• Maria Theodoulou, Gerald Batist, Susana Campos, Eric Winer, Lauri Welles, and Clifford Hudis.
• Division of Solid Tumor Oncology, Department of Medicine, Breast Cancer Medicine Service, Memorial Sloan-Kettering Cancer Center, New York, NY 10021-6007, USA. theodoum@mskcc.org
• Clin. Breast Cancer. 2009 May 1; 9 (2): 101-7.

BackgroundThis was an open-label, nonrandomized, multicenter, 2-stage phase I trial of safety and preliminary efficacy of nonpegylated liposomal doxorubicin (NLD) in combination with trastuzumab in advanced breast cancer, with emphasis on cardiac toxicity.Patients And MethodsForty patients (median age, 48 years; range, 30-74 years) with HER2/neu 2+ or 3+ tumors (by immunohistochemistry) were recruited December 1999 to November 2002. Patients were eligible if they received or= 1 cycle. Cardiac safety was assessed after completing >or= 4 full treatment cycles.ResultsThirty out of 40 patients (75%) received >or= 4 treatment cycles and were evaluable for cardiac safety. Five patients (13%), 4 who were doxorubicin pretreated, developed left ventricular ejection fraction reductions to < 50%, and 2 (5%) of these patients experienced clinical cardiac toxicity. Fifty percent of the patients had objective tumor responses; median progression-free survival was approximately 21 weeks. Twenty-six patients (65%) had grade 3/4 neutropenia; 2 patients experienced febrile neutropenia.ConclusionNonpegylated liposomal doxorubicin plus trastuzumab is active in HER2-positive patients with advanced breast cancer and is associated with a lower risk of cardiac toxicity than conventional doxorubicin plus trastuzumab.

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