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dc.contributorSistema FMUSP-HC: Faculdade de Medicina da Universidade de São Paulo (FMUSP) e Hospital das Clínicas da FMUSP-
dc.contributor.authorBASELGA, Jose-
dc.contributor.authorCORTES, Javier-
dc.contributor.authorKIM, Sung-Bae-
dc.contributor.authorIM, Seock-Ah-
dc.contributor.authorHEGG, Roberto-
dc.contributor.authorIM, Young-Hyuck-
dc.contributor.authorROMAN, Laslo-
dc.contributor.authorPEDRINI, Jose Luiz-
dc.contributor.authorPIENKOWSKI, Tadeusz-
dc.contributor.authorKNOTT, Adam-
dc.contributor.authorCLARK, Emma-
dc.contributor.authorBENYUNES, Mark C.-
dc.contributor.authorROSS, Graham-
dc.contributor.authorSWAIN, Sandra M.-
dc.identifier.citationNEW ENGLAND JOURNAL OF MEDICINE, v.366, n.2, p.109-119, 2012-
dc.description.abstractBACKGROUND The anti-human epidermal growth factor receptor 2 (HER2) humanized monoclonal antibody trastuzumab improves the outcome in patients with HER2-positive metastatic breast cancer. However, most cases of advanced disease eventually progress. Pertuzumab, an anti-HER2 humanized monoclonal antibody that inhibits receptor dimerization, has a mechanism of action that is complementary to that of trastuzumab, and combination therapy with the two antibodies has shown promising activity and an acceptable safety profile in phase 2 studies involving patients with HER2-positive breast cancer. METHODS We randomly assigned 808 patients with HER2-positive metastatic breast cancer to receive placebo plus trastuzumab plus docetaxel (control group) or pertuzumab plus trastuzumab plus docetaxel (pertuzumab group) as first-line treatment until the time of disease progression or the development of toxic effects that could not be effectively managed. The primary end point was independently assessed progression-free survival. Secondary end points included overall survival, progression-free survival as assessed by the investigator, the objective response rate, and safety. RESULTS The median progression-free survival was 12.4 months in the control group, as compared with 18.5 months in the pertuzumab group (hazard ratio for progression or death, 0.62; 95% confidence interval, 0.51 to 0.75; P<0.001). The interim analysis of overall survival showed a strong trend in favor of pertuzumab plus trastuzumab plus docetaxel. The safety profile was generally similar in the two groups, with no increase in left ventricular systolic dysfunction; the rates of febrile neutropenia and diarrhea of grade 3 or above were higher in the pertuzumab group than in the control group. CONCLUSIONS The combination of pertuzumab plus trastuzumab plus docetaxel, as compared with placebo plus trastuzumab plus docetaxel, when used as first-line treatment for HER2-positive metastatic breast cancer, significantly prolonged progression-free survival, with no increase in cardiac toxic effects. (Funded by F. Hoffmann-La Roche/Genentech; number, NCT00567190.)-
dc.description.sponsorshipF. Hoffmann-La Roche/Genentech, a member of the Roche Group-
dc.relation.ispartofNew England Journal of Medicine-
dc.subject.otherphase-ii trial-
dc.titlePertuzumab plus Trastuzumab plus Docetaxel for Metastatic Breast Cancer-
dc.rights.holderCopyright MASSACHUSETTS MEDICAL SOC-
dc.contributor.groupauthorCLEOPATRA Study Grp-
dc.subject.wosMedicine, General & Internal-
dc.type.categoryoriginal article-
dc.type.versionpublishedVersion-, Jose:Massachusetts Gen Hosp, Ctr Canc, Boston, MA 02114 USA; Harvard Univ, Sch Med, Boston, MA USA-, Javier:Vall dHebron Inst Oncol, Barcelona, Spain-, Sung-Bae:Univ Ulsan, Dept Oncol, Asan Med Ctr, Coll Med, Seoul, South Korea-, Seock-Ah:Seoul Natl Univ, Coll Med, Dept Internal Med, Div Hematol & Med Oncol, Seoul 151, South Korea-, Young-Hyuck:Sungkyunkwan Univ, Sch Med, Samsung Med Ctr, Div Hematol & Med Oncol,Dept Internal Med, Seoul, South Korea-, Laslo:Leningrad Reg Oncol Dispensary, St Petersburg, Russia-, Jose Luiz:Conceicao Hosp, Mastol Unit, Ctr Pesquisas Med & Ensaios Clin, Porto Alegre, RS, Brazil-, Tadeusz:Ctr Onkol, Warsaw, Poland-, Adam:Roche, Welwyn Garden City, England-, Emma:Roche, Welwyn Garden City, England-, Mark C.:Genentech Inc, San Francisco, CA 94080 USA-, Graham:Roche, Welwyn Garden City, England-, Sandra M.:MedStar Washington Hosp Ctr, Washington Canc Inst, Washington, DC USA-
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Appears in Collections:

Artigos e Materiais de Revistas Científicas - FM/MOG
Departamento de Obstetrícia e Ginecologia - FM/MOG

Artigos e Materiais de Revistas Científicas - HC/ICHC
Instituto Central - HC/ICHC

Artigos e Materiais de Revistas Científicas - LIM/58
LIM/58 - Laboratório de Ginecologia Estrutural e Molecular

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