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
18 Years
N/A
Both
Breast Cancer, Metastases
Trial Information
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
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.
Inclusion 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).
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Time to tumor progression.
Principal Investigator
ICD CSD
Investigator Role:
Study Director
Investigator Affiliation:
Sanofi
Authority:
United States: Food and Drug Administration
Study ID:
EFC6089
NCT ID:
NCT00081796
Start Date:
April 2004
Completion Date:
September 2006
Related Keywords:
- Breast Cancer
- Metastases
- Metastatic Breast Cancer
- Breast Neoplasms
- Neoplasm Metastasis
Name | Location |
|---|---|
| Hinsdale, Illinois 60521 | |
| New Britain, Connecticut 06052 | |
| Albany, Georgia 31701 | |
| Great Falls, Montana 59405 | |
| Birmingham, Alabama 35294 | |
| Phoenix, Arizona 85012 | |
| Fountain Valley, California 92708 | |
| Miami, Florida 33176 | |
| Columbia, Missouri 65203 | |
| Albany, New York 12208 | |
| Cleveland, Ohio 44195 | |
| Philadelphia, Pennsylvania 19104 | |
| Nashville, Tennessee 37203-1632 | |
| Austin, Texas 78705 | |
| Seattle, Washington 98195 | |
| Flint, Michigan 48532 | |
| Louisville, Kentucky 40207 | |
| McLean, Virginia 22101 | |
| Little Rock, Arkansas 72205-7199 | |
| Hackensack, New Jersey 07601 | |
| Metairie, Louisiana 70006 | |
| Baltimore, Maryland 21287 | |
| Charlotte, North Carolina | |
| Wilmington, Delaware | |
| Indianapolis, Indiana | |
| Charleston, South Carolina | |
| Charleston, West Virginia 25304 | |
| Bismarck, North Dakota 58501 |
