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The recent FDA approval of the drug-antibody conjugate T-DM1 (trastuzumab emtansine, brand name Kadcyla) had been eagerly anticipated. Its arrival brings to the clinic a novel agent capable of delivering a cytotoxic to its target (human epidermal growth factor receptor 2 [HER2]–positive breast cancer) more effectively and with less toxicity than chemotherapy plus trastuzumab or other anti-HER2 agents such as lapatanib (JW Oncol Hematol Oct 23 2012).
Now, industry-supported investigators report the results of a phase II randomized trial of T-DM1 involving 137 patients with HER2-positive, metastatic or recurrent locally advanced breast cancer. The patients were randomly assigned to receive first-line treatment with trastuzumab plus docetaxel (…