An Open-label Study of Trastuzumab Emtansine (T-DM1) vs Capecitabine + Lapatinib in Patients With HER2-positive Locally Advanced or Metastatic Breast Cancer (EMILIA)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00829166
First received: January 22, 2009
Last updated: January 7, 2014
Last verified: January 2014
Results First Received: February 22, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: Trastuzumab emtansine [Kadcyla]
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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Trastuzumab Emtansine Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) over 30-90 minutes on Day 1 of each 21-day treatment cycle.
Lapatinib + Capecitabine Patients received lapatinib 1250 mg/day orally once per day of each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle.

Participant Flow:   Overall Study
    Trastuzumab Emtansine     Lapatinib + Capecitabine  
STARTED     495     496  
COMPLETED     308     262  
NOT COMPLETED     187     234  
Death                 149                 182  
Lost to Follow-up                 3                 1  
Physician's Decision                 4                 2  
Subject's Decision                 28                 48  
Reason Not Specified                 3                 1  



  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.
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Reporting Groups
  Description
Trastuzumab Emtansine Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) over 30-90 minutes on Day 1 of each 21-day treatment cycle.
Lapatinib + Capecitabine Patients received lapatinib 1250 mg/day orally once per day of each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle.
Total Total of all reporting groups

Baseline Measures
    Trastuzumab Emtansine     Lapatinib + Capecitabine     Total  
Number of Participants  
[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
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1.  Primary:   Progression-free Survival (PFS) Assessed by an Independent Review Committee   [ 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:   Overall Survival   [ Time Frame: From the date of randomization through the data cut-off date of 31 Jul 2012 (up to 3 years, 5 months) ]

3.  Primary:   1 and 2 Year Survival   [ Time Frame: From the date of randomization through the data cut-off date of 31 Jul 2012 (up to 3 years, 5 months) ]

4.  Secondary:   Progression-free Survival (PFS) 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) ]

5.  Secondary:   Objective Response (OR) Assessed by the Independent Review Committee   [ Time Frame: From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) ]

6.  Secondary:   Duration of Objective Response (OR)   [ Time Frame: From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) ]

7.  Secondary:   Clinical Benefit   [ Time Frame: 6 months after randomization ]

8.  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) ]

9.  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


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