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Paclitaxel With / Without GW572016 (Lapatinib) As First Line Therapy For Women With Advanced Or Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT00075270
Recruitment Status : Completed
First Posted : January 9, 2004
Results First Posted : March 31, 2014
Last Update Posted : May 6, 2015
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Neoplasms, Breast
Interventions: Drug: Paclitaxel
Drug: GW572016 (Lapatinib)

  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
A total of 580 participants were enrolled and randomized to treatment; however one participant withdrew from the study before taking any medication. Thus, only 579 participants were included in the Intent-to-Treat Population (comprised of all randomized participants who had received at least one dose of randomized therapy [lapatinib or placebo]).

Reporting Groups
  Description
Lapatinib With Paclitaxel Participants received lapatinib 1500 milligrams (mg) orally once daily (OD) with paclitaxel 175 mg/meters squared (m^2) intravenously (IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
Placebo With Paclitaxel Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.

Participant Flow:   Overall Study
    Lapatinib With Paclitaxel   Placebo With Paclitaxel
STARTED   291   288 
Missing   26 [1]   13 [1] 
COMPLETED   5   4 
NOT COMPLETED   286   284 
Withdrawal by Subject                28                21 
Lost to Follow-up                25                28 
Protocol Violation                0                2 
Death                198                215 
Other/Unknown                9                5 
Missing                26                13 
[1] These participants have no completion status information recorded on the case report forms.



  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 With Paclitaxel Participants received lapatinib 1500 milligrams (mg) orally once daily (OD) with paclitaxel 175 mg/meters squared (m^2) intravenously (IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
Placebo With Paclitaxel Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
Total Total of all reporting groups

Baseline Measures
   Lapatinib With Paclitaxel   Placebo With Paclitaxel   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 291   288   579 
Age 
[Units: Years]
Mean (Standard Deviation) 		 51.3  (10.45)   52.4  (10.98)   51.8  (10.72) 
Gender 
[Units: Participants]
 		     
Female   291   288   579 
Male   0   0   0 
Race/Ethnicity, Customized 
[Units: Participants]
 		     
White   190   182   372 
Black   10   10   20 
Asian   30   35   65 
American Hispanic   54   53   107 
Unknown   7   8   15 


  Outcome Measures

1.  Primary:   Time to Progression as Evaluated by the Investigator   [ Time Frame: Randomization until the date of disease progression or death (average of 26 weeks) ]
  Show Outcome Measure 1

2.  Primary:   Time to Progression as Evaluated by the Independent Review Committee (IRC)   [ Time Frame: Randomization until the date of disease progression or death (average of 26 weeks) ]
  Show Outcome Measure 2

3.  Secondary:   Number of Participants With Tumor Response as Evaluated by the Investigator   [ Time Frame: Randomization until the date of disease progression or death (average of 26 weeks) ]
  Show Outcome Measure 3

4.  Secondary:   Number of Participants With Tumor Response as Evaluated by the Independent Review Committee   [ Time Frame: Randomization until the date of disease progression or death (average of 26 weeks) ]
  Show Outcome Measure 4

5.  Secondary:   Percentage of Participants With Clinical Benefit (CB) as Assessed by the Investigator   [ Time Frame: Randomization until the date of disease progression or death (average of 26 weeks) ]
  Show Outcome Measure 5

6.  Secondary:   Number of Participants With a Response of CR or PR by the Indicated Study Week   [ Time Frame: Weeks 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, and 72 ]
  Show Outcome Measure 6

7.  Secondary:   Duration of Response (DOR)   [ Time Frame: From the time of the first documented complete or partial response until the first documented evidence of progression or death (average of 26 weeks) ]
  Show Outcome Measure 7

8.  Secondary:   Progression-Free Survival (PFS)   [ Time Frame: Randomization until the date of disease progression or death (average of 26 weeks) ]
  Show Outcome Measure 8

9.  Secondary:   Number of Participants Who Progressed or Died at or Prior to 6 Months, as a Measure of Six Months Progression-free Survival (PFS)   [ Time Frame: Randomization until the date of disease progression or death (average of 26 weeks) ]
  Show Outcome Measure 9

10.  Secondary:   Overall Survival   [ Time Frame: Randomization until the date of death due to any cause (average of 24 months) ]
  Show Outcome Measure 10

11.  Secondary:   Change From Baseline in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) Questionnaire Scores   [ Time Frame: Baseline (Day 1); Weeks 9, 21, 33, and 45; Withdrawal ]
  Show Outcome Measure 11

12.  Secondary:   Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire Scores   [ Time Frame: Baseline (Day 1); Weeks 9, 21, 33, and 45; Withdrawal ]
  Show Outcome Measure 12

13.  Secondary:   Change From Baseline in Trial Outcome Index (TOI) Questionnaire Scores   [ Time Frame: Baseline (Day 1); Weeks 9, 21, 33, and 45; Withdrawal ]
  Hide Outcome Measure 13

Measure Type Secondary
Measure Title Change From Baseline in Trial Outcome Index (TOI) Questionnaire Scores
Measure Description The TOI questionnaire was designed to measure multidimensional QOL in participants with cancer and includes subscales for physical, functional well-being, and additional cancer concerns. The physical and functional well-being subscale scores range from 0 to 28, based on 7 questions (each question scored from 0 [not at all] to 4 [very much]); the breast cancer unweighted subscale scores range from 0 to 36, based on 9 questions. The total TOI score (ranging from 0 [better QOL] to 92 [worse QOL]) is the sum of the TOI subscale scores.
Time Frame Baseline (Day 1); Weeks 9, 21, 33, and 45; Withdrawal  

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.
ITT Population. Only participants contributing data at the indicated time points were analyzed. Only observed data were collected, and score analyses were conducted using the LOCF method.

Reporting Groups
  Description
Lapatinib With Paclitaxel Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
Placebo With Paclitaxel Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.

Measured Values
   Lapatinib With Paclitaxel   Placebo With Paclitaxel 
Participants Analyzed 
[Units: Participants]
 		 208   232 
Change From Baseline in Trial Outcome Index (TOI) Questionnaire Scores 
[Units: Scores on a scale]
Mean (Standard Deviation) 		   
Week 9, n=208, 232   -2.3  (12.32)   -2.6  (11.88) 
Week 21, n=126, 125   -0.5  (11.99)   -2.7  (12.42) 
Week 33, n=72, 65   -0.1  (12.83)   -2.9  (9.05) 
Week 45, n=36, 38   1.5  (15.91)   -2.8  (8.98) 
Withdrawal, n=190, 212   -4.4  (14.30)   -6.1  (12.84) 

No statistical analysis provided for Change From Baseline in Trial Outcome Index (TOI) Questionnaire Scores



14.  Secondary:   Number of Participants With the Indicated ErbB2 Status at Baseline   [ Time Frame: Baseline ]
  Show Outcome Measure 14

15.  Secondary:   ErbB2 Ratio   [ Time Frame: Baseline ]
  Show Outcome Measure 15

16.  Secondary:   Number of Participants With the Indicated Immunohistochemistry (IHC) Results at Screening   [ Time Frame: Screening (Day -1) ]
  Show Outcome Measure 16

17.  Secondary:   Number of Participants With the Indicated ErbB2 Fluorescence in Situ Hybridization (FISH) Results   [ Time Frame: Baseline ]
  Show Outcome Measure 17

18.  Secondary:   Serum ErbB1 Concentration   [ Time Frame: Screening (Day-1) and Withdrawal (up to Study Week 129) ]
  Show Outcome Measure 18

19.  Secondary:   Serum ErbB2 Concentration   [ Time Frame: Screening (Day-1) and Withdrawal (up to Study Week 129) ]
  Show Outcome Measure 19

20.  Secondary:   Number of Participants With the Indicated Adverse Events (AEs) With a Maximum Toxicity Grade of 3 or 4   [ Time Frame: Baseline (Day 1) until 30 days after the last dose of randomized therapy (average of 26 weeks) ]
  Show Outcome Measure 20


  Serious Adverse Events


  Other Adverse Events


  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

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:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00075270     History of Changes
Obsolete Identifiers: NCT00085046
Other Study ID Numbers: EGF30001
First Submitted: January 7, 2004
First Posted: January 9, 2004
Results First Submitted: March 14, 2013
Results First Posted: March 31, 2014
Last Update Posted: May 6, 2015