Treatment of HER2-Positive Metastatic Breast Cancer With Herceptin and Bevacizumab (Antibodies Against HER2 and VEGF)

Completed · Phase 1/Phase 2

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT00095706

Run by

Translational Oncology Research International

People needed

50

Starts

2003-06-01

Expected to finish

2012-01-01

Last updated by the study team

2015-09-25

Who can join

Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

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)
• Prior therapy with Herceptin or rhuMAb VEGF (bevacizumab)

Where it is running

• 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

Full record on ClinicalTrials.gov

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