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01-05-2009 | Clinical Trial

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

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

Published in: Breast Cancer Research and Treatment | Issue 1/2009

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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Title: Efficacy and safety of erlotinib in patients with locally advanced or metastatic breast cancer
Authors: Maura N. Dickler
Melody A. Cobleigh
Kathy D. Miller
Pamela M. Klein
Eric P. Winer
Publication date: 01-05-2009
Publisher: Springer US
Published in: Breast Cancer Research and Treatment / Issue 1/2009
Print ISSN: 0167-6806
Electronic ISSN: 1573-7217
DOI: https://doi.org/10.1007/s10549-008-0055-9

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