18 and older, female only, with Metastases, Brain. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Central Nervous System (CNS) Metastases (as Assessed by Independent Review) as the Site of First RelapsePrimary· From randomization until disease progression, death, or discontinuation from the study (average of 10 months). Cut-off 11-Jun-2012
CNS relapse is defined as the appearance of \>=1 enhancing lesion measuring \>=6 millimeters (mm) on T1Weighted (T1W) Magnetic Resonance Imaging (MRI) without CNS symptoms that were considered to be unequivocal based on all relevant radiological features (e.g., associated T2W signal abnormality); the appearance of any enhancing lesion on T1W MRI with CNS symptoms; unequivocal finding of leptomeningeal disease (defined as the dissemination of cancer throughout the spinal fluid), with or without symptoms; and unequivocal finding of multifocal intraparenchymal lesions with or without symptoms. In
Group
Value
95% CI
Lapatinib Plus Capecitabine
8
Trastuzumab Plus Capecitabine
12
Progression Free Survival (PFS), as Assessed by the InvestigatorSecondary· From randomization until disease progression, death, or discontinuation from the study (average of 10 months). Cut-off 11-Jun-2012
PFS is defined as the interval between the date of randomization and the earliest date of progressive disease (PD), or death due to any cause. PD is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, compared with the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions based on investigator assessment of both CNS and non-CNS for response.
Group
Value
95% CI
Lapatinib Plus Capecitabine
6.60
5.72 – 8.11
Trastuzumab Plus Capecitabine
8.05
6.14 – 8.90
Time to First CNS Progression, Defined as the Time From Randomization Until the Date of Documented CNS Progression as the First Site of RelapseSecondary· From randomization until the date of documented CNS progression (average of 10 months). Cut-off 11-Jun-2012
CNS relapse is defined as the appearance of \>=1 enhancing lesion measuring \>=6 mm on T1W MRI without CNS symptoms that were considered to be unequivocal based on all relevant radiological features (e.g., associated T2W signal abnormality); the appearance of any enhancing lesion on T1W MRI with CNS symptoms; unequivocal finding of leptomeningeal disease (defined as the dissemination of cancer throughout the spinal fluid), with or without symptoms; and unequivocal finding of multifocal intraparenchymal lesions with or without symptoms. In the event of the appearance of a \<6 mm lesions(s) with
Group
Value
95% CI
Lapatinib Plus Capecitabine
8.2
± 6.78
Trastuzumab Plus Capecitabine
6.7
± 6.94
Overall SurvivalSecondary· From randomization until death due to any cause (average of 10 months). Cut-off 11-Jun-2012
Overall survival is defined as the time from randomization until death due to any cause or to the date of censor. In the absence of confirmation of death, survival time was to be censored at the time of the last investigator contact.
Group
Value
95% CI
Lapatinib Plus Capecitabine
22.7
19.5 – NA
Trastuzumab Plus Capecitabine
27.3
23.7 – NA
Number of Participants With Overall Response (OR), as Assessed by the InvestigatorSecondary· From randomization until disease progression, death, or discontinuation from the study (average of 10 months). Cut-off 11-Jun-2012
OR is defined as the number of participants with either a confirmed complete response (CR; disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of the LD of the target lesions, compared with the baseline sum LD). CR and PR were assessed per Response Evaluation Criteria in Solid Tumors (RECIST). To be assigned a status of PR or CR, a confirmatory disease assessment was to be performed 28 days (4 weeks) or greater after the criteria for response were first met. In addition, a bone scan must have been obtained to rule out the presence of new bone lesion
CR
Group
Value
95% CI
Lapatinib Plus Capecitabine
8
Trastuzumab Plus Capecitabine
12
PR
Group
Value
95% CI
Lapatinib Plus Capecitabine
65
Trastuzumab Plus Capecitabine
73
Overall Response (CR+PR)
Group
Value
95% CI
Lapatinib Plus Capecitabine
73
Trastuzumab Plus Capecitabine
85
Number of Participants With Clinical Benefit (CB)Secondary· From randomization until disease progression, death, or discontinuation from the study (average of 10 months). Cut-off 11-Jun-2012
CB is defined as the number of participants with evidence of confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of the LD of the target lesions, compared with the baseline sum LD) at any time or stable disease (SD, neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD \[defined as at least a 20% increase in the sum of the LD of target lesions, compared with the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions\] based on investigator assessment), for at least 24 weeks.
CR
Group
Value
95% CI
Lapatinib Plus Capecitabine
8
Trastuzumab Plus Capecitabine
12
PR
Group
Value
95% CI
Lapatinib Plus Capecitabine
65
Trastuzumab Plus Capecitabine
73
SD >= 24 weeks
Group
Value
95% CI
Lapatinib Plus Capecitabine
39
Trastuzumab Plus Capecitabine
33
Clinical Benefit (CR + PR + SD >= 24 weeks)
Group
Value
95% CI
Lapatinib Plus Capecitabine
112
Trastuzumab Plus Capecitabine
118
Duration of ResponseSecondary· From the time of the first documented confirmed complete or partial response until disease progression or death, if sooner (average of 10 months). Cut-off 11-Jun-2012
Duration of response is defined as the time from the first documented evidence of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of the LD of the target lesions, compared with the baseline sum LD) until the first documented sign of PD (at least a 20% increase in the sum of the LD of target lesions, compared with the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions) or death due to breast cancer. In the absence of confirmation of death, survival time was to be censored at the time of the last investigator contac
Group
Value
95% CI
Lapatinib Plus Capecitabine
6.2
5.3 – 10.6
Trastuzumab Plus Capecitabine
8.4
6.0 – 21.6
Number of Participants With CNS Progression at Any TimeSecondary· From the time of randomization until death due to any cause (average of 10 months). Cut-off 11-Jun-2012
CNS progression was documented by a brain scan and was indicated by the investigator on the follow-up electronic Case Report Form. CNS relapse is defined as the appearance of \>=1 enhancing lesion measuring \>=6 mm on T1W MRI without CNS symptoms that were considered to be unequivocal based on all relevant radiological features (e.g., associated T2W signal abnormality); the appearance of any enhancing lesion on T1W MRI with CNS symptoms; unequivocal finding of leptomeningeal disease, with or without symptoms; and unequivocal finding of multifocal intraparenchymal lesions with or without sympto
Group
Value
95% CI
Lapatinib Plus Capecitabine
17
Trastuzumab Plus Capecitabine
15
Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events (AEs) Occurring in >=2% of Participants in Either Treatment ArmSecondary· From the first dose of study medication until 30 days after the last dose of study treatment (average of 10 months).
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The Investigator assessed whether the AE was related to study drug. AEs were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0=No AE or within normal limits; 1=Mild AE; 2=Moderate AE; 3=Severe and undesirable AE; 4=Life-threatening or disabling AE; 5=Death related to AE.
Palmar-plantar erythrodysaesthesia syndrome
Group
Value
95% CI
Lapatinib Plus Capecitabine
29
Trastuzumab Plus Capecitabine
45
Diarrhoea
Group
Value
95% CI
Lapatinib Plus Capecitabine
19
Trastuzumab Plus Capecitabine
22
Aspartate aminotransferase increased
Group
Value
95% CI
Lapatinib Plus Capecitabine
11
Trastuzumab Plus Capecitabine
4
Neutropenia
Group
Value
95% CI
Lapatinib Plus Capecitabine
9
Trastuzumab Plus Capecitabine
18
Asthenia
Group
Value
95% CI
Lapatinib Plus Capecitabine
9
Trastuzumab Plus Capecitabine
6
Fatigue
Group
Value
95% CI
Lapatinib Plus Capecitabine
7
Trastuzumab Plus Capecitabine
4
Alanine aminotransferase increased
Group
Value
95% CI
Lapatinib Plus Capecitabine
4
Trastuzumab Plus Capecitabine
6
Hypokalaemia
Group
Value
95% CI
Lapatinib Plus Capecitabine
3
Trastuzumab Plus Capecitabine
11
Adverse events — posted to ClinicalTrials.gov
Time frame: From randomization until up to and including 30 days after the last dose of study treatment (up to 7 years post randomization).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This open label study was designed to evaluate Lapatinib effect on incidence of brain metastases in ErbB2 (HER2) positive metastatic breast cancer patients exposed to prior taxanes or anthracyclines.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 2 April 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00820222.