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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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) ]
  Hide Outcome Measure 6

Measure Type Secondary
Measure Title Duration of Objective Response (OR)
Measure Description Duration of OR was defined as the time from first documented OR to first documented progressive disease (PD) or death from any cause, whichever occurred earlier. PD for target lesions was defined as ≥ 20% increase in the sum of the longest diameter, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of 1 or more new lesions. PD for non-target lesions was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.
Time Frame From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)  
Safety Issue No  

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: All randomized patients on the basis of the treatment assigned at randomization. Only patients with an objective response were included in the analysis.

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.

Measured Values
    Trastuzumab Emtansine     Lapatinib + Capecitabine  
Number of Participants Analyzed  
[units: participants]
  173     120  
Duration of Objective Response (OR)  
[units: Months]
Median ( 95% Confidence Interval )
  12.6  
  ( 8.38 to 20.76 )  
  6.5  
  ( 5.45 to 7.16 )  

No statistical analysis provided for Duration of Objective Response (OR)



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


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
phone: 800 821-8590


No publications provided by Hoffmann-La Roche

Publications automatically indexed to this study:

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00829166     History of Changes
Other Study ID Numbers: BO21977, TDM4370g
Study First Received: January 22, 2009
Results First Received: February 22, 2013
Last Updated: January 7, 2014
Health Authority: United States: Food and Drug Administration