Treatment of HER2-Positive Metastatic Breast Cancer With Herceptin and Bevacizumab (Antibodies Against HER2 and VEGF)
Phase I/II Combined Biological Therapy of Breast Cancer Using Monoclonal Antibodies Directed Against HER2/Neu Proto-Oncogene and Vascular Endothelial Growth Factor
3 other identifiers
interventional
50
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 breast-cancer
Started Jun 2003
Longer than P75 for phase_1 breast-cancer
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2003
CompletedFirst Submitted
Initial submission to the registry
November 5, 2004
CompletedFirst Posted
Study publicly available on registry
November 8, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedSeptember 25, 2015
September 1, 2015
3.8 years
November 5, 2004
September 23, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Translational Oncology Research Internationallead
- Genentech, Inc.collaborator
Study Sites (18)
Central Hematology Oncology Medical Group, Inc.
Alhambra, California, 91801, United States
Comprehensive Blood and Cancer Center
Bakersfield, California, 93309, United States
Virginia K. Crosson Cancer Center
Fullerton, California, 92835, United States
Pacific Shores Medical Group
Long Beach, California, 90813, United States
UCLA Medical Center
Los Angeles, California, 90095, United States
North Valley Hematology/Oncology Medical Group
Northridge, California, 91328, United States
Ventura County Hematology-Oncology Specialists
Oxnard, California, 93030, United States
Wilshire Oncology Medical Group, Inc.
Pomona, California, 91767, United States
Cancer Care Associates Medical Group, Inc.
Redondo Beach, California, 90277, United States
Sansum Santa Barbara Medical Foundation Clinic
Santa Barbara, California, 93105, United States
Santa Barbara Hematology Oncology Medical Group, Inc.
Santa Barbara, California, 93105, United States
San Diego Cancer Center
Vista, California, 92081, United States
Cancer Institute of Florida, P.A.
Orlando, Florida, 32804, United States
Northeast Georgia Cancer Care, LLC
Athens, Georgia, 30607, United States
Suburban Hematology-Oncology Associates, P.A.
Lawrenceville, Georgia, 30045, United States
Northwest Georgia Oncology Centers, P.C.
Marietta, Georgia, 30060, United States
Oncology Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, 61615, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89109, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark D Pegram, MD
University of California, Los Angeles
- STUDY CHAIR
Fairooz Kabbinavar, MD
Chief Medical Officer, TORI
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 5, 2004
First Posted
November 8, 2004
Study Start
June 1, 2003
Primary Completion
April 1, 2007
Study Completion
January 1, 2012
Last Updated
September 25, 2015
Record last verified: 2015-09