Status:
COMPLETED
Treatment of HER2-Positive Metastatic Breast Cancer With Herceptin and Bevacizumab (Antibodies Against HER2 and VEGF)
Lead Sponsor:
Translational Oncology Research International
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE1
PHASE2
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 ...
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 fro...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2012
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00095706
Start Date
June 1 2003
End Date
January 1 2012
Last Update
September 25 2015
Active Locations (18)
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1
Central Hematology Oncology Medical Group, Inc.
Alhambra, California, United States, 91801
2
Comprehensive Blood and Cancer Center
Bakersfield, California, United States, 93309
3
Virginia K. Crosson Cancer Center
Fullerton, California, United States, 92835
4
Pacific Shores Medical Group
Long Beach, California, United States, 90813