A Randomized Phase III Tial Of Paclitaxel Versus Paclitaxel Plus Bevacizumab (rhuMAb VEGF) As First-Line Therapy For Locally Recurrent or Metastatic Breast Cancer
- Compare the time to treatment failure in patients with locally recurrent or metastatic
breast cancer treated with paclitaxel with or without bevacizumab.
- Compare the objective response rate, duration of response, overall survival, and time
to progression in patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to disease-free interval (no more than 24 months vs more than 24 months), number
of metastatic sites (less than 3 vs 3 or more), treatment with prior adjuvant chemotherapy
(yes vs no), and estrogen receptor status (positive vs negative vs unknown). Patients are
randomized to one of two treatment arms.
- Arm I: Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 followed by
bevacizumab IV over 30-90 minutes on days 1 and 15.
- Arm II: Patients receive paclitaxel as in arm I. In both arms, courses repeat every 4
weeks in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and on day 1 of weeks 17 and 33.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
PROJECTED ACCRUAL: A total of 316-650 patients (158-325 per treatment arm) will be accrued
for this study within 31 months.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Assessed every 3 months for 2 years, then every 6 months for 3 years
Kathy Miller, MD
Indiana University Melvin and Bren Simon Cancer Center
United States: Food and Drug Administration
|Mayo Clinic - Jacksonville||Jacksonville, Florida 32224|
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|CCOP - Upstate Carolina||Spartanburg, South Carolina 29303|
|CCOP - Atlanta Regional||Atlanta, Georgia 30342-1701|
|CCOP - Missouri Valley Cancer Consortium||Omaha, Nebraska 68131|
|CCOP - Illinois Oncology Research Association||Peoria, Illinois 61602|
|CCOP - Carle Cancer Center||Urbana, Illinois 61801|
|CCOP - Iowa Oncology Research Association||Des Moines, Iowa 50309-1016|
|CCOP - Metro-Minnesota||Saint Louis Park, Minnesota 55416|
|CCOP - Michigan Cancer Research Consortium||Ann Arbor, Michigan 48106|
|CCOP - Duluth||Duluth, Minnesota 55805|
|CCOP - Cedar Rapids Oncology Project||Cedar Rapids, Iowa 52403-1206|
|Siouxland Hematology-Oncology||Sioux City, Iowa 51101-1733|
|CCOP - Ochsner||New Orleans, Louisiana 70121|
|CCOP - Merit Care Hospital||Fargo, North Dakota 58122|
|Rapid City Regional Hospital||Rapid City, South Dakota 57709|
|CCOP - Sioux Community Cancer Consortium||Sioux Falls, South Dakota 57105-1080|
|CCOP - Dayton||Kettering, Ohio 45429|
|CCOP - Geisinger Clinic and Medical Center||Danville, Pennsylvania 17822-2001|
|CCOP - St. Vincent Hospital Cancer Center, Green Bay||Green Bay, Wisconsin 54301|
|MBCCOP - Gulf Coast||Mobile, Alabama 36688|
|CCOP - Oklahoma||Tulsa, Oklahoma 74136|
|Allegheny General Hospital||Pittsburgh, Pennsylvania 15212-4772|
|CCOP - Toledo Community Hospital||Toledo, Ohio 43623-3456|
|Medcenter One Health System||Bismarck, North Dakota 58501|
|CentraCare Health Plaza||Saint Cloud, Minnesota 56303|
|Altru Cancer Center||Grand Forks, North Dakota 58206|
|CCOP - Mayo Clinic Scottsdale Oncology Program||Scottsdale, Arizona 85259|