Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Lapatinib Combined With Paclitaxel For Patients With First-Line ErbB2-Amplified Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00356811
First received: July 25, 2006
Last updated: June 19, 2014
Last verified: May 2014
Results First Received: May 8, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Neoplasms, Breast
Interventions: Drug: Lapatinib oral tablets
Drug: Paclitaxel infusion

  Participant Flow
  Hide Participant Flow

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
Lapatinib With Paclitaxel Participants received lapatinib 1500 milligrams (mg) orally once daily (OD) with paclitaxel, administered as a 1-hour intravenous (IV) infusion at a dose of 80 mg/meters squared (m^2) on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.

Participant Flow:   Overall Study
    Lapatinib With Paclitaxel  
STARTED     57  
COMPLETED     8  
NOT COMPLETED     49  
Death                 35  
Lost to Follow-up                 2  
Withdrawal by Subject                 6  
Participant Could Not Make a Checkup                 1  
Study Is Terminating                 3  
Site Closed during Follow-up                 2  



  Baseline Characteristics
  Hide Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Lapatinib Plus Paclitaxel Participants received lapatinib 1500 mg orally OD with paclitaxel, administered as a 1-hour IV infusion at a dose of 80 mg/m^2 on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.

Baseline Measures
    Lapatinib Plus Paclitaxel  
Number of Participants  
[units: participants]
  57  
Age  
[units: Years]
Mean ± Standard Deviation
  52.3  ± 9.30  
Gender  
[units: Participants]
 
Female     57  
Male     0  
Race/Ethnicity, Customized  
[units: Participants]
 
White - White/Caucasian/European Heritage     57  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Partial Response (PR), as Assessed by the Independent Review Committee (IRC)   [ Time Frame: From the first dose of study medication to the first documented evidence of a confirmed CR or PR (up to Week 86) ]

2.  Secondary:   Number of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Partial Response (PR), as Assessed by the Investigator   [ Time Frame: From the first dose of study medication to the first documented evidence of a confirmed CR or PR (up to Week 86) ]

3.  Secondary:   Duration of Response (DoR), as Assessed by the IRC   [ Time Frame: From the first documented evidence of a PR or CR until the earlier of the date of disease progression or the date of death due to breast cancer (up to Week 86) ]

4.  Secondary:   Duration of Response (DoR), as Assessed by the Investigator   [ Time Frame: From the first documented evidence of a PR or CR until the earlier of the date of disease progression or the date of death due to breast cancer (up to Week 86) ]

5.  Secondary:   Time to Response, as Assessed by the IRC   [ Time Frame: From randomization until the first documented evidence of a PR or CR (up to Week 86) ]

6.  Secondary:   Time to Response, as Assessed by the Investigator   [ Time Frame: From randomization until the first documented evidence of a PR or CR (up to Week 86) ]

7.  Secondary:   Time to Progression, as Assessed by the IRC and the Investigator   [ Time Frame: From the start date of treatment until the date of radiological disease progression or the date of death due to breast cancer (up to Week 86) ]

8.  Secondary:   Progression-free Survival, as Assessed by the IRC and the Investigator   [ Time Frame: From the start date of treatment until the date of radiological disease progression or death due to any cause, whichever occurs first (up to Week 86) ]

9.  Secondary:   Overall Survival   [ Time Frame: From the date of the first dose until the date of death due to any cause (up to Week 86) ]

10.  Secondary:   Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)   [ Time Frame: From the start of study medication until 28 days after the last dose (up to Study Week 381) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


  More Information
  Hide More Information

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:
Jagiello-Gruszfeld A, Tjulandin Sergei S, Dobrovolskaya N et al, Lapatinib (L) with weekly paclitaxel (P) as first-line therapy for patients (pts) with HER2+ metastatic breast cancer (MBC). The 31st Annual San Antonio Breast Cancer Symposium; San Antonio TX: December 10-14 2008. Abstract 3145.

Publications automatically indexed to this study:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00356811     History of Changes
Other Study ID Numbers: EGF105764
Study First Received: July 25, 2006
Results First Received: May 8, 2014
Last Updated: June 19, 2014
Health Authority: Russia: Ministry of Health of the Russian Federation