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Trial record 37 of 193 for:    Oral Cancer | ( Map: Mexico )

Tykerb Evaluation After Chemotherapy (TEACH): Lapatinib Versus Placebo In Women With Early-Stage Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00374322
Recruitment Status : Completed
First Posted : September 11, 2006
Results First Posted : August 18, 2014
Last Update Posted : August 18, 2014
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Neoplasms, Breast
Interventions Drug: lapatinib
Other: placebo
Enrollment 3166
Recruitment Details Women with early-stage ErbB2-overexpressing breast cancer who had not been previously treated with trastuzumab were enrolled in this Phase III study. Women who subsequently had no clinical or radiologic evidence of disease were enrolled after completion of primary neoadjuvant/adjuvant chemotherapy.
Pre-assignment Details The study consisted of a Screening Period, a 1-year Treatment Period, and a Follow-up (FU) Period of up to 5 years after the date of study drug withdrawal/completion, for disease status/survival. A total of 3161 eligible participants (par.) (of the 3166 enrolled) were randomized, out of which 3147 par. received at least one dose of study treatment.
Arm/Group Title Lapatinib 1500 mg Placebo
Hide Arm/Group Description Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal. Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
Period Title: Overall Study
Started 1579 1582
Received >=1 Dose of Study Treatment 1571 1576
Completed 322 278
Not Completed 1257 1304
Reason Not Completed
Lost to Follow-up             92             90
Protocol Violation             8             3
Withdrawal by Subject             235             167
Sponsor Terminated Study             866             990
Physician Decision             36             32
Par. Consented to Survival FU Only             3             1
Sponsor Decision             2             3
FU by a Non-Principal Investigator (PI)             2             3
Seen in FU by a Non-Primary Investigator             1             0
Severe Toxicity             1             0
Site Closed             2             2
Participant Changed Physician             1             0
Started Another Chemotherapy Regimen             0             1
Noncompliance with Study Requirements             0             1
Withdrew Consent During Follow-up             0             5
Did Not Receive Study Medication             8             6
Arm/Group Title Lapatinib 1500 mg Placebo Total
Hide Arm/Group Description Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal. Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal. Total of all reporting groups
Overall Number of Baseline Participants 1571 1576 3147
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1571 participants 1576 participants 3147 participants
51.7  (9.89) 52.3  (9.94) 52.0  (9.92)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1571 participants 1576 participants 3147 participants
Female
1571
 100.0%
1576
 100.0%
3147
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1571 participants 1576 participants 3147 participants
African American/ African Heritage 53 62 115
American Indian or Alaskan Native 65 67 132
Asian - Central/South Asian Heritage 20 19 39
Asian - East Asian Heritage 236 229 465
Asian - Japanese Heritage 1 2 3
Asian - South East Asian Heritage 81 81 162
Native Hawaiian or Other Pacific Islander 5 11 16
White - Arabic/North African Heritage 3 11 14
White - White/Caucasian/European Heritage 1126 1121 2247
[1]
Measure Description: Participants can appear in more than one race category.
1.Primary Outcome
Title Number of Participants (Par.) With Any Recurrence of the Initial Disease, Second Primary Cancer, Contralateral Breast Cancer, or Death (Disease-free Survival [DFS])
Hide Description DFS=interval between the date of randomization and the date of the first occurrence of an objective disease recurrence, a second primary cancer, or death from any cause. The date of the event is the earliest date of the occurrence of any of the following: local recurrence (LR) following mastectomy; LR in ipsilateral breast following lumpectomy; regional recurrence; distant recurrence; contralateral breast cancer, including ductal carcinoma in situ; other second primary cancer (excluding squamous or basal cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the cervix, or lobular carcinoma in situ of the breast); death from any cause without a prior event. Par. who started additional anti-cancer adjuvant therapy prior to the recurrence of their disease were to be censored. Par. who did not withdraw from the study and did not experience a specified event or death were to be censored (follow-up ongoing) at the last visit date available at which progression was assessed.
Time Frame From randomization until date of the first occurrence of an objective disease recurrence, a second primary cancer, or death from any cause (assessed up to 6 years; 1 year of treatment, 5 years of follow-up [median of 5.3 years for final analysis])
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: all randomized participants who received at least one dose of randomized treatment (lapatinib or placebo). Data for the end-of-study analysis (conducted in 2013) are reported.
Arm/Group Title Lapatinib 1500 mg Placebo
Hide Arm/Group Description:
Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
Overall Number of Participants Analyzed 1571 1576
Measure Type: Number
Unit of Measure: Participants
Any recurrence or death 252 290
Censored, New Anti-cancer Agent/Radiotherapy 1 1
Censored, Follow-up Ended 1318 1285
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lapatinib 1500 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.286
Comments The p-value was calculated from a stratified log-rank test, stratifying for hormone receptor status, time since initial diagnosis, and lymph node involvement.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
0.77 to 1.08
Estimation Comments Estimate of the treatment hazard ratio (HR) was calcuated using the pike estimator.
2.Secondary Outcome
Title Number of Participants Who Died (Overall Survival)
Hide Description Overall Survival (OS) is defined as the time from randomization until death from any cause. Data are presented as the number of participants who died. For participants who did not die, time to death was censored at the last date the participant was known to be alive.
Time Frame From the date of randomization until death from any cause (assessed up to 6 years; 1 year of treatment and 5 years of follow-up [median of 5.3 years for final analysis])
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Data for the primary analysis (conducted in 2011) are reported.
Arm/Group Title Lapatinib 1500 mg Placebo
Hide Arm/Group Description:
Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
Overall Number of Participants Analyzed 1571 1576
Measure Type: Number
Unit of Measure: Participants
Died 115 126
Censored, Follow-up Ended 1456 1450
3.Secondary Outcome
Title Percentage of Participants With the Indicated Period of Recurrence-free Survival (Time to First Recurrence)
Hide Description Recurrence is defined as experiencing a recurrence of initial disease or contralateral breast cancer after randomization. Time to first recurrence is defined as the interval between the date of randomization and the date of the first occurrence of an objective disease recurrence or contralateral breast cancer. Time to first recurrence included the first occurrence at one of the following sites as an event: local recurrence following mastectomy; local recurrence in ipsilateral breast following lumpectomy; regional recurrence; distant recurrence; contralateral breast cancer, including ductal carcinoma in situ (DCIS).
Time Frame From the date of randomization until the date of the first occurrence of an objective disease recurrence or contralateral breast cancer (assessed up to 6 years; 1 year of treatment and 5.3 years of follow-up [median of 5 years for final analysis])
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Data for the primary analysis (conducted in 2011) are reported.
Arm/Group Title Lapatinib 1500 mg Placebo
Hide Arm/Group Description:
Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
Overall Number of Participants Analyzed 1571 1576
Measure Type: Number
Unit of Measure: Percentage of participants
6 Months 1.3 2.8
1Year 3.7 5.4
18 Months 5.6 8.2
2 Years 7.7 9.9
3 Years 10.6 12.6
4 Years 13.3 15.8
5 Years NA [1]  24.9
[1]
There was not sufficient follow-up to allow reasonable estimation of recurrence rates at time points beyond 5 years, when this analysis was carried out at the primary time point.
4.Secondary Outcome
Title Percentage of Participants With the Indicated Period of Distant Recurrence-free Survival (Time to Distant Recurrence)
Time Frame From the date of randomization until the date of the first occurrence of a distant recurrence (assessed up to 6 years; 1 year of treatment and 5 years of follow-up [median of 5.3 years for final analysis])
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Data for the primary analysis (conducted in 2011) are reported.
Arm/Group Title Lapatinib 1500 mg Placebo
Hide Arm/Group Description:
Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
Overall Number of Participants Analyzed 1571 1576
Measure Type: Number
Unit of Measure: Percentage of participants
6 Months 0.9 1.9
1Year 2.9 3.8
18 Months 4.3 6.0
2 Years 5.9 7.2
3 Years 8.1 9.1
4 Years 9.3 11.1
5 Years NA [1]  14.2
[1]
There was not sufficient follow-up to allow reasonable estimation of recurrence rates at time points beyond 5 years, when this analysis was carried out at the primary time point.
5.Secondary Outcome
Title Time to Central Nervous System (CNS) Recurrence
Hide Description Time to CNS recurrence is defined as the interval between the date of randomization and the date of the occurrence of a CNS recurrence if noted as part of the participant's first recurrence. Time to CNS recurrence was not calculated; data are presented as the number of participants with CNS recurrence in the subsequent outcome measure table.
Time Frame From the date of randomization until the date of the first occurrence of a CNS recurrence (assessed up to 6 years [1 year of treatment and 5 years of follow-up; median of 5.3 years for final analysis])
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lapatinib 1500 mg Placebo
Hide Arm/Group Description:
Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Number of Participants With CNS Recurrence
Hide Description The number of participants experiencing a CNS recurrence was summarized.
Time Frame From the date of randomization until the date of the first occurrence of a CNS recurrence (assessed up to 6 years [1 year of treatment and 5 years of follow-up; median of 5.3 years for final analysis])
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Data for the end-of-study analysis (conducted in 2013) are reported.
Arm/Group Title Lapatinib 1500 mg Placebo
Hide Arm/Group Description:
Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
Overall Number of Participants Analyzed 1571 1576
Measure Type: Number
Unit of Measure: Participants
15 21
7.Secondary Outcome
Title Modified Disease-free Survival (MDFS)
Hide Description Modified disease recurrence=interval between the date of randomization and the date of the first occurrence of an objective disease recurrence, contralateral breast cancer, or death from any cause. The date of the event=the earliest date of the occurrence of any of the following events: local recurrence following mastectomy; local recurrence in ipsilateral breast following lumpectomy; regional recurrence; distant recurrence; contralateral breast cancer, including DCIS; death from any cause without a prior event. MDFS was not calculated; data are presented as the number of participants with any recurrence of the initial disease, contralateral breast cancer, or death (disease-free survival) in the subsequent outcome measure table.
Time Frame From the date of randomization until the date of the first occurrence of an objective disease recurrence, contralateral breast cancer, or death from any cause (assessed up to 6 years)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lapatinib 1500 mg Placebo
Hide Arm/Group Description:
Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Number of Participants With Any Recurrence of the Initial Disease, Contralateral Breast Cancer, or Death (Disease-free Survival [DFS])
Hide Description DFS=interval between the date of randomization and the date of the first occurrence of an objective disease recurrence, a second primary cancer, or death from any cause. The date of the event is the earliest date of the occurrence of any of the following: local recurrence (LR) following mastectomy; LR in ipsilateral breast following lumpectomy; regional recurrence; distant recurrence and contralateral breast cancer, including ductal carcinoma in situ; or death from any cause without a prior event. Participants who started additional anti-cancer adjuvant therapy prior to the recurrence of their disease were to be censored. Participants who did not withdraw from the study and did not experience a specified event or death were to be censored (follow-up ongoing) at the last visit date available at which progression was assessed.
Time Frame From the date of randomization until the date of the first occurrence of an objective disease recurrence, contralateral breast cancer, or death from any cause (assessed up to 6 years)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Data for the end-of-study analysis (conducted in 2013) are reported.
Arm/Group Title Lapatinib 1500 mg Placebo
Hide Arm/Group Description:
Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
Overall Number of Participants Analyzed 1571 1576
Measure Type: Number
Unit of Measure: Participants
184 231
9.Secondary Outcome
Title Change From Baseline in Short Form-36 Version 2 (SF-36 v2) Scores for the Physical Component Summary (PCS)
Hide Description The SF-36 v2 is a self-administered, health-related quality of life (QoL) metric. It is a 36-item questionnaire designed to measure 8 domains of functional health status and well-being: physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. Each domain is scored from 0 (poorer health) to 100 (better health).The PCS score is a summary score representing overall physical health, which is derived from the 8 domain scores. As with each domain score, the PCS score ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as the post-Baseline score minus the Baseline score. Missing post-Baseline data were imputed using the last observation carried forward (LOCF) method. The scores were analyzed using an analysis of covariance (ANCOVA) model, adjusting for Baseline sub-scale score, treatment, and country. Positive changes from Baseline indicate improvement.
Time Frame Baseline, Month 6, Month 12, and every 6 months after discontinuation of study treatment for 24 months (up to a maximum of 3 study years)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population (primary analysis [conducted in 2011]). Only those participants available (represented as n=X, X in the category titles) at the specified time points were analyzed.
Arm/Group Title Lapatinib 1500 mg Placebo
Hide Arm/Group Description:
Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal
Overall Number of Participants Analyzed 1092 1283
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
Month 6, n=1092, 1283 -0.78  (0.217) -0.44  (0.211)
Month 12, n=1007, 1204 -0.84  (0.251) -0.54  (0.242)
Follow-up, Month 6, n= 983, 1074 -0.53  (0.287) -0.87  (0.281)
Follow-up, Month 12, n= 940, 988 -0.88  (0.290) -0.82  (0.289)
Follow-up, Month 18, n=834, 889 -0.61  (0.350) -0.89  (0.346)
Follow-up, Month 24, n=807, 824 -0.99  (0.412) -0.66  (0.417)
Early inv. product discontinuation, n=289, 120 -4.39  (0.712) -4.00  (0.886)
10.Secondary Outcome
Title Change From Baseline in SF-36 v2 Scores for the Mental Component Summary (MCS)
Hide Description The SF-36 v2 is a self-administered, health-related quality of life (QoL) metric. It is a 36-item questionnaire designed to measure 8 domains of functional health status and well-being: physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. Each domain is scored from 0 (poorer health) to 100 (better health).The MCS score is a summary score representing overall mental health, which is derived from the 8 domain scores. As with each domain score, the MCS score ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as the post-Baseline score minus the Baseline score. Missing post-Baseline data were imputed using the LOCF method. The scores were analyzed using an ANCOVA model adjusting for Baseline sub-scale score, treatment, and country. Positive changes from Baseline indicate improvement.
Time Frame Baseline, Month 6, Month 12, and every 6 months after discontinuation of study treatment for 24 months (up to a maximum of 3 study years)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population (primary analysis [conducted in 2011]). Only those participants available (represented as n=X, X in the category titles) at the specified time points were analyzed.
Arm/Group Title Lapatinib 1500 mg Placebo
Hide Arm/Group Description:
Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
Overall Number of Participants Analyzed 1092 1283
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
Month 6, n=1092, 1283 -2.34  (0.306) -1.74  (0.297)
Month 12, n=1007, 1204 -2.74  (0.332) -2.29  (0.322)
Follw-up, Month 6, n=983, 1074 -2.22  (0.368) -1.87  (0.361)
Follow-up, Month 12, n= 940, 988 -3.08  (0.393) -2.76  (0.392)
Follow-up, Month 18, n=834, 889 -2.38  (0.480) -2.08  (0.475)
Follow-up, Month 24, n=807, 824 -2.78  (0.547) -3.05  (0.554)
Early inv. product discontinuation, n=289, 120 -6.65  (0.985) -8.11  (1.221)
11.Secondary Outcome
Title Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)
Hide Description The SF-36 v2 is a self-administered, health-related quality of life (QoL) metric. It is a 36-item questionnaire designed to measure 8 domains of functional health status and well-being: physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH) perceptions, vitality (VT), social functioning (SF), role-emotional (RE), and mental health (MH). Each domain is scored from 0 (poorer health) to 100 (better health); higher scores represent better health. Change from Baseline was calculated as the post-Baseline score minus the Baseline score. Missing post-Baseline data were imputed using the LOCF method. The scores were analyzed using an ANCOVA model, adjusting for Baseline sub-scale score, treatment, and country. Positive changes from Baseline indicate improvement.
Time Frame Baseline, Month 6, Month 12, and every 6 months after discontinuation of study treatment for 24 months (up to a maximum of 3 study years)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population (primary analysis [conducted in 2011]). Only those participants available (represented as n=X, X in the category titles) at the specified time points were analyzed.
Arm/Group Title Lapatinib 1500 mg Placebo
Hide Arm/Group Description:
Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
Overall Number of Participants Analyzed 1132 1345
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
PF, Month 6, n=1132, 1345 -0.52  (0.235) -0.65  (0.227)
PF, Month 12, n=1025, 1234 -0.59  (0.269) -0.91  (0.260)
PF, Follow-up, Month 6, n=997, 1097 -0.45  (0.296) -0.81  (0.289)
PF, Follow-up, Month 12, n=955, 1013 -1.11  (0.317) -1.40  (0.316)
PF, Follow-up, Month 18, n=851, 913 -0.80  (0.363) -1.10  (0.358)
PF, Follow-up, Month 24, n=818, 845 -1.06  (0.438) -1.17  (0.442)
PF, Early inv. Product discontinuation, n=304, 128 -4.30  (0.755) -4.43  (0.928)
RP, Month 6, n=1130, 1335 -1.37  (0.276) -0.87  (0.267)
RP, Month 12, n=1023, 1230 -1.52  (0.303) -0.83  (0.293)
RP, Follow-up, Month 6, n=997, 1094 -1.14  (0.328) -1.45  (0.322)
RP, Follow-up, Month 12, n=955, 1009 -1.78  (0.344) -1.47  (0.343)
RP, Follow-up, Month 18, n=851, 909 -1.72  (0.410) -1.68  (0.405)
RP, Follow-up, Month 24, n=818, 842 -1.77  (0.486) -1.54  (0.491)
RP, Early inv. product discontinuation, n=303, 127 -6.96  (0.882) -7.09  (1.087)
BP, Month 6, n=1130, 1331 -1.58  (0.304) -1.31  (0.295)
BP, Month 12, n=1024, 1229 -1.75  (0.338) -1.62  (0.326)
BP, Follow-up, Month 6, n=995, 1094 -1.13  (0.376) -1.35  (0.368)
BP, Follow-up, Month 12, n=954, 1007 -1.06  (0.383) -1.19  (0.382)
BP, Follow-up, Month 18, n=847, 909 -0.69  (0.461) -1.07  (0.455)
BP, Follow-up, Month 24, n=817, 840 -1.69  (0.547) -1.41  (0.553)
BP, Early inv. product discontinuation, n=302, 126 -4.92  (0.950) -4.97  (1.164)
GH, Month 6, n=1124, 1319 -1.01  (0.244) -0.34  (0.236)
GH, Month 12, n=1020, 1221 -1.33  (0.275) -0.70  (0.266)
GH, Follow-up, Month 6, n=994, 1085 -1.25  (0.314) -1.34  (0.308)
GH, Follow-up, Month 12, n=951, 1002 -1.93  (0.330) -1.48  (0.329)
GH, Follow-up, Month 18, n=844, 902 -1.28  (0.397) -1.28  (0.392)
GH, Follow-up, Month 24, n=813, 835 -1.29  (0.471) -1.02  (0.476)
GH, Early inv. product discontinuation, n=299, 124 -5.12  (0.775) -6.30  (0.965)
VT, Month 6, n=1126, 1332 -2.30  (0.283) -1.83  (0.274)
VT, Month 12, n=1022, 1225 -2.49  (0.309) -1.88  (0.299)
VT, Follow-up, Month 6, n=993, 1090 -1.55  (0.335) -1.61  (0.328)
VT, Follow-up, Month 12, n=953, 1006 -2.45  (0.355) -2.01  (0.354)
VT, Follow-up, Month 18, n=848, 906 -1.53  (0.426) -1.25  (0.421)
VT, Follow-up, Month 24, n=817, 837 -2.03  (0.501) -1.96  (0.507)
VT, Early inv. product discontinuation, n=303, 125 -5.54  (0.867) -5.78  (1.067)
SF, Month 6, n=1138, 1347 -2.34  (0.299) -1.42  (0.289)
SF, Month 12, n=1025, 1234 -2.63  (0.333) -2.05  (0.322)
SF, Follow-up, Month 6, n=997, 1098 -1.80  (0.371) -1.51  (0.363)
SF, Follow-up, Month 12, n=957, 1011 -2.47  (0.383) -2.17  (0.382)
SF, Follow-up, Month 18, n=850, 912 -1.96  (0.462) -2.01  (0.456)
SF, Follow-up, Month 24, n=819, 843 -2.94  (0.526) -2.75  (0.532)
SF, Early inv. product discontinuation, n=305, 127 -7.05  (1.017) -7.94  (1.247)
RE, Month 6, n=1124, 1328 -1.80  (0.335) -1.69  (0.325)
RE, Month 12, n=1023, 1226 -1.99  (0.357) -1.99  (0.345)
RE, Follow-up, Month 6, n=996, 1091 -1.87  (0.393) -1.88  (0.385)
RE, Follow-up, Month 12, n=955, 1004 -2.88  (0.425) -2.72  (0.425)
RE, Follow-up,Month 18, n=851, 905 -2.47  (0.509) -2.50  (0.503)
RE, Follow-up,Month 24, n=818, 839 -2.75  (0.582) -2.95  (0.589)
RE, Early inv. product discontinuation, n=303, 126 -6.85  (1.020) -8.00  (1.258)
MH, Month 6, n=1124, 1332 -1.96  (0.303) -1.46  (0.293)
MH, Month 12, n=1021, 1225 -2.38  (0.333) -2.11  (0.322)
MH, Follow-up, Month 6, n=993, 1090 -1.92  (0.367) -1.70  (0.360)
MH, Follow-up, Month 12, n=953, 1006 -2.47  (0.390) -2.47  (0.389)
MH, Follow-up, Month 18, n=848, 906 -1.91  (0.469) -1.58  (0.464)
MH, Follow-up, Month 24, n=817, 837 -2.16  (0.545) -2.54  (0.552)
MH, Early inv. product discontinuation, n=303, 125 -5.96  (0.964) -7.87  (1.187)
12.Secondary Outcome
Title Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters
Hide Description The hematology parameters assessed were: basophils (Bs) in giga (10^9) per liter (GI/L) and in percentage (%), eosinophils (Eo) in GI/L and %, hematocrit, hemoglobin, lymphocytes (Lmph) in GI/L and %, monocytes (Mono) in GI/L and %, platelet count, Red Blood Cell (RBC) count, total neutrophil count (TNC) in GI/L and %, and White Blood Cell (WBC) count. The Baseline (BL) value is the last available pre-treatment result recorded. "Any post-Baseline value" was based on results recorded at any scheduled or unscheduled post-Baseline visits. The prevalence of values lying outside the reference (ref.) range (high or low) is presented for BL and "any post-Baseline" (APBL) visit. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm. Data for the primary analysis (conducted in 2011) are reported.
Time Frame At Baseline and every 3 months thereafter up to Month 12/Early Withdrawal Visit
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population (SP): all randomized participants (par.) who received >=1 dose of randomized treatment. Only those par. available (n=X, X in the category titles) at the specified time points were analyzed. Different par. may have been analyzed for different parameters, so the overall number of par. analyzed reflects everyone in the SP.
Arm/Group Title Lapatinib 1500 mg Placebo
Hide Arm/Group Description:
Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
Overall Number of Participants Analyzed 1573 1574
Measure Type: Number
Unit of Measure: Participants
Bs (GI/L), BL, ref. range high, n=1555, 1563 0 1
Bs (GI/L), BL, ref. range low, n=1555, 1563 0 0
Bs (GI/L), APBL, ref. range high, n=1466, 1537 7 7
Bs (GI/L), APBL, ref. range low, n=1466, 1537 7 2
Eo (GI/L), BL, ref. range high, n=1557, 1562 34 35
Eo (GI/L), BL, ref. range low, n=1557, 1562 242 184
Eo (GI/L), APBL, ref. range high, n=1466, 1537 84 75
Eo (GI/L), APBL, ref. range low, n=1466, 1537 322 370
Hematocrit, BL, ref. range high, n=1560, 1563 20 30
Hematocrit, BL, ref. range low, n=1560, 1563 72 96
Hematocrit, APBL, ref. range high, n=1474, 1538 46 65
Hematocrit, APBL, ref. range low, n=1474, 1538 196 145
Hemoglobin, BL, ref. range high, n=1560, 1563 8 16
Hemoglobin, BL, ref. range low, n=1560, 1563 148 160
Hemoglobin, APBL, ref. range high, n=1474, 1538 32 34
Hemoglobin, APBL, ref. range low, n=1474, 1538 295 212
Lmph (GI/L), BL, ref. range high, n=1557, 1562 5 1
Lmph (GI/L), BL, ref. range low, n=1557, 1562 80 89
Lmph (GI/L), APBL, ref. range high, n=1468, 1538 12 11
Lmph (GI/L), APBL, ref. range low, n=1468, 1538 106 100
Mono (GI/L), BL, ref. range high, n=1557, 1562 2 4
Mono (GI/L), BL, ref. range low, n=1557, 1562 236 239
Mono (GI/L), APBL, ref. range high, n=1466, 1538 7 7
Mono (GI/L), APBL, ref. range low, n=1466, 1538 425 431
Platelet count, BL, ref. range high, n=1553, 1559 34 33
Platelet count, BL, ref. range low, n=1553, 1559 21 15
Platelet count, APBL, ref. range high, n=1473, 153 95 56
Platelet count, APBL, ref. range low, n=1473, 1538 40 37
RBC count, BL, ref. range high, n=1559, 1563 10 18
RBC count, BL, ref. range low, n=1559, 1563 144 148
RBC count, APBL, ref. range high, n=1474, 1538 25 36
RBC count, APBL, ref. range low, n=1474, 1538 270 207
TNC (GI/L), BL, ref. range high, n=1557, 1563 17 15
TNC (GI/L), BL, ref. range low, n=1557, 1563 47 41
TNC (GI/L), APBL, ref. range high, n=1469, 1538 38 53
TNC (GI/L), APBL, ref. range low, n=1469, 1538 115 161
WBC count, BL, ref. range high, n=1559, 1563 18 14
WBC count, BL, ref. range low, n=1559, 1563 142 104
WBC count, APBL, ref. range high, n=1471, 1537 42 57
WBC count, APBL, ref. range low, n=1471, 1537 191 198
Bs (%), BL, ref. range high, n=64, 55 8 4
Bs (%), BL, ref. range low, n=64, 55 1 0
Bs (%), APBL, ref. range high, n=131, 131 17 18
Bs (%), APBL, ref. range low, n=131, 131 4 1
Eo (%), BL, ref. range high, n=65, 55 7 9
Eo (%), BL, ref. range low, n=65, 55 2 1
Eo (%), APBL, ref. range high, n=135, 132 16 20
Eo (%), APBL, ref. range low, n=135, 132 9 4
Lmph (%), BL, ref. range high, n=68, 57 4 3
Lmph (%), BL, ref. range low, n=68, 57 10 10
Lmph (%), APBL, ref. range high, n=152, 143 14 18
Lmph (%), APBL, ref. range low, n=152, 143 19 16
Mono (%), BL, ref. range high, n=67, 54 13 11
Mono (%), BL, ref. range low, n=67, 54 0 0
Mono (%), APBL, ref. range high, n=137, 139 28 11
Mono (%), APBL, ref. range low, n=137, 139 6 4
TNC (%), BL, ref. range high, n=68, 58 7 2
TNC (%), BL, ref. range low, n=68, 58 5 4
TNC (%), APBL, ref. range high, n=150, 145 9 10
TNC (%), APBL, ref. range low, n=150, 145 19 12
13.Secondary Outcome
Title Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters
Hide Description The clinical chemistry parameters assessed were: alanine amino transferase (ALT), albumin, alkaline phosphatase (ALP), aspartate amino transferase (AST), bicarbonate, blood urea nitrogen (BUN), bone alkaline phosphatase (Bone ALP), calcium, chloride, creatinine, creatinine clearance (Cr. Clearance), creatinine clearance estimated (Cr. Clrnc. est.), glucose, potassium, sodium, total bilirubin (Total Bln), total protein, urea, and uric acid. The Baseline (BL) value is the last available pre-treatment result recorded. "Any post-Baseline" value was based on results recorded at scheduled or unscheduled post-Baseline visits. The prevalence of values lying outside the reference (ref.) range (high or low) was presented for BL and "any post-Baseline" (APBL) visit. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
Time Frame At Baseline and every 6 weeks thereafter up to Month 12/Early Withdrawal Visit
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population (primary analysis [conducted in 2011]). Only those participants available (represented as n=X, X in the category titles) at the specified time points were analyzed. Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population.
Arm/Group Title Lapatinib 1500 mg Placebo
Hide Arm/Group Description:
Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
Overall Number of Participants Analyzed 1573 1574
Measure Type: Number
Unit of Measure: Participants
ALT, BL, ref. range high, n=1569, 1569 55 78
ALT, BL, ref. range low, n=1569, 1569 1 1
ALT, APBL, ref. range high, n=1478, 1542 271 141
ALT, APBL, ref. range low, n=1478, 1542 3 5
Albumin, BL, ref. range high, n=1568, 1568 36 41
Albumin, BL, ref. range low, n=1568, 1568 0 0
Albumin, APBL, ref. range high, n=1475, 1542 51 70
Albumin, APBL, ref. range low, n=1475, 1542 11 8
ALP, BL, ref. range high, n=1569, 1569 68 66
ALP, BL, ref. range low, n=1569, 1569 0 0
ALP, APBL, ref. range high, n=1477, 1542 213 155
ALP, APBL, ref. range low, n=1477, 1542 4 5
AST, BL, ref. range high, n=1569, 1565 49 59
AST, BL, ref. range low, n=1569, 1565 0 0
AST, APBL, ref. range high, n=1478, 1541 260 139
AST, APBL, ref. range low, n=1478, 1541 0 3
Bicarbonate, BL, ref. range high, n=36, 33 0 3
Bicarbonate, BL, ref. range low, n=36, 33 4 3
Bicarbonate, APBL, ref. range high, n=60, 71 3 2
Bicarbonate, APBL, ref. range low, n=60, 71 4 9
BUN, BL, ref. range high, n=63, 56 8 4
BUN, BL, ref. range low, n=63, 56 0 0
BUN, APBL, ref. range high, n=161, 155 15 17
BUN, APBL, ref. range low, n=161, 155 6 4
Bone ALP, BL, ref. range high, n=230, 219 0 0
Bone ALP, BL, ref. range low, n=230, 219 0 0
Bone ALP, APBL, ref. range high, n=188, 160 0 0
Bone ALP, APBL, ref. range low, n=188, 160 0 0
Calcium, BL, ref. range high, n=1568, 1565 17 36
Calcium, BL, ref. range low, n=1568, 1565 16 14
Calcium, APBL, ref. range high, n=1476, 1542 56 84
Calcium, APBL, ref. range low, n=1476, 1542 66 79
Chloride, BL, ref. range high, n=52, 46 2 2
Chloride, BL, ref. range low, n=52, 46 0 1
Chloride, APBL, ref. range high, n=102, 108 10 5
Chloride, APBL, ref. range low, n=102, 108 2 5
Creatinine, BL, ref. range high, n=1569, 1569 5 4
Creatinine, BL, ref. range low, n=1569, 1569 7 8
Creatinine, APBL, ref. range high, n=1479, 1542 16 13
Creatinine, APBL, ref. range low, n=1479, 1542 22 27
Cr. Clearance, BL, ref. range high, n=4, 9 2 2
Cr. Clearance, BL, ref. range low, n=4, 9 1 0
Cr. Clearance, APBL, ref. range high, n=11, 10 0 1
Cr. Clearance, APBL, ref. range low, n=11, 10 2 2
Cr. Clrnc. est., BL, ref. range high, n=373, 388 0 0
Cr. Clrnc. est., BL, ref. range low, n=373, 388 0 0
Cr. Clrnc. est., APBL, ref. range high, n=380, 418 0 0
Cr. Clrnc. est., APBL, ref. range low, n=380, 418 0 0
Glucose, BL, ref. range high, n=1566, 1569 170 143
Glucose, BL, ref. range low, n=1566, 1569 31 32
Glucose, APBL, ref. range high, n=1475, 1541 245 329
Glucose, APBL, ref. range low, n=1475, 1541 94 94
Potassium, BL, ref. range high, n=1567, 1565 13 13
Potassium, BL, ref. range low, n=1567, 1565 21 11
Potassium, APBL, ref. range high, n=1476, 1542 28 54
Potassium, APBL, ref. range low, n=1476, 1542 54 44
Sodium, BL, ref. range high, n=1568, 1568 9 4
Sodium, BL, ref. range low, n=1568, 1568 7 9
Sodium, APBL, ref. range high, n=1477, 1542 29 27
Sodium, APBL, ref. range low, n=1477, 1542 24 30
Total Bln., BL, ref. range high, n=1569, 1569 14 19
Total Bln., BL, ref. range low, n=1569, 1569 1 0
Total Bln., APBL, ref. range high, n=1478, 1542 152 46
Total Bln., APBL, ref. range low, n=1478, 1542 4 3
Total Protein, BL, ref. range high, n=1566, 1568 3 9
Total Protein, BL, ref. range low, n=1566, 1568 4 1
Total Protein, APBL, ref. range high, n=1476, 1542 27 38
Total Protein, APBL, ref. range low, n=1476, 1542 11 13
Urea, BL, ref. range high, n=1560, 1566 18 19
Urea, BL, ref. range low, n=1560, 1566 17 24
Urea, APBL, ref. range high, n=1465, 1535 35 48
Urea, APBL, ref. range low, n=1465, 1535 45 48
Uric acid, BL, ref. range high, n=37, 26 7 5
Uric acid, BL, ref. range low, n=37, 26 0 1
Uric acid, APBL, ref. range high, n=73, 76 10 12
Uric acid, APBL, ref. range low, n=73, 76 3 4
14.Secondary Outcome
Title Number of Participants With Non-laboratory Toxicities of the Indicated Toxicity Grades
Hide Description Non-laboratory toxicities are defined as adverse events (AEs). The number of partcipants with any treatment-emergent AE of the indicated toxicity grade are summarized. Toxicity grading was according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 as follows: Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=life threatening; Grade 5=death. The events that were not given a toxicity grade are categorized as "Not Applicable."
Time Frame From the first dose of study treatment up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm. Data for the primary analysis (conducted in 2011) are reported.
Arm/Group Title Lapatinib 1500 mg Placebo
Hide Arm/Group Description:
Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
Overall Number of Participants Analyzed 1573 1574
Measure Type: Number
Unit of Measure: Participants
Grade 1 414 558
Grade 2 674 505
Grade 3 333 104
Grade 4 21 15
Grade 5 3 3
Not Applicable 5 8
15.Secondary Outcome
Title Number of Participants Experiencing Primary or Secondary Cardiac Events
Hide Description A cardiac event is classified as a primary cardiac endpoint (PCE) or a secondary cardiac endpoint (SCE). PCE is defined as: cardiac death (cardiac death due to heart failure, myocardial infarction, or arrhythmia;or probable cardiac death defined as sudden, unexpected death within 24 hours of a definite or probable cardiac event); severe symptomatic congestive heart failure (CHF) (as per New York Heart Association [NYHA] Class III or IV and an absolute decrease in left ventricular ejection fraction [LVEF] of more than 10 percentage points from Baseline and to a left ventricular ejection fraction [LVEF] value below 50%). SCE is defined as asymptomatic or mildly symptomatic cardiac events (NYHA Class I or II) and a significant decrease in LVEF, defined as an absolute decrease in LVEF of more than 10 percentage points from Baseline and to an LVEF value below 50%.
Time Frame From the date of randomization up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population (SP). Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm. Data for the primary analysis (conducted in 2011) are reported.
Arm/Group Title Lapatinib 1500 mg Placebo
Hide Arm/Group Description:
Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
Overall Number of Participants Analyzed 1573 1574
Measure Type: Number
Unit of Measure: Participants
PCE, Cardiac death 0 1
PCE, Severe symptomatic CHF 2 3
SCE 6 6
16.Secondary Outcome
Title Number of Participants With the Indicated Electrocardiogram (ECG) Findings
Hide Description 12-lead ECG measurements were taken at Screening and at study conclusion/withdrawal. The number of participants with normal, abnormal clinically significant (CS), and abnormal not clinically significant (NCS) ECG findings, as classified by the investigator, were summarized. Participants with missing values were categorized as missing. Data for the primary analysis (conducted in 2011) are reported.
Time Frame Screening and Month 12/Early Withdrawal Visit
Hide Outcome Measure Data
Hide Analysis Population Description
SP. Only those participants (par.) available at the specified time points were analyzed. Two par. were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
Arm/Group Title Lapatinib 1500 mg Placebo
Hide Arm/Group Description:
Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
Overall Number of Participants Analyzed 1543 1549
Measure Type: Number
Unit of Measure: Participants
Screening, normal, n=1543, 1549 1203 1197
Screening, abnormal CS, n=1543, 1549 0 1
Screening, abnormal NCS, n=1543, 1549 339 351
Screening, missing, n=1543, 1549 1 0
Conclusion/ Withdrawal, normal, n=1243, 1306 960 979
Conclusion/ Withdrawal, abnormal CS, n=1243, 1306 5 3
Conclusion/ Withdrawal, abnormal NCS, n=1243, 1306 276 323
Conclusion/ Withdrawal, missing, n=1243, 1306 2 1
Time Frame Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Adverse Event Reporting Description Non-serious AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of randomized treatment. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.
 
Arm/Group Title Lapatinib 1500 mg Placebo
Hide Arm/Group Description Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal. Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
All-Cause Mortality
Lapatinib 1500 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lapatinib 1500 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   99/1573 (6.29%)   78/1574 (4.96%) 
Blood and lymphatic system disorders     
Neutropenia  1  2/1573 (0.13%)  0/1574 (0.00%) 
Cardiac disorders     
Left ventricular dysfunction  1  3/1573 (0.19%)  1/1574 (0.06%) 
Cardiac failure  1  0/1573 (0.00%)  3/1574 (0.19%) 
Myocardial infarction  1  2/1573 (0.13%)  0/1574 (0.00%) 
Acute myocardial infarction  1  0/1573 (0.00%)  1/1574 (0.06%) 
Atrial fibrillation  1  0/1573 (0.00%)  1/1574 (0.06%) 
Atrioventricular block first degree  1  1/1573 (0.06%)  0/1574 (0.00%) 
Myocardial ischaemia  1  0/1573 (0.00%)  1/1574 (0.06%) 
Pericardial effusion  1  1/1573 (0.06%)  0/1574 (0.00%) 
Tachycardia  1  0/1573 (0.00%)  1/1574 (0.06%) 
Ear and labyrinth disorders     
Vertigo  1  1/1573 (0.06%)  0/1574 (0.00%) 
Endocrine disorders     
Thyroiditis subacute  1  0/1573 (0.00%)  1/1574 (0.06%) 
Gastrointestinal disorders     
Diarrhoea  1  7/1573 (0.45%)  0/1574 (0.00%) 
Abdominal pain  1  3/1573 (0.19%)  0/1574 (0.00%) 
Enteritis  1  1/1573 (0.06%)  1/1574 (0.06%) 
Gastritis  1  0/1573 (0.00%)  2/1574 (0.13%) 
Nausea  1  0/1573 (0.00%)  2/1574 (0.13%) 
Abdominal hernia  1  1/1573 (0.06%)  0/1574 (0.00%) 
Abdominal pain upper  1  1/1573 (0.06%)  0/1574 (0.00%) 
Enterocolitis  1  1/1573 (0.06%)  0/1574 (0.00%) 
Gastric ulcer  1  1/1573 (0.06%)  0/1574 (0.00%) 
Haematochezia  1  1/1573 (0.06%)  0/1574 (0.00%) 
Haemorrhoids  1  1/1573 (0.06%)  0/1574 (0.00%) 
Intestinal obstruction  1  1/1573 (0.06%)  0/1574 (0.00%) 
Intestinal perforation  1  1/1573 (0.06%)  0/1574 (0.00%) 
Pancreatitis  1  0/1573 (0.00%)  1/1574 (0.06%) 
Umbilical hernia  1  0/1573 (0.00%)  1/1574 (0.06%) 
General disorders     
Asthenia  1  0/1573 (0.00%)  2/1574 (0.13%) 
Death  1  1/1573 (0.06%)  0/1574 (0.00%) 
Non-cardiac chest pain  1  0/1573 (0.00%)  1/1574 (0.06%) 
Oedema peripheral  1  0/1573 (0.00%)  1/1574 (0.06%) 
Hepatobiliary disorders     
Hepatotoxicity  1  2/1573 (0.13%)  0/1574 (0.00%) 
Cholecystitis  1  0/1573 (0.00%)  1/1574 (0.06%) 
Cholelithiasis  1  1/1573 (0.06%)  0/1574 (0.00%) 
Cytolytic hepatitis  1  1/1573 (0.06%)  0/1574 (0.00%) 
Hepatitis  1  1/1573 (0.06%)  0/1574 (0.00%) 
Hepatitis toxic  1  1/1573 (0.06%)  0/1574 (0.00%) 
Immune system disorders     
Drug hypersensitivity  1  1/1573 (0.06%)  0/1574 (0.00%) 
Hypersensitivity  1  1/1573 (0.06%)  0/1574 (0.00%) 
Infections and infestations     
Erysipelas  1  8/1573 (0.51%)  0/1574 (0.00%) 
Cellulitis  1  5/1573 (0.32%)  0/1574 (0.00%) 
Pneumonia  1  3/1573 (0.19%)  2/1574 (0.13%) 
Appendicitis  1  1/1573 (0.06%)  1/1574 (0.06%) 
Gastroenteritis  1  1/1573 (0.06%)  1/1574 (0.06%) 
Herpes zoster  1  2/1573 (0.13%)  0/1574 (0.00%) 
Abscess  1  1/1573 (0.06%)  0/1574 (0.00%) 
Breast abscess  1  0/1573 (0.00%)  1/1574 (0.06%) 
Breast cellulitis  1  1/1573 (0.06%)  0/1574 (0.00%) 
Bronchitis  1  0/1573 (0.00%)  1/1574 (0.06%) 
Bronchopneumonia  1  1/1573 (0.06%)  0/1574 (0.00%) 
Cystitis  1  0/1573 (0.00%)  1/1574 (0.06%) 
Device related infection  1  0/1573 (0.00%)  1/1574 (0.06%) 
Gastroenteritis viral  1  1/1573 (0.06%)  0/1574 (0.00%) 
Implant site cellulitis  1  1/1573 (0.06%)  0/1574 (0.00%) 
Influenza  1  1/1573 (0.06%)  0/1574 (0.00%) 
Lobar pneumonia  1  0/1573 (0.00%)  1/1574 (0.06%) 
Pyelonephritis  1  0/1573 (0.00%)  1/1574 (0.06%) 
Sepsis  1  1/1573 (0.06%)  0/1574 (0.00%) 
Sinusitis  1  1/1573 (0.06%)  0/1574 (0.00%) 
Streptococcal sepsis  1  1/1573 (0.06%)  0/1574 (0.00%) 
Urinary tract infection  1  1/1573 (0.06%)  0/1574 (0.00%) 
Urosepsis  1  0/1573 (0.00%)  1/1574 (0.06%) 
Wound infection  1  1/1573 (0.06%)  0/1574 (0.00%) 
Vomiting  1  0/1573 (0.00%)  2/1574 (0.13%) 
Injury, poisoning and procedural complications     
Ankle fracture  1  1/1573 (0.06%)  1/1574 (0.06%) 
Accidental overdose  1  1/1573 (0.06%)  0/1574 (0.00%) 
Chest injury  1  1/1573 (0.06%)  0/1574 (0.00%) 
Femoral neck fracture  1  1/1573 (0.06%)  0/1574 (0.00%) 
Foot fracture  1  0/1573 (0.00%)  1/1574 (0.06%) 
Fracture  1  0/1573 (0.00%)  1/1574 (0.06%) 
Humerus fracture  1  1/1573 (0.06%)  0/1574 (0.00%) 
Muscle strain  1  1/1573 (0.06%)  0/1574 (0.00%) 
Rib fracture  1  0/1573 (0.00%)  1/1574 (0.06%) 
Road tracffic accident  1  1/1573 (0.06%)  0/1574 (0.00%) 
Transplant failure  1  1/1573 (0.06%)  0/1574 (0.00%) 
Ulna fracture  1  0/1573 (0.00%)  1/1574 (0.06%) 
Wound dehiscence  1  1/1573 (0.06%)  0/1574 (0.00%) 
Investigations     
Ejection fraction decreased  1  5/1573 (0.32%)  6/1574 (0.38%) 
Alanine aminotransferase increased  1  1/1573 (0.06%)  0/1574 (0.00%) 
Blood bilirubin abnormal  1  1/1573 (0.06%)  0/1574 (0.00%) 
Transaminases increased  1  1/1573 (0.06%)  0/1574 (0.00%) 
Metabolism and nutrition disorders     
Hypoglycaemia  1  1/1573 (0.06%)  2/1574 (0.13%) 
Dehydration  1  0/1573 (0.00%)  1/1574 (0.06%) 
Diabetes mellitus  1  0/1573 (0.00%)  1/1574 (0.06%) 
Electrolyte imbalance  1  1/1573 (0.06%)  0/1574 (0.00%) 
Hyperkalaemia  1  0/1573 (0.00%)  1/1574 (0.06%) 
Hypocalcaemia  1  0/1573 (0.00%)  1/1574 (0.06%) 
Musculoskeletal and connective tissue disorders     
Osteoarthritis  1  0/1573 (0.00%)  2/1574 (0.13%) 
Arthropathy  1  0/1573 (0.00%)  1/1574 (0.06%) 
Back pain  1  1/1573 (0.06%)  0/1574 (0.00%) 
Bone pain  1  0/1573 (0.00%)  1/1574 (0.06%) 
Costochondritis  1  0/1573 (0.00%)  1/1574 (0.06%) 
Intervertebral disc compression  1  0/1573 (0.00%)  1/1574 (0.06%) 
Myalgia  1  0/1573 (0.00%)  1/1574 (0.06%) 
Osteochondrosis  1  1/1573 (0.06%)  0/1574 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer  1  0/1573 (0.00%)  2/1574 (0.13%) 
Colon cancer  1  1/1573 (0.06%)  2/1574 (0.13%) 
Endometrial cancer  1  2/1573 (0.13%)  1/1574 (0.06%) 
Basal cell carcinoma  1  0/1573 (0.00%)  2/1574 (0.13%) 
Contralataral breast cancer  1  1/1573 (0.06%)  1/1574 (0.06%) 
Acute myeloid leukaemia  1  0/1573 (0.00%)  1/1574 (0.06%) 
Benign breast neoplasm  1  1/1573 (0.06%)  0/1574 (0.00%) 
Bladder papilloma  1  1/1573 (0.06%)  0/1574 (0.00%) 
Breast cancer in situ  1  0/1573 (0.00%)  1/1574 (0.06%) 
Cardiac neoplasm unspecified  1  1/1573 (0.06%)  0/1574 (0.00%) 
Cervix carcinoma  1  0/1573 (0.00%)  1/1574 (0.06%) 
Haemangioma of liver  1  1/1573 (0.06%)  0/1574 (0.00%) 
Intraductal papilloma of breast  1  0/1573 (0.00%)  1/1574 (0.06%) 
Leiomyosarcoma  1  0/1573 (0.00%)  1/1574 (0.06%) 
Malignant melanoma in situ  1  1/1573 (0.06%)  0/1574 (0.00%) 
Ovarian epithelial cancer  1  1/1573 (0.06%)  0/1574 (0.00%) 
Ovarian germ cell teratoma benign  1  1/1573 (0.06%)  0/1574 (0.00%) 
Pancreatic carcinaom metastatic  1  1/1573 (0.06%)  0/1574 (0.00%) 
Skin cancer  1  1/1573 (0.06%)  0/1574 (0.00%) 
Thyroid cancer  1  1/1573 (0.06%)  0/1574 (0.00%) 
Uterine cancer  1  0/1573 (0.00%)  1/1574 (0.06%) 
Uterine leiomyoma  1  1/1573 (0.06%)  0/1574 (0.00%) 
Uterine leiomyosarcoma  1  1/1573 (0.06%)  0/1574 (0.00%) 
Nervous system disorders     
Carotid artery stenosis  1  1/1573 (0.06%)  0/1574 (0.00%) 
Cerebellar infarction  1  0/1573 (0.00%)  1/1574 (0.06%) 
Cerebral haemorrhage  1  0/1573 (0.00%)  1/1574 (0.06%) 
Cerebral infarction  1  0/1573 (0.00%)  1/1574 (0.06%) 
Cerebral ischaemia  1  0/1573 (0.00%)  1/1574 (0.06%) 
Cerebrovascular accident  1  0/1573 (0.00%)  1/1574 (0.06%) 
Convulsion  1  1/1573 (0.06%)  0/1574 (0.00%) 
Headache  1  0/1573 (0.00%)  1/1574 (0.06%) 
Paraesthesia  1  0/1573 (0.00%)  1/1574 (0.06%) 
Syncope  1  1/1573 (0.06%)  0/1574 (0.00%) 
Psychiatric disorders     
Depression  1  1/1573 (0.06%)  1/1574 (0.06%) 
Suicide attempt  1  1/1573 (0.06%)  1/1574 (0.06%) 
Suicidal ideation  1  1/1573 (0.06%)  0/1574 (0.00%) 
Renal and urinary disorders     
Nephrolithiasis  1  0/1573 (0.00%)  1/1574 (0.06%) 
Reproductive system and breast disorders     
Breast disorder  1  1/1573 (0.06%)  0/1574 (0.00%) 
Breast mass  1  1/1573 (0.06%)  0/1574 (0.00%) 
Menometrorrhagia  1  0/1573 (0.00%)  1/1574 (0.06%) 
Menstrual disorder  1  0/1573 (0.00%)  1/1574 (0.06%) 
Ovarian cyst  1  0/1573 (0.00%)  1/1574 (0.06%) 
Ovarian enlargement  1  0/1573 (0.00%)  1/1574 (0.06%) 
Respiratory, thoracic and mediastinal disorders     
Atelectasis  1  1/1573 (0.06%)  0/1574 (0.00%) 
Dyspnoea exertional  1  0/1573 (0.00%)  1/1574 (0.06%) 
Laryngeal oedema  1  1/1573 (0.06%)  0/1574 (0.00%) 
Pulmonary embolism  1  0/1573 (0.00%)  1/1574 (0.06%) 
Skin and subcutaneous tissue disorders     
Rash  1  2/1573 (0.13%)  0/1574 (0.00%) 
Vascular disorders     
Capillary leak syndrome  1  1/1573 (0.06%)  0/1574 (0.00%) 
Femoral artery occlusion  1  0/1573 (0.00%)  1/1574 (0.06%) 
Hypertensive crisis  1  0/1573 (0.00%)  1/1574 (0.06%) 
Thrombosis  1  1/1573 (0.06%)  0/1574 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lapatinib 1500 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   1443/1573 (91.74%)   1175/1574 (74.65%) 
Eye disorders     
Stomatitis  1  98/1573 (6.23%)  30/1574 (1.91%) 
Gastrointestinal disorders     
Diarrhoea  1  955/1573 (60.71%)  256/1574 (16.26%) 
Nausea  1  279/1573 (17.74%)  179/1574 (11.37%) 
Vomiting  1  104/1573 (6.61%)  71/1574 (4.51%) 
Dyspepsia  1  106/1573 (6.74%)  57/1574 (3.62%) 
Abdominal pain  1  105/1573 (6.68%)  56/1574 (3.56%) 
General disorders     
Fatigue  1  251/1573 (15.96%)  202/1574 (12.83%) 
Infections and infestations     
Paronychia  1  154/1573 (9.79%)  5/1574 (0.32%) 
Metabolism and nutrition disorders     
Decreased appetite  1  99/1573 (6.29%)  36/1574 (2.29%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  69/1573 (4.39%)  113/1574 (7.18%) 
Nervous system disorders     
Headache  1  140/1573 (8.90%)  185/1574 (11.75%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  75/1573 (4.77%)  103/1574 (6.54%) 
Epistaxis  1  118/1573 (7.50%)  8/1574 (0.51%) 
Skin and subcutaneous tissue disorders     
Rash  1  922/1573 (58.61%)  243/1574 (15.44%) 
Dry skin  1  220/1573 (13.99%)  45/1574 (2.86%) 
Pruritus  1  130/1573 (8.26%)  49/1574 (3.11%) 
Alopecia  1  135/1573 (8.58%)  25/1574 (1.59%) 
Nail disorder  1  131/1573 (8.33%)  16/1574 (1.02%) 
Skin fissures  1  83/1573 (5.28%)  1/1574 (0.06%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
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.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00374322     History of Changes
Other Study ID Numbers: EGF105485
First Submitted: September 7, 2006
First Posted: September 11, 2006
Results First Submitted: July 17, 2014
Results First Posted: August 18, 2014
Last Update Posted: August 18, 2014