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

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
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

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 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

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) ]

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) ]

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) ]

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) ]

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) ]

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 ]

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) ]

8.  Secondary:

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

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) ]

10.  Secondary:

Overall Survival   [ Time Frame: Randomization until the date of death due to any cause (average of 24 months) ]

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 ]

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 ]

13.  Secondary:

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

14.  Secondary:

Number of Participants With the Indicated ErbB2 Status at Baseline   [ Time Frame: Baseline ]

15.  Secondary:

ErbB2 Ratio   [ Time Frame: Baseline ]

16.  Secondary:

Number of Participants With the Indicated Immunohistochemistry (IHC) Results at Screening   [ Time Frame: Screening (Day -1) ]

17.  Secondary:

Number of Participants With the Indicated ErbB2 Fluorescence in Situ Hybridization (FISH) Results   [ Time Frame: Baseline ]

18.  Secondary:

Serum ErbB1 Concentration   [ Time Frame: Screening (Day-1) and Withdrawal (up to Study Week 129) ]

19.  Secondary:

Serum ErbB2 Concentration   [ Time Frame: Screening (Day-1) and Withdrawal (up to Study Week 129) ]

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) ]

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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