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Background. Adjuvant trastuzumab therapy improves the outcome of patients with early breast cancer (EBC) and overexpression of human epidermal growth factor receptor 2 (HER2). However, it is potentially cardiotoxic. This study aims to evaluate the relationship between the use of angiotensin-converting enzyme inhibitors/receptor blockers (ACEi/ARBs) and/or ␤-blockers and development of heart failure (HF) and/or left ventricular dysfunction during 1 year of adjuvant trastuzumab therapy.Methods. A total of 499 women receiving adjuvant trastuzumab therapy for EBC entered in a multicenter registry and were divided into four subgroups according to treatment with ACEi/ARBs and/or ␤-blockers. Occurrence of HF and decrease of left ventricular ejection fraction (LVEF; minimum 10 percentage points) were recorded.Results. HF occurred in 2% of patients who did not take either ACEi/ARBs or ␤-blockers, 8% of patients receiving

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New onset CHF occurs seldom in HER2-positive women with EBC, prevalently in the first 6 months of therapy. CHF is associated with a significant reduction in LVEF and is predicted by a history of hypertension.