A Double-Blind, Randomized Phase 2b Study Evaluating the Efficacy and Safety of Sorafenib Compared to Placebo When Administered in Combination With Paclitaxel in Patients With Locally Recurrent or Metastatic Breast Cancer
- Compare progression-free survival of patients with locally recurrent or metastatic
breast cancer treated with sorafenib tosylate and paclitaxel versus placebo and
paclitaxel as first-line therapy.
- Compare the objective response rate and duration of response in patients treated with
- Compare the time to progression in patients treated with these regimens.
- Compare the survival of patients treated with these regimens.
- Compare the safety of patients treated with these regimens.
- Compare the change from baseline in the Functional Assessment of Cancer Therapy for
Breast Cancer quality of life assessment score in patients treated with these regimens.
OUTLINE: This is a double-blind, randomized, multicenter study. Patients are stratified
according to site of metastatic disease (visceral [i.e., soft internal organs of the body,
including lungs, heart, and the organs of the digestive, excretory, and reproductive
systems] vs nonvisceral [i.e., osseous or soft tissue] sites). Patients are randomized to 1
of 2 treatment arms.
- Arm I: Patients receive paclitaxel IV over 1 hour once weekly for 3 weeks. Patients
also receive oral sorafenib tosylate twice daily on days 1-28.
- Arm II: Patients receive paclitaxel as in arm I and oral placebo twice daily on days
In both arms, treatment repeats every 28 days in the absence of disease progression or
Quality of life is assessed at baseline, and every 8 weeks for 24 weeks, and then every 12
weeks for the duration of study participation.
After completion of study therapy, patients are followed every 4 months.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
At disease progression or death
William J. Gradishar, MD
Robert H. Lurie Cancer Center
United States: Federal Government
|Hinsdale Hematology Oncology Associates||Hinsdale, Illinois 60521|
|Sutter Cancer Center||Sacramento, California 95816|
|Mountain States Tumor Institute at St. Luke's Regional Medical Center||Boise, Idaho 83712-6297|
|Gundersen Lutheran Center for Cancer and Blood||La Crosse, Wisconsin 54601|
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University||Chicago, Illinois 60611|
|Decatur Memorial Hospital Cancer Care Institute||Decatur, Illinois 62526|
|Helen and Harry Gray Cancer Center at Hartford Hospital||Hartford, Connecticut 06102-5037|
|Midwest Center for Hematology/Oncology||Joliet, Illinois 60432|
|Hematology/Oncology of the North Shore at Gross Point Medical Center||Skokie, Illinois 60076|
|Fort Wayne Medical Oncology and Hematology||Fort Wayne, Indiana 46815|
|Mary Bird Perkins Cancer Center - Baton Rouge||Baton Rouge, Louisiana 70809|
|North Coast Cancer Care, Incorporated||Sandusky, Ohio 44870|
|Cascade Cancer Center at Evergreen Hospital Medical Center||Kirkland, Washington 98034-3013|
|Hematology-Oncology Associates of Illinois||Chicago, Illinois 60611-2998|
|Eastern Connecticut Hematology and Oncology Associates||Norwich, Connecticut 06360|
|Kellogg Cancer Care Center||Highland Park, Illinois 60035|
|Highlands Oncology Group - Fayetteville||Fayetteville, Arkansas 72703|
|Fountain Valley, California 92708|
|Piedmont Hematology-Oncology Associates||Winston-Salem, North Carolina 27103|
|Kentuckiana Cancer Institute, PLLC||Louisville, Kentucky 40202|
|Hematology and Oncology Associates of Rhode Island||Cranston, Rhode Island 02920|
|Pacific Cancer Medical Center, Incorporated||Anaheim, California 92801|
|Medical and Surgical Specialists, LLC||Galesburg, Illinois 61401|
|Northeast Georgia Cancer Care, LLC - Medical Oncology||Athens, Georgia 30607|
|Cancer Institute at Alexian Brothers||Elk Grove Village, Illinois 60007|
|Cancer Prevention and Treatment Center at Dominican and Watsonville Community Hospital||Soquel, California 95073|
|Essex Oncology of North Jersey||Belleville, New Jersey 07109|
|Nebraska Hematology-Oncology, PC||Lincoln, Nebraska 68506|
|Family Medicine of Vincennes Clinical Trial Center||Vincennes, Indiana 47591|
|Northwest Alabama Cancer Center, PC - Muscle Shoals||Muscle Shoals, Alabama 35661|
|Pacific Coast Hematology/Oncology Medical Group, Incorporated||Fountain Valley, California 92708|
|Desert Hematology-Oncology Medical Group, Incorporated||Rancho Mirage, California 92270|
|Medical Oncology and Hematology, PC at Harold Leever Cancer Center||Waterbury, Connecticut 06708|
|George Washington University Cancer Institute||Washington, District of Columbia 20037|
|Pasco Hernando Oncology Associates, PA - Brooksville||Brooksville, Florida 34613|
|Pasco Hernando Oncology Associates, PA - New Port Richey||New Port Richey, Florida 34652|
|Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center||Columbia, Missouri 65201|
|Sussex County Medical Associates - Sparta||Sparta, New Jersey 07871|
|Tri-County Hematology/Oncology Associates, Incorporated||Canton, Ohio 44718|
|Hematology Oncology Consultants, Incorporated||Columbus, Ohio 43235|
|West Clinic - East Memphis||Memphis, Tennessee 38120|
|Patients' Comprehensive Cancer Center - Carrollton||Carrollton, Texas 75010-4602|
|Oncology Consultants - Memorial City||Houston, Texas 77024|