Phase I/II Combined Biological Therapy of Breast Cancer Using Monoclonal Antibodies Directed Against HER2/Neu Proto-Oncogene and Vascular Endothelial Growth Factor
Based on preclinical experiments conducted in our laboratories, we hypothesize that the
aggressive behavior of HER2-overexpressing breast cancers is due in part to increased
angiogenesis resulting from HER2-induced increases in vascular endothelial growth factor
(VEGF) expression. In vivo experiments suggest that combined blockade of the HER2 receptor
and VEGF results in superior anti-tumor efficacy compared with either treatment alone.
The current clinical trial, for which the phase I portion has been completed, will examine
the efficacy and safety of trastuzumab (Herceptin) and bevacizumab (anti-VEGF antibody) in
the treatment of HER2-overexpressing metastatic breast cancer.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To establish the maximum tolerated dose (MTD) or recommended phase II dose of rhuMAb VEGF (bevacizumab) administered intravenously every 14 days to patients with HER2-amplified relapsed or metastatic breast cancer receiving concomitant Herceptin therapy
Mark D Pegram, MD
Principal Investigator
University of California, Los Angeles
United States: Food and Drug Administration
TORI B-03
NCT00095706
June 2003
Name | Location |
---|---|
Comprehensive Cancer Centers of Nevada | Las Vegas, Nevada 89109 |
Wilshire Oncology Medical Group, Inc. | Rancho Cucamonga, California 91730 |
Comprehensive Blood and Cancer Center | Bakersfield, California 93309 |
Pacific Shores Medical Group | Long Beach, California 90813 |
UCLA Medical Center | Los Angeles, California 90095-7059 |
Northeast Georgia Cancer Care, LLC | Athens, Georgia 30607 |
San Diego Cancer Center | Vista, California 92083 |
Virginia K. Crosson Cancer Center | Fullerton, California 92835 |
North Valley Hematology/Oncology Medical Group | Northridge, California 91328 |
Ventura County Hematology-Oncology Specialists | Oxnard, California 93030 |
Santa Barbara Hematology Oncology Medical Group, Inc. | Santa Barbara, California 93105 |
Cancer Care Associates Medical Group, Inc. | Torrance, California 90505 |
Northwest Georgia Oncology Centers, P.C. | Marietta, Georgia 30060 |
Central Hematology Oncology Medical Group, Inc. | Alhambra, California 91801 |
Sansum Santa Barbara Medical Foundation Clinic | Santa Barbara, California 93105 |
Cancer Institute of Florida, P.A. | Orlando, Florida 32804 |
Suburban Hematology-Oncology Associates, P.A. | Lawrenceville, Georgia 30045 |
Oncology Hematology Associates of Central Illinois, P.C. | Peoria, Illinois 61615 |