A Study of Trastuzumab Emtansine (T-DM1) Sequentially With Anthracycline-based Chemotherapy, as Adjuvant or Neoadjuvant Therapy for Patients With Early Stage Herceptin (HER)2-positive Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01196052
First received: September 3, 2010
Last updated: May 27, 2014
Last verified: May 2014
Results First Received: May 27, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Cancer
Intervention: Drug: Trastuzumab emtansine

  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 Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.

Participant Flow:   Overall Study
    Trastuzumab Emtansine  
STARTED     153  
Received Trastuzumab Emtansine     148  
COMPLETED     130  
NOT COMPLETED     23  
Adverse Event                 9  
Lost to Follow-up                 1  
Noncompliance to Protocol Requirements                 2  
Reason not Specified                 5  
Withdrawal by Subject                 6  



  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.
Enrolled participant population: All participants enrolled in the study.

Reporting Groups
  Description
Trastuzumab Emtansine Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.

Baseline Measures
    Trastuzumab Emtansine  
Number of Participants  
[units: participants]
  153  
Age  
[units: years]
Mean ± Standard Deviation
  51.1  ± 11.23  
Gender  
[units: participants]
 
Female     153  
Male     0  



  Outcome Measures
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1.  Primary:   Percentage of Participants With a Cardiac Event Within 12 Weeks After the Start of Trastuzumab Emtansine Treatment   [ Time Frame: Baseline to 12 weeks after the start of trastuzumab emtansine treatment ]

2.  Primary:   Adverse Events, LVEF Function, and Deaths   [ Time Frame: From the start to the end of trastuzumab emtansine treatment (up to 51 weeks) ]

3.  Secondary:   Percentage of Participants Who Experienced at Least 1 Adverse Event During Concurrent Radiotherapy With Trastuzumab Emtansine Treatment   [ Time Frame: From the start to the end of concurrent radiotherapy (up to 51 weeks) ]

4.  Secondary:   Percentage of Participants Who Experienced at Least 1 Adverse Event During Concurrent Hormonal Therapy With Trastuzumab Emtansine Treatment   [ Time Frame: From the start to the end of concurrent hormonal therapy (up to 51 weeks) ]

5.  Secondary:   Percentage of Participants Who Completed the Planned Duration of Trastuzumab Emtansine Treatment   [ Time Frame: From the start to the end of trastuzumab emtansine treatment (up to 51 weeks) ]

6.  Secondary:   Percentage of Participants Who Completed ≥ 95% of the Planned Radiotherapy Treatment With Concurrent Trastuzumab Emtansine Administration Without Significant (> 5 Days) Delay   [ Time Frame: From the start to the end of radiotherapy treatment (up to 51 weeks) ]

7.  Secondary:   Percentage of Participants With a Pathological Complete Response   [ Time Frame: Day of surgery ]

8.  Secondary:   Disease-free Survival at Month 12   [ Time Frame: From the start of trastuzumab emtansine for adjuvant patients and from the date of surgery for neoadjuvant patients to 12 months later ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  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.


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
phone: 800 821-8590
e-mail: genentech@druginfo.com


No publications provided


Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01196052     History of Changes
Other Study ID Numbers: BO22857, TDM4874g
Study First Received: September 3, 2010
Results First Received: May 27, 2014
Last Updated: May 27, 2014
Health Authority: United States: Food and Drug Administration