Anthracycline-induced cardiotoxicity: A case report and review of literature

Table 3 Selected ongoing randomized adult clinical trials on the pharmacological prevention of anthracycline-induced cardiotoxicity

Trial No./phase/name	Patient (n) and selection	Randomization schema	Primary endpoint
NCT02236806/Phase III/Cardiotoxicity prevention in breast cancer patients treated with anthracyclines and/or trastuzumab (SAFE)	480 non-metastatic breast cancer receiving anthracycline-based regimens with or without trastuzumab	2 × 2 factorial design. Arm 1: Bisoprolol plus ramipril; Arm 2: Bisoprolol plus placebo; Arm 3: Ramipril plus placebo; and Arm 4: Placebo	Maximum change in left ventricular ejection fraction at months 6, 9, 12 and 24, compared to baseline
NCT03265574/Phase III/Can we prevent chemotherapy-related heart damage in patients with breast cancer? (PROACT)	170 breast cancer receiving epirubicin-based adjuvant chemotherapy	Open-label comparing enalapril versus standard care	Cardiac troponin T release during epirubicin treatment
NCT03760588/Phase II/Prevention of cardiac dysfunction during breast cancer therapy (PRADAII)	300 breast cancer receiving anthracycline-based adjuvant chemotherapy	Double-blinded comparing LCZ696 (neprilysin inhibitor plus angiotensin receptor blocker) versus placebo	Left ventricular ejection fraction at 18 mo
ISRCTN24439460/Phase II/Can heart muscle injury related to chemotherapy be prevented? (cardiac CARE)	168 breast cancer or non-Hodgkin’s lymphoma with elevated troponin I level during anthracycline-based chemotherapy	Open-label comparing carvedilol plus candesartan versus standard care	Left ventricular ejection fraction at 6 mo
NCT02943590/Phase II/Statins to prevent the cardiotoxicity from anthracyclines (STOP-CA)	300 newly diagnosed non-Hodgkin’s lymphoma receiving doxorubicin-based regimens	Double-blinded comparing atorvastatin versus placebo	Left ventricular ejection fraction at 12 mo
NCT01988571/Phase II/Preventing anthracycline cardiovascular toxicity with statins (PREVENT)	279 breast cancer receiving anthracycline-based adjuvant chemotherapy	Double-blinded comparing atorvastatin versus placebo	Left ventricular ejection fraction at 24 mo