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Lapatinib In Chemotherapy-Naive Or Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00089999
First received: August 18, 2004
Last updated: September 11, 2014
Last verified: August 2014
Results First Received: August 18, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel 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
Participants (par.) with histologically confirmed invasive breast cancer with incurable stage IIIb, stage IIIc with T4 lesion, or stage IV disease at primary diagnosis or at relapse after curative-intent surgery and whose tumors overexpressed ErbB2 protein, documented by FISH were eligible for inclusion in this phase II study.

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 1500 mg QD Participants received lapatinib 1500 milligram (mg) orally once daily (QD). Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
Lapatinib 500 mg BID Participants received lapatinib 500 mg orally twice daily (BID). Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.

Participant Flow:   Overall Study
    Lapatinib 1500 mg QD     Lapatinib 500 mg BID  
STARTED     69     69  
COMPLETED     0     0  
NOT COMPLETED     69     69  
Adverse Event                 4                 7  
Withdrawal by Subject                 0                 4  
Lost to Follow-up                 2                 1  
Radiological Progression of Cancer                 52                 44  
Symptomatic Progression of Cancer                 2                 5  
Death                 3                 3  
Poor General Condition                 1                 0  
Clinical Progression                 1                 2  
Physician Decision                 2                 2  
Patient Underwent Surgery                 2                 0  
Skin Nodule Over Right Mastectomy                 0                 1  



  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.
No text entered.

Reporting Groups
  Description
Lapatinib 1500 mg QD Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
Lapatinib 500 mg BID Participants received lapatinib 500 mg orally BID. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
Total Total of all reporting groups

Baseline Measures
    Lapatinib 1500 mg QD     Lapatinib 500 mg BID     Total  
Number of Participants  
[units: participants]
  69     69     138  
Age  
[units: Years]
Mean ± Standard Deviation
  53.2  ± 14.27     53.4  ± 13.66     53.3  ± 13.92  
Gender  
[units: Participants]
     
Female     69     69     138  
Male     0     0     0  
Race/Ethnicity, Customized  
[units: Participants]
     
White     2     1     3  
Black     0     1     1  
Asian     36     35     71  
American Hispanic     31     32     63  



  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 date of the first dose of investigational product to the first documented evidence of a confirmed CR or PR (up to Study Week 103) ]

2.  Primary:   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 date of the first dose of investigational product to the first documented evidence of a confirmed CR or PR (up to Study Week 103) ]

3.  Secondary:   Percentage of Participants With Clinical Benefit (CR or PR or Stable Disease [SD] for at Least 24 Weeks), as Assessed by the IRC and Investigator   [ Time Frame: From the date of the first dose of investigational product until the date of disease progression or death due to breast cancer (up to Study Week 103) ]

4.  Secondary:   Time to Response, as Assessed by the IRC and Investigator   [ Time Frame: From the date of the first dose of investigational product until the first documented evidence of a PR or CR (up to Study Week 103) ]

5.  Secondary:   Duration of Response (DoR), as Assessed by the IRC and 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 Study Week 103) ]

6.  Secondary:   Progression-free Survival, as Assessed by the IRC and Investigator   [ Time Frame: From the date of the first dose of investigational product until the earlier of the date of disease progression or death due to any cause (up to Study Week 103) ]

7.  Secondary:   Time to Treatment Failure, as Assessed by IRC and Investigator   [ Time Frame: From randomization until the first documented sign of disease progression, death due to any cause, or early discontinuation from investigational product (up to Study Week 103) ]

8.  Secondary:   Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)   [ Time Frame: From the date of the first dose of investigational product until 30 days after the last dose of investigational product (up to study week 192) ]


  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


No publications provided


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00089999     History of Changes
Other Study ID Numbers: EGF20009
Study First Received: August 18, 2004
Results First Received: August 18, 2014
Last Updated: September 11, 2014
Health Authority: United States: Food and Drug Administration