SAFE
Cardiotoxicity prevention in breast cancer patients treated with anthracyclines with or without trastuzumab (SAFE trial)
Paciente / Población Intervención / Exposición Comparación Desenlace
In 262 women with non-metastatic breast cancer receiving anthracycline-based chemotherapy, ramipril, bisoprolol or both for 12 months reduced subclinical cardiac damage at 24 months compared with placebo.
N
262
Diseño
2×2 factorial, double-blind, placebo-controlled RCT
Desenlace
Subclinical cardiac damage at 24 months (a fall of ≥10 % in 3D ejection fraction or global longitudinal strain)
Relevancia
3
Resultado3D-LVEF fell by 10.6 % with placebo vs 2.1 % (ramipril), 2.2 % (bisoprolol) and 3.4 % (combination; all p<0.001). Subclinical damage 11.4 % vs 39.3 % with versus without ramipril (p<0.001).
Meattini I, Becherini C, Martella F, et al. ESMO Open. 2025;10(6):105116. 10.1016/j.esmoop.2025.105116
Discusión y crítica
Modest in size, with an echocardiographic surrogate endpoint and a placebo-arm ejection-fraction decline (10.6 %) far larger than in comparable trials such as PRADA, which raises questions about measurement variability. It is the largest factorial trial of combined ACE-inhibitor plus beta-blocker prophylaxis.