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

September 23, 2015 updated by: Translational Oncology Research International

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Alhambra, California, United States, 91801
        • Central Hematology Oncology Medical Group, Inc.
      • Bakersfield, California, United States, 93309
        • Comprehensive Blood and Cancer Center
      • Fullerton, California, United States, 92835
        • Virginia K. Crosson Cancer Center
      • Long Beach, California, United States, 90813
        • Pacific Shores Medical Group
      • Los Angeles, California, United States, 90095
        • UCLA Medical Center
      • Northridge, California, United States, 91328
        • North Valley Hematology/Oncology Medical Group
      • Oxnard, California, United States, 93030
        • Ventura County Hematology-Oncology Specialists
      • Pomona, California, United States, 91767
        • Wilshire Oncology Medical Group, Inc.
      • Redondo Beach, California, United States, 90277
        • Cancer Care Associates Medical Group, Inc.
      • Santa Barbara, California, United States, 93105
        • Sansum Santa Barbara Medical Foundation Clinic
      • Santa Barbara, California, United States, 93105
        • Santa Barbara Hematology Oncology Medical Group, Inc.
      • Vista, California, United States, 92081
        • San Diego Cancer Center
    • Florida
      • Orlando, Florida, United States, 32804
        • Cancer Institute of Florida, P.A.
    • Georgia
      • Athens, Georgia, United States, 30607
        • Northeast Georgia Cancer Care, LLC
      • Lawrenceville, Georgia, United States, 30045
        • Suburban Hematology-Oncology Associates, P.A.
      • Marietta, Georgia, United States, 30060
        • Northwest Georgia Oncology Centers, P.C.
    • Illinois
      • Peoria, Illinois, United States, 61615
        • Oncology Hematology Associates of Central Illinois, P.C.
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Comprehensive Cancer Centers of Nevada

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Translational Oncology Research International

Collaborators

Genentech, Inc.

Investigators

  • Principal Investigator: Mark D Pegram, MD, University of California, Los Angeles

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

November 5, 2004

First Submitted That Met QC Criteria

November 5, 2004

First Posted (Estimate)

November 8, 2004

Study Record Updates

Last Update Posted (Estimate)

September 25, 2015

Last Update Submitted That Met QC Criteria

September 23, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TORI B-03
  • Western IRB #20041069
  • UCLA IRB #01-09-030

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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