Pertuzumab plus trastuzumab in combination with standard neoadjuvant anthracycline-containing and anthracycline-free chemotherapy regimens in patients with HER2-positive early breast cancer: A randomized phase II cardiac safety study (TRYPHAENA)

A. Schneeweiss, S. Chia, T. Hickish, V. Harvey, A. Eniu, R. Hegg, C. Tausch, J. H. Seo, Y. F. Tsai, J. Ratnayake, V. McNally, G. Ross, J. Cortés

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Abstract

Background: Pertuzumab (P) combined with trastuzumab (H)-based chemotherapy improves efficacy in early and advanced HER2-positive breast cancer. We assessed the tolerability, with particular focus on cardiac safety, of H and P with chemotherapy in the neoadjuvant treatment of HER2-positive early breast cancer. Patients and methods: In this multicenter, open-label phase II study, patients with operable, locally advanced, or inflammatory breast cancer were randomized 1: 1: 1 to receive six neoadjuvant cycles q3w (Arm A: 5-fluorouracil, epirubicin, cyclophosphamide [FEC] + H + P ×3→ docetaxel [T] + H + P ×3; Arm B: FEC ×3 →T + H + P ×3; Arm C: T + carboplatin + H [TCH]+P ×6). pCR was assessed at surgery and adjuvant therapy given to complete 1 year of H. Results: Two hundred twenty-five patients were randomized. During neoadjuvant treatment, two patients (2.7%; Arm B) experienced symptomatic left ventricular systolic dysfunction (LVSD) and 11 patients (Arm A: 4 [5.6%]; Arm B: 4 [5.3%]; Arm C: 3 [3.9%]) had declines in left ventricular ejection fraction of ≥10% points from baseline to <50%. Diarrhea was the most common adverse event. pCR (ypT0/is) was reported for 61.6% (Arm A), 57.3% (Arm B), and 66.2% (Arm C) of patients. Conclusion: The combination of P with H and standard chemotherapy resulted in low rates of symptomatic LVSD.

Original languageEnglish
Article numbermdt182
Pages (from-to)2278-2284
Number of pages7
JournalAnnals of Oncology
Volume24
Issue number9
DOIs
Publication statusPublished - 2013 Sep

Keywords

  • Early breast cancer
  • HER2
  • LVSD
  • Neoadjuvant
  • Pertuzumab
  • Trastuzumab

ASJC Scopus subject areas

  • Hematology
  • Oncology

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