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| Sponsor: | Sanofi-Aventis |
|---|---|
| Information provided by: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00081796 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Metastases |
Drug: larotaxel (RPR109881, XRP9881) Drug: capecitabine |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Enrollment: | 438 |
| Study Start Date: | April 2004 |
| Study Completion Date: | September 2006 |
| Primary Completion Date: | September 2006 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Eligibility Criteria
In order to be eligible for this trial you must:
Additionally, there are other criteria for study entry that a doctor participating in this study will need to review in detail with you and clinical assessments may need to be performed (e.g., lab tests, CT scans).
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Birmingham, Alabama, United States, 35216 | |
| United States, Arizona | |
| Tucson, Arizona, United States, 85704 | |
| United States, Arkansas | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Fountain Valley, California, United States, 92708 | |
| Gilroy, California, United States, 95020 | |
| San Diego, California, United States, 92123 | |
| Pamona, California, United States, 91767 | |
| San Francisco, California, United States, 94115 | |
| Burbank, California, United States, 91505 | |
| Monterey Park, California, United States, 91754 | |
| Porterville, California, United States, 93257 | |
| Los Angeles, California, United States, 90095 | |
| Oxnard, California, United States, 93030 | |
| Pomona, California, United States, 91767 | |
| Fresno, California, United States, 93720 | |
| Bakersfield, California, United States, 93309 | |
| Long Beach, California, United States, 90806 | |
| Santa Barbara, California, United States, 93105 | |
| Concord, California, United States, 94520 | |
| Fullerton, California, United States, 92835 | |
| Redondo Beach, California, United States, 90272 | |
| Vista, California, United States, 92081 | |
| Northridge, California, United States, 91328 | |
| Soquel, California, United States, 95073 | |
| United States, Connecticut | |
| New London, Connecticut, United States, 06320 | |
| United States, Delaware | |
| Newark, Delaware, United States, 19718 | |
| United States, Florida | |
| Gainsville, Florida, United States, 32605 | |
| Fort Lauderdale, Florida, United States, 33308 | |
| Jacksonville, Florida, United States, 32209 | |
| Lake Worth, Florida, United States, 33461 | |
| West Palm Beach, Florida, United States, 33401 | |
| Orlando, Florida, United States, 32804 | |
| Ft Lauderdale, Florida, United States, 33316 | |
| United States, Georgia | |
| Lawrenceville, Georgia, United States, 30045 | |
| Macon, Georgia, United States, 31201 | |
| Marietta, Georgia, United States, 30060 | |
| Roswell, Georgia, United States, 30076 | |
| United States, Illinois | |
| Centralia, Illinois, United States, 62801 | |
| Skokie, Illinois, United States, 66077 | |
| Chicago, Illinois, United States, 60640 | |
| Peoria, Illinois, United States, 61615 | |
| United States, Indiana | |
| Fort Wayne, Indiana, United States, 46815 | |
| New Albany, Indiana, United States, 47150 | |
| United States, Kentucky | |
| Lexington, Kentucky, United States, 40503 | |
| Hazard, Kentucky, United States, 41701 | |
| Danville, Kentucky, United States, 40422 | |
| United States, Louisiana | |
| Shreveport, Louisiana, United States, 71101 | |
| Lafayette, Louisiana, United States, 70503 | |
| United States, Maryland | |
| Annapolis, Maryland, United States, 21401 | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Michigan | |
| Southfield, Michigan, United States, 48076 | |
| St. Joseph, Michigan, United States, 49085 | |
| United States, Missouri | |
| St. Louis, Missouri, United States, 63141 | |
| St. Louis, Missouri, United States, 63110 | |
| United States, Montana | |
| Billings, Montana, United States, 59101 | |
| United States, New Jersey | |
| Hackensack, New Jersey, United States, 07601 | |
| United States, New York | |
| Utica, New York, United States, 13502 | |
| Nyack, New York, United States, 10960 | |
| United States, North Carolina | |
| Charlotte, North Carolina, United States, 28203 | |
| Greenville, North Carolina, United States, 27834 | |
| Wilmington, North Carolina, United States, 28401 | |
| Winston-Salem, North Carolina, United States, 27103 | |
| Charlotte, North Carolina, United States, 28204 | |
| Raleigh, North Carolina, United States, 27609 | |
| Chapel Hill, North Carolina, United States, 27599 | |
| United States, North Dakota | |
| Bismarck, North Dakota, United States, 58501 | |
| United States, Ohio | |
| Cincinatti, Ohio, United States, 45267 | |
| Worthington, Ohio, United States, 43085 | |
| Cleveland, Ohio, United States, 44109 | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Pennsylvania | |
| Dunmore, Pennsylvania, United States, 18512 | |
| Hershey, Pennsylvania, United States, 17033 | |
| Philadelphia, Pennsylvania, United States, 19106 | |
| Philadelphia, Pennsylvania, United States, 19146 | |
| Philadelphia, Pennsylvania, United States, 19115 | |
| Kingston, Pennsylvania, United States, 18704 | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Kttaning, Pennsylvania, United States, 16201 | |
| United States, South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| Charleston, South Carolina, United States, 29403 | |
| Greenville, South Carolina, United States, 29615 | |
| United States, Tennessee | |
| Nashville, Tennessee, United States, 37205 | |
| United States, Texas | |
| Richardson, Texas, United States, 75082 | |
| Fort Worth, Texas, United States, 76104 | |
| Dallas, Texas, United States, 75390 | |
| United States, Virginia | |
| Arlington, Virginia, United States, 22205 | |
| Abingdon, Virginia, United States, 24211 | |
| United States, Washington | |
| Kirkland, Washington, United States, 98034 | |
| Spokane, Washington, United States, 99202 | |
| United States, West Virginia | |
| Huntington, West Virginia, United States, 25701 | |
| Argentina | |
| Santa Fe, Argentina | |
| Buenos Aires, Argentina | |
| Capital Federal, Argentina | |
| Australia | |
| Melbourne, Australia | |
| St. Leonards, Australia | |
| Sydney, Australia | |
| Perth, Australia | |
| Austria | |
| Vienna, Austria | |
| Bludesch, Austria | |
| Brazil | |
| Sao Paolo, Brazil | |
| Brazil, San Paulo | |
| Sorocaba, San Paulo, Brazil | |
| Canada | |
| Quebec, Canada | |
| Montreal, Canada | |
| Ottawa, Canada | |
| Ontario, Canada | |
| Canada, Newfoundland and Labrador | |
| St. John's, Newfoundland and Labrador, Canada | |
| Canada, Quebec | |
| Levis, Quebec, Canada | |
| Chile | |
| Las Condes | |
| Santiago, Chile | |
| Santiago, Chile | |
| Colombia | |
| Medellin, Colombia | |
| Bogota, Colombia | |
| Cali Valle, Colombia | |
| Czech Republic | |
| Nora Ves Pod Plesi, Czech Republic | |
| Ostrava, Czech Republic | |
| Hradec Kralove, Czech Republic | |
| Finland | |
| oulu, Finland | |
| Kemi, Finland | |
| France | |
| Besancon, France | |
| Paris, France | |
| Saint Herblain, France | |
| Saint Cloud, France | |
| Montpellier, France | |
| Marseille, France | |
| Lyon, France | |
| Nice, France | |
| Germany | |
| Aschaffenburg, Germany | |
| Berlin, Germany | |
| Frankfurt, Germany | |
| Halle, Germany | |
| Oldenberg, Germany | |
| Kiel, Germany | |
| Heidelberg, Germany | |
| Munich, Germany | |
| Munchen Bayern, Germany | |
| Hungary | |
| Budapest, Hungary | |
| Szeged, Hungary | |
| Israel | |
| Haifa, Israel | |
| Tel HaShomer, Israel | |
| Tel Aviv, Israel | |
| Ashkelon, Israel | |
| Beer-Sheva, Israel | |
| Italy | |
| Novara, Italy | |
| Largo Agostino Gemelli, Italy | |
| Pavia, Italy | |
| Napoli, Italy | |
| Modena, Italy | |
| Bologna, Italy | |
| Sassari, Italy | |
| Cuneo, Italy | |
| Livorno, Italy | |
| Palermo, Italy | |
| Korea, Republic of | |
| Gyeonggi-Do, Korea, Republic of | |
| Seoul, Korea, Republic of | |
| Mexico | |
| Mexico DF Distrio Federal, Mexico | |
| Tuluea Estand de Mexico, Mexico | |
| New Zealand | |
| Auckland, New Zealand | |
| Christchurch, New Zealand | |
| Poland | |
| Warsaw, Poland | |
| Kracow, Poland | |
| Portugal | |
| Coimbra, Portugal | |
| Lisboa, Portugal | |
| Beja, Portugal | |
| Porto, Portugal | |
| Romania | |
| Cluj Napoca, Romania | |
| Craiova, Romania | |
| Bucharest, Romania | |
| Slovenia | |
| Maribor, Slovenia | |
| South Africa | |
| Pretoria, South Africa | |
| Durban, South Africa | |
| Johannesburg, South Africa | |
| Capetown, South Africa | |
| Parktown, South Africa | |
| Spain | |
| Jaen, Spain | |
| Madrid, Spain | |
| Navarra, Spain | |
| Valencia, Spain | |
| Alicante, Spain | |
| Taiwan | |
| Taipai, Taiwan | |
| Taoyuang, Taiwan | |
| United Kingdom | |
| Ipswich, United Kingdom | |
| Nottingham, United Kingdom | |
| Manchester, United Kingdom | |
| Surrey, United Kingdom | |
| London, United Kingdom | |
| Bristol, United Kingdom | |
| Birmingham, United Kingdom | |
| United Kingdom, Carduff | |
| Cardiff, Carduff, United Kingdom | |
| Study Director: | ICD CSD | Sanofi-Aventis |
More Information
| Responsible Party: | sanofi-aventis ( ICD Study Director ) |
| Study ID Numbers: | EFC6089, XRP9881B-3001 |
| Study First Received: | April 20, 2004 |
| Last Updated: | August 20, 2008 |
| ClinicalTrials.gov Identifier: | NCT00081796 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Metastatic Breast Cancer |
|
Antimetabolites Capecitabine Antimetabolites, Antineoplastic Skin Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Breast Neoplasms Pharmacologic Actions |
Neoplasms Neoplastic Processes Neoplasms by Site Pathologic Processes Therapeutic Uses Neoplasm Metastasis Breast Diseases |
