An Open-label Study of Trastuzumab Emtansine (T-DM1) vs Capecitabine + Lapatinib in Patients With HER2-positive Locally Advanced or Metastatic Breast Cancer (EMILIA) (NCT00829166)
This is a Phase III, randomized, multicenter, international, 2-arm, open-label clinical trial designed to compare the safety and efficacy of ado-trastuzumab emtansine (T-DM1, Kadcyla®; Genentech, Inc.) with that of capecitabine (Xeloda®;Genentech, Inc.) + lapatinib (Tykerb®; Novartis Pharmacueticals Co.) for HER2-positive metastatic breast cancer (MBC). Patients were treated until disease progression, unmanageable toxicity, or study termination. Once disease progression was reported, all patients were followed for survival every 3 months until death, loss to follow-up, withdrawal of consent, or study termination.
This trial is sponsored by F. Hoffmann-La Roche. 
- Condition: Breast Cancer
- Phase: III
- Enrollment: 991
- Start: February 2009
- Estimated Completion: June 2015
- Last verified: April 2015
Last Editorial review: July 28, 2015
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.
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