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An Open-label Study of Xeloda Plus Avastin at Time of Disease Progression in Treatment-naïve Women With HER2-negative Metastatic Breast Cancer
This single-arm study was designed to evaluate the efficacy and safety of oral Xeloda plus intravenous Avastin as first-line treatment in women with metastatic breast cancer. Patients received Xeloda 1000 mg/m² orally (PO) twice daily (BID) on Days 1-15, and Avastin 15 mg intravenously (IV) on Day 1 of each 3-week cycle. The anticipated time on study treatment was until disease progression or unacceptable toxicity. The target sample size was \<100 individuals.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Birmingham, Alabama, United States
Birmingham, Alabama, United States
Birmingham, Alabama, United States
Birmingham, Alabama, United States
Birmingham, Alabama, United States
Birmingham, Alabama, United States
Burbank, California, United States
Glendale, California, United States
Glendale, California, United States
Los Angeles, California, United States
Start Date
June 1, 2005
Primary Completion Date
December 1, 2008
Completion Date
December 1, 2008
Last Updated
April 27, 2011
109
ACTUAL participants
Capecitabine
DRUG
Bevacizumab
DRUG
Lead Sponsor
Hoffmann-La Roche
NCT05245812
NCT05372640
Data Source & Attribution
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