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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00829166
First Posted: January 26, 2009
Last Update Posted: October 31, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
Results First Submitted: February 22, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: Trastuzumab emtansine
Drug: Lapatinib
Drug: Capecitabine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants of "Lapatinib + Capecitabine" arm were allowed to cross over to receive trastuzumab emtansine based on statistically significant Overall Survival (OS) benefit in favor of trastuzumab emtansine demonstrated in second interim analysis (cut-off date 31 July 2012). The safety analysis of the arm was then reported.

Reporting Groups
  Description
Trastuzumab Emtansine Participants received trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) intravenous (IV) infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until disease progression (PD) (as assessed by the investigator), unmanageable toxicity, or study termination.
Lapatinib + Capecitabine Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 milligrams per square meter (mg/m^2) orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.

Participant Flow:   Overall Study
    Trastuzumab Emtansine   Lapatinib + Capecitabine
STARTED   495   496 
Treated   490   488 
COMPLETED   0   0 
NOT COMPLETED   495   496 
Death                305                333 
Lost to Follow-up                5                4 
Physician's Decision                4                3 
Subject's Decision                41                55 
Sponsor’s Decision                137                98 
Reason Not Specified                3                3 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-treat (ITT) population included all randomized participants on the basis of the treatment assigned at randomization.

Reporting Groups
  Description
Trastuzumab Emtansine Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
Lapatinib + Capecitabine Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
Total Total of all reporting groups

Baseline Measures
   Trastuzumab Emtansine   Lapatinib + Capecitabine   Total 
Overall Participants Analyzed 
[Units: Participants]
 495   496   991 
Age 
[Units: Years]
Mean (Standard Deviation)
 52.2  (11.0)   53.2  (10.8)   52.7  (10.9) 
Gender 
[Units: Participants]
     
Female   494   492   986 
Male   1   4   5 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With PD or Death as Assessed by an Independent Review Committee (IRC)   [ Time Frame: From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) ]

2.  Primary:   Progression-free Survival (PFS) as Assessed by an IRC (Co-primary Endpoint)   [ Time Frame: From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) ]

3.  Primary:   Percentage of Participants Who Died: Second Interim Analysis   [ Time Frame: From the date of randomization through the data cut-off date of 31 Jul 2012 (up to 3 years, 5 months) ]

4.  Primary:   Overall Survival: Second Interim Analysis (Co-primary Endpoint)   [ Time Frame: From the date of randomization through the data cut-off date of 31 Jul 2012 (up to 3 years, 5 months) ]

5.  Primary:   Percentage of Participants Who Died: Final Analysis   [ Time Frame: From the date of randomization through the data cut-off date of 31 Dec 2014 (up to 5 years, 11 months) ]

6.  Primary:   Overall Survival: Final Analysis   [ Time Frame: From the date of randomization through the data cut-off date of 31 Dec 2014 (up to 5 years, 11 months) ]

7.  Primary:   Percentage of Participants Who Were Alive at Year 1   [ Time Frame: Year 1 ]

8.  Primary:   Percentage of Participants Who Were Alive at Year 2   [ Time Frame: Year 2 ]

9.  Secondary:   Percentage of Participants With PD or Death as Assessed by the Investigator   [ Time Frame: From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) ]

10.  Secondary:   PFS as Assessed by the Investigator   [ Time Frame: From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) ]

11.  Secondary:   Percentage of Participants With Objective Response (OR) as Assessed by an IRC   [ Time Frame: From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) ]

12.  Secondary:   Duration of Objective Response (DOR) as Assessed by an IRC   [ Time Frame: From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) ]

13.  Secondary:   Percentage of Participants With Clinical Benefit as Assessed by an IRC   [ Time Frame: From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) ]

14.  Secondary:   Percentage of Participants With Treatment Failure   [ Time Frame: From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) ]

15.  Secondary:   Time to Treatment Failure   [ Time Frame: From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) ]

16.  Secondary:   Percentage of Participants With Symptom Progression   [ Time Frame: From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) ]

17.  Secondary:   Time to Symptom Progression   [ Time Frame: From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats


  More Information