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An Observational Study of Patients With HER2-Positive Metastatic or Locally Advanced Breast Cancer Treated With Herceptin (Trastuzumab) in 1st Line and Without Progression For 3 Years

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01480674
First received: August 18, 2011
Last updated: June 6, 2016
Last verified: June 2016
Results First Received: January 27, 2016  
Study Type: Observational
Study Design: Observational Model: Cohort
Condition: Breast Cancer
Intervention: Drug: Trastuzumab

  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
A total of 160 participants were recruited from 28 March 2011 to 16 November 2012.

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 Eligible participants with human epidermal growth factor receptor 2 (HER2)-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab (Herceptin) as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.

Participant Flow:   Overall Study
    Trastuzumab  
STARTED     160  
Safety Set     154  
Analysed Set     128  
COMPLETED     125  
NOT COMPLETED     35  
Death                 23  
Lost to Follow-up                 2  
visit not done                 10  



  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.
Analyzed set population included all enrolled participants without any protocol deviation used as a primary analysis population for all efficacy outcome measures.

Reporting Groups
  Description
Trastuzumab Eligible participants with HER2-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.

Baseline Measures
    Trastuzumab  
Number of Participants  
[units: participants]
  128  
Age  
[units: Years]
Mean (Standard Deviation)
  61.3  (12.2)  
Gender  
[units: participants]
 
Female     128  
Male     0  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Tumor Hormone Receptor Status of Participants Without Progression   [ Time Frame: Up to 3 years ]

2.  Primary:   Percentage of Participants With Prevalence of Bone Metastases Without Progression for at Least 3 Years After the Beginning of 1st Line Herceptin Treatment   [ Time Frame: Up to 3 years ]

3.  Secondary:   Progression-free Survival   [ Time Frame: Up to 12 years ]

4.  Secondary:   Time to Progression   [ Time Frame: Up to 12 years ]

5.  Secondary:   Overall Survival   [ Time Frame: Up to 12 years ]

6.  Secondary:   Dosage Schedule of Herceptin Treatment   [ Time Frame: Up to 12 years ]

7.  Secondary:   Number of Participants With Antineoplastic Treatment in Combination With Trastuzumab and After Discontinuation of Trastuzumab Treatment   [ Time Frame: Up to 12 years ]

8.  Secondary:   Number of Participants With Any Adverse Events and Serious Adverse Events   [ Time Frame: Up to 1 year ]

9.  Secondary:   The Duration of Treatment of Trastuzumab   [ Time Frame: Up to 1 Year ]


  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: Roche Trial Information Hotline
Organization: F. Hoffmann-La Roche AG
phone: +41 616878333
e-mail: global.trial_information@roche.com



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01480674     History of Changes
Other Study ID Numbers: ML23001
Study First Received: August 18, 2011
Results First Received: January 27, 2016
Last Updated: June 6, 2016
Health Authority: France: Commission Nationale de l'Informatique et des Libertés (CNIL)