Status:
UNKNOWN
Trial of Myocet in Metastatic Breast Cancer
Lead Sponsor:
Sopherion Therapeutics
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
The purpose of the study is to examine the safety and effectiveness of the drug combination of Myocet, paclitaxel and trastuzumab compared to paclitaxel and trastuzumab without Myocet, as first line t...
Eligibility Criteria
Inclusion
- Metastatic Her2+ Breast cancer by FISH analysis
- No prior chemotherapy for metastatic disease
- Measurable disease
- normal left ventricular ejection fraction
Exclusion
- prior doxorubicin treatment exceeding 300 mg/m2 or epirubicin exceeding 600 mg/m2
- relapse within 12 months of completion of adjuvant trastuzumab, taxane or anthracycline therapy
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
363 Patients enrolled
Trial Details
Trial ID
NCT00294996
Start Date
January 1 2006
Last Update
March 31 2009
Active Locations (105)
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1
Scripps Cancer Center Clinical Research
San Diego, California, United States, 92121
2
University of Colorado
Aurora, Colorado, United States, 80045
3
Northwest Hematology/Oncology Associates
Coral Springs, Florida, United States, 33065
4
Osceola Cancer Center
Kissimmee, Florida, United States, 34741