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

Translational Oncology Research International50 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

Bevacizumab (drug), Herceptin (drug)DRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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)

Locations (18)

Central Hematology Oncology Medical Group, Inc.

Alhambra, California, United States

Comprehensive Blood and Cancer Center

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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