493
Participants
Start Date
June 30, 2007
Primary Completion Date
April 30, 2013
Study Completion Date
April 30, 2013
Taxotere
On Day 1 of each 21-day cycle for a total of 4 cycles, patients will receive, in this order: docetaxel 75 mg/m2 IV (over 1 hour), plus cyclophosphamide 600 mg/m2 IV (over 15-30 minutes), plus weekly trastuzumab 4 mg/kg IV (loading dose, over 90 minutes Day 1, Cycle 1 only) and 2 mg/kg IV (over 30-60 minutes on Days 1, 8, and 15) thereafter. Once 4 cycles of TC+H have been received, patients will continue with trastuzumab 6 mg/kg every 3 weeks to complete 1 year of anti-HER2 therapy as per the current standard of care. The anticipated time to study completion is 5 years.
Cytoxan
On Day 1 of each 21-day cycle for a total of 4 cycles, patients will receive, in this order: docetaxel 75 mg/m2 IV (over 1 hour), plus cyclophosphamide 600 mg/m2 IV (over 15-30 minutes), plus weekly trastuzumab 4 mg/kg IV (loading dose, over 90 minutes Day 1, Cycle 1 only) and 2 mg/kg IV (over 30-60 minutes on Days 1, 8, and 15) thereafter. Once 4 cycles of TC+H have been received, patients will continue with trastuzumab 6 mg/kg every 3 weeks to complete 1 year of anti-HER2 therapy as per the current standard of care. The anticipated time to study completion is 5 years.
Herceptin
On Day 1 of each 21-day cycle for a total of 4 cycles, patients will receive, in this order: docetaxel 75 mg/m2 IV (over 1 hour), plus cyclophosphamide 600 mg/m2 IV (over 15-30 minutes), plus weekly trastuzumab 4 mg/kg IV (loading dose, over 90 minutes Day 1, Cycle 1 only) and 2 mg/kg IV (over 30-60 minutes on Days 1, 8, and 15) thereafter. Once 4 cycles of TC+H have been received, patients will continue with trastuzumab 6 mg/kg every 3 weeks to complete 1 year of anti-HER2 therapy as per the current standard of care. The anticipated time to study completion is 5 years.
Ruth Oratz MD, New York
New York Oncology Hematology, P.C., Albany
Interlakes Oncology Hematology, PC, Rochester
Medical Oncology Associates, Kingston
Maryland Oncology Hematology, P.A., Columbia
Alliance Hematology Oncology P.A., Westminster
Fairfax Northern VA Hem-Onc PC, Fairfax
Virginia Oncology Associates, Norfolk
Onc and Hem Associates of SW VA, Inc., Salem
Cancer Centers of North Carolina, Raleigh
Cancer Centers of the Carolinas, Greenville
Ocala Oncology Center, Ocala
Florida Cancer Institute, New Port Richey
Cancer Centers of Florida, P.A., Ocoee
Birmingham Hematology and Oncology, Birmingham
Greater Dayton Cancer Center, Kettering
Central Indiana Cancer Centers, Indianapolis
Hope Center, Terre Haute
Minnesota Oncology Hematology, P.A., Minneapolis
Hematology Oncology Associates of IL, Chicago
Cancer Care & Hematology Specialists of Chicagoland, Niles
Arch Medical Services, Inc., St Louis
Missouri Cancer Associates, Columbia
Kansas City Cancer Centers-Southwest, Overland Park
Texas Oncology, P.A., Garland
Lake Vista Cancer Center, Lewisville
Texas Cancer Center-Sherman, Sherman
Texas Cancer Center of Mesquite, Mesquite
Texas Cancer Center at Medical City, Dallas
Texas Oncology, P.A., Dallas
Methodist Charlton Cancer Ctr., Dallas
Texas Oncology, P.A., Dallas
Paris Regional Cancer Center, Paris
Longview Cancer Center, Longview
Tyler Cancer Center, Tyler
Texas Cancer Center, Arlington
Texas Oncology, P.A.-Bedford, Bedford
Texas Oncology, P.A., Fort Worth
Texas Cancer Center, Denton
Texoma Cancer Center, Wichita Falls
Texas Oncology Cancer Care and Research, Waco
Texas Oncology, P.A., Houston
Texas Oncology Cancer Center-Sugar Land, Sugar Land
Texas Oncology PA, Webster
Mamie McFaddin Ward Cancer Center, Beaumont
San Antonio Tumor and Blood Clinic, San Antonio
HOAST-Medical Dr., San Antonio
South Texas Cancer Center-McAllen, McAllen
Texas Oncology Cancer Center, Austin
Texas Oncology, P.A.-Amarillo, Amarillo
Texas Cancer Center-Abilene (South), Abilene
Allison Cancer Center, Midland
Texas Oncology-Odessa, Odessa
El Paso Cancer Treatment Ctr, El Paso
Rocky Mountain Cancer Center-Rose, Denver
Hematology Oncology Associates, Phoenix
Arizona Oncology Associates DBA HOPE, Tucson
Northern AZ Hematology & Oncology Associates, Sedona
New Mexico Cancer Care Associates, Santa Fe
Comprehensive Cancer Centers of Nevada, Henderson
Willamette Valley Cancer Center, Eugene
Puget Sound Cancer Center-Edmonds, Edmonds
Puget Sound Cancer Center-Seattle, Seattle
Highline Medical Oncology, Burien
Northwest Cancer Specialists-Vancouver, Vancouver
Yakima Valley Mem Hosp/North Star Lodge, Yakima
Cancer Care Northwest-South, Spokane
Connecticut Oncology & Hematology, LLP, Torrington
Hematology-Oncology Associates of NNJ, P.A., Morristown
Collaborators (1)
Sanofi
INDUSTRY
US Oncology Research
INDUSTRY