Trial of Myocet in Metastatic Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT00294996
- Lead Sponsor
- Sopherion Therapeutics
- 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 treatment for patients with metastatic HER2+ breast cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 363
- Metastatic Her2+ Breast cancer by FISH analysis
- No prior chemotherapy for metastatic disease
- Measurable disease
- normal left ventricular ejection fraction
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Progression-Free Survival
- Secondary Outcome Measures
Name Time Method Overall Survival Safety
Trial Locations
- Locations (105)
Scripps Cancer Center Clinical Research
🇺🇸San Diego, California, United States
University of Colorado
🇺🇸Aurora, Colorado, United States
Northwest Hematology/Oncology Associates
🇺🇸Coral Springs, Florida, United States
Osceola Cancer Center
🇺🇸Kissimmee, Florida, United States
UM/Sylvester Cancer Center
🇺🇸Plantation, Florida, United States
John B. Amos Cancer Center
🇺🇸Columbus, Georgia, United States
Clintell, Inc
🇺🇸Skokie, Illinois, United States
Hutchinson Clinic P.A.
🇺🇸Hutchinson, Kansas, United States
Western Maryland Health System
🇺🇸Cumberland, Maryland, United States
Brody School of Medicine @ ECU
🇺🇸Greenville, North Carolina, United States
Scroll for more (95 remaining)Scripps Cancer Center Clinical Research🇺🇸San Diego, California, United States