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Muralidhar Beeram, Ian E. Krop, Howard A. Burris, Sandhya R. Girish, Wei Yu, Michael W. Lu, Scott N. Holden and Shanu Modi A phase 1 study of weekly dosing of trastuzumab emtansine (T-DM1) in patients with advanced human epidermal growth factor 2–positive breast cancer Cancer 118

Version of Record online: 30 MAY 2012 | DOI: 10.1002/cncr.27622

We conducted a phase 1, multicenter, open-label dose-escalation study (TDM3569g) to assess the safety, tolerability, and pharmacokinetics of single-agent trastuzumab emtansine (T-DM1) administered weekly and once every 3 weeks in patients with HER2-positive metastatic breast cancer previously treated with trastuzumab. The weekly dose results suggest that T-DM1 administered weekly at 2.4 mg/kg has antitumor activity and is well tolerated in these patients.

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