancer that has spread to surrounding, healthy tissue. Most invasive breast cancers start in the ducts, but can spread to other parts of the body through the blood and lymph systems. Breast cancer is the most common cancer among women, other than skin cancer. It is the second leading cause of cancer death in women, after lung cancer. According to the American Cancer Society (ACS), about 178,480 women in the United States will be found to have invasive breast cancer in 2007 and about 40,460 women will die from the disease this year.

About the Study

This multi-center, open-label XeNA trial enrolled 157 (156 evaluable) patients with newly-diagnosed invasive breast cancer (planned sample size 122 HER2-negative; 34 HER2-positive) and was designed to investigate the activity of a short non-anthracycline-based preoperative treatment for early breast cancer. Efficacy results for 134 patients as well as toxicity data for the total evaluable population (156 patients) were included in this interim analysis. The primary endpoint was the rate of pathological complete response rate (pCR) plus near pCR in the
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SOURCE Roche
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