• Thomas P Ahern, Timothy L Lash, Per Damkier, Peer M Christiansen, and Deirdre P Cronin-Fenton.
• Departments of Surgery and Biochemistry, University of Vermont College of Medicine, Burlington, VT, USA. Electronic address: thomas.ahern@med.uvm.edu.
• Lancet Oncol. 2014 Sep 1; 15 (10): e461-8.

AbstractMuch preclinical and epidemiological evidence supports the anticancer effects of statins. Epidemiological evidence does not suggest an association between statin use and reduced incidence of breast cancer, but does support a protective effect of statins--especially simvastatin--on breast cancer recurrence. Here, we argue that the existing evidence base is sufficient to justify a clinical trial of breast cancer adjuvant therapy with statins and we advocate for such a trial to be initiated without delay. If a protective effect of statins on breast cancer recurrence is supported by trial evidence, then the indications for a safe, well tolerated, and inexpensive treatment can be expanded to improve outcomes for breast cancer survivors. We discuss several trial design opportunities--including candidate predictive biomarkers of statin safety and efficacy--and offer solutions to the key challenges involved in the enrolment, follow-up, and analysis of such a trial.Copyright © 2014 Elsevier Ltd. All rights reserved.

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