60
Participants
Start Date
February 28, 2009
Primary Completion Date
July 31, 2011
Study Completion Date
October 31, 2014
Ixabepilone
Ixabepilone 40mg/m2 IV infusion over 3 hours on day 1 of cycles 1-6 (all treatment cycles are 21 days in length)
Trastuzumab
Trastuzumab 8mg/kg IV over 90 minutes for the first infusion (Cycle 1, Day 1) with a 60 minute post-infusion observation period. Subsequent infusions (Day 1 of Cycles 2-6 with all cycles being 21 days in length) 6mg/kg over 30 minutes if the previous dose was well tolerated; peri-operative trastuzumab 6mg/kg IV every 3-4 weeks; post-operative trastuzumab 6mg/kg IV day 1 every 3 weeks until week 52
Carboplatin
Carboplatin AUC=6 IV per institutional guidelines on Day 1 of Cycles 1-6 (all treatment cycles are 21 days in length)
Center for Cancer and Blood Disorders, Bethesda
National Capital Clinical Research Consortium, Bethesda
Virginia Cancer Institute, Richmond
Medical Oncology Associates of Augusta, Augusta
Florida Cancer Specialists, Fort Myers
Tennessee Oncology, PLLC, Nashville
Oncology Hematology Care, Cincinnati
Providence Medical Group, Terre Haute
Grand Rapids Clinical Oncology Program, Grand Rapids
St. Louis Cancer Care, Chesterfield
Mercy Hospital, Portland
Hematology Oncology Associates of Northern NJ, Morristown
Collaborators (2)
Bristol-Myers Squibb
INDUSTRY
Genentech, Inc.
INDUSTRY
SCRI Development Innovations, LLC
OTHER