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
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.
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.
Eligibility Criteria
In order to be eligible for this trial you must:
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).
Gainsville, Florida 32605, United States
Kttaning, Pennsylvania 16201, United States
Capital Federal, Argentina
Ontario, Canada
Cali Valle, Colombia
Nora Ves Pod Plesi, Czechia
Munchen Bayern, Germany
Oldenberg, Germany
Largo Agostino Gemelli, Italy
Mexico DF Distrio Federal, Mexico
Tuluea Estand de Mexico, Mexico
Kracow, Poland
Capetown, South Africa
Navarra, Spain
Taipai, Taiwan
Taoyuang, Taiwan
Surrey, United Kingdom