A Study of the Efficacy and Safety of Trastuzumab Emtansine (Trastuzumab-MCC-DM1) vs. Trastuzumab (Herceptin®) and Docetaxel (Taxotere®) in Patients With Metastatic HER2-positive Breast Cancer Who Have Not Received Prior Chemotherapy for Metastatic Disease (NCT00679341)
This was a Phase II, randomized, multicenter, international, 2-arm, open-label clinical trial designed to explore the efficacy and safety of ado-trastuzumab emtansine (T-DM1, Kadcyla®; Genentech, Inc.) relative to the combination of trastuzumab (Herceptin®;Genentech, Inc.) and docetaxel (Docefrez®; Sun Pharmaceutical Industries Ltd.) in patients with human epidermal growth factor receptor 2 (HER2)-positive, unresectable, locally advanced breast cancer and/or metastatic breast cancer who have not received prior chemotherapy for metastatic disease.
This trial is sponsored by F. Hoffmann-La Roche. 
- Condition: Breast Cancer
- Phase: II
- Enrollment: 137
- Start: September 2008
- Completion: May 2012
- Last verified: December 2013
Last Editorial review: July 28, 2015
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.
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