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Brief Title: Breast Cancer Trial of RPR109881 Versus Capecitabine in Male or Female Patients With Advanced Breast Cancer
Official Title: A Randomized, Open-Label, Phase III Study of RPR109881 IV Every 3 Weeks Versus Capecitabine (Xeloda) Tablets Twice Daily for 2 Weeks in 3-Week Cycles in Patients With Metastatic Breast Cancer Progressing After Taxanes and Anthracycline Therapy
Study ID: NCT00081796
Brief Summary: The purpose of this clinical trial is to determine if RPR109881 is a better treatment than capecitabine (Xeloda) for advanced breast cancer in patients that no longer benefit from docetaxel and/or paclitaxel.
Detailed Description: All patients in this trial will receive either the investigational drug or capecitabine, a chemotherapy drug that is already approved to treat your disease. These drugs prevent tumor cells from dividing, so they may stop growing or die. The investigational drug in this clinical trial is a chemotherapy drug given through the vein once every three weeks. Patients who receive capecitabine will receive this drug by mouth for 14 days, every 21 days.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
, Birmingham, Alabama, United States
, Tucson, Arizona, United States
, Little Rock, Arkansas, United States
, Bakersfield, California, United States
, Burbank, California, United States
, Concord, California, United States
, Fountain Valley, California, United States
, Fresno, California, United States
, Fullerton, California, United States
, Gilroy, California, United States
, Long Beach, California, United States
, Los Angeles, California, United States
, Monterey Park, California, United States
, Northridge, California, United States
, Oxnard, California, United States
, Pamona, California, United States
, Pomona, California, United States
, Porterville, California, United States
, Redondo Beach, California, United States
, San Diego, California, United States
, San Francisco, California, United States
, Santa Barbara, California, United States
, Soquel, California, United States
, Vista, California, United States
, New London, Connecticut, United States
, Newark, Delaware, United States
, Fort Lauderdale, Florida, United States
, Ft Lauderdale, Florida, United States
, Gainsville, Florida, United States
, Jacksonville, Florida, United States
, Lake Worth, Florida, United States
, Orlando, Florida, United States
, West Palm Beach, Florida, United States
, Lawrenceville, Georgia, United States
, Macon, Georgia, United States
, Marietta, Georgia, United States
, Roswell, Georgia, United States
, Centralia, Illinois, United States
, Chicago, Illinois, United States
, Peoria, Illinois, United States
, Skokie, Illinois, United States
, Fort Wayne, Indiana, United States
, New Albany, Indiana, United States
, Danville, Kentucky, United States
, Hazard, Kentucky, United States
, Lexington, Kentucky, United States
, Lafayette, Louisiana, United States
, Shreveport, Louisiana, United States
, Annapolis, Maryland, United States
, Baltimore, Maryland, United States
, Southfield, Michigan, United States
, St. Joseph, Michigan, United States
, St. Louis, Missouri, United States
, St. Louis, Missouri, United States
, Billings, Montana, United States
, Hackensack, New Jersey, United States
, Nyack, New York, United States
, Utica, New York, United States
, Chapel Hill, North Carolina, United States
, Charlotte, North Carolina, United States
, Charlotte, North Carolina, United States
, Greenville, North Carolina, United States
, Raleigh, North Carolina, United States
, Wilmington, North Carolina, United States
, Winston-Salem, North Carolina, United States
, Bismarck, North Dakota, United States
, Cincinatti, Ohio, United States
, Cleveland, Ohio, United States
, Cleveland, Ohio, United States
, Worthington, Ohio, United States
, Dunmore, Pennsylvania, United States
, Hershey, Pennsylvania, United States
, Kingston, Pennsylvania, United States
, Kttaning, Pennsylvania, United States
, Philadelphia, Pennsylvania, United States
, Philadelphia, Pennsylvania, United States
, Philadelphia, Pennsylvania, United States
, Pittsburgh, Pennsylvania, United States
, Charleston, South Carolina, United States
, Charleston, South Carolina, United States
, Greenville, South Carolina, United States
, Nashville, Tennessee, United States
, Dallas, Texas, United States
, Fort Worth, Texas, United States
, Richardson, Texas, United States
, Abingdon, Virginia, United States
, Arlington, Virginia, United States
, Kirkland, Washington, United States
, Spokane, Washington, United States
, Huntington, West Virginia, United States
, Buenos Aires, , Argentina
, Capital Federal, , Argentina
, Santa Fe, , Argentina
, Melbourne, , Australia
, Perth, , Australia
, St. Leonards, , Australia
, Sydney, , Australia
, Bludesch, , Austria
, Vienna, , Austria
, Sorocaba, San Paulo, Brazil
, Sao Paolo, , Brazil
, St. John's, Newfoundland and Labrador, Canada
, Levis, Quebec, Canada
, Montreal, , Canada
, Ontario, , Canada
, Ottawa, , Canada
, Quebec, , Canada
Las Condes, Santiago, , Chile
, Santiago, , Chile
, Bogota, , Colombia
, Cali Valle, , Colombia
, Medellin, , Colombia
, Hradec Kralove, , Czech Republic
, Nora Ves Pod Plesi, , Czech Republic
, Ostrava, , Czech Republic
, Kemi, , Finland
, Oulu, , Finland
, Besancon, , France
, Lyon, , France
, Marseille, , France
, Montpellier, , France
, Nice, , France
, Paris, , France
, Saint Cloud, , France
, Saint Herblain, , France
, Aschaffenburg, , Germany
, Berlin, , Germany
, Frankfurt, , Germany
, Halle, , Germany
, Heidelberg, , Germany
, Kiel, , Germany
, Munchen Bayern, , Germany
, Munich, , Germany
, Oldenberg, , Germany
, Budapest, , Hungary
, Szeged, , Hungary
, Ashkelon, , Israel
, Beer-Sheva, , Israel
, Haifa, , Israel
, Tel Aviv, , Israel
, Tel HaShomer, , Israel
, Bologna, , Italy
, Cuneo, , Italy
, Largo Agostino Gemelli, , Italy
, Livorno, , Italy
, Modena, , Italy
, Napoli, , Italy
, Novara, , Italy
, Palermo, , Italy
, Pavia, , Italy
, Sassari, , Italy
, Gyeonggi-Do, , Korea, Republic of
, Seoul, , Korea, Republic of
, Mexico DF Distrio Federal, , Mexico
, Tuluea Estand de Mexico, , Mexico
, Auckland, , New Zealand
, Christchurch, , New Zealand
, Kracow, , Poland
, Warsaw, , Poland
, Beja, , Portugal
, Coimbra, , Portugal
, Lisboa, , Portugal
, Porto, , Portugal
, Bucharest, , Romania
, Cluj Napoca, , Romania
, Craiova, , Romania
, Maribor, , Slovenia
, Capetown, , South Africa
, Durban, , South Africa
, Johannesburg, , South Africa
, Parktown, , South Africa
, Pretoria, , South Africa
, Alicante, , Spain
, Jaen, , Spain
, Madrid, , Spain
, Navarra, , Spain
, Valencia, , Spain
, Taipai, , Taiwan
, Taoyuang, , Taiwan
, Cardiff, Carduff, United Kingdom
, Birmingham, , United Kingdom
, Bristol, , United Kingdom
, Ipswich, , United Kingdom
, London, , United Kingdom
, Manchester, , United Kingdom
, Nottingham, , United Kingdom
, Surrey, , United Kingdom
Name: ICD CSD
Affiliation: Sanofi
Role: STUDY_DIRECTOR