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

NCT ID: NCT00095706

Last Updated: 2015-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-06-30
• Study Completion Date: 2012-01-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Bevacizumab (drug), Herceptin (drug)

Intervention Type: DRUG

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Translational Oncology Research International

OTHER

Sponsor Role: lead

Responsible Party

University of California, Los Angeles

Principal Investigators

Mark D Pegram, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Fairooz Kabbinavar, MD

Role: STUDY_CHAIR

Chief Medical Officer, TORI

Locations

Central Hematology Oncology Medical Group, Inc.

Alhambra, California, United States

Comprehensive Blood and Cancer Center

Bakersfield, California, United States

Virginia K. Crosson Cancer Center

Fullerton, California, United States

Pacific Shores Medical Group

Long Beach, California, United States

UCLA Medical Center

Los Angeles, California, United States

North Valley Hematology/Oncology Medical Group

Northridge, California, United States

Ventura County Hematology-Oncology Specialists

Oxnard, California, United States

Wilshire Oncology Medical Group, Inc.

Pomona, California, United States

Cancer Care Associates Medical Group, Inc.

Redondo Beach, California, United States

Sansum Santa Barbara Medical Foundation Clinic

Santa Barbara, California, United States

Santa Barbara Hematology Oncology Medical Group, Inc.

Santa Barbara, California, United States

San Diego Cancer Center

Vista, California, United States

Cancer Institute of Florida, P.A.

Orlando, Florida, United States

Northeast Georgia Cancer Care, LLC

Athens, Georgia, United States

Suburban Hematology-Oncology Associates, P.A.

Lawrenceville, Georgia, United States

Northwest Georgia Oncology Centers, P.C.

Marietta, Georgia, United States

Oncology Hematology Associates of Central Illinois, P.C.

Peoria, Illinois, United States

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

Countries

United States

Other Identifiers

Western IRB #20041069

Identifier Type: -

Identifier Source: secondary_id

UCLA IRB #01-09-030

Identifier Type: -

Identifier Source: secondary_id

TORI B-03

Identifier Type: -

Identifier Source: org_study_id

NCT00093535

Identifier Type: -

Identifier Source: nct_alias