Document Detail

Open-label, phase II, multicenter, randomized study of the efficacy and safety of two dose levels of Pertuzumab, a human epidermal growth factor receptor 2 dimerization inhibitor, in patients with human epidermal growth factor receptor 2-negative metastatic breast cancer.
MedLine Citation:
PMID:  20124183     Owner:  NLM     Status:  MEDLINE    
PURPOSE: Pertuzumab is a humanized monoclonal antibody inhibiting human epidermal growth factor receptor 2 (HER2) dimerization. The aim of this phase II trial was to assess the antitumor activity and safety profile of pertuzumab monotherapy in patients with HER2-negative metastatic breast cancer. The utility of biomarkers detected in paraffin-embedded tissue as predictors of response was also explored. PATIENTS AND METHODS: This was an international, multicenter, open-label, randomized phase II study. Patients (n = 79) with centrally confirmed HER2-negative metastatic breast cancer were randomly assigned to receive pertuzumab once every 3 weeks with a loading dose of 840 mg followed thereafter by either 420 mg (arm A) or 1,050 mg (arm B). Patients were stratified by country and prior taxane therapy. RESULTS: Of 79 patients who were randomly assigned, 78 were included in the intent-to-treat population. In arm A (n = 41), two patients had partial responses, and 18 patients (44%) experienced stable disease (SD) lasting > or = 12 weeks. In arm B (n = 37), SD was observed in 14 patients (38%). Overall, six of 78 patients responded or had SD > or = 6 months. Pertuzumab was generally well tolerated, and most adverse events were mild to moderate. Decline in left ventricular ejection fraction of > or = 10% and/or to less than 50% was observed in eight patients, with one case of congestive heart failure in arm A. Pharmacokinetic data supported a fixed dose of pertuzumab once every 3 weeks. CONCLUSION: The limited efficacy observed in this study, generally SD of relatively short duration, suggested little benefit of further investigation of single-agent pertuzumab in unselected patients with HER2-negative disease.
Luca Gianni; Anna Llad?; Giulia Bianchi; Javier Cortes; Pirkko-Liisa Kellokumpu-Lehtinen; David A Cameron; David Miles; Stefania Salvagni; Andrew Wardley; Jean-Charles Goeminne; Veronica Hersberger; Jos? Baselga
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Publication Detail:
Type:  Clinical Trial, Phase II; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2010-02-01
Journal Detail:
Title:  Journal of clinical oncology : official journal of the American Society of Clinical Oncology     Volume:  28     ISSN:  1527-7755     ISO Abbreviation:  J. Clin. Oncol.     Publication Date:  2010 Mar 
Date Detail:
Created Date:  2010-02-25     Completed Date:  2010-03-25     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8309333     Medline TA:  J Clin Oncol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1131-7     Citation Subset:  IM    
Oncologia Medica 1, Istituto Nazionale Tumori, Via Venezian, 1, 20133 Milano, Italy.
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MeSH Terms
Antibodies, Monoclonal / adverse effects,  pharmacokinetics,  therapeutic use*
Breast Neoplasms / drug therapy*,  pathology
Middle Aged
Neoplasm Metastasis
Receptor, erbB-2 / analysis,  antagonists & inhibitors*
Ventricular Function, Left / drug effects
Reg. No./Substance:
0/Antibodies, Monoclonal; 380610-27-5/pertuzumab; EC protein, human; EC, erbB-2

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