105
Participants
Start Date
May 31, 2007
Primary Completion Date
December 31, 2009
Study Completion Date
May 31, 2014
Epirubicin
Both Cohorts: Epirubicin 90 mg/m2 IV every 21 days x 4 cycles
Cyclophosphamide
Both Cohorts: Cyclophosphamide 600 mg/m2 IV every 21 days x 4 cycles
Docetaxel
Both Cohorts: Docetaxel 100 mg/m2 IV on Day 1 every 21 days x 4 cycles
Trastuzumab
"Cohort A: Pre-op therapy - 4 mg/kg IV first dose, then subsequent doses at 2 mg/kg IV weekly (16+ weeks) until 1-7 days prior to surgery. Post-operative therapy (beginning no sooner than 28 days after surgery and continuing every 3 weeks x 13 doses) - 8 mg/kg IV first post-op dose, then subsequent doses at 6 mg/kg IV~Cohort B: 4 mg/kg IV first dose, then subsequent doses at 2 mg/kg IV weekly on days 1, 8, and 15. Three (3) weeks after last dose of docetaxel, 6 mg/kg IV and continuing every 3 weeks x 13 doses"
Bevacizumab
"Cohort A: Cycles 1-4, 15 mg/kg IV on day 1 of cycle 4 only; Cycles 5-7, 15 mg/kg IV on day 1 every 21 days x 3 cycles; post-operative therapy (beginning no sooner than 28 days after surgery), 15 mg/kg IV every 3 weeks x 13 doses~Cohort B: Cycles 5-8, 15 mg/kg IV on day 1 every 21 days x 4 cycles; beginning 3 weeks after last dose of docetaxel, 15 mg/kg IV every 3 weeks x 13 doses"
University Hospital and Medical Center - SUNY, Stony Brook
Allegheny General Hospital/Allegheny-Singer Research Institute, Pittsburgh
NSABP Foundation, Inc., Pittsburgh
University of Pittsburgh, Pittsburgh
Mercy Hospital, Scranton
Kimmel Cancer Center at Jefferson, Philadelphia
MBCCOP, Virginia Commonwealth University, Richmond
East Carolina University, Greenville
CCOP, Southeast Cancer Control Consortium, Charlotte
CCOP, Upstate Carolina, Spartanburg
Baptist Regional Cancer Institute, Jacksonville
Clearview Cancer Institute- Huntsville, Huntsville
NortonHealtcare Inc., Louisville
Case Western Reserve/University Hospitals-Ireland Cancer Cntr., Cleveland
Aultman Hospital, Canton
CCOP, Dayton, OH, Dayton
CCOP, Northern Indiana Cancer Research Consortium, South Bend
CCOP, Michigan Cancer Research Consortium, Grosse Pointe Woods
Michigan State University - Breslin Cancer Center, Lansing
CCOP, Kalamazoo, MI, Kalamazoo
CCOP, Grand Rapids Clnical Oncology Program, Grand Rapids
University of Iowa, Iowa City
CCOP, Marshfield Clinic, Marshfield
CCOP, Metro-Minnesota, Minneapolis
Rush University Medical Center, Chicago
CCOP, Central Illinois, Springfield
CCOP, Cancer Research for the Ozarks, Springfield
CCOP, Scott and White Memorial Hospital, Temple
Joe Arrington Cancer Research & Treatment Center, Lubbock
CCOP, Colorado Cancer Research Program, Inc., Denver
Kaiser Permanente-San Diego, San Diego
Kaiser Permanente-Vallejo, Vallejo
CCOP, Columbia River Oncology, Portland
Cancer Institute of New Jersey, New Brunswick
Albert Einstein Healthcare Network, Philadelphia
University of Montreal Hospital Group, Montreal
Collaborators (2)
Genentech, Inc.
INDUSTRY
International Drug Development Institute
OTHER
NSABP Foundation Inc
NETWORK