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

Translational Oncology Research International

Status and phase

Completed

Phase 2

Phase 1

Conditions

Breast Cancer

Treatments

Drug: Bevacizumab (drug), Herceptin (drug)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00095706

TORI B-03

UCLA IRB #01-09-030

Western IRB #20041069

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

Female

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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)