Treatment of HER2-Positive Metastatic Breast Cancer With Herceptin and Bevacizumab (Antibodies Against HER2 and VEGF)
- Conditions
- Breast Cancer
- Registration Number
- NCT00095706
- Lead Sponsor
- Translational Oncology Research International
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 50
- Metastatic or relapsed locally advanced breast cancer
- HER2-positive by FISH
- No prior chemotherapy for metastatic disease
- ECOG performance status 0-2
- Normal left ventricular ejection fraction
- Bidimensionally measurable disease
- Oxygen saturation > 90% on room air
- Other invasive malignancy within 5 years
- More than 3 different metastatic sites
- >50% liver involvement by metastasis
- Newly diagnosed untreated Stage IIIB breast cancer
- Prior chemotherapy for metastatic disease
- Clinically significant cardiovascular disease
- History or evidence of CNS disease
- Major surgery within 28 days prior to day 0
- Current or recent use of parenteral anticoagulants
- WBC < 3,000/uL
- Platelet count < 75,000/uL
- Hemoglobin < 9.0 g/dL
- Total Bilirubin > 2.0 mg/dL
- AST or ALT > 5 time upper limit of normal for subjects with documented liver metastases; > 2.5 times upper limit of normal for subjects without evidence of liver metastases
- Proteinuria (> 1g protein/24 hours at baseline)
- Prior therapy with Herceptin or rhuMAb VEGF (bevacizumab)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method To evaluate the clinical safety and toxicities of rhuMAb VEGF when administered in combination with Herceptin To characterize the pharmacokinetics of rhuMAb VEGF and Herceptin given in combination To evaluate the efficacy of rhuMAb VEGF plus Herceptin in terms of clinical activity when administered as an intravenous infusion, in patients with previously untreated metastatic or relapsed breast cancer
Trial Locations
- Locations (18)
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
Ventura County Hematology-Oncology Specialists
🇺🇸Oxnard, California, United States
UCLA Medical Center
🇺🇸Los Angeles, California, United States
North Valley Hematology/Oncology Medical Group
🇺🇸Northridge, 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
Suburban Hematology-Oncology Associates, P.A.
🇺🇸Lawrenceville, Georgia, United States
Northeast Georgia Cancer Care, LLC
🇺🇸Athens, Georgia, United States
Northwest Georgia Oncology Centers, P.C.
🇺🇸Marietta, Georgia, United States
Comprehensive Cancer Centers of Nevada
🇺🇸Las Vegas, Nevada, United States
Oncology Hematology Associates of Central Illinois, P.C.
🇺🇸Peoria, Illinois, United States