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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

Open access
Gianni, Luca, Lladó, Anna, Bianchi, Giulia, Cortes, Javier, Kellokumpu-Lehtinen, Pirkko-Liisa, Cameron, David A., Miles, David, Salvagni, Stefania, Wardley, Andrew, Goeminne, Jean-Charles, Hersberger, Veronica, Baselga, José·2010·Journal of Clinical Oncology

Abstract

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 ≥ 12 weeks. In arm B (n = 37), SD was observed in 14 patients (38%). Overall, six of 78 patients responded or had SD ≥ 6 months. Pertuzumab was generally well tolerated, and most adverse events were mild to moderate. Decline in left ventricular ejection fraction of ≥ 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.

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Metadata

Authors
Gianni, L., Lladó, A., Bianchi, G., Cortes, J., Kellokumpu-Lehtinen, P.-L., Cameron, D. A., Miles, D., Salvagni, S., Wardley, A., Goeminne, J.-C., Hersberger, V., & Baselga, J.
Venue
Journal of Clinical Oncology
Published
2010-03-01
Volume
28
Issue
7
Pages
1131-1137
ISSN
  • 0732-183X (ISSN-L)
  • 1527-7755
OpenAlex
W2096111541
Cited by
262
References
36
FWCI
12.25
Type
journal article
Language
en
Open access
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CoChat. (2026). Citation check: 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. https://app.cochat.ai/papers/10.1200/jco.2009.24.1661
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Gianni, L., Lladó, A., Bianchi, G., Cortes, J., Kellokumpu-Lehtinen, P.-L., Cameron, D. A., Miles, D., Salvagni, S., Wardley, A., Goeminne, J.-C., Hersberger, V., & Baselga, J. (2010). 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. Journal of Clinical Oncology. https://doi.org/10.1200/jco.2009.24.1661

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

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