Efficacy and safety of erlotinib in patients with locally advanced or metastatic breast cancer

Maura N. Dickler, Melody A. Cobleigh, Kathy D. Miller, Pamela M. Klein, Eric P. Winer

Research output: Contribution to journalArticlepeer-review

95 Scopus citations


Purpose To evaluate the efficacy and safety of erlotinib in advanced breast cancer. Experimental design Multicenter, phase II study of erlotinib (150 mg orally daily). Cohort 1: progression after anthracyclines, taxanes, and capecitabine (n = 47). Cohort 2: progression after >1 chemotherapy for advanced-stage disease (n = 22). Primary endpoint was response rate (World Health Organization criteria). Secondary endpoints were safety, time to progression, and survival. Results One patient in each cohort (n = 2, 3.0%) had a partial response. Response duration was 17 weeks for the Cohort 1 patient and 32 weeks for the Cohort 2 patient. Median time to progression was 43 days for Cohort 1 (range 1-204) and 43 days for Cohort 2 (range 25-419). Common adverse events were diarrhea, rash, dry skin, asthenia, nausea, anorexia. Conclusion Erlotinib had minimal activity in unselected previously treated women with advanced breast cancer. Predictive factors are needed to identify breast cancer patients who may derive benefit from erlotinib treatment.

Original languageEnglish (US)
Pages (from-to)115-121
Number of pages7
JournalBreast Cancer Research and Treatment
Issue number1
StatePublished - May 1 2009


  • Epidermal growth factor receptor (EGFR/HER1)
  • Erlotinib
  • Metastatic breast cancer
  • Patient selection

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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