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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

SAN ANTONIO, Dec. 15 /PRNewswire/ -- Interim results of the Phase II XeNA (Xeloda in NeoAdjuvant) trial suggest that the combination of oral Xeloda(R) (capecitabine) and Taxotere(R) (docetaxel), with the addition of Herceptin(R) (trastuzumab) in HER2-positive patients, may be an active and well-tolerated neoadjuvant (pre-surgical) treatment option for women with invasive breast cancer. These data were presented today at the San Antonio Breast Cancer Symposium (SABCS).

In the multi-center, open-label trial -- designed to investigate the activity of a short non-anthracycline-based preoperative treatment for early breast cancer in both HER2-negative and HER2-positive patients -- promising results were achieved after only four cycles of pre-surgical treatment as compared to the standard eight cycles. The majority of the 156 patients responded to the Xeloda-based therapy regardless of HER2 status, and both patient groups experienced a clinically significant reduction in tumor size.

"These early XeNA trial results highlight the potential of the Xeloda/Taxotere combination, with Herceptin for HER2-positive patients, to provide an effective and safe treatment option in a shorter period of time before surgery among patients with invasive breast cancer," said Dr. Debu Tripathy, lead investigator of the XeNA trial and Professor of Medicine and Director of the Komen/UT Southwestern Breast Cancer Research Program at the University of Texas Southwestern Medical Center at Dallas. "While these findings warrant additional studies, the real-world impact of the reduction in tumor size could translate into the difference between a lumpectomy instead of a more drastic mastectomy."

In the interim analysis, following four treatment cycles, the combination of Xeloda, Taxotere and Herceptin in HER2-positive patients resulted in a 73 percent clinical response rate (complete and partial response) and a 50 percent pathologic response (pathologic complete response, w
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SOURCE Roche
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