A Phase I/II Dose-Escalation Trial of Bevacizumab in Previously Treated Metastatic Breast Cancer

Melody A. Cobleigh, Virginia K. Langmuir, George W. Sledge, Kathy D. Miller, Latrice Haney, William F. Novotny, James D. Reimann, Amy Vassel

Research output: Contribution to journalArticle

425 Scopus citations


Vascular endothelial growth factor promotes angiogenesis, an important mediator of growth and metastasis in human breast cancer. Bevacizumab, a monoclonal antibody to vascular endothelial growth factor, is under investigation as an anti-angiogenic agent. This phase I/II trial evaluated the safety and efficacy of bevacizumab in patients with previously treated metastatic breast cancer. Seventy-five patients were treated with escalating doses of bevacizumab ranging from 3 mg/kg to 20 mg/kg administered intravenously every other week. Tumor response was assessed before the sixth (70 days) and 12th (154 days) doses. Safety was evaluated during every cycle. Eighteen patients were treated at 3 mg/kg, 41 at 10 mg/kg, and 16 at 20 mg/kg. Four patients discontinued study treatment because of an adverse event. Hypertension was reported as an adverse event in 17 patients (22%). The overall response rate was 9.3% (confirmed response rate, 6.7%). The median duration of confirmed response was 5.5 months (range, 2.3 to 13.7 months). At the final tumor assessment on day 154, 12 of 75 patients (16%) had stable disease or an ongoing response. The optimal dose of bevacizumab in this trial was 10 mg/kg every other week and toxicity was acceptable. These data support the initiation of trials in metastatic breast cancer combining bevacizumab with chemotherapy.

Original languageEnglish (US)
Pages (from-to)117-124
Number of pages8
JournalSeminars in Oncology
Issue number5 SUPPL. 16
StatePublished - Oct 2003


ASJC Scopus subject areas

  • Hematology
  • Oncology

Cite this

Cobleigh, M. A., Langmuir, V. K., Sledge, G. W., Miller, K. D., Haney, L., Novotny, W. F., Reimann, J. D., & Vassel, A. (2003). A Phase I/II Dose-Escalation Trial of Bevacizumab in Previously Treated Metastatic Breast Cancer. Seminars in Oncology, 30(5 SUPPL. 16), 117-124. https://doi.org/10.1053/j.seminoncol.2003.08.013