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Study In Women And Men With Metastatic Breast Cancer That Have Overexpression Of ErbB2

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00281658
First received: January 23, 2006
Last updated: January 16, 2014
Last verified: January 2014
Results First Received: May 5, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Neoplasms, Breast
Interventions: Drug: lapatinib (GW572016) oral tablets
Drug: paclitaxel infusion

  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
At the time of disease progression, participants had the option to be unblinded. Participants (pts) who were on placebo+paclitaxel could continue in an open-label lapatinib monotherapy extension phase until further progression or an unacceptable toxicity. All participants were followed for survival. The unblinding was performed by a third party.

Reporting Groups
  Description
Lapatinib Plus Paclitaxel Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks
Placebo Plus Paclitaxel Matching placebo administered once daily plus paclitaxel 80 mg/m^2 administered IV weekly for 3 weeks every 4 weeks
Lapatinib 1500 mg Lapatinib 1500 mg administered once daily

Participant Flow for 2 periods

Period 1:   Double-blind, Randomized Phase
    Lapatinib Plus Paclitaxel     Placebo Plus Paclitaxel     Lapatinib 1500 mg  
STARTED     222     222 [1]   0  
COMPLETED     85 [2]   168 [2]   0  
NOT COMPLETED     137     54     0  
Death                 120                 46                 0  
Lost to Follow-up                 12                 5                 0  
Withdrawal by Subject                 4                 1                 0  
Participant Entered New Protocol                 1                 1                 0  
Screen Failure; Randomized in Error                 0                 1                 0  
[1] Of these participants, 149 entered the open-label extension phase.
[2] For the purposes of this report, completed pts are pts ongoing at the time of the analysis.

Period 2:   Open-label Monotherapy Extension Phase
    Lapatinib Plus Paclitaxel     Placebo Plus Paclitaxel     Lapatinib 1500 mg  
STARTED     0     0     149  
COMPLETED     0     0     48 [1]
NOT COMPLETED     0     0     101  
Death                 0                 0                 97  
Lost to Follow-up                 0                 0                 3  
Withdrawal by Subject                 0                 0                 1  
[1] For the purposes of this report, completed pts are pts ongoing at the time of the analysis.



  Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Survival   [ Time Frame: Randomization to death (up to maximum of Month 53) ]

2.  Secondary:   Progression-free Survival   [ Time Frame: Randomization to disease progression or death (up to a maximum of Month 53) ]

3.  Secondary:   Overall Response (OR)   [ Time Frame: Randomization to disease progression or death (up to a maximum of Month 53) ]

4.  Secondary:   Clinical Benefit   [ Time Frame: Randomization to disease progression or death (up to a maximum of Month 53) ]

5.  Secondary:   Duration of Response   [ Time Frame: Randomization to disease progression or death (up to a maximum of Month 53) ]

6.  Secondary:   Number of Participants With a CR or PR at Weeks 8, 12, 16, 24, 32, 40, 48, 56, 64, and 72   [ Time Frame: Weeks 8, 12, 16, 24, 32, 40, 48, 56, 64, and 72 ]


  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
Some participants (PAR) are captured as withdrawing from the study due to death. Per protocol, PAR who died were considered to be study completers and did not withdraw from the study; for the purposes of this report, they are classified as withdrawn.


  More Information