GW572016 In Patients With ErbB2 Over - Expressing Advanced Or Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00320411
First received: May 1, 2006
Last updated: April 11, 2013
Last verified: May 2012
Results First Received: November 10, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Neoplasms, Breast
Intervention: Drug: lapatinib

  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
Lapatinib Monotherapy Lapatinib: 1500 mg (six 250 mg tablets) orally once daily

Participant Flow:   Overall Study
    Lapatinib Monotherapy  
STARTED     62  
COMPLETED     58  
NOT COMPLETED     4  
No investigational product admin.                 4  



  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
Lapatinib Monotherapy Lapatinib: 1500 mg (six 250 mg tablets) orally once daily

Baseline Measures
    Lapatinib Monotherapy  
Number of Participants  
[units: participants]
  58  
Age  
[units: years]
Mean ± Standard Deviation
  54.6  ± 8.52  
Gender  
[units: participants]
 
Female     58  
Male     0  
Race/Ethnicity, Customized  
[units: participants]
 
Asian     58  



  Outcome Measures
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1.  Primary:   Overall Tumor Response   [ Time Frame: Baseline and then followed every 4 weeks until disease progression or death. If treatment was terminated due to adverse events, then followed every 12 weeks until disease progression is noted. ]

2.  Secondary:   Duration of Response   [ Time Frame: First noted efficacy to disease progression; baseline and followed every 4 weeks until disease progression or death. If treatment was terminated due to adverse events, then followed every 12 weeks until disease progression is noted. ]

3.  Secondary:   Time to Progression   [ Time Frame: Baseline to disease progression or death; baseline and then followed every 4 weeks until disease progression or death. If treatment was terminated due to adverse events, then followed every 12 weeks until disease progression or death. ]

4.  Secondary:   Clinical Benefit   [ Time Frame: Time at which all participants had been followed for at least 24 weeks; baseline and then followed every 4 weeks until disease progression (DP) or death. If treatment was terminated due to adverse events, then followed every 12 weeks until DP or death. ]

5.  Secondary:   Time to Response   [ Time Frame: Time at which all participants had been followed for at least 24 weeks; baseline and then followed every 4 weeks until disease progression (DP) or death. If treatment was terminated due to adverse event, then followed every 12 weeks until DP or death. ]

6.  Secondary:   4-month Progression Free Survival   [ Time Frame: Baseline to Month 4 (Week 16) ]

7.  Secondary:   6-month Progression Free Survival   [ Time Frame: Baseline to Month 6 (Week 24) ]

8.  Secondary:   Overall Survival   [ Time Frame: Start of dosing to death; baseline and then followed every 4 weeks until death while on treatment. If alive at time of treatment termination, then followed every 12 weeks until death. ]

9.  Secondary:   Mean Phosphorylated 58 kDa Serine/Threonine Protein Kinase (p-AKT) H Score for All Participants   [ Time Frame: Tumor samples taken at baseline ]

10.  Secondary:   Mean p-BAD H Score for All Participants   [ Time Frame: Tumor samples taken at baseline ]

11.  Secondary:   Mean Bcl-2 H Score for All Participants   [ Time Frame: Tumor samples taken at baseline ]

12.  Secondary:   Mean Epidermal Growth Factor Receptor 3 (ErbB3) H Score for All Participants   [ Time Frame: Tumor samples taken at baseline ]

13.  Secondary:   Mean Epidermal Growth Factor Receptor 4 (ErbB4) H Score for All Participants   [ Time Frame: Tumor samples taken at baseline ]

14.  Secondary:   Mean Phosphorylated Extracellular Signal-regulated Kinase (p-ERK) H Score for All Participants   [ Time Frame: Tumor samples taken at baseline ]

15.  Secondary:   Mean Heregulin H Score for All Participants   [ Time Frame: Tumor samples taken at baseline ]

16.  Secondary:   Mean Insulin-like Growth Factor 1 Receptor (IGF1R) H Score for All Participants   [ Time Frame: Tumor samples taken at baseline ]

17.  Secondary:   Mean Survivin H Score for All Participants   [ Time Frame: Tumor samples taken at baseline ]

18.  Secondary:   Mean Terminal Deoxynucleotidyl Transferase Biotin-dUTP Nick End Labeling (TUNEL) H Score for All Participants   [ Time Frame: Tumor samples taken at baseline ]


  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: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


Publications:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00320411     History of Changes
Other Study ID Numbers: EGF104911
Study First Received: May 1, 2006
Results First Received: November 10, 2009
Last Updated: April 11, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare