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Brief Title: Vinflunine Plus Trastuzumab in Human Epidermal Growth Factor Receptor 2 (HER2neu) Over-Expressing Metastatic Breast Cancer
Official Title: Phase II Trial of Vinflunine Plus Trastuzumab in Human Epidermal Growth Factor Receptor 2 (HER2neu) Over-Expressing Metastatic Breast Cancer
Study ID: NCT00284180
Brief Summary: This research study involves the anti-cancer medication trastuzumab and the investigational drug vinflunine. The purpose of this trials is to see if trastuzumab and vinflunine used in combination or vinflunine alone is effective in the treatment of metastatic breast cancer
Detailed Description: If the tumor is HER2neu positive, eligible patients will receive trastuzumab and vinflunine intravenously (IV) every 3 weeks. If the tumor is HER2neu negative, eligible patients will receive vinflunine intravenously (IV) every 3 weeks. Patients whose cancer does not grow or decreases in size may continue to receive treatment until cancer progression. Evaluation of cancer will be every 9 weeks.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Northeast Alabama Regional Medical Center, Anniston, Alabama, United States
Florida Cancer Specialists, Fort Myers, Florida, United States
Integrated Community Oncology Network, Jacksonville, Florida, United States
Watson Clinic Center for Cancer Care and Research, Lakeland, Florida, United States
Northeast Georgia Medical Center, Gainesville, Georgia, United States
Hematology Oncology Life Center, Alexandria, Louisiana, United States
Grand Rapids Clinical Oncology Program, Grand Rapids, Michigan, United States
Spartanburg Regional Medical Center, Spartanburg, South Carolina, United States
Associates in Hematology Oncology, Chattanooga, Tennessee, United States
Tennessee Oncology, Nashville, Tennessee, United States
Name: Denise A Yardley, MD
Affiliation: SCRI Development Innovations, LLC
Role: PRINCIPAL_INVESTIGATOR