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

NCT ID: NCT00081796

Last Updated: 2008-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

438 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2006-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer Metastases

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Metastatic Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

larotaxel (RPR109881, XRP9881)

Intervention Type DRUG

capecitabine

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

sanofi-aventis

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

ICD CSD

Role: STUDY_DIRECTOR

Sanofi

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Birmingham, Alabama, United States

Site Status

Tucson, Arizona, United States

Site Status

Little Rock, Arkansas, United States

Site Status

Bakersfield, California, United States

Site Status

Burbank, California, United States

Site Status

Concord, California, United States

Site Status

Fountain Valley, California, United States

Site Status

Fresno, California, United States

Site Status

Fullerton, California, United States

Site Status

Gilroy, California, United States

Site Status

Long Beach, California, United States

Site Status

Los Angeles, California, United States

Site Status

Monterey Park, California, United States

Site Status

Northridge, California, United States

Site Status

Oxnard, California, United States

Site Status

Pomona, California, United States

Site Status

Porterville, California, United States

Site Status

Redondo Beach, California, United States

Site Status

San Diego, California, United States

Site Status

San Francisco, California, United States

Site Status

Santa Barbara, California, United States

Site Status

Soquel, California, United States

Site Status

Vista, California, United States

Site Status

New London, Connecticut, United States

Site Status

Newark, Delaware, United States

Site Status

Fort Lauderdale, Florida, United States

Site Status

Fort Lauderdale, Florida, United States

Site Status

Gainsville, Florida, United States

Site Status

Jacksonville, Florida, United States

Site Status

Lake Worth, Florida, United States

Site Status

Orlando, Florida, United States

Site Status

West Palm Beach, Florida, United States

Site Status

Lawrenceville, Georgia, United States

Site Status

Macon, Georgia, United States

Site Status

Marietta, Georgia, United States

Site Status

Roswell, Georgia, United States

Site Status

Centralia, Illinois, United States

Site Status

Chicago, Illinois, United States

Site Status

Peoria, Illinois, United States

Site Status

Skokie, Illinois, United States

Site Status

Fort Wayne, Indiana, United States

Site Status

New Albany, Indiana, United States

Site Status

Danville, Kentucky, United States

Site Status

Hazard, Kentucky, United States

Site Status

Lexington, Kentucky, United States

Site Status

Lafayette, Louisiana, United States

Site Status

Shreveport, Louisiana, United States

Site Status

Annapolis, Maryland, United States

Site Status

Baltimore, Maryland, United States

Site Status

Saint Joseph, Michigan, United States

Site Status

Southfield, Michigan, United States

Site Status

St Louis, Missouri, United States

Site Status

St Louis, Missouri, United States

Site Status

Billings, Montana, United States

Site Status

Hackensack, New Jersey, United States

Site Status

Nyack, New York, United States

Site Status

Utica, New York, United States

Site Status

Chapel Hill, North Carolina, United States

Site Status

Charlotte, North Carolina, United States

Site Status

Charlotte, North Carolina, United States

Site Status

Greenville, North Carolina, United States

Site Status

Raleigh, North Carolina, United States

Site Status

Wilmington, North Carolina, United States

Site Status

Winston-Salem, North Carolina, United States

Site Status

Bismarck, North Dakota, United States

Site Status

Cincinnati, Ohio, United States

Site Status

Cleveland, Ohio, United States

Site Status

Cleveland, Ohio, United States

Site Status

Worthington, Ohio, United States

Site Status

Dunmore, Pennsylvania, United States

Site Status

Hershey, Pennsylvania, United States

Site Status

Kingston, Pennsylvania, United States

Site Status

Kttaning, Pennsylvania, United States

Site Status

Philadelphia, Pennsylvania, United States

Site Status

Philadelphia, Pennsylvania, United States

Site Status

Philadelphia, Pennsylvania, United States

Site Status

Pittsburgh, Pennsylvania, United States

Site Status

Charleston, South Carolina, United States

Site Status

Charleston, South Carolina, United States

Site Status

Greenville, South Carolina, United States

Site Status

Nashville, Tennessee, United States

Site Status

Dallas, Texas, United States

Site Status

Fort Worth, Texas, United States

Site Status

Richardson, Texas, United States

Site Status

Abingdon, Virginia, United States

Site Status

Arlington, Virginia, United States

Site Status

Kirkland, Washington, United States

Site Status

Spokane, Washington, United States

Site Status

Huntington, West Virginia, United States

Site Status

Buenos Aires, , Argentina

Site Status

Capital Federal, , Argentina

Site Status

Santa Fe, , Argentina

Site Status

Melbourne, , Australia

Site Status

Perth, , Australia

Site Status

St Leonards, , Australia

Site Status

Sydney, , Australia

Site Status

Bludesch, , Austria

Site Status

Vienna, , Austria

Site Status

Sorocaba, São Paulo, Brazil

Site Status

São Paulo, , Brazil

Site Status

St. John's, Newfoundland and Labrador, Canada

Site Status

Lévis, Quebec, Canada

Site Status

Québec, Quebec, Canada

Site Status

Montreal, , Canada

Site Status

Ontario, , Canada

Site Status

Ottawa, , Canada

Site Status

Québec, , Canada

Site Status

Las Condes

Santiago, , Chile

Site Status

Santiago, , Chile

Site Status

Bogotá, , Colombia

Site Status

Cali Valle, , Colombia

Site Status

Medellín, , Colombia

Site Status

Hradec Králové, , Czechia

Site Status

Nora Ves Pod Plesi, , Czechia

Site Status

Ostrava, , Czechia

Site Status

Kemi, , Finland

Site Status

Oulu, , Finland

Site Status

Besançon, , France

Site Status

Lyon, , France

Site Status

Marseille, , France

Site Status

Montpellier, , France

Site Status

Nice, , France

Site Status

Paris, , France

Site Status

Saint-Cloud, , France

Site Status

Saint-Herblain, , France

Site Status

Aschaffenburg, , Germany

Site Status

Berlin, , Germany

Site Status

Frankfurt, , Germany

Site Status

Halle, , Germany

Site Status

Heidelberg, , Germany

Site Status

Kiel, , Germany

Site Status

Munchen Bayern, , Germany

Site Status

Munich, , Germany

Site Status

Oldenberg, , Germany

Site Status

Budapest, , Hungary

Site Status

Szeged, , Hungary

Site Status

Ashkelon, , Israel

Site Status

Beersheba, , Israel

Site Status

Haifa, , Israel

Site Status

Tel Aviv, , Israel

Site Status

Tel Litwinsky, , Israel

Site Status

Bologna, , Italy

Site Status

Cuneo, , Italy

Site Status

Largo Agostino Gemelli, , Italy

Site Status

Livorno, , Italy

Site Status

Modena, , Italy

Site Status

Napoli, , Italy

Site Status

Novara, , Italy

Site Status

Palermo, , Italy

Site Status

Pavia, , Italy

Site Status

Sassari, , Italy

Site Status

Mexico DF Distrio Federal, , Mexico

Site Status

Tuluea Estand de Mexico, , Mexico

Site Status

Auckland, , New Zealand

Site Status

Christchurch, , New Zealand

Site Status

Kracow, , Poland

Site Status

Warsaw, , Poland

Site Status

Porto, Porto District, Portugal

Site Status

Beja, , Portugal

Site Status

Coimbra, , Portugal

Site Status

Lisbon, , Portugal

Site Status

Bucharest, Bucharest, Romania

Site Status

Cluj-Napoca, , Romania

Site Status

Craiova, , Romania

Site Status

Maribor, , Slovenia

Site Status

Capetown, , South Africa

Site Status

Durban, , South Africa

Site Status

Johannesburg, , South Africa

Site Status

Parktown, , South Africa

Site Status

Pretoria, , South Africa

Site Status

Gyeonggi-do, , South Korea

Site Status

Seoul, , South Korea

Site Status

Alicante, , Spain

Site Status

Jaén, , Spain

Site Status

Madrid, , Spain

Site Status

Navarra, , Spain

Site Status

Valencia, , Spain

Site Status

Taipai, , Taiwan

Site Status

Taoyuang, , Taiwan

Site Status

Birmingham, Birmingham, United Kingdom

Site Status

Cardiff, Carduff, United Kingdom

Site Status

Bristol, , United Kingdom

Site Status

Ipswich, , United Kingdom

Site Status

London, , United Kingdom

Site Status

Manchester, , United Kingdom

Site Status

Nottingham, , United Kingdom

Site Status

Surrey, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium Costa Rica Ireland Norway United States Argentina Australia Austria Brazil Canada Chile Colombia Czechia Finland France Germany Hungary Israel Italy Mexico New Zealand Poland Portugal Romania Slovenia South Africa South Korea Spain Taiwan United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

XRP9881B-3001

Identifier Type: -

Identifier Source: secondary_id

EFC6089

Identifier Type: -

Identifier Source: org_study_id

NCT00107406

Identifier Type: -

Identifier Source: nct_alias