Pegylated liposomal doxorubicin plus carboplatin in patients with metastatic breast cancer: a phase II study

cycle; human epidermal growth factor receptor-2 (HER2)-positive patients also received trastuzumab. Results: Arm 1 received PLD plus carboplatin (N = 41 arm 1a, taxane naive; N= 42 arm 1b, taxane pretreated); Arm 2 patients received PLD plus carboplatin + Herceptin (N= 46). Overall response rates: 31%, 31%, and 56%, respectively. Median overall survival durations were not reached in arm 1a and were 13 and 33 months for arms 1b and 2. Median progression-free survival: 8, 5, 10 months, respectively. Grades 3–4 treatment-related toxic effects for arms 1a, 1b, 2, respectively, were neutropenia 22%, 31%, 35%; thrombocytopenia 34%, 26%, 17%; and fatigue 2%, 14%, 13%. Conclusions: PLD plus carboplatin has moderate antitumor activity and excellent tolerability. Herceptin and PLD plus carboplatin in HER2-positive patients have antitumor activity without significant cardiac toxicity. Toxicity results suggest