Breast Cancer Clinical Trial

Breast Cancer Trial of RPR109881 Versus Capecitabine in Male or Female Patients With Advanced Breast Cancer

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

Eligibility Criteria

In order to be eligible for this trial you must:

Have a diagnosis of breast cancer that is now metastatic (meaning the cancer has spread beyond its original location) or a recurrence of the cancer in its original location that cannot be removed by surgery.
Have received previous treatment with anthracyclines (e.g., adriamycin, Doxorubicin) and taxanes (e.g., paclitaxel, docetaxel, Taxol®, Taxotere®) for your breast cancer and your doctor has determined that these treatment are no longer of benefit to you.
Be at least 18 years of age.
Not be taking other treatments for your cancer at the time you enter this trial.
Not be pregnant.

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).

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

438

Study ID:

NCT00081796

Recruitment Status:

Completed

Sponsor:

Sanofi

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There are 89 Locations for this study

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Birmingham Alabama, 35216, United States

Tucson Arizona, 85704, United States

Little Rock Arkansas, 72205, United States

Bakersfield California, 93309, United States

Burbank California, 91505, United States

Concord California, 94520, United States

Fountain Valley California, 92708, United States

Fresno California, 93720, United States

Fullerton California, 92835, United States

Gilroy California, 95020, United States

Long Beach California, 90806, United States

Los Angeles California, 90095, United States

Monterey Park California, 91754, United States

Northridge California, 91328, United States

Oxnard California, 93030, United States

Pamona California, 91767, United States

Pomona California, 91767, United States

Porterville California, 93257, United States

Redondo Beach California, 90272, United States

San Diego California, 92123, United States

San Francisco California, 94115, United States

Santa Barbara California, 93105, United States

Soquel California, 95073, United States

Vista California, 92081, United States

New London Connecticut, 06320, United States

Newark Delaware, 19718, United States

Fort Lauderdale Florida, 33308, United States

Ft Lauderdale Florida, 33316, United States

Gainsville Florida, 32605, United States

Jacksonville Florida, 32209, United States

Lake Worth Florida, 33461, United States

Orlando Florida, 32804, United States

West Palm Beach Florida, 33401, United States

Lawrenceville Georgia, 30045, United States

Macon Georgia, 31201, United States

Marietta Georgia, 30060, United States

Roswell Georgia, 30076, United States

Centralia Illinois, 62801, United States

Chicago Illinois, 60640, United States

Peoria Illinois, 61615, United States

Skokie Illinois, 66077, United States

Fort Wayne Indiana, 46815, United States

New Albany Indiana, 47150, United States

Danville Kentucky, 40422, United States

Hazard Kentucky, 41701, United States

Lexington Kentucky, 40503, United States

Lafayette Louisiana, 70503, United States

Shreveport Louisiana, 71101, United States

Annapolis Maryland, 21401, United States

Baltimore Maryland, 21201, United States

Southfield Michigan, 48076, United States

St. Joseph Michigan, 49085, United States

St. Louis Missouri, 63110, United States

St. Louis Missouri, 63141, United States

Billings Montana, 59101, United States

Hackensack New Jersey, 07601, United States

Nyack New York, 10960, United States

Utica New York, 13502, United States

Chapel Hill North Carolina, 27599, United States

Charlotte North Carolina, 28203, United States

Charlotte North Carolina, 28204, United States

Greenville North Carolina, 27834, United States

Raleigh North Carolina, 27609, United States

Wilmington North Carolina, 28401, United States

Winston-Salem North Carolina, 27103, United States

Bismarck North Dakota, 58501, United States

Cincinatti Ohio, 45267, United States

Cleveland Ohio, 44109, United States

Cleveland Ohio, 44195, United States

Worthington Ohio, 43085, United States

Dunmore Pennsylvania, 18512, United States

Hershey Pennsylvania, 17033, United States

Kingston Pennsylvania, 18704, United States

Kttaning Pennsylvania, 16201, United States

Philadelphia Pennsylvania, 19106, United States

Philadelphia Pennsylvania, 19115, United States

Philadelphia Pennsylvania, 19146, United States

Pittsburgh Pennsylvania, 15213, United States

Charleston South Carolina, 29403, United States

Charleston South Carolina, 29425, United States

Greenville South Carolina, 29615, United States

Nashville Tennessee, 37205, United States

Dallas Texas, 75390, United States

Fort Worth Texas, 76104, United States

Richardson Texas, 75082, United States

Abingdon Virginia, 24211, United States

Arlington Virginia, 22205, United States

Kirkland Washington, 98034, United States

Spokane Washington, 99202, United States

Huntington West Virginia, 25701, 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

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

438

Study ID:

NCT00081796

Recruitment Status:

Completed

Sponsor:


Sanofi

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