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

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Breast Cancer Research and Treatment Aims and scope Submit manuscript

Abstract

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.

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Acknowledgments

We thank OSI Pharmaceuticals for providing erlotinib and all investigators in the OSI2288g study group: Louis Fehrenbacher, George Geils, Carolyn Britten, Joanne Mortimer, Ray Page and Charles Shapiro. Genentech, Inc. provided support for the clinical trial and manuscript preparation.

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Authors and Affiliations

  1. Memorial Sloan-Kettering Cancer Center, 1275 York Avenue, New York, NY, 10021, USA

    Maura N. Dickler

  2. Rush University Medical Center, 1725 West Harrison Street, Chicago, IL, 60612, USA

    Melody A. Cobleigh

  3. Indiana Cancer Pavillion, 535 Barnhill Drive, Indianapolis, IN, 46202, USA

    Kathy D. Miller

  4. Genentech, Inc., 1 DNA Way, South San Francisco, CA, USA

    Pamela M. Klein

  5. Dana-Farber Cancer Institute, 44 Binney Street, Boston, MA, 02115, USA

    Eric P. Winer

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  1. Maura N. Dickler
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Correspondence to Maura N. Dickler.

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Dickler, M.N., Cobleigh, M.A., Miller, K.D. et al. Efficacy and safety of erlotinib in patients with locally advanced or metastatic breast cancer. Breast Cancer Res Treat 115, 115–121 (2009). https://doi.org/10.1007/s10549-008-0055-9

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  • DOI: https://doi.org/10.1007/s10549-008-0055-9

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