Spots Global Cancer Trial Database for A Study to Assess Capecitabine (Xeloda®) in Patients With Locally Advanced or Metastatic Breast Cancer
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Trial Identification
Brief Title: A Study to Assess Capecitabine (Xeloda®) in Patients With Locally Advanced or Metastatic Breast Cancer
Official Title: A Randomized, Open-label Study of the Effect of Different Dosing Regimens of Xeloda® in Combination With Taxotere® on Disease Progression in Patients With Locally Advanced and/or Metastatic Breast Cancer
Study ID: NCT00077857
Conditions
Study Description
Brief Summary: This 2 arm study compared the efficacy and safety of label dose of capecitabine (Xeloda®) to that of a lower dose of Xeloda® plus docetaxel (Taxotere®) in patients with locally advanced or metastatic breast cancer after failure of chemotherapy with an anthracycline. Patients were randomized to receive either 1250 mg/m\^2 or 825 mg/m\^2 orally twice a day (po bid) on days 1-14 of each 3 week cycle, in combination with Taxotere® 75 mg/m2 intravenous (iv) on day 1 of each 3 week cycle. The anticipated time on study treatment was until disease progression and the target sample size was 440 individuals.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
, 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
, St 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, , Czech Republic
, Praha, , Czech Republic
, Praha, , Czech Republic
, Praha, , Czech Republic
, Tabor, , Czech Republic
, Ahmedabad, , India
, Bangalore, , India
, Bangalore, , India
, Cochin, , India
, Hyderabad, , India
, Hyderabad, , India
, Hyderabad, , India
, Jaipur, , India
, Kolkata, , India
, Ludhiana, , India
, Manipal, , India
, Mumbai, , India
, New Delhi, , India
, Trivandrum, , India
, Vellore, , India
, Poznan, , Poland
, Wroclaw, , Poland
, Chelyabinsk, , Russian Federation
, Ivanovo, , Russian Federation
, Kazan, , Russian Federation
, Kazan, , Russian Federation
, Moscow, , Russian Federation
, Moscow, , Russian Federation
, Omsk, , Russian Federation
, Ryazan, , Russian Federation
, Samara, , Russian Federation
, St Petersburg, , Russian Federation
, St Petersburg, , Russian Federation
, Yaroslavl, , Russian Federation
, Bloemfontein, , South Africa
, Durban, , South Africa
, Polokwane, , South Africa
, Bangkok, , Thailand
, Chiang Mai, , Thailand
, Khon Kaen, , Thailand
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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