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Brief Title: Treatment of HER2-Positive Metastatic Breast Cancer With Herceptin and Bevacizumab (Antibodies Against HER2 and VEGF)
Official Title: Phase I/II Combined Biological Therapy of Breast Cancer Using Monoclonal Antibodies Directed Against HER2/Neu Proto-Oncogene and Vascular Endothelial Growth Factor
Study ID: NCT00095706
Brief Summary: The purpose of this study is to evaluate the safety and effectiveness of combined treatment with trastuzumab (Herceptin) and bevacizumab (anti-VEGF antibody) in patients with HER2-positive metastatic breast cancer.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Central Hematology Oncology Medical Group, Inc., Alhambra, California, United States
Comprehensive Blood and Cancer Center, Bakersfield, California, United States
Virginia K. Crosson Cancer Center, Fullerton, California, United States
Pacific Shores Medical Group, Long Beach, California, United States
UCLA Medical Center, Los Angeles, California, United States
North Valley Hematology/Oncology Medical Group, Northridge, California, United States
Ventura County Hematology-Oncology Specialists, Oxnard, California, United States
Wilshire Oncology Medical Group, Inc., Pomona, California, United States
Cancer Care Associates Medical Group, Inc., Redondo Beach, California, United States
Sansum Santa Barbara Medical Foundation Clinic, Santa Barbara, California, United States
Santa Barbara Hematology Oncology Medical Group, Inc., Santa Barbara, California, United States
San Diego Cancer Center, Vista, California, United States
Cancer Institute of Florida, P.A., Orlando, Florida, United States
Northeast Georgia Cancer Care, LLC, Athens, Georgia, United States
Suburban Hematology-Oncology Associates, P.A., Lawrenceville, Georgia, United States
Northwest Georgia Oncology Centers, P.C., Marietta, Georgia, United States
Oncology Hematology Associates of Central Illinois, P.C., Peoria, Illinois, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
Name: Mark D Pegram, MD
Affiliation: University of California, Los Angeles
Role: PRINCIPAL_INVESTIGATOR
Name: Fairooz Kabbinavar, MD
Affiliation: Chief Medical Officer, TORI
Role: STUDY_CHAIR