Multicenter phase I trial of trastuzumab emtansine (T-DM1) in combination with non-pegylated liposomal doxorubicin (NPLD) in HER2[+] metastatic breast cancer (MBC). THELMA study

Background null EMILIA, TH3RESA, and KAMILLA phase III trials showed that T-DM1 is highly active and safe as single agent in HER2[+] MBC. T-DM1 and NPLD may be safely combined to increase antitumor effect compared to each agent alone. The aim of this trial is to determine the dose-limiting toxicity (DLT) and maximum tolerate dose (MTD) of T-DM1 plus NPLD in HER2[+] MBC. null null null Methods null A 3 + 3 dose escalation design was used. Main...