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

Phase I/II Combined Biological Therapy of Breast Cancer Using Monoclonal Antibodies Directed Against HER2/Neu Proto-Oncogene and Vascular Endothelial Growth Factor

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00095706

Enrollment

Registered

2004-11-08

Start date

2003-06-30

Completion date

2012-01-31

Last updated

2015-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Metastatic breast cancer, HER2, Trastuzumab, Herceptin, VEGF, Bevacizumab, Avastin

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 breast cancer.

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 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.

Interventions

DRUGBevacizumab (drug), Herceptin (drug)

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 75 Years

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)

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026