First-line, single-agent Herceptin® (trastuzumab) in metastatic breast cancer: A preliminary report

C. Vogel, M. A. Cobleigh, D. Tripathy, J. C. Gutheil, L. N. Harris, L. Fehrenbacher, D. J. Slamon, M. Murphy, W. F. Novotny, M. Burchmore, S. Shak, S. J. Stewart

Research output: Contribution to journalArticlepeer-review

166 Scopus citations


Following confirmation of the appropriate dosage, safety and potential efficacy of Herceptin® (trastuzumab) in small-scale phase I and II trials involving patients with refractory disease, a large trial was conducted in 222 patients with breast cancer who had relapsed after one or two chemotherapy regimens for their metastatic disease. The results showed a positive and durable overall response rate (15% according to a response evaluation committee (REC) assessment) using trastuzumab monotherapy (initial dose 4 mg/kg intravenously (i.v.) followed by 2 mg/kg i.v. weekly). In another recently completed phase II trial, 113 patients were randomised to two dose levels (initial dose of 4 mg/kg i.v. dose followed by 2 mg/kg i.v. weekly, or initial dose of 8 mg/kg followed by 4 mg/kg i.v. weekly) of single-agent trastuzumab as first-line therapy for metastatic disease. The preliminary overall response rate was 23% based on investigator assessment, and tolerability was excellent as in previous trials; efficacy was similar in both dose groups, but the side-effects tended to be more frequent in the higher dose group. The preferred dosage is therefore the same as that currently recommended, i.e. an initial dose of 4 mg/kg i.v. followed by 2 mg/kg weekly i.v. until disease progression.

Original languageEnglish (US)
Pages (from-to)25-29
Number of pages5
JournalEuropean Journal of Cancer
StatePublished - 2001


  • Clinical trial
  • Efficacy
  • First-line
  • Herceptin® (trastuzumab)
  • Metastatic breast cancer

ASJC Scopus subject areas

  • Cancer Research
  • Hematology
  • Oncology


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