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

Med Oncol. 2017 May;34(5):75. doi: 10.1007/s12032-017-0938-x. Epub 2017 Mar 31.

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.

Trial registration: ClinicalTrials.gov NCT02236806.

Keywords: Adjuvant anthracyclines; Beta-blockers; Breast cancer; Cardiotoxicity prevention; Trastuzumab.

Publication types

  • Review

MeSH terms

  • Anthracyclines / adverse effects*
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects*
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use
  • Bisoprolol / therapeutic use
  • Breast Neoplasms / drug therapy*
  • Cardiotonic Agents / therapeutic use*
  • Cardiotoxicity / prevention & control*
  • Clinical Trials, Phase III as Topic
  • Female
  • Humans
  • Ramipril / therapeutic use
  • Randomized Controlled Trials as Topic
  • Trastuzumab / administration & dosage
  • Trastuzumab / adverse effects*

Substances

  • Anthracyclines
  • Cardiotonic Agents
  • Ramipril
  • Trastuzumab
  • Bisoprolol

Associated data

  • ClinicalTrials.gov/NCT02236806