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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

affected breast after preoperative administration of Xeloda and Taxotere for HER2-negative patients and in combination with Herceptin for HER2-positive patients. Secondary endpoints included safety profile; quality of life; local recurrence; disease-free survival; distant disease-free survival; and overall survival. Other secondary endpoints included pCR in sentinel and axillary, or underarm, lymph nodes; clinical response rate; ability of blood and tissue markers; genomic profiling of the tumors; circulating tumor cells for HER2-neu positive patients; and p53 gene mutations to predict short-term clinical and pathological responses.

Study participants were limited to female outpatients, aged 18 and older, who were diagnosed with HER2-negative or HER2-positive breast cancer, with no evidence of metastatic disease except ipsilateral axillary lymph nodes, or axillary lymph nodes found on the same side of the body, and no prior history of treatment.

Patients received four three-week cycles of the treatment regimen. HER2-negative patients received Xeloda 825 mg/m2 twice a day for 14 days with seven days off, and also received Taxotere 75 mg/m2 IV on the first day. HER2-positive patients were on the same regimen, but also received Herceptin each week with a loading dose of 4 mg/kg for 90 minutes followed by 2 mg/kg for 30 minutes for a total of 12 weeks before definitive surgery.

The most frequent adverse events (AEs) were hematologic toxicities and hand-foot syndrome. Five HER2-neu negative patients and one HER2-positive patient experienced progression before surgery. There were no treatment- related deaths prior to surgery, nor were there clinical or subclinical cardiac events.

About Xeloda

Xeloda is the only FDA-approved oral chemotherapy for both metastatic breast cancer and adjuvant and metastatic colorectal cancer. Inactive in pill form, Xeloda is enzymatically activated within the body; when it comes into contact with a naturally
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SOURCE Roche
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