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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
Pertuzumab Monotherapy in HER2-Negative Metastatic Breast Cancer
L Gianni, A Lladó, G Bianchi, J Cortes, P-L Kellokumpu-Lehtinen, DA Cameron, D Miles, S Salvagni, A Wardley, J-C Goeminne, V Hersberger, J Baselga
Yes
20100201
2010 Mar 1
J Clin Oncol
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
J Clin Oncol. 2010 Mar 1;28(7):1131-1137, L Gianni, A Lladó, G Bianchi, J Cortes, P-L Kellokumpu-Lehtinen, DA Cameron, D Miles, S Salvagni, A Wardley, J-C Goeminne, V Hersberger, J Baselga
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Abstract
SUMMARY
OncologySTAT Editorial Team
Pertuzumab is a humanized monoclonal antibody that prevents dimerization of HER2, thus inhibiting downstream HER2 signaling. Results of a phase I study showed that pertuzumab is well tolerated and active against advanced solid tumors when used at a fixed dose of either 420 mg or 1050 mg every 3 weeks. In this randomized, open-label phase II study, Gianni et al investigated the safety and efficacy of pertuzumab, given at either dosage, in patients with HER2-negative metastatic breast cancer. The multinational...