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

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Translational Oncology Research International
• Collaborator: Genentech, Inc.
• Treatments: Antibodies; Bevacizumab; Endothelial Growth Factors; Trastuzumab

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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)