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NCT00829166 (EMILIA) (Clinical Trial/ Ado-Trastuzumab Emtansine)

Study Title
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)

Trial Description
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. [1]

Study Data

  • Condition: Breast Cancer
  • Interventions:
  • Phase: III
  • Enrollment: 991
  • Start: February 2009
  • Estimated Completion: June 2015
  • Last verified: April 2015

Study Schematic

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Last Editorial review: July 28, 2015
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.

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