A Study of Xeloda (Capecitabine) in Women With HER2-Negative Metastatic Breast Cancer
NCT ID: NCT00121836
Last Updated: 2011-04-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
109 participants
INTERVENTIONAL
2005-06-30
2008-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Capecitabine
1000 mg/m² PO BID on Days 1-15 of each 3-week cycle
Bevacizumab
15 mg IV on Day 1 of each 3-week cycle
Interventions
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Capecitabine
1000 mg/m² PO BID on Days 1-15 of each 3-week cycle
Bevacizumab
15 mg IV on Day 1 of each 3-week cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HER2-negative metastatic breast cancer
* Previous adjuvant chemotherapy or hormonal treatment
* \>=1 measurable target lesion
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Hoffmann-La Roche
Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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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
San Diego, California, United States
Farmington, Connecticut, United States
Bonita Springs, Florida, United States
Boynton Beach, Florida, United States
Bradenton, Florida, United States
Cape Coral, Florida, United States
Fort Myers, Florida, United States
Fort Myers, Florida, United States
Naples, Florida, United States
Naples, Florida, United States
Port Charlotte, Florida, United States
Sarasota, Florida, United States
Sarasota, Florida, United States
Venice, Florida, United States
Atlanta, Georgia, United States
Augusta, Georgia, United States
Tucker, Georgia, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Indianapolis, Indiana, United States
Waterloo, Iowa, United States
Scarborough, Maine, United States
Prince Frederick, Maryland, United States
Lansing, Michigan, United States
Kansas City, Missouri, United States
Kansas City, Missouri, United States
Kansas City, Missouri, United States
Kansas City, Missouri, United States
Kansas City, Missouri, United States
Kansas City, Missouri, United States
Lincoln, Nebraska, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
Brick, New Jersey, United States
Neptune City, New Jersey, United States
Red Bank, New Jersey, United States
Rochester, New York, United States
Hickory, North Carolina, United States
Canton, Ohio, United States
Oklahoma City, Oklahoma, United States
Beaufort, South Carolina, United States
Charleston, South Carolina, United States
Florence, South Carolina, United States
Hilton Head Island, South Carolina, United States
Sumter, South Carolina, United States
Abingdon, Virginia, United States
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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ML18527
Identifier Type: -
Identifier Source: org_study_id
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