Trial of Myocet in Metastatic Breast Cancer

Status unconfirmed · Phase 3

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT00294996

Run by

Sopherion Therapeutics

People needed

363

Starts

2006-01-01

Last updated by the study team

2009-03-31

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Metastatic Her2+ Breast cancer by FISH analysis
• No prior chemotherapy for metastatic disease
• Measurable disease
• normal left ventricular ejection fraction

You may not qualify if…

• 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

Where it is running

• 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
• Aultman Hospital Cancer Center — Canton, Ohio, United States
• Hematology Oncology Consultants, Inc. — Columbus, Ohio, United States
• Vita Hematology Oncology — Bethlehem, Pennsylvania, United States
• Hematology & Oncology Associates of NEPA — Dunmore, Pennsylvania, United States
• PA Oncology Hematology Asso — Philadelphia, Pennsylvania, United States
• M. Francisco Gonzalez — Columbia, South Carolina, United States
• Sioux Valley Clinic — Sioux Falls, South Dakota, United States
• Tennessee Cancer Specialists — Knoxville, Tennessee, United States
• Centro Oncologico de Excelencia — Buenos Aires, Argentina
• Hospital Enrique Tornú — Buenos Aires, Argentina
• Hospital Interzonal Gral de Agudos " EVITA" — Buenos Aires, Argentina
• Hospital Profesor A. Posadas — Buenos Aires, Argentina
• Santorio Municipal Dr. J. Mendez — Buenos Aires, Argentina
• Unidad Oncologica del Neuquen — Neuquén, Argentina
• CAICI Instituto — Santa Fe, Argentina
• Scripps Cancer Center Clinical Research — San Diego, California, United States

Full record on ClinicalTrials.gov

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