Breast Cancer Clinical Trial
A Study of Xeloda (Capecitabine) in Women With HER2-Negative Metastatic Breast Cancer
Summary
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.
Eligibility Criteria
Inclusion Criteria:
Women >=18 years of age
HER2-negative metastatic breast cancer
Previous adjuvant chemotherapy or hormonal treatment
>=1 measurable target lesion
Exclusion Criteria:
Previous treatment with chemotherapy, an anti-angiogenic agent, or a biologic therapy for advanced or metastatic cancer
Radiation therapy within 4 weeks of study treatment start or insufficient recovery from the effects of prior radiation therapy
Central nervous system metastases
Other malignancy within last 5 years, except cured basal cell carcinoma of skin and carcinoma in situ of uterine cervix
Serious concurrent infection
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There are 57 Locations for this study
Birmingham Alabama, 35022, United States
Birmingham Alabama, 35205, United States
Birmingham Alabama, 35209, United States
Birmingham Alabama, 35211, United States
Birmingham Alabama, 35213, United States
Birmingham Alabama, 35235, United States
Burbank California, 91505, United States
Glendale California, 91204, United States
Glendale California, 91206, United States
Los Angeles California, 90057, United States
San Diego California, 92121, United States
Farmington Connecticut, 06030, United States
Bonita Springs Florida, 34135, United States
Boynton Beach Florida, 33435, United States
Bradenton Florida, 34209, United States
Cape Coral Florida, 33990, United States
Fort Myers Florida, 33901, United States
Fort Myers Florida, 33908, United States
Naples Florida, 34102, United States
Naples Florida, 34119, United States
Port Charlotte Florida, 33980, United States
Sarasota Florida, 34232, United States
Sarasota Florida, 34236, United States
Venice Florida, 34292, United States
Atlanta Georgia, 30341, United States
Augusta Georgia, 30901, United States
Tucker Georgia, 30084, United States
Chicago Illinois, 60611, United States
Indianapolis Indiana, 46202, United States
Indianapolis Indiana, 46219, United States
Waterloo Iowa, 50702, United States
Scarborough Maine, 04074, United States
Prince Frederick Maryland, 20678, United States
Lansing Michigan, 48909, United States
Kansas City Missouri, 64064, United States
Kansas City Missouri, 64111, United States
Kansas City Missouri, 64131, United States
Kansas City Missouri, 64154, United States
Kansas City Missouri, 66112, United States
Kansas City Missouri, 66210, United States
Lincoln Nebraska, 68510, United States
Omaha Nebraska, 68114, United States
Las Vegas Nevada, 89106, United States
Brick New Jersey, 08724, United States
Neptune New Jersey, 07754, United States
Red Bank New Jersey, 07701, United States
Rochester New York, 14642, United States
Hickory North Carolina, 28602, United States
Canton Ohio, 44718, United States
Oklahoma City Oklahoma, 73112, United States
Beaufort South Carolina, 29902, United States
Charleston South Carolina, 29406, United States
Florence South Carolina, 29506, United States
Hilton Head Island South Carolina, 29926, United States
Sumter South Carolina, 29150, United States
Abingdon Virginia, 24211, United States
Milwaukee Wisconsin, 53215, United States
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