Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
Study NCT ID:
NCT00281658
Status:
COMPLETED
Last Update Posted:
2023-02-10
First Post:
2006-01-23
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study In Women And Men With Metastatic Breast Cancer That Have Overexpression Of ErbB2
Sponsor:
Organization:
Raw JSON
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However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The data collected for China patients after 01JUL2019 were excluded from analysis due to local regulations in China.'}}, 'adverseEventsModule': {'timeFrame': 'From study treatment start date till 30 days safety follow-up, assessed up to 190 months (Final OS analysis cut-off date = 23-Nov-2021)', 'description': 'Any sign or symptom that occurs during the treatment period plus 30 days post-treatment. The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.', 'eventGroups': [{'id': 'EG000', 'title': 'Lapatinib 1500 mg + Paclitaxel', 'description': 'Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m\\^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks', 'otherNumAtRisk': 222, 'deathsNumAtRisk': 222, 'otherNumAffected': 219, 'seriousNumAtRisk': 222, 'deathsNumAffected': 10, 'seriousNumAffected': 67}, {'id': 'EG001', 'title': 'Placebo + Paclitaxel', 'description': 'Matching placebo administered once daily plus paclitaxel 80 mg/m\\^2 administered IV weekly for 3 weeks every 4 weeks', 'otherNumAtRisk': 221, 'deathsNumAtRisk': 221, 'otherNumAffected': 206, 'seriousNumAtRisk': 221, 'deathsNumAffected': 15, 'seriousNumAffected': 30}, {'id': 'EG002', 'title': 'Open Label - Monotherapy', 'description': 'Open Label - Monotherapy (Lapatinib)', 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 221, 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{'term': 'Mucosal erosion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 1}, 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'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Survival (OS) at 53 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lapatinib 1500 mg + Paclitaxel', 'description': 'Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters 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A hazard ratio \\<1 indicates a lower risk with Lapatinib 1500mg + Paclitaxel compared with Placebo + Paclitaxel.', 'groupDescription': 'Primary OS analysis cut-off date = 18-Jun-2010', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of randomization until date of death from any cause, assessed up to 53 months (Primary OS analysis cut-off date = 18-Jun-2010)', 'description': 'Overall Survival (OS) was defined as the interval of time (in months) between the date of randomization and the date of death due to any cause.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population. The ITT population was comprised of all randomized subjects and was based on the treatment to which the subject was randomized.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS) at 190 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lapatinib 1500 mg + Paclitaxel', 'description': 'Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m\\^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks'}, {'id': 'OG001', 'title': 'Placebo + Paclitaxel', 'description': 'Matching placebo administered once daily plus paclitaxel 80 mg/m\\^2 administered IV weekly for 3 weeks every 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '27.6', 'groupId': 'OG000', 'lowerLimit': '23.7', 'upperLimit': '31.5'}, {'value': '20.3', 'groupId': 'OG001', 'lowerLimit': '17.9', 'upperLimit': '24.3'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.80', 'ciLowerLimit': '0.64', 'ciUpperLimit': '0.98', 'estimateComment': 'The treatment hazard ratio based on the proportional hazard model stratifying for metastatic disease sites and hormonal status. A hazard ratio \\<1 indicates a lower risk with Lapatinib 1500mg + Paclitaxel compared with Placebo + Paclitaxel.', 'groupDescription': 'Final OS analysis cut-0ff date = 23-Nov-2021', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of randomization until date of death from any cause, assessed up to 190 months (Final OS analysis cut-off date = 23-Nov-2021)', 'description': 'Overall Survival (OS) was defined as the interval of time (in months) between the date of randomization and the date of death due to any cause.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population. The ITT population was comprised of all randomized subjects and was based on the treatment to which the subject was randomized.'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival (PFS) by Investigator Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lapatinib 1500 mg + Paclitaxel', 'description': 'Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m\\^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks'}, {'id': 'OG001', 'title': 'Placebo + Paclitaxel', 'description': 'Matching placebo administered once daily plus paclitaxel 80 mg/m\\^2 administered IV weekly for 3 weeks every 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '9.7', 'groupId': 'OG000', 'lowerLimit': '9.2', 'upperLimit': '11.1'}, {'value': '6.5', 'groupId': 'OG001', 'lowerLimit': '5.5', 'upperLimit': '7.3'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.54', 'ciLowerLimit': '0.44', 'ciUpperLimit': '0.66', 'estimateComment': 'The Pike estimator of the treatment hazard ratio based on the log rank test stratifying for metastatic disease sites and hormonal status. A hazard ratio \\<1 indicates a lower risk with Lapatinib 1500mg + Paclitaxel compared with Placebo + Paclitaxel.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up to 190 months (Final analysis cut-off date = 23-Nov-2021)', 'description': 'Progression-free survival (PFS) during the randomized phase was defined as the interval of time (in months) between the date of randomization and the earlier of date of disease progression (radiological or clinical assessment of symptomatic progression), or date of death due to any cause.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population. The ITT population was comprised of all randomized subjects and was based on the treatment to which the subject was randomized.'}, {'type': 'SECONDARY', 'title': 'Overall Response Rate (ORR) by Investigator Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lapatinib 1500 mg + Paclitaxel', 'description': 'Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m\\^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks'}, {'id': 'OG001', 'title': 'Placebo + Paclitaxel', 'description': 'Matching placebo administered once daily plus paclitaxel 80 mg/m\\^2 administered IV weekly for 3 weeks every 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000', 'lowerLimit': '62.9', 'upperLimit': '75.4'}, {'value': '50', 'groupId': 'OG001', 'lowerLimit': '42.8', 'upperLimit': '56.3'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.30', 'ciLowerLimit': '1.54', 'ciUpperLimit': '3.47', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 190 months (Final analysis cut-off date = 23-Nov-2021)', 'description': 'Overall response rate (ORR) during the randomized phase was evaluated per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) and defined as the percentage of subjects achieving either a Complete Response (CR) or a Partial Response (PR). Participants with unknown or missing responses were treated as non-responders.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population. The ITT population was comprised of all randomized subjects and was based on the treatment to which the subject was randomized.'}, {'type': 'SECONDARY', 'title': 'Clinical Benefit Rate (CBR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lapatinib 1500 mg + Paclitaxel', 'description': 'Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m\\^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks'}, {'id': 'OG001', 'title': 'Placebo + Paclitaxel', 'description': 'Matching placebo administered once daily plus paclitaxel 80 mg/m\\^2 administered IV weekly for 3 weeks every 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000', 'lowerLimit': '68.5', 'upperLimit': '80.3'}, {'value': '56', 'groupId': 'OG001', 'lowerLimit': '49.1', 'upperLimit': '62.5'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.34', 'ciLowerLimit': '1.54', 'ciUpperLimit': '3.58', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up to 53 months (Primary analysis cut-off date = 18-Jun-2010)', 'description': 'Clinical benefit rate (CBR) was defined as the percentage of subjects with evidence of CR or PR or stable disease (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease \\[at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of \\>=1 new lesions\\], taking as reference the smallest sum LD since treatment start) of \\>=24 weeks, based on confirmed responses from the investigator assessment of best overall response during the randomized phase.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population. The ITT population was comprised of all randomized subjects and was based on the treatment to which the subject was randomized.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lapatinib 1500 mg + Paclitaxel', 'description': 'Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m\\^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks'}, {'id': 'OG001', 'title': 'Placebo + Paclitaxel', 'description': 'Matching placebo administered once daily plus paclitaxel 80 mg/m\\^2 administered IV weekly for 3 weeks every 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '9.3', 'groupId': 'OG000', 'lowerLimit': '7.7', 'upperLimit': '10.7'}, {'value': '5.8', 'groupId': 'OG001', 'lowerLimit': '5.6', 'upperLimit': '7.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of confirmed CR or PR until date of progression or date of death from any cause, whichever comes first, assessed up to 190 months (Final analysis cut-off date = 23-Nov-2021)', 'description': 'For subjects who show CR or PR, duration of response (DOR) was defined to be the time from first documented evidence of PR or CR until the first documented sign of disease progression (radiological or clinical assessment of symptomatic progression) or death due to any cause, if sooner during the randomized phase.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Subset of participants in the Intent-to-Treat (ITT) Population with a confirmed CR or PR'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a CR or PR at Weeks 8, 12, 16, 24, 32, 40, 48, 56, 64, and 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lapatinib 1500 mg + Paclitaxel', 'description': 'Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m\\^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks'}, {'id': 'OG001', 'title': 'Placebo + Paclitaxel', 'description': 'Matching placebo administered once daily plus paclitaxel 80 mg/m\\^2 administered IV weekly for 3 weeks every 4 weeks'}], 'classes': [{'title': 'Week 8', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Week 32', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Week 40', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 56', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 64', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 72', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 8, 12, 16, 24, 32, 40, 48, 56, 64, and 72', 'description': "The original outcome measure to be analyzed was Time to response (TTR) during the randomized phase defined as the time from randomization until first documented evidence of PR or CR (whichever status was recorded first); however, data were presented as the number of participants with a response at each nominal visit. Responses were based on the investigator's assessment, and only participants with a confirmed CR or PR were included in this analysis.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Intent-to-Treat (ITT) Population with a confirmed CR or PR'}, {'type': 'SECONDARY', 'title': 'Number of Tumors Evaluable for PIK3CA Mutations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lapatinib 1500 mg + Paclitaxel', 'description': 'Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m\\^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks'}, {'id': 'OG001', 'title': 'Placebo + Paclitaxel', 'description': 'Matching placebo administered once daily plus paclitaxel 80 mg/m\\^2 administered IV weekly for 3 weeks every 4 weeks'}], 'classes': [{'categories': [{'title': 'PIK3CA mutation', 'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}, {'title': 'PIK3CA wild-type', 'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}, {'title': 'PIK3CA indeterminate', 'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline', 'description': 'Phosphatidylinositol 3-kinase (PI3K) pathway deregulation (that is PIK3CA mutations and/or phosphatase and tensin homolog (PTEN) loss) was studied to evaluate the predictive and prognostic value of PIK3CA mutations and/or PTEN low in HER2-positive patients receiving first-line treatment with paclitaxel alone or in combination with lapatinib. A PIK3CA mutation test kit was used to assess mutation status on genomic deoxyribonucleic acid (DNA) isolated from tumor tissue.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Intent-to-Treat (ITT) Population with tumors evaluable for PIK3CA mutations'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Tumors Evaluable for PTEN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lapatinib 1500 mg + Paclitaxel', 'description': 'Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m\\^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks'}, {'id': 'OG001', 'title': 'Placebo + Paclitaxel', 'description': 'Matching placebo administered once daily plus paclitaxel 80 mg/m\\^2 administered IV weekly for 3 weeks every 4 weeks'}], 'classes': [{'categories': [{'title': 'PTEN IHC 0', 'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}, {'title': 'PTEN IHC 1+', 'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}, {'title': 'PTEN IHC 2+/3+', 'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline', 'description': 'Phosphatidylinositol 3-kinase (PI3K) pathway deregulation (that is PIK3CA mutations and/or phosphatase and tensin homolog (PTEN) loss) was studied to evaluate the predictive and prognostic value of PIK3CA mutations and/or PTEN low in HER2-positive patients receiving first-line treatment with paclitaxel alone or in combination with lapatinib. Immunohistochemistry (IHC) staining in an analytically validated assay was used in the assessment of PTEN protein expression on tumor tissue. Staining intensity was allocated a score of 0, 1+, 2+ or 3+. Tumors scored IHC 0 were considered as exhibiting an absence of PTEN expression whereas those scored ICH 1+, 2+ or 3+ were considered as exhibiting any PTEN expression, being 3+ the highest expression.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Intent-to-Treat (ITT) Population with tumors evaluable for PTEN'}, {'type': 'SECONDARY', 'title': 'Predictive Effect of PIK3CA Mutations Status on Overall Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lapatinib 1500 mg + Paclitaxel', 'description': 'Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m\\^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks'}, {'id': 'OG001', 'title': 'Placebo + Paclitaxel', 'description': 'Matching placebo administered once daily plus paclitaxel 80 mg/m\\^2 administered IV weekly for 3 weeks every 4 weeks'}], 'classes': [{'title': 'PIK3CA mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}, {'title': 'PIK3CA wild-type', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.78', 'ciLowerLimit': '1.07', 'ciUpperLimit': '7.57', 'groupDescription': 'Participants with PIK3CA wild-type', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 53 months (Primary OS analysis cut-off date = 18-Jun-2010)', 'description': 'ORR was evaluated per RECIST v1.1 and defined as the percentage of subjects achieving either CR or PR. Phosphatidylinositol 3-kinase (PI3K) pathway deregulation (that is PIK3CA mutations and/or phosphatase and tensin homolog (PTEN) loss) was studied to evaluate the predictive and prognostic value of PIK3CA mutations and/or PTEN low in HER2-positive patients receiving first-line treatment with paclitaxel alone or in combination with lapatinib. A PIK3CA mutation test kit was used to assess mutation status on genomic deoxyribonucleic acid (DNA) isolated from tumor tissue.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Intent-to-Treat (ITT) Population with tumors evaluable for PIK3CA mutations (PIK3CA mutation and PIK3CA wild type)'}, {'type': 'SECONDARY', 'title': 'Predictive Effect of PTEN Low on Overall Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lapatinib 1500 mg + Paclitaxel', 'description': 'Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m\\^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks'}, {'id': 'OG001', 'title': 'Placebo + Paclitaxel', 'description': 'Matching placebo administered once daily plus paclitaxel 80 mg/m\\^2 administered IV weekly for 3 weeks every 4 weeks'}], 'classes': [{'title': 'PTEN low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}, {'title': 'Without PTEN low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.42', 'ciLowerLimit': '1.28', 'ciUpperLimit': '4.63', 'groupDescription': 'Participants with PTEN low', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.21', 'ciLowerLimit': '1.04', 'ciUpperLimit': '4.82', 'groupDescription': 'Participants without PTEN low', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 53 months (Primary OS analysis cut-off date = 18-Jun-2010)', 'description': 'ORR was evaluated per RECIST v1.1 and defined as the percentage of subjects achieving either CR or PR. Phosphatidylinositol 3-kinase (PI3K) pathway deregulation (that is PIK3CA mutations and/or phosphatase and tensin homolog (PTEN) loss) was studied to evaluate the predictive and prognostic value of PIK3CA mutations and/or PTEN low in HER2-positive patients receiving first-line treatment with paclitaxel alone or in combination with lapatinib. Immunohistochemistry (IHC) staining in an analytically validated assay was used in the assessment of PTEN protein expression on tumor tissue. Staining intensity was allocated a score of 0, 1+, 2+ or 3+. Tumors scored IHC 0 were considered as exhibiting an absence of PTEN expression whereas those scored ICH 1+, 2+ or 3+ were considered as exhibiting any PTEN expression, being 3+ the highest expression. Tumors scored IHC 0/1+ were considered PTEN low.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Intent-to-Treat (ITT) Population with PTEN low and without PTEN low'}, {'type': 'SECONDARY', 'title': 'Predictive Effect of PIK3CA Mutations Status on Clinical Benefit Rate (CBR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lapatinib 1500 mg + Paclitaxel', 'description': 'Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m\\^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks'}, {'id': 'OG001', 'title': 'Placebo + Paclitaxel', 'description': 'Matching placebo administered once daily plus paclitaxel 80 mg/m\\^2 administered IV weekly for 3 weeks every 4 weeks'}], 'classes': [{'title': 'PIK3CA mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}]}, {'title': 'PIK3CA wild-type', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 53 months (Primary OS analysis cut-off date = 18-Jun-2010)', 'description': 'CBR was evaluated per RECIST v1.1 and defined as the percentage of subjects achieving CR or PR or stable disease. Phosphatidylinositol 3-kinase (PI3K) pathway deregulation (that is PIK3CA mutations and/or phosphatase and tensin homolog (PTEN) loss) was studied to evaluate the predictive and prognostic value of PIK3CA mutations and/or PTEN low in HER2-positive patients receiving first-line treatment with paclitaxel alone or in combination with lapatinib. A PIK3CA mutation test kit was used to assess mutation status on genomic deoxyribonucleic acid (DNA) isolated from tumor tissue.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Intent-to-Treat (ITT) Population with tumors evaluable for PIK3CA mutations (PIK3CA mutation and PIK3CA wild type)'}, {'type': 'SECONDARY', 'title': 'Predictive Effect of PTEN Low on Clinical Benefit Rate (CBR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lapatinib 1500 mg + Paclitaxel', 'description': 'Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m\\^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks'}, {'id': 'OG001', 'title': 'Placebo + Paclitaxel', 'description': 'Matching placebo administered once daily plus paclitaxel 80 mg/m\\^2 administered IV weekly for 3 weeks every 4 weeks'}], 'classes': [{'title': 'PTEN low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}]}, {'title': 'Without PTEN low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.15', 'ciLowerLimit': '1.58', 'ciUpperLimit': '6.49', 'groupDescription': 'Participants with PTEN low', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.49', 'ciLowerLimit': '1.13', 'ciUpperLimit': '5.66', 'groupDescription': 'Participants without PTEN low', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 53 months (Primary OS analysis cut-off date = 18-Jun-2010)', 'description': 'CBR was evaluated per RECIST v1.1 and defined as the percentage of subjects achieving CR or PR or stable disease. Phosphatidylinositol 3-kinase (PI3K) pathway deregulation (that is PIK3CA mutations and/or phosphatase and tensin homolog (PTEN) loss) was studied to evaluate the predictive and prognostic value of PIK3CA mutations and/or PTEN low in HER2-positive patients receiving first-line treatment with paclitaxel alone or in combination with lapatinib. Immunohistochemistry (IHC) staining in an analytically validated assay was used in the assessment of PTEN protein expression on tumor tissue. Staining intensity was allocated a score of 0, 1+, 2+ or 3+. Tumors scored IHC 0 were considered as exhibiting an absence of PTEN expression whereas those scored ICH 1+, 2+ or 3+ were considered as exhibiting any PTEN expression, being 3+ the highest expression. Tumors scored IHC 0/1+ were considered PTEN low.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Intent-to-Treat (ITT) Population with PTEN low and without PTEN low'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lapatinib 1500 mg + Paclitaxel', 'description': 'Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m\\^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks'}, {'id': 'FG001', 'title': 'Placebo + Paclitaxel', 'description': 'Matching placebo administered once daily plus paclitaxel 80 mg/m\\^2 administered IV weekly for 3 weeks every 4 weeks'}, {'id': 'FG002', 'title': 'Open Label - Monotherapy', 'description': 'Open Label - Monotherapy (Lapatinib)'}, {'id': 'FG003', 'title': 'Open Label - Combination Therapy', 'description': 'Open Label - Combination Therapy (Lapatinib and Paclitaxel)'}], 'periods': [{'title': 'Randomized Phase', 'milestones': [{'type': 'STARTED', 'comment': 'All randomized subjects were included in the Intent-to-Treat (ITT) Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '222'}, {'groupId': 'FG001', 'numSubjects': '222'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Safety Population', 'comment': 'All randomized subjects who received at least one dose of study medication', 'achievements': [{'groupId': 'FG000', 'numSubjects': '222'}, {'groupId': 'FG001', 'numSubjects': '221'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '133'}, {'groupId': 'FG001', 'numSubjects': '149'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '89'}, {'groupId': 'FG001', 'numSubjects': '73'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Study closed/terminated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Other reasons as defined per protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Reason for withdrawal unspecified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Treatment ongoing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Open Label Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '149'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '104'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '45'}, {'groupId': 'FG003', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Relocation of patient', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Reason for withdrawal unspecified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study was conducted in 43 centers in eight participating countries: Brazil (7), China (20), Hong Kong (3), Pakistan (3), Peru (1), Russian Federation (6), Thailand (2) and Ukraine (1).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'BG000'}, {'value': '222', 'groupId': 'BG001'}, {'value': '444', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Lapatinib 1500 mg + Paclitaxel', 'description': 'Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m\\^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks'}, {'id': 'BG001', 'title': 'Placebo + Paclitaxel', 'description': 'Matching placebo administered once daily plus paclitaxel 80 mg/m\\^2 administered IV weekly for 3 weeks every 4 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.1', 'spread': '10.74', 'groupId': 'BG000'}, {'value': '49.3', 'spread': '9.75', 'groupId': 'BG001'}, {'value': '49.2', 'spread': '10.25', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '222', 'groupId': 'BG000'}, {'value': '217', 'groupId': 'BG001'}, {'value': '439', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '192', 'groupId': 'BG000'}, {'value': '192', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Number of participants with any visceral metastatic disease and with only non-visceral disease', 'classes': [{'categories': [{'title': 'Visceral', 'measurements': [{'value': '187', 'groupId': 'BG000'}, {'value': '186', 'groupId': 'BG001'}, {'value': '373', 'groupId': 'BG002'}]}, {'title': 'Non-visceral', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Metastasis is defined as the spread of a tumor or cancerous cells from the primary site to one or more sites elsewhere in the body. Visceral metastasis is defined as the spread of cancer to viscera, the internal organs of the body, specifically those within the chest (as the heart or lungs) or abdomen (as the liver, pancreas, or intestines). Non-visceral organs are defined as any organ not considered visceral.', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Participants with the Indicated Hormone Receptor Status', 'classes': [{'categories': [{'title': 'ER+ and/or PgR+ or Unknown', 'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '224', 'groupId': 'BG002'}]}, {'title': 'ER- and PgR-', 'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '220', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Cancer cells have hormone receptor expression of Estrogen Receptor (ER) and/or Progesterone Receptor (PR) and are thus considered to be ER+ and/or PgR+ cells, respectively.', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Participants with the Indicated Stage of Disease at Initial Diagnosis', 'classes': [{'categories': [{'title': 'Stage I to II', 'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '226', 'groupId': 'BG002'}]}, {'title': 'Stage III', 'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '143', 'groupId': 'BG002'}]}, {'title': 'Stage IV', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The stage of cancer is a description of the extent to which the cancer has spread. Stage I cancer is localized; Stage II cancer has not started to spread into the surrounding tissue, but the tumor is larger than in Stage I; Stage III cancer is locally advanced and/or involves local lymph nodes; Stage IV cancer has spread to other organs.', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Participants with the Indicated Eastern Cooperative Oncology Group Performance Status', 'classes': [{'categories': [{'title': '0, Fully Active', 'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '216', 'groupId': 'BG002'}]}, {'title': '1, Ambulatory, Restricted Strenuous Activity', 'measurements': [{'value': '119', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '228', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Eastern Cooperative Oncology Group (ECOG) Performance Status classifies participants according to their functional impairment, and scores indicate: 0, fully active; 1, ambulatory, restricted strenuous activity; 2, ambulatory, no work activity; 3, partially confined to bed; 4, totally confined in bed; 5, death. Participants were required to have a baseline ECOG performance status of 0 or 1 for study participation.', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Participants with the Indicated Number of Metastatic Sites', 'classes': [{'categories': [{'title': 'Greater than or equal to 3', 'measurements': [{'value': '131', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '246', 'groupId': 'BG002'}]}, {'title': 'Less than 3', 'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '198', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Tumor cells move from the primary site to other sites in the body, where they continue to multiply and eventually form another clinically detectable tumor; thus, the site becomes metastatic. The table indicates number of metastatic sites.', 'unitOfMeasure': 'Participants'}, {'title': 'Mean Time of Disease-Free Interval', 'classes': [{'categories': [{'measurements': [{'value': '27.51', 'spread': '27.481', 'groupId': 'BG000'}, {'value': '29.04', 'spread': '34.522', 'groupId': 'BG001'}, {'value': '28.27', 'spread': '31.174', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The disease-free interval was defined as the time from initial diagnosis to metastases', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 444}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2021-11-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-09', 'studyFirstSubmitDate': '2006-01-23', 'resultsFirstSubmitDate': '2011-05-05', 'studyFirstSubmitQcDate': '2006-01-24', 'lastUpdatePostDateStruct': {'date': '2023-02-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-05-05', 'studyFirstPostDateStruct': {'date': '2006-01-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-06-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival (OS) at 53 Months', 'timeFrame': 'From date of randomization until date of death from any cause, assessed up to 53 months (Primary OS analysis cut-off date = 18-Jun-2010)', 'description': 'Overall Survival (OS) was defined as the interval of time (in months) between the date of randomization and the date of death due to any cause.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS) at 190 Months', 'timeFrame': 'From date of randomization until date of death from any cause, assessed up to 190 months (Final OS analysis cut-off date = 23-Nov-2021)', 'description': 'Overall Survival (OS) was defined as the interval of time (in months) between the date of randomization and the date of death due to any cause.'}, {'measure': 'Progression-free Survival (PFS) by Investigator Assessment', 'timeFrame': 'From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up to 190 months (Final analysis cut-off date = 23-Nov-2021)', 'description': 'Progression-free survival (PFS) during the randomized phase was defined as the interval of time (in months) between the date of randomization and the earlier of date of disease progression (radiological or clinical assessment of symptomatic progression), or date of death due to any cause.'}, {'measure': 'Overall Response Rate (ORR) by Investigator Assessment', 'timeFrame': 'From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 190 months (Final analysis cut-off date = 23-Nov-2021)', 'description': 'Overall response rate (ORR) during the randomized phase was evaluated per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) and defined as the percentage of subjects achieving either a Complete Response (CR) or a Partial Response (PR). Participants with unknown or missing responses were treated as non-responders.'}, {'measure': 'Clinical Benefit Rate (CBR)', 'timeFrame': 'From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up to 53 months (Primary analysis cut-off date = 18-Jun-2010)', 'description': 'Clinical benefit rate (CBR) was defined as the percentage of subjects with evidence of CR or PR or stable disease (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease \\[at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of \\>=1 new lesions\\], taking as reference the smallest sum LD since treatment start) of \\>=24 weeks, based on confirmed responses from the investigator assessment of best overall response during the randomized phase.'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'From date of confirmed CR or PR until date of progression or date of death from any cause, whichever comes first, assessed up to 190 months (Final analysis cut-off date = 23-Nov-2021)', 'description': 'For subjects who show CR or PR, duration of response (DOR) was defined to be the time from first documented evidence of PR or CR until the first documented sign of disease progression (radiological or clinical assessment of symptomatic progression) or death due to any cause, if sooner during the randomized phase.'}, {'measure': 'Number of Participants With a CR or PR at Weeks 8, 12, 16, 24, 32, 40, 48, 56, 64, and 72', 'timeFrame': 'Weeks 8, 12, 16, 24, 32, 40, 48, 56, 64, and 72', 'description': "The original outcome measure to be analyzed was Time to response (TTR) during the randomized phase defined as the time from randomization until first documented evidence of PR or CR (whichever status was recorded first); however, data were presented as the number of participants with a response at each nominal visit. Responses were based on the investigator's assessment, and only participants with a confirmed CR or PR were included in this analysis."}, {'measure': 'Number of Tumors Evaluable for PIK3CA Mutations', 'timeFrame': 'Baseline', 'description': 'Phosphatidylinositol 3-kinase (PI3K) pathway deregulation (that is PIK3CA mutations and/or phosphatase and tensin homolog (PTEN) loss) was studied to evaluate the predictive and prognostic value of PIK3CA mutations and/or PTEN low in HER2-positive patients receiving first-line treatment with paclitaxel alone or in combination with lapatinib. A PIK3CA mutation test kit was used to assess mutation status on genomic deoxyribonucleic acid (DNA) isolated from tumor tissue.'}, {'measure': 'Number of Participants With Tumors Evaluable for PTEN', 'timeFrame': 'Baseline', 'description': 'Phosphatidylinositol 3-kinase (PI3K) pathway deregulation (that is PIK3CA mutations and/or phosphatase and tensin homolog (PTEN) loss) was studied to evaluate the predictive and prognostic value of PIK3CA mutations and/or PTEN low in HER2-positive patients receiving first-line treatment with paclitaxel alone or in combination with lapatinib. Immunohistochemistry (IHC) staining in an analytically validated assay was used in the assessment of PTEN protein expression on tumor tissue. Staining intensity was allocated a score of 0, 1+, 2+ or 3+. Tumors scored IHC 0 were considered as exhibiting an absence of PTEN expression whereas those scored ICH 1+, 2+ or 3+ were considered as exhibiting any PTEN expression, being 3+ the highest expression.'}, {'measure': 'Predictive Effect of PIK3CA Mutations Status on Overall Response Rate (ORR)', 'timeFrame': 'From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 53 months (Primary OS analysis cut-off date = 18-Jun-2010)', 'description': 'ORR was evaluated per RECIST v1.1 and defined as the percentage of subjects achieving either CR or PR. Phosphatidylinositol 3-kinase (PI3K) pathway deregulation (that is PIK3CA mutations and/or phosphatase and tensin homolog (PTEN) loss) was studied to evaluate the predictive and prognostic value of PIK3CA mutations and/or PTEN low in HER2-positive patients receiving first-line treatment with paclitaxel alone or in combination with lapatinib. A PIK3CA mutation test kit was used to assess mutation status on genomic deoxyribonucleic acid (DNA) isolated from tumor tissue.'}, {'measure': 'Predictive Effect of PTEN Low on Overall Response Rate (ORR)', 'timeFrame': 'From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 53 months (Primary OS analysis cut-off date = 18-Jun-2010)', 'description': 'ORR was evaluated per RECIST v1.1 and defined as the percentage of subjects achieving either CR or PR. Phosphatidylinositol 3-kinase (PI3K) pathway deregulation (that is PIK3CA mutations and/or phosphatase and tensin homolog (PTEN) loss) was studied to evaluate the predictive and prognostic value of PIK3CA mutations and/or PTEN low in HER2-positive patients receiving first-line treatment with paclitaxel alone or in combination with lapatinib. Immunohistochemistry (IHC) staining in an analytically validated assay was used in the assessment of PTEN protein expression on tumor tissue. Staining intensity was allocated a score of 0, 1+, 2+ or 3+. Tumors scored IHC 0 were considered as exhibiting an absence of PTEN expression whereas those scored ICH 1+, 2+ or 3+ were considered as exhibiting any PTEN expression, being 3+ the highest expression. Tumors scored IHC 0/1+ were considered PTEN low.'}, {'measure': 'Predictive Effect of PIK3CA Mutations Status on Clinical Benefit Rate (CBR)', 'timeFrame': 'From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 53 months (Primary OS analysis cut-off date = 18-Jun-2010)', 'description': 'CBR was evaluated per RECIST v1.1 and defined as the percentage of subjects achieving CR or PR or stable disease. Phosphatidylinositol 3-kinase (PI3K) pathway deregulation (that is PIK3CA mutations and/or phosphatase and tensin homolog (PTEN) loss) was studied to evaluate the predictive and prognostic value of PIK3CA mutations and/or PTEN low in HER2-positive patients receiving first-line treatment with paclitaxel alone or in combination with lapatinib. A PIK3CA mutation test kit was used to assess mutation status on genomic deoxyribonucleic acid (DNA) isolated from tumor tissue.'}, {'measure': 'Predictive Effect of PTEN Low on Clinical Benefit Rate (CBR)', 'timeFrame': 'From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 53 months (Primary OS analysis cut-off date = 18-Jun-2010)', 'description': 'CBR was evaluated per RECIST v1.1 and defined as the percentage of subjects achieving CR or PR or stable disease. Phosphatidylinositol 3-kinase (PI3K) pathway deregulation (that is PIK3CA mutations and/or phosphatase and tensin homolog (PTEN) loss) was studied to evaluate the predictive and prognostic value of PIK3CA mutations and/or PTEN low in HER2-positive patients receiving first-line treatment with paclitaxel alone or in combination with lapatinib. Immunohistochemistry (IHC) staining in an analytically validated assay was used in the assessment of PTEN protein expression on tumor tissue. Staining intensity was allocated a score of 0, 1+, 2+ or 3+. Tumors scored IHC 0 were considered as exhibiting an absence of PTEN expression whereas those scored ICH 1+, 2+ or 3+ were considered as exhibiting any PTEN expression, being 3+ the highest expression. Tumors scored IHC 0/1+ were considered PTEN low.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ErbB2 positive', 'human epidermal growth factor receptor 2 positive (Her2+)', 'metastatic breast cancer', 'Fluorescence in situ hybridization (FISH) positive', 'Stage IV'], 'conditions': ['Neoplasms, Breast']}, 'referencesModule': {'references': [{'pmid': '25056500', 'type': 'DERIVED', 'citation': 'Xu B, Guan Z, Shen Z, Tong Z, Jiang Z, Yang J, DeSilvio M, Russo M, Leigh M, Ellis C. Association of phosphatase and tensin homolog low and phosphatidylinositol 3-kinase catalytic subunit alpha gene mutations on outcome in human epidermal growth factor receptor 2-positive metastatic breast cancer patients treated with first-line lapatinib plus paclitaxel or paclitaxel alone. Breast Cancer Res. 2014 Jul 24;16(4):405. doi: 10.1186/s13058-014-0405-y.'}, {'pmid': '23509322', 'type': 'DERIVED', 'citation': 'Guan Z, Xu B, DeSilvio ML, Shen Z, Arpornwirat W, Tong Z, Lorvidhaya V, Jiang Z, Yang J, Makhson A, Leung WL, Russo MW, Newstat B, Wang L, Chen G, Oliva C, Gomez H. Randomized trial of lapatinib versus placebo added to paclitaxel in the treatment of human epidermal growth factor receptor 2-overexpressing metastatic breast cancer. J Clin Oncol. 2013 Jun 1;31(16):1947-53. doi: 10.1200/JCO.2011.40.5241. Epub 2013 Mar 18.'}], 'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=17997', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This was a randomized, double-blind, placebo-controlled, multicenter, Phase III study to evaluate and compare the efficacy and safety of Lapatinib + Paclitaxel versus Placebo + Paclitaxel in men and women with ErbB2 amplified metastatic (Stage IV) breast cancer who had not received prior therapy for metastatic disease.', 'detailedDescription': 'Subjects were randomized to receive either Lapatinib (1500 mg once daily) + Paclitaxel (80 mg/m2 IV weekly for 3 weeks every 4 weeks) or Placebo (once daily) + Paclitaxel (80 mg/m2 IV weekly for 3 weeks every 4 weeks).\n\nSubjects who progressed while on study and were on the placebo+paclitaxel arm were permitted to enter an extension phase of open label monotherapy therapy with lapatinib or open label combination therapy with lapatinib+paclitaxel and followed for response, progression and survival.\n\nBased on the positive results in the primary analysis, Protocol Amendment 02 (dated 09 May 2011) discontinued further entry into the lapatinib monotherapy extension phase, and ongoing subjects taking placebo were permitted to replace it with open label lapatinib therapy (with or without continued paclitaxel therapy).\n\nFollowing the primary Overall Survival (OS) analysis and subsequent implementation of Protocol Amendment 03, subjects who were still receiving active treatment entered the Long-term follow-up (LTFU) phase of the study. Reporting requirements in the LTFU phase were limited to Adverse events of special interest (AESI), Serious adverse events (SAEs) and pregnancy, and the subjects continued to receive treatment until the occurrence of unacceptable toxicity or disease progression (as determined by the investigator) or permanent withdrawal from treatment for any reason. Subjects who were no longer receiving active treatment were withdrawn from the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Signed informed consent;\n* Male or female ≥18 years;\n* Histologically confirmed invasive breast cancer with stage IV disease; If the disease is restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology or histology.\n* Documented amplification of ErbB2 by fluorescence in situ hybridization (FISH) in primary or metastatic tumor tissue by the central laboratory for randomization into the study;\n* If a taxane was administered in the neoadjuvant or adjuvant setting, progression must have occurred \\>12 months after completion of this treatment and the patient recovered from all associated toxicities;\n* Measurable lesion(s) according to RECIST (Response Evaluation Criteria in Solid Tumors);\n* Radiotherapy as palliative treatment for painful metastatic disease is permitted but must have been stopped within 2 weeks prior to initiation of any investigational treatment. All subjects must have recovered from all radiotherapy related toxicities prior to initiation of any investigational treatment. The site of radiotherapy must not be used as a site of measurable disease;\n* Bisphosphonate therapy for bone metastases and is allowed; however, treatment must be initiated prior to the first dose of investigational treatment. Prophylactic use of bisphosphonates in subjects without bone disease is not permitted, except for the treatment of osteoporosis;\n* For those patients whose disease is ER+ and/or PR+ the following criteria should be met:\n\nPatients with visceral disease that requires chemotherapy (eg., patients with liver or lung metastases) Rapidly progressing or life threatening disease, as determined by the investigator Patients who received hormonal therapy and are no longer benefiting from this therapy and the hormonal treatment must have been stopped before the first dose of investigational treatment;\n\n* Cardiac ejection fraction within institutional range of normal as measured by echocardiogram. MUGA scans will be accepted in cases where an echocardiogram cannot be performed or is inconclusive;\n* ECOG Performance Status of 0 to 1;\n* Life expectancy of ≥ 12 weeks;\n* Able to swallow and retain oral medication;\n* Archived tumor tissue available for testing;\n* Women and men with potential to have children must be willing to practice acceptable methods of birth control during the study;\n* Willing to complete all screening assessments as outlined in the protocol;\n* Adequate organ function as defined in Table 1 Baseline Laboratory Values;\n\nExclusion Criteria:\n\n* Pregnant or lactating females at anytime during the study\n* Subjects with only non-measurable metastatic sites of disease per RECIST, (e.g. bone metastases, pleural effusion, or ascites, etc. (Refer to Section 5.3 Efficacy for list sites considered to be non-measurable disease.);\n* Received prior chemotherapy, immunotherapy, biologic therapy, or anti-ErbB1/ErbB2 therapy for metastatic disease.\n* Prior therapy with an ErbB1 and/or ErbB2 inhibitor, other than trastuzumab in the adjuvant setting. If trastuzumab was administered in the adjuvant setting, then \\> 12 months must have elapsed since completion of trastuzumab therapy;\n* Planned concurrent anti-cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy) while taking investigational treatment;\n* Unresolved or unstable, serious toxicity from prior administration of another investigational drug and/or of prior cancer treatment;\n* Peripheral neuropathy of Grade 2 or greater;\n* Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Subjects with ulcerative colitis are also excluded;\n* History of other malignancy. However, subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma, are eligible;\n* Concurrent disease or condition that would make the subject inappropriate for study participation, or any serious medical disorder that would interfere with the subject's safety;\n* Uncontrolled infection;\n* Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent;\n* Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure;\n* Known history or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis;\n* Concurrent treatment with prohibited medications, including herbal remedies and Chinese traditional medicines;\n* Concurrent treatment with an investigational agent or participation in another clinical trial involving investigational agents;\n* Used an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of investigational treatment;\n* Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to paclitaxel or lapatinib or their excipients."}, 'identificationModule': {'nctId': 'NCT00281658', 'briefTitle': 'Study In Women And Men With Metastatic Breast Cancer That Have Overexpression Of ErbB2', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase III Study of Lapatinib (GW572016) in Combination With Paclitaxel Versus Paclitaxel Plus Placebo in Subjects With ErbB2 Amplified Metastatic Breast Cancer', 'orgStudyIdInfo': {'id': 'EGF104535'}, 'secondaryIdInfos': [{'id': 'CLAP016A2302', 'type': 'OTHER', 'domain': 'Novartis'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Paclitaxel and Lapatinib (Blinded)', 'description': 'Paclitaxel and Lapatinib (Blinded)', 'interventionNames': ['Drug: Lapatinib (GW572016) oral tablets', 'Drug: Paclitaxel infusion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Paclitaxel and Placebo (Blinded)', 'description': 'Paclitaxel and Placebo (Blinded)', 'interventionNames': ['Drug: Paclitaxel infusion', 'Drug: Placebo']}, {'type': 'OTHER', 'label': 'Open Label - Monotherapy (Extension Phase)', 'description': 'Open Label - Monotherapy (Lapatinib)', 'interventionNames': ['Drug: Lapatinib (GW572016) oral tablets']}, {'type': 'OTHER', 'label': 'Open Label - Combination Therapy (Extension Phase)', 'description': 'Open Label - Combination Therapy (Lapatinib and Paclitaxel)', 'interventionNames': ['Drug: Lapatinib (GW572016) oral tablets', 'Drug: Paclitaxel infusion']}], 'interventions': [{'name': 'Lapatinib (GW572016) oral tablets', 'type': 'DRUG', 'description': '1500 mg oral daily continuously', 'armGroupLabels': ['Open Label - Combination Therapy (Extension Phase)', 'Open Label - Monotherapy (Extension Phase)', 'Paclitaxel and Lapatinib (Blinded)']}, {'name': 'Paclitaxel infusion', 'type': 'DRUG', 'description': 'Paclitaxel 80 mg/m2 every 3 weeks, 4th week rest for minimum 6 months', 'armGroupLabels': ['Open Label - Combination Therapy (Extension Phase)', 'Paclitaxel and Lapatinib (Blinded)', 'Paclitaxel and Placebo (Blinded)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Paclitaxel Matching Placebo', 'armGroupLabels': ['Paclitaxel and Placebo (Blinded)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40.050-410', 'city': 'Salvador', 'state': 'Estado de Bahia', 'country': 'Brazil', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -12.97563, 'lon': -38.49096}}, {'zip': '40285-001', 'city': 'Salvador', 'state': 'Estado de Bahia', 'country': 'Brazil', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -12.97563, 'lon': -38.49096}}, {'zip': '30150-281', 'city': 'Belo Horizonte', 'state': 'Minas Gerais', 'country': 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These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.\n\nThis trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}