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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
438

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time to tumor progression.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Overall survival.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2004

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2006

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2006

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 20, 2004

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2004

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 22, 2004

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 21, 2008

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2008

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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