A Study to Assess Capecitabine (Xeloda®) in Patients With Locally Advanced or Metastatic Breast Cancer
NCT ID: NCT00077857
Last Updated: 2013-05-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
470 participants
INTERVENTIONAL
2003-07-31
2010-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1250 mg/m^2 capecitabine + docetaxel
1250 mg/m\^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m\^2 intravenous on day 1 of each 3 week cycle.
capecitabine (Xeloda®)
825 mg/m\^2 or 1250 mg/m2 orally twice a day on days 1 to 14 of each 3 week cycle.
docetaxel (Taxotere®)
75 mg/m\^2 intravenous on day 1 of each 3 week cycle
825 mg/m^2 capecitabine + docetaxel
825 mg/m\^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m\^2 intravenous on day 1 of each 3 week cycle.
capecitabine (Xeloda®)
825 mg/m\^2 or 1250 mg/m2 orally twice a day on days 1 to 14 of each 3 week cycle.
docetaxel (Taxotere®)
75 mg/m\^2 intravenous on day 1 of each 3 week cycle
Interventions
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capecitabine (Xeloda®)
825 mg/m\^2 or 1250 mg/m2 orally twice a day on days 1 to 14 of each 3 week cycle.
docetaxel (Taxotere®)
75 mg/m\^2 intravenous on day 1 of each 3 week cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* \>=1 target lesion;
* locally advanced or metastatic breast cancer;
* demonstrated resistance to anthracycline;
* \>=2 regimens of chemotherapy for advanced/metastatic disease.
Exclusion Criteria
* previous treatment with paclitaxel or docetaxel for advanced/metastatic disease.
18 Years
FEMALE
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Birmingham, Alabama, United States
Hoover, Alabama, United States
Tucson, Arizona, United States
Berkeley, California, United States
Poway, California, United States
Boca Raton, Florida, United States
Fort Lauderdale, Florida, United States
Inverness, Florida, United States
Jacksonville, Florida, United States
Miami Shores, Florida, United States
Port Saint Lucie, Florida, United States
Tamarac, Florida, United States
Skokie, Illinois, United States
Urbana, Illinois, United States
Beech Grove, Indiana, United States
Des Moines, Iowa, United States
Overland Park, Kansas, United States
Houma, Louisiana, United States
Baltimore, Maryland, United States
Baltimore, Maryland, United States
Frederick, Maryland, United States
Rockville, Maryland, United States
Boston, Massachusetts, United States
Detroit, Michigan, United States
Kalamazoo, Michigan, United States
Jefferson City, Missouri, United States
Saint Joseph, Missouri, United States
Paramus, New Jersey, United States
Summit, New Jersey, United States
Williamsville, New York, United States
Canton, Ohio, United States
Mayfield Heights, Ohio, United States
Allentown, Pennsylvania, United States
Kingston, Pennsylvania, United States
Charleston, South Carolina, United States
Columbia, South Carolina, United States
Collierville, Tennessee, United States
Knoxville, Tennessee, United States
Austin, Texas, United States
Houston, Texas, United States
Colchester, Vermont, United States
Abingdon, Virginia, United States
Walla Walla, Washington, United States
Mostar, , Bosnia and Herzegovina
Sarajevo, , Bosnia and Herzegovina
Tuzla, , Bosnia and Herzegovina
Beijing, , China
Beijing, , China
Bengbu, , China
Dalian, , China
Dalian, , China
Hangzhou, , China
Shanghai, , China
Tianjin, , China
Pardubice, , Czechia
Prague, , Czechia
Prague, , Czechia
Prague, , Czechia
Tábor, , Czechia
Ahmedabad, , India
Bangalore, , India
Bangalore, , India
Hyderabad, , India
Hyderabad, , India
Hyderabad, , India
Jaipur, , India
Kochi, , India
Kolkata, , India
Ludhiana, , India
Manipal, , India
Mumbai, , India
New Delhi, , India
Trivandrum, , India
Vellore, , India
Poznan, , Poland
Wroclaw, , Poland
Chelyabinsk, , Russia
Ivanovo, , Russia
Kazan', , Russia
Kazan', , Russia
Moscow, , Russia
Moscow, , Russia
Omsk, , Russia
Ryazan, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Samara, , Russia
Yaroslavl, , Russia
Bloemfontein, , South Africa
Durban, , South Africa
Polokwane, , South Africa
Bangkok, , Thailand
Chiang Mai, , Thailand
Khon Kaen, , Thailand
Countries
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Other Identifiers
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NO16853
Identifier Type: -
Identifier Source: org_study_id
NCT00083200
Identifier Type: -
Identifier Source: nct_alias
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