Status:
COMPLETED
Intravenous RPR109881 in Male or Female Patients With Advanced Breast Cancer Who no Longer Respond to Anthracycline, Taxane and Capecitabine Treatment
Lead Sponsor:
Sanofi
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this clinical trial is to determine if the investigational drug is able to reduce/shrink advanced breast cancer tumors in patients who no longer benefit from anthracyclines, taxanes and...
Detailed Description
All patients in this trial will receive the investigational (chemotherapy) drug at an optimal dose as determined by previous clinical trials. The investigational drug is given through a vein once ever...
Eligibility Criteria
Inclusion
- 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. doxorubicin \[Adriamycin or Doxil\] or epirubicin \[Ellence\]), taxanes (paclitaxel \[Taxol or Abraxane\] or docetaxel \[Taxotere\]) and capecitabine (e.g. Xeloda) for your breast cancer and your doctor has determined that these treatments 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 the 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 (lab tests, CT scans).
Exclusion
- None listed here. Can be discussed with your doctor.
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT00087958
Start Date
August 1 2004
End Date
April 1 2009
Last Update
May 1 2009
Active Locations (15)
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1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
2
Sanofi-Aventis Administrative Office
Buenos Aires, Argentina
3
Sanofi-Aventis Administrative Office
Diegem, Belgium
4
Sanofi-Aventis Administrative Office
Laval, Canada