SAFE trial: an ongoing randomized clinical study to assess the role of cardiotoxicity prevention in breast cancer patients treated with anthracyclines with or without trastuzumab

Icro Meattini, Giuseppe Curigliano, Francesca Terziani, Carlotta Becherini, Mario Airoldi, Giacomo Allegrini, Domenico Amoroso, Sandro Barni, Carmelo Bengala, Valentina Guarneri, Paolo Marchetti, Francesca Martella, Pierluigi Piovano, Agnese Vannini, Isacco Desideri, Roberto Tarquini, Giorgio Galanti, Giuseppe Barletta, Lorenzo Livi

Research output: Contribution to journalReview articlepeer-review

Abstract

Over the years, thanks to the addition of new generation systemic agents, as well as the use of more advanced and precise radiotherapy techniques, it was able to obtain a high curability rate for breast cancer. Anthracyclines play a key role in the treatment of breast disease, with a well-known benefit on disease-free survival of patients with positive nodal status. Trastuzumab have shown a significant outcome advantage after 1-year administration in case of HER2-positive disease. Unfortunately, significant increase in cardiotoxicity has been observed after anthracyclines and trastuzumab therapies. Even though the cardiology and oncology community strongly recommend a cardiotoxicity prevention strategy for this subset of patients, there is still no consensus on the optimal patient's approach. We aimed to review the published and ongoing researches on cardioprevention strategies and to present the SAFE trial (CT registry ID: NCT2236806; EudraCT number: 2015-000914-23). It is a randomized phase 3, four-arm, single-blind, placebo-controlled study that aims to evaluate the effect of bisoprolol, ramipril or both drugs, compared to placebo, on subclinical heart damage evaluated by speckle tracking cardiac ultrasound in non-metastatic breast cancer patients.

Original languageEnglish
Pages (from-to)75
JournalMedical Oncology
Volume34
Issue number5
DOIs
Publication statusPublished - May 2017

Keywords

  • Anthracyclines
  • Antineoplastic Combined Chemotherapy Protocols
  • Bisoprolol
  • Breast Neoplasms
  • Cardiotonic Agents
  • Cardiotoxicity
  • Clinical Trials, Phase III as Topic
  • Female
  • Humans
  • Ramipril
  • Randomized Controlled Trials as Topic
  • Trastuzumab
  • Journal Article
  • Review

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