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
OBJECTIVES:
Primary
- 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.
Secondary
- Compare the objective response rate and duration of response in patients treated with
these regimens.
- 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
1-28.
In both arms, treatment repeats every 28 days in the absence of disease progression or
unacceptable toxicity.
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Progression-free survival
At disease progression or death
No
William J. Gradishar, MD
Study Chair
Robert H. Lurie Cancer Center
United States: Federal Government
NU 07B1
NCT00499525
June 2007
December 2014
Name | Location |
---|---|
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 |