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

August 20, 2008 updated by: Sanofi

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

438

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
      • Capital Federal, Argentina
      • Santa Fe, Argentina
  • Australia
      • Melbourne, Australia
      • Perth, Australia
      • St. Leonards, Australia
      • Sydney, Australia
  • Austria
      • Bludesch, Austria
      • Vienna, Austria
  • Brazil
      • Sao Paolo, Brazil
    • San Paulo
      • Sorocaba, San Paulo, Brazil
  • Canada
      • Montreal, Canada
      • Ontario, Canada
      • Ottawa, Canada
      • Quebec, Canada
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada
    • Quebec
      • Levis, Quebec, Canada
  • Chile
      • Santiago, Chile
      • Santiago, Chile
        • Las Condes
  • Colombia
      • Bogota, Colombia
      • Cali Valle, Colombia
      • Medellin, Colombia
  • Czech Republic
      • Hradec Kralove, Czech Republic
      • Nora Ves Pod Plesi, Czech Republic
      • Ostrava, Czech Republic
  • Finland
      • Kemi, Finland
      • Oulu, Finland
  • France
      • Besancon, France
      • Lyon, France
      • Marseille, France
      • Montpellier, France
      • Nice, France
      • Paris, France
      • Saint Cloud, France
      • Saint Herblain, France
  • Germany
      • Aschaffenburg, Germany
      • Berlin, Germany
      • Frankfurt, Germany
      • Halle, Germany
      • Heidelberg, Germany
      • Kiel, Germany
      • Munchen Bayern, Germany
      • Munich, Germany
      • Oldenberg, Germany
  • Hungary
      • Budapest, Hungary
      • Szeged, Hungary
  • Israel
      • Ashkelon, Israel
      • Beer-Sheva, Israel
      • Haifa, Israel
      • Tel Aviv, Israel
      • Tel HaShomer, Israel
  • Italy
      • Bologna, Italy
      • Cuneo, Italy
      • Largo Agostino Gemelli, Italy
      • Livorno, Italy
      • Modena, Italy
      • Napoli, Italy
      • Novara, Italy
      • Palermo, Italy
      • Pavia, Italy
      • Sassari, 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
      • Kracow, Poland
      • Warsaw, Poland
  • Portugal
      • Beja, Portugal
      • Coimbra, Portugal
      • Lisboa, Portugal
      • Porto, Portugal
  • Romania
      • Bucharest, Romania
      • Cluj Napoca, Romania
      • Craiova, Romania
  • Slovenia
      • Maribor, Slovenia
  • South Africa
      • Capetown, South Africa
      • Durban, South Africa
      • Johannesburg, South Africa
      • Parktown, South Africa
      • Pretoria, South Africa
  • Spain
      • Alicante, Spain
      • Jaen, Spain
      • Madrid, Spain
      • Navarra, Spain
      • Valencia, Spain
  • Taiwan
      • Taipai, Taiwan
      • Taoyuang, Taiwan
  • United Kingdom
      • Birmingham, United Kingdom
      • Bristol, United Kingdom
      • Ipswich, United Kingdom
      • London, United Kingdom
      • Manchester, United Kingdom
      • Nottingham, United Kingdom
      • Surrey, United Kingdom
    • Carduff
      • Cardiff, Carduff, United Kingdom
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35216
    • Arizona
      • Tucson, Arizona, United States, 85704
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
    • California
      • Bakersfield, California, United States, 93309
      • Burbank, California, United States, 91505
      • Concord, California, United States, 94520
      • Fountain Valley, California, United States, 92708
      • Fresno, California, United States, 93720
      • Fullerton, California, United States, 92835
      • Gilroy, California, United States, 95020
      • Long Beach, California, United States, 90806
      • Los Angeles, California, United States, 90095
      • Monterey Park, California, United States, 91754
      • Northridge, California, United States, 91328
      • Oxnard, California, United States, 93030
      • Pamona, California, United States, 91767
      • Pomona, California, United States, 91767
      • Porterville, California, United States, 93257
      • Redondo Beach, California, United States, 90272
      • San Diego, California, United States, 92123
      • San Francisco, California, United States, 94115
      • Santa Barbara, California, United States, 93105
      • Soquel, California, United States, 95073
      • Vista, California, United States, 92081
    • Connecticut
      • New London, Connecticut, United States, 06320
    • Delaware
      • Newark, Delaware, United States, 19718
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
      • Ft Lauderdale, Florida, United States, 33316
      • Gainsville, Florida, United States, 32605
      • Jacksonville, Florida, United States, 32209
      • Lake Worth, Florida, United States, 33461
      • Orlando, Florida, United States, 32804
      • West Palm Beach, Florida, United States, 33401
    • Georgia
      • Lawrenceville, Georgia, United States, 30045
      • Macon, Georgia, United States, 31201
      • Marietta, Georgia, United States, 30060
      • Roswell, Georgia, United States, 30076
    • Illinois
      • Centralia, Illinois, United States, 62801
      • Chicago, Illinois, United States, 60640
      • Peoria, Illinois, United States, 61615
      • Skokie, Illinois, United States, 66077
    • Indiana
      • Fort Wayne, Indiana, United States, 46815
      • New Albany, Indiana, United States, 47150
    • Kentucky
      • Danville, Kentucky, United States, 40422
      • Hazard, Kentucky, United States, 41701
      • Lexington, Kentucky, United States, 40503
    • Louisiana
      • Lafayette, Louisiana, United States, 70503
      • Shreveport, Louisiana, United States, 71101
    • Maryland
      • Annapolis, Maryland, United States, 21401
      • Baltimore, Maryland, United States, 21201
    • Michigan
      • Southfield, Michigan, United States, 48076
      • St. Joseph, Michigan, United States, 49085
    • Missouri
      • St. Louis, Missouri, United States, 63110
      • St. Louis, Missouri, United States, 63141
    • Montana
      • Billings, Montana, United States, 59101
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
    • New York
      • Nyack, New York, United States, 10960
      • Utica, New York, United States, 13502
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
      • Charlotte, North Carolina, United States, 28204
      • Charlotte, North Carolina, United States, 28203
      • Greenville, North Carolina, United States, 27834
      • Raleigh, North Carolina, United States, 27609
      • Wilmington, North Carolina, United States, 28401
      • Winston-Salem, North Carolina, United States, 27103
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
    • Ohio
      • Cincinatti, Ohio, United States, 45267
      • Cleveland, Ohio, United States, 44109
      • Cleveland, Ohio, United States, 44195
      • Worthington, Ohio, United States, 43085
    • Pennsylvania
      • Dunmore, Pennsylvania, United States, 18512
      • Hershey, Pennsylvania, United States, 17033
      • Kingston, Pennsylvania, United States, 18704
      • Kttaning, Pennsylvania, United States, 16201
      • Philadelphia, Pennsylvania, United States, 19146
      • Philadelphia, Pennsylvania, United States, 19115
      • Philadelphia, Pennsylvania, United States, 19106
      • Pittsburgh, Pennsylvania, United States, 15213
    • South Carolina
      • Charleston, South Carolina, United States, 29425
      • Charleston, South Carolina, United States, 29403
      • Greenville, South Carolina, United States, 29615
    • Tennessee
      • Nashville, Tennessee, United States, 37205
    • Texas
      • Dallas, Texas, United States, 75390
      • Fort Worth, Texas, United States, 76104
      • Richardson, Texas, United States, 75082
    • Virginia
      • Abingdon, Virginia, United States, 24211
      • Arlington, Virginia, United States, 22205
    • Washington
      • Kirkland, Washington, United States, 98034
      • Spokane, Washington, United States, 99202
    • West Virginia
      • Huntington, West Virginia, United States, 25701

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time to tumor progression.

Secondary Outcome Measures

Outcome Measure
Overall survival.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (Actual)

September 1, 2006

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

April 20, 2004

First Submitted That Met QC Criteria

April 21, 2004

First Posted (Estimate)

April 22, 2004

Study Record Updates

Last Update Posted (Estimate)

August 21, 2008

Last Update Submitted That Met QC Criteria

August 20, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFC6089
  • XRP9881B-3001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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