Cardiac tolerability of pertuzumab plus trastuzumab plus docetaxel in patients with HER2-positive metastatic breast cancer in CLEOPATRA: A randomized, double-blind, placebo-controlled phase III study

Sandra M. Swain, Michael S. Ewer, Javier Cortés, Dino Amadori, David Miles, Adam Knott, Emma Clark, Mark C. Benyunes, Graham Ross, José Baselga

Research output: Contribution to journalArticlepeer-review

Abstract

Introduction. We report cardiac tolerability of pertuzumab plus trastuzumab plus docetaxel versus placebo plus trastuzumab plus docetaxel observed in the phase III study CLEOPATRA in patients with HER2-positive first-line metastatic breast cancer (MBC). Patients and Methods. Left ventricular ejection fraction (LVEF) ≥50% and ECOG performance status of 0 or 1 were required for study entry. During the study, LVEF assessments took place every 9 weeks. Pertuzumab/placebo was given at 840 mg, then 420 mg q3w; trastuzumab was administered at 8 mg/kg, then 6 mg/kg q3w, and docetaxel was initiated at 75 mg/m2 q3w. Results. The incidence of cardiac adverse events (all grades) was 16.4% in the placebo arm and 14.5% in the pertuzumab arm, with left ventricular systolic dysfunction (LVSD, all grades) being the most frequently reported event (8.3% versus 4.4% in the placebo and pertuzumab arm). Declines in LVEF ≥by 10% points from baseline and to

Original languageEnglish
Pages (from-to)257-264
Number of pages8
JournalThe oncologist
Volume18
Issue number3
DOIs
Publication statusPublished - Mar 2013

Keywords

  • Cardiac safety
  • HER2
  • LVSD
  • Metastatic breast cancer
  • Pertuzumab
  • Trastuzumab

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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