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

Phase 1/Phase 2
18 Years
75 Years
Open (Enrolling)
Breast Cancer

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Trial Information

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

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.

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

- Proteinuria (> 1g protein/24 hours at baseline)

- Prior therapy with Herceptin or rhuMAb VEGF (bevacizumab)

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Principal Investigator

Mark D Pegram, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, Los Angeles


United States: Food and Drug Administration

Study ID:




Start Date:

June 2003

Completion Date:

Related Keywords:

  • Breast Cancer
  • Metastatic breast cancer
  • HER2
  • Trastuzumab
  • Herceptin
  • VEGF
  • Bevacizumab
  • Avastin
  • Breast Neoplasms



Comprehensive Cancer Centers of Nevada Las Vegas, Nevada  89109
Wilshire Oncology Medical Group, Inc. Rancho Cucamonga, California  91730
Comprehensive Blood and Cancer Center Bakersfield, California  93309
Pacific Shores Medical Group Long Beach, California  90813
UCLA Medical Center Los Angeles, California  90095-7059
Northeast Georgia Cancer Care, LLC Athens, Georgia  30607
San Diego Cancer Center Vista, California  92083
Virginia K. Crosson Cancer Center Fullerton, California  92835
North Valley Hematology/Oncology Medical Group Northridge, California  91328
Ventura County Hematology-Oncology Specialists Oxnard, California  93030
Santa Barbara Hematology Oncology Medical Group, Inc. Santa Barbara, California  93105
Cancer Care Associates Medical Group, Inc. Torrance, California  90505
Northwest Georgia Oncology Centers, P.C. Marietta, Georgia  30060
Central Hematology Oncology Medical Group, Inc. Alhambra, California  91801
Sansum Santa Barbara Medical Foundation Clinic Santa Barbara, California  93105
Cancer Institute of Florida, P.A. Orlando, Florida  32804
Suburban Hematology-Oncology Associates, P.A. Lawrenceville, Georgia  30045
Oncology Hematology Associates of Central Illinois, P.C. Peoria, Illinois  61615