XeNA Study - A Study of Xeloda (Capecitabine) in Patients With Invasive Breast Cancer
Status:
Completed
Trial end date:
2009-07-01
Target enrollment:
Participant gender:
Summary
This single arm study stratified patients into two treatment cohorts based on HER2-neu
overexpression/amplification. Each cohort will be independently powered for the primary
endpoint. The study will evaluate the efficacy, safety and impact on quality of life of
treatment with oral Xeloda plus intravenous (iv) Taxotere (docetaxel). Patients with HER2-neu
negative breast cancer will receive chemotherapy alone with oral Xeloda plus intravenous (iv)
Taxotere (docetaxel). Patients with HER2-neu positive breast cancer, will receive the same
chemotherapy in combination with intravenous (iv) Herceptin (trastuzumab). Patients will
receive 3-weekly cycles of treatment with Xeloda (825mg/m2 oral administration [po] twice
daily (bid) on days 1-14) + Taxotere (75mg/m2 iv on day 1). HER2-neu positive patients will
also receive Herceptin (loading dose of 4mg/kg iv followed by 2mg/kg iv weekly). The
anticipated time on study treatment is 3-12 months, and the target sample size is 100-500
individuals.