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Clinical trial

A Study of Trastuzumab Emtansine Versus Capecitabine + Lapatinib in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer (EMILIA)

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Last updated:1st Feb 2009
Identifier: NCT00829166

This is a Phase III, randomized, multicenter, international, 2-arm, open-label clinical trial designed to compare the safety and efficacy of trastuzumab emtansine (T-DM1) with that of capecitabine + lapatinib in participants with human epidermal growth factor receptor 2 (HER2)-positive locally advanced or metastatic breast cancer. Participants will be treated until disease progression (PD), unmanageable toxicity, or study termination. Once disease progression is reported, all participants will be followed for survival every 3 months until death, loss to follow-up, withdrawal of consent, or study termination.

Study Type: Interventional  (Clinical Trial)
Actual Enrollment: 991 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Phase III Open-label Study of the Efficacy and Safety of Trastuzumab MCC-DM1 vs. Capecitabine + Lapatinib in Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab-Based Therapy
Study Start Date: February 2009
Actual Primary Completion Date: July 2012
Actual Study Completion Date: September 2015

- Experimental:
Trastuzumab emtansine
- Active Comparator: Lapatinib + Capecitabine

Category Value
Date last updated at source 2016-10-31
Study type(s) Interventional
Expected enrolment 991
Study start date 2009-02-01
Estimated primary completion date 2015-09-01

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