Ignite Creation Date:
2025-12-24 @ 4:24 PM
Ignite Modification Date:
2026-03-20 @ 10:14 AM
Study NCT ID:
NCT00829166
Status:
COMPLETED
Last Update Posted:
2016-10-31
First Post:
2009-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Trastuzumab Emtansine Versus Capecitabine + Lapatinib in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000080044', 'term': 'Ado-Trastuzumab Emtansine'}, {'id': 'D000077341', 'term': 'Lapatinib'}, {'id': 'D000069287', 'term': 'Capecitabine'}], 'ancestors': [{'id': 'D008453', 'term': 'Maytansine'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D047029', 'term': 'Lactams, Macrocyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000068878', 'term': 'Trastuzumab'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '800-821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann-La Roche'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Only study-related serious adverse events (SAEs) were reported from randomization to first treatment; all SAEs and non-SAEs were reported from start of treatment until 30 days after treatment; and thereafter only treatment related SAEs were reported until data cut-off date of 21-Sep-2015 (up to 6 years and 7 months). For participants who crossed over from lapatinib + capecitabine to trastuzumab emtansine, data is reported from time of cross-over until 21-Sep-2015 (up to 3 years and 2 months).', 'description': 'Safety population included participants who received at least 1 dose of study medication. Safety analyses were based on the actual treatment received.', 'eventGroups': [{'id': 'EG000', 'title': 'Trastuzumab Emtansine', 'description': 'Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.', 'otherNumAtRisk': 490, 'otherNumAffected': 474, 'seriousNumAtRisk': 490, 'seriousNumAffected': 92}, {'id': 'EG001', 'title': 'Lapatinib + Capecitabine', 'description': 'Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m\\^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.', 'otherNumAtRisk': 488, 'otherNumAffected': 471, 'seriousNumAtRisk': 488, 'seriousNumAffected': 99}, {'id': 'EG002', 'title': 'Lapatinib + Capecitabine/ Trastuzumab Emtansine', 'description': 'Participants of "Lapatinib + Capecitabine" arm were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.', 'otherNumAtRisk': 136, 'otherNumAffected': 115, 'seriousNumAtRisk': 136, 'seriousNumAffected': 19}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 490, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 488, 'numAffected': 40}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 11}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 490, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 488, 'numAffected': 43}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 490, 'numAffected': 150}, {'groupId': 'EG001', 'numAtRisk': 488, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 23}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 490, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 488, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 7}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 490, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 488, 'numAffected': 50}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 490, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 488, 'numAffected': 45}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 490, 'numAffected': 139}, {'groupId': 'EG001', 'numAtRisk': 488, 'numAffected': 59}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 490, 'numAffected': 123}, {'groupId': 'EG001', 'numAtRisk': 488, 'numAffected': 385}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 490, 'numAffected': 85}, {'groupId': 'EG001', 'numAtRisk': 488, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 490, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 488, 'numAffected': 57}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Gingival bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 490, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 488, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 490, 'numAffected': 202}, {'groupId': 'EG001', 'numAtRisk': 488, 'numAffected': 224}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 35}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 490, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 488, 'numAffected': 70}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 490, 'numAffected': 98}, {'groupId': 'EG001', 'numAtRisk': 488, 'numAffected': 145}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 490, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 488, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 490, 'numAffected': 91}, {'groupId': 'EG001', 'numAtRisk': 488, 'numAffected': 86}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 23}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 490, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 488, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 490, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 488, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 490, 'numAffected': 180}, {'groupId': 'EG001', 'numAtRisk': 488, 'numAffected': 145}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 30}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 490, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 488, 'numAffected': 93}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 490, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 488, 'numAffected': 38}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 490, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 488, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 490, 'numAffected': 95}, {'groupId': 'EG001', 'numAtRisk': 488, 'numAffected': 43}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 490, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 488, 'numAffected': 46}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 490, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 488, 'numAffected': 41}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Paronychia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 490, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 488, 'numAffected': 59}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 490, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 488, 'numAffected': 40}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 490, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 488, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 490, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 488, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 8}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 490, 'numAffected': 92}, {'groupId': 'EG001', 'numAtRisk': 488, 'numAffected': 48}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 14}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 490, 'numAffected': 123}, {'groupId': 'EG001', 'numAtRisk': 488, 'numAffected': 53}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 25}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 490, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 488, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 490, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 488, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 490, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 488, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 490, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 488, 'numAffected': 37}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 490, 'numAffected': 105}, {'groupId': 'EG001', 'numAtRisk': 488, 'numAffected': 117}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 21}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 490, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 488, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 490, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 488, 'numAffected': 45}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 490, 'numAffected': 102}, {'groupId': 'EG001', 'numAtRisk': 488, 'numAffected': 46}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 21}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 490, 'numAffected': 78}, {'groupId': 'EG001', 'numAtRisk': 488, 'numAffected': 63}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 490, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 488, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 490, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 488, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 490, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 488, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 490, 'numAffected': 70}, {'groupId': 'EG001', 'numAtRisk': 488, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 16}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 490, 'numAffected': 71}, {'groupId': 'EG001', 'numAtRisk': 488, 'numAffected': 61}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 490, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 488, 'numAffected': 50}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 490, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 488, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 490, 'numAffected': 146}, {'groupId': 'EG001', 'numAtRisk': 488, 'numAffected': 77}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 28}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 490, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 488, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 16}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 490, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 488, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 490, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 488, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 490, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 488, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 490, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 488, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 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'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 490, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 488, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 490, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 488, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Skin haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 490, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 488, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 490, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 488, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Abortion induced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 490, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 488, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 490, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 488, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Labile blood pressure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 490, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 488, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 490, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 488, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 490, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 488, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With PD or Death as Assessed by an Independent Review Committee (IRC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '495', 'groupId': 'OG000'}, {'value': '496', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trastuzumab Emtansine', 'description': 'Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.'}, {'id': 'OG001', 'title': 'Lapatinib + Capecitabine', 'description': 'Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m\\^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.'}], 'classes': [{'categories': [{'measurements': [{'value': '53.5', 'groupId': 'OG000'}, {'value': '61.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)', 'description': 'PD was assessed by an IRC using modified Response Evaluation Criteria in Solid Tumors (RECIST). All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as target lesions (TLs) and recorded at baseline. TLs should be selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements either by imaging or clinically. A sum of the longest diameter for all TLs was calculated as baseline sum longest diameter (SLD). All other lesions (or sites of disease) should be identified as non-TLs and recorded at baseline. PD for TLs was defined as greater than or equal to (\\>/=) 20 percent (%) increase in SLD, taking as reference smallest SLD recorded since treatment started or appearance of 1 or more new lesions. PD for non-TLs was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. Percentage of Participants with PD by IRC or death from any cause was reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants on the basis of the treatment assigned at randomization.'}, {'type': 'PRIMARY', 'title': 'Progression-free Survival (PFS) as Assessed by an IRC (Co-primary Endpoint)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '495', 'groupId': 'OG000'}, {'value': '496', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trastuzumab Emtansine', 'description': 'Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.'}, {'id': 'OG001', 'title': 'Lapatinib + Capecitabine', 'description': 'Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m\\^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.6', 'groupId': 'OG000', 'lowerLimit': '8.25', 'upperLimit': '10.64'}, {'value': '6.4', 'groupId': 'OG001', 'lowerLimit': '5.68', 'upperLimit': '7.06'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.650', 'ciLowerLimit': '0.549', 'ciUpperLimit': '0.771', 'estimateComment': 'HR (relative to Lapatinib + Capecitabine) was estimated by Cox regression.', 'groupDescription': 'Analysis stratified by region of enrollment, number of prior chemotherapeutic regimens (0-1 or greater than \\[\\>\\] 1), and visceral/ non-visceral disease.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)', 'description': 'Tumor response was assessed by an IRC according to modified RECIST. All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as TLs (on the basis of their size and their suitability for accurate repeated measurements either by imaging or clinically) and recorded at baseline. A sum of the longest diameter for all TLs was calculated as baseline SLD. All other lesions were identified as non-TLs and recorded at baseline. PD for TLs: \\>/= 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or appearance of 1 or more new lesions. PD for non-TLs: appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. PFS: time from randomization to first documented PD by IRC or death from any cause (whichever occurred earlier). The median duration of PFS was estimated using Kaplan-Meier method. The 95% confidence interval (CI) was computed using the method of Brookmeyer and Crowley.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants on the basis of the treatment assigned at randomization.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Died: Second Interim Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '495', 'groupId': 'OG000'}, {'value': '496', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trastuzumab Emtansine', 'description': 'Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.'}, {'id': 'OG001', 'title': 'Lapatinib + Capecitabine', 'description': 'Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m\\^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.1', 'groupId': 'OG000'}, {'value': '36.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the date of randomization through the data cut-off date of 31 Jul 2012 (up to 3 years, 5 months)', 'description': 'The percentage of participants who died from any cause was reported. The results are reported from second interim analysis, which deemed to be the confirmatory.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants on the basis of the treatment assigned at randomization.'}, {'type': 'PRIMARY', 'title': 'Overall Survival: Second Interim Analysis (Co-primary Endpoint)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '495', 'groupId': 'OG000'}, {'value': '496', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trastuzumab Emtansine', 'description': 'Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.'}, {'id': 'OG001', 'title': 'Lapatinib + Capecitabine', 'description': 'Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m\\^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.9', 'groupId': 'OG000', 'lowerLimit': '26.81', 'upperLimit': '34.27'}, {'value': '25.1', 'groupId': 'OG001', 'lowerLimit': '22.74', 'upperLimit': '27.96'}]}]}], 'analyses': [{'pValue': '0.0006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.682', 'ciLowerLimit': '0.548', 'ciUpperLimit': '0.849', 'estimateComment': 'HR (relative to Lapatinib + Capecitabine) was estimated by Cox regression.', 'groupDescription': 'Analysis stratified by region of enrollment, number of prior chemotherapeutic regimens (0-1 or \\>1), and visceral/ non-visceral disease.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of randomization through the data cut-off date of 31 Jul 2012 (up to 3 years, 5 months)', 'description': 'OS was defined as the time from the date of randomization to the date of death from any cause. The median duration of OS was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley. The results are reported from second interim analysis, which deemed to be the confirmatory.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants on the basis of the treatment assigned at randomization.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Died: Final Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '495', 'groupId': 'OG000'}, {'value': '496', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trastuzumab Emtansine', 'description': 'Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.'}, {'id': 'OG001', 'title': 'Lapatinib + Capecitabine', 'description': 'Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m\\^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.'}], 'classes': [{'categories': [{'measurements': [{'value': '61.2', 'groupId': 'OG000'}, {'value': '67.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the date of randomization through the data cut-off date of 31 Dec 2014 (up to 5 years, 11 months)', 'description': 'The percentage of participants who died from any cause was reported. The results reported are from the final analysis. The final analysis is descriptive.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants on the basis of the treatment assigned at randomization.'}, {'type': 'PRIMARY', 'title': 'Overall Survival: Final Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '495', 'groupId': 'OG000'}, {'value': '496', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trastuzumab Emtansine', 'description': 'Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.'}, {'id': 'OG001', 'title': 'Lapatinib + Capecitabine', 'description': 'Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m\\^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.9', 'groupId': 'OG000', 'lowerLimit': '26.32', 'upperLimit': '34.10'}, {'value': '25.9', 'groupId': 'OG001', 'lowerLimit': '22.74', 'upperLimit': '28.32'}]}]}], 'analyses': [{'pValue': '0.0003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.749', 'ciLowerLimit': '0.639', 'ciUpperLimit': '0.877', 'estimateComment': 'HR (relative to Lapatinib + Capecitabine) was estimated by Cox regression.', 'groupDescription': 'Analysis stratified by region of enrollment, number of prior chemotherapeutic regimens (0-1 or \\>1), and visceral/ non-visceral disease.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of randomization through the data cut-off date of 31 Dec 2014 (up to 5 years, 11 months)', 'description': 'OS was defined as the time from the date of randomization to the date of death from any cause. The median duration of OS was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley. The results reported are from the final analysis. The final analysis is descriptive.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants on the basis of the treatment assigned at randomization.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Were Alive at Year 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '495', 'groupId': 'OG000'}, {'value': '496', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trastuzumab Emtansine', 'description': 'Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.'}, {'id': 'OG001', 'title': 'Lapatinib + Capecitabine', 'description': 'Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m\\^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.'}], 'classes': [{'categories': [{'measurements': [{'value': '85.3', 'groupId': 'OG000', 'lowerLimit': '82.15', 'upperLimit': '88.54'}, {'value': '78.9', 'groupId': 'OG001', 'lowerLimit': '75.19', 'upperLimit': '82.65'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Year 1', 'description': '1 year survival was defined as the percentage of participants alive 1 year after starting treatment. The results reported are from the final analysis.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants on the basis of the treatment assigned at randomization.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Were Alive at Year 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '495', 'groupId': 'OG000'}, {'value': '496', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trastuzumab Emtansine', 'description': 'Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.'}, {'id': 'OG001', 'title': 'Lapatinib + Capecitabine', 'description': 'Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m\\^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.'}], 'classes': [{'categories': [{'measurements': [{'value': '59.6', 'groupId': 'OG000', 'lowerLimit': '55.10', 'upperLimit': '64.06'}, {'value': '52.4', 'groupId': 'OG001', 'lowerLimit': '47.81', 'upperLimit': '57.08'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Year 2', 'description': '2 year survival was defined as the percentage of participants alive 2 years after starting treatment. The results reported are from the final analysis.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants on the basis of the treatment assigned at randomization.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With PD or Death as Assessed by the Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '495', 'groupId': 'OG000'}, {'value': '496', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trastuzumab Emtansine', 'description': 'Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.'}, {'id': 'OG001', 'title': 'Lapatinib + Capecitabine', 'description': 'Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m\\^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.'}], 'classes': [{'categories': [{'measurements': [{'value': '58.0', 'groupId': 'OG000'}, {'value': '67.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)', 'description': 'PD was assessed by the investigator using modified RECIST. All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as TLs and recorded at baseline. A sum of the longest diameter for all TLs was calculated as baseline SLD. PD for TLs was defined as \\>/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions. PD for non-TLs was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. The percentage of participants who died or experienced PD by Investigator was reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants on the basis of the treatment assigned at randomization.'}, {'type': 'SECONDARY', 'title': 'PFS as Assessed by the Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '495', 'groupId': 'OG000'}, {'value': '496', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trastuzumab Emtansine', 'description': 'Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.'}, {'id': 'OG001', 'title': 'Lapatinib + Capecitabine', 'description': 'Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m\\^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000', 'lowerLimit': '7.49', 'upperLimit': '10.78'}, {'value': '5.8', 'groupId': 'OG001', 'lowerLimit': '5.59', 'upperLimit': '6.93'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.658', 'ciLowerLimit': '0.560', 'ciUpperLimit': '0.774', 'estimateComment': 'HR (relative to Lapatinib + Capecitabine) was estimated by Cox regression.', 'groupDescription': 'Analysis stratified by region of enrollment, number of prior chemotherapeutic regimens (0-1 or \\>1), and visceral/ non-visceral disease.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)', 'description': 'Tumor response was assessed by the investigator according to modified RECIST. All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as TLs and recorded at baseline. A sum of the longest diameter for all TLs was calculated as baseline SLD. PD for TLs was defined as \\>/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions. PD for non-TLs was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. PFS was defined as the time from randomization to first documented PD by Investigator or death from any cause (whichever occurred earlier). The median duration of PFS was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants on the basis of the treatment assigned at randomization.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Objective Response (OR) as Assessed by an IRC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '397', 'groupId': 'OG000'}, {'value': '389', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trastuzumab Emtansine', 'description': 'Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.'}, {'id': 'OG001', 'title': 'Lapatinib + Capecitabine', 'description': 'Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m\\^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.'}], 'classes': [{'categories': [{'measurements': [{'value': '43.6', 'groupId': 'OG000', 'lowerLimit': '38.6', 'upperLimit': '48.6'}, {'value': '30.8', 'groupId': 'OG001', 'lowerLimit': '26.3', 'upperLimit': '35.7'}]}]}], 'analyses': [{'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Objective Response Rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.7', 'ciLowerLimit': '6.0', 'ciUpperLimit': '19.4', 'estimateComment': 'The 95% CI for the difference in objective response rate (Trastuzumab emtansine minus Lapatinib + Capecitabine) was computed by using the approximate normal method.', 'groupDescription': 'Analysis stratified by region of enrollment, number of prior chemotherapeutic regimens (0-1 or \\>1), and visceral/ non-visceral disease.', 'statisticalMethod': 'Mantel-Haenszel chi-squared test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)', 'description': 'Tumor response was assessed by an IRC according to modified RECIST. OR was defined as the percentage of participants with a complete response (CR) or partial response (PR). All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as TLs and recorded at baseline. A sum of the longest diameter for all TLs was calculated as baseline SLD. For TLs, a CR was defined as the disappearance of all TLs and a PR was defined as \\>/= 30% decrease in the SLD of TLs, taking as reference the baseline SLD. For non-TLs, a CR was defined as the disappearance of all non-TLs and a PR was defined as the persistence of 1 or more non-TLs. Confirmation of response at a consecutive tumor assessment at least 4 weeks apart was required. Participants without a post-baseline tumor assessment were considered non-responders. The percentage of participants with CR or PR by IRC was reported. The 95% CI was computed using Blyth-Still Casella exact CI method.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants on the basis of the treatment assigned at randomization. Only participants with measurable disease at baseline were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Duration of Objective Response (DOR) as Assessed by an IRC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trastuzumab Emtansine', 'description': 'Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.'}, {'id': 'OG001', 'title': 'Lapatinib + Capecitabine', 'description': 'Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m\\^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.6', 'groupId': 'OG000', 'lowerLimit': '8.38', 'upperLimit': '20.76'}, {'value': '6.5', 'groupId': 'OG001', 'lowerLimit': '5.45', 'upperLimit': '7.16'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)', 'description': 'Tumor response was assessed by an IRC according to modified RECIST. DOR was defined as the time from first documented OR to first documented PD or death from any cause, whichever occurred earlier. OR was defined as a CR or PR determined on 2 consecutive tumor assessments at least 4 weeks apart. For TLs, CR was defined as the disappearance of all TLs; PR was defined as \\>/=30% decrease in the SLD of TLs, taking as reference the baseline SLD; and PD was defined as \\>/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions. For non-TLs, CR was defined as the disappearance of all non-TLs; PR was defined as the persistence of 1 or more non-TLs; and PD was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. The 95% CI was computed using the method of Brookmeyer and Crowley.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants on the basis of the treatment assigned at randomization. Only participants with an objective response were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinical Benefit as Assessed by an IRC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '397', 'groupId': 'OG000'}, {'value': '389', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trastuzumab Emtansine', 'description': 'Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.'}, {'id': 'OG001', 'title': 'Lapatinib + Capecitabine', 'description': 'Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m\\^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.'}], 'classes': [{'categories': [{'measurements': [{'value': '58.2', 'groupId': 'OG000', 'lowerLimit': '53.3', 'upperLimit': '63.1'}, {'value': '44.2', 'groupId': 'OG001', 'lowerLimit': '39.2', 'upperLimit': '49.2'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Clinical Benefit Rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14', 'ciLowerLimit': '7.0', 'ciUpperLimit': '20.9', 'estimateComment': 'The 95% CI for the difference in clinical benefit rate (Trastuzumab emtansine minus Lapatinib + Capecitabine) was computed by using the normal approximation method.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)', 'description': 'Tumor response was assessed by an IRC according to modified RECIST. Participants were considered as experienced clinical benefit if they had an OR or maintained stable disease (SD) for at least 6 months from randomization. OR: CR or PR determined on 2 consecutive tumor assessments \\>/=4 weeks apart. For TLs, CR: disappearance of all TLs; PR: \\>/=30% decrease in the SLD of TLs, taking as reference the baseline SLD; PD: \\>/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or appearance of 1 or more new lesions; and SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. For non-TLs, CR: disappearance of all non-TLs; PR/SD: persistence of 1 or more non-TLs; and PD: appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. Participants without a post-baseline tumor assessment were considered non-responders. The 95% CI was computed using Blyth-Still Casella exact CI method.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants on the basis of the treatment assigned at randomization. Only participants with measurable disease at Baseline were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Treatment Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '495', 'groupId': 'OG000'}, {'value': '496', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trastuzumab Emtansine', 'description': 'Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.'}, {'id': 'OG001', 'title': 'Lapatinib + Capecitabine', 'description': 'Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m\\^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.'}], 'classes': [{'categories': [{'measurements': [{'value': '63.2', 'groupId': 'OG000'}, {'value': '74.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)', 'description': 'Treatment failure was defined as discontinuation of treatment for any reason, including PD (per investigator review), treatment toxicity, or death from any cause. For "Lapatinib + Capecitabine" arm, a participant was considered as treatment failure only if both drugs were discontinued. For TLs, PD was defined as \\>/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions. For non-TLs, PD was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. Percentage of participants with treatment failure was reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants on the basis of the treatment assigned at randomization.'}, {'type': 'SECONDARY', 'title': 'Time to Treatment Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '495', 'groupId': 'OG000'}, {'value': '496', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trastuzumab Emtansine', 'description': 'Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.'}, {'id': 'OG001', 'title': 'Lapatinib + Capecitabine', 'description': 'Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m\\^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.9', 'groupId': 'OG000', 'lowerLimit': '6.41', 'upperLimit': '9.00'}, {'value': '5.8', 'groupId': 'OG001', 'lowerLimit': '5.52', 'upperLimit': '6.31'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.703', 'ciLowerLimit': '0.602', 'ciUpperLimit': '0.820', 'estimateComment': 'HR (relative to Lapatinib + Capecitabine) was estimated by Cox regression.', 'groupDescription': 'Analysis stratified by region of enrollment, number of prior chemotherapeutic regimens (0-1 or \\>1), and visceral/ non-visceral disease.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)', 'description': 'Time to treatment failure was defined as the time from randomization to discontinuation of treatment for any reason, including PD (per investigator review), treatment toxicity, or death from any cause. For "Lapatinib + Capecitabine" arm, a participant was considered as treatment failure only if both drugs were discontinued with treatment failure date as the later of the 2 discontinuation dates. For TLs, PD was defined as \\>/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions. For non-TLs, PD was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. The median time to treatment failure was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants on the basis of the treatment assigned at randomization.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Symptom Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '450', 'groupId': 'OG000'}, {'value': '445', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trastuzumab Emtansine', 'description': 'Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.'}, {'id': 'OG001', 'title': 'Lapatinib + Capecitabine', 'description': 'Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m\\^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.'}], 'classes': [{'categories': [{'measurements': [{'value': '54.7', 'groupId': 'OG000'}, {'value': '57.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)', 'description': 'Symptom progression was defined as the documentation of a \\>/= 5-point decrease from baseline in the scoring of responses as measured by the Functional Assessment of Cancer Therapy-for participants with Breast Cancer (FACT-B) questionnaire with the Trial Outcomes Index-Physical/Functional/Breast (TOI-PFB) subscale. The FACT-B TOI-PFB subscale contained 24 items from 3 subsections of the FACT-B questionnaire: Physical well-being, functional well-being, and additional concerns for breast cancer participants (breast cancer subscale \\[BCS\\]). All items in the questionnaire were rated by the participant on a 5-point scale ranging from 0 ("not at all") to 4 ("very much"). The total score ranged from 0 to 96 with higher score indicating better perceived quality of life. The percentage of participants with symptom progression was reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants on the basis of the treatment assigned at randomization. Only female participants with a Baseline assessment and at least 1 follow-up assessment were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Time to Symptom Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '450', 'groupId': 'OG000'}, {'value': '445', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trastuzumab Emtansine', 'description': 'Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.'}, {'id': 'OG001', 'title': 'Lapatinib + Capecitabine', 'description': 'Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m\\^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000', 'lowerLimit': '5.59', 'upperLimit': '8.44'}, {'value': '4.6', 'groupId': 'OG001', 'lowerLimit': '4.14', 'upperLimit': '5.78'}]}]}], 'analyses': [{'pValue': '0.0121', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.796', 'ciLowerLimit': '0.667', 'ciUpperLimit': '0.951', 'estimateComment': 'HR (relative to Lapatinib + Capecitabine) was estimated by Cox regression.', 'groupDescription': 'Analysis stratified by region of enrollment, number of prior chemotherapeutic regimens (0-1 or \\>1), and visceral/ non-visceral disease.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)', 'description': 'Time to symptom progression was defined as the time from randomization to the first documentation of a \\>/= 5-point decrease from baseline in the scoring of responses as measured by the FACT-B questionnaire with the TOI-PFB subscale. The FACT-B TOI-PFB subscale contained 24 items from 3 subsections of the FACT-B questionnaire: Physical well-being, functional well-being, and additional concerns for breast cancer participants (BCS). All items in the questionnaire were rated by the participant on a 5-point scale ranging from 0 ("not at all") to 4 ("very much"). The total score ranged from 0 to 96 with higher score indicating better perceived quality of life. The median time to symptom progression was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants on the basis of the treatment assigned at randomization. Only female participants with a Baseline assessment and at least 1 follow-up assessment were included in the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Trastuzumab Emtansine', 'description': 'Participants received trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) intravenous (IV) infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until disease progression (PD) (as assessed by the investigator), unmanageable toxicity, or study termination.'}, {'id': 'FG001', 'title': 'Lapatinib + Capecitabine', 'description': 'Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 milligrams per square meter (mg/m\\^2) orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '495'}, {'groupId': 'FG001', 'numSubjects': '496'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '490'}, {'groupId': 'FG001', 'numSubjects': '488'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '495'}, {'groupId': 'FG001', 'numSubjects': '496'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '305'}, {'groupId': 'FG001', 'numSubjects': '333'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': "Physician's Decision", 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': "Subject's Decision", 'reasons': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '55'}]}, {'type': "Sponsor's Decision", 'reasons': [{'groupId': 'FG000', 'numSubjects': '137'}, {'groupId': 'FG001', 'numSubjects': '98'}]}, {'type': 'Reason Not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'preAssignmentDetails': 'Participants of "Lapatinib + Capecitabine" arm were allowed to cross over to receive trastuzumab emtansine based on statistically significant Overall Survival (OS) benefit in favor of trastuzumab emtansine demonstrated in second interim analysis (cut-off date 31 July 2012). The safety analysis of the arm was then reported.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '495', 'groupId': 'BG000'}, {'value': '496', 'groupId': 'BG001'}, {'value': '991', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Trastuzumab Emtansine', 'description': 'Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.'}, {'id': 'BG001', 'title': 'Lapatinib + Capecitabine', 'description': 'Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m\\^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.2', 'spread': '11.0', 'groupId': 'BG000'}, {'value': '53.2', 'spread': '10.8', 'groupId': 'BG001'}, {'value': '52.7', 'spread': '10.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '494', 'groupId': 'BG000'}, {'value': '492', 'groupId': 'BG001'}, {'value': '986', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-treat (ITT) population included all randomized participants on the basis of the treatment assigned at randomization.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 991}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-10', 'studyFirstSubmitDate': '2009-01-22', 'resultsFirstSubmitDate': '2013-02-22', 'studyFirstSubmitQcDate': '2009-01-22', 'lastUpdatePostDateStruct': {'date': '2016-10-31', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-04-22', 'studyFirstPostDateStruct': {'date': '2009-01-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-04-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With PD or Death as Assessed by an Independent Review Committee (IRC)', 'timeFrame': 'From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)', 'description': 'PD was assessed by an IRC using modified Response Evaluation Criteria in Solid Tumors (RECIST). All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as target lesions (TLs) and recorded at baseline. TLs should be selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements either by imaging or clinically. A sum of the longest diameter for all TLs was calculated as baseline sum longest diameter (SLD). All other lesions (or sites of disease) should be identified as non-TLs and recorded at baseline. PD for TLs was defined as greater than or equal to (\\>/=) 20 percent (%) increase in SLD, taking as reference smallest SLD recorded since treatment started or appearance of 1 or more new lesions. PD for non-TLs was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. Percentage of Participants with PD by IRC or death from any cause was reported.'}, {'measure': 'Progression-free Survival (PFS) as Assessed by an IRC (Co-primary Endpoint)', 'timeFrame': 'From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)', 'description': 'Tumor response was assessed by an IRC according to modified RECIST. All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as TLs (on the basis of their size and their suitability for accurate repeated measurements either by imaging or clinically) and recorded at baseline. A sum of the longest diameter for all TLs was calculated as baseline SLD. All other lesions were identified as non-TLs and recorded at baseline. PD for TLs: \\>/= 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or appearance of 1 or more new lesions. PD for non-TLs: appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. PFS: time from randomization to first documented PD by IRC or death from any cause (whichever occurred earlier). The median duration of PFS was estimated using Kaplan-Meier method. The 95% confidence interval (CI) was computed using the method of Brookmeyer and Crowley.'}, {'measure': 'Percentage of Participants Who Died: Second Interim Analysis', 'timeFrame': 'From the date of randomization through the data cut-off date of 31 Jul 2012 (up to 3 years, 5 months)', 'description': 'The percentage of participants who died from any cause was reported. The results are reported from second interim analysis, which deemed to be the confirmatory.'}, {'measure': 'Overall Survival: Second Interim Analysis (Co-primary Endpoint)', 'timeFrame': 'From the date of randomization through the data cut-off date of 31 Jul 2012 (up to 3 years, 5 months)', 'description': 'OS was defined as the time from the date of randomization to the date of death from any cause. The median duration of OS was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley. The results are reported from second interim analysis, which deemed to be the confirmatory.'}, {'measure': 'Percentage of Participants Who Died: Final Analysis', 'timeFrame': 'From the date of randomization through the data cut-off date of 31 Dec 2014 (up to 5 years, 11 months)', 'description': 'The percentage of participants who died from any cause was reported. The results reported are from the final analysis. The final analysis is descriptive.'}, {'measure': 'Overall Survival: Final Analysis', 'timeFrame': 'From the date of randomization through the data cut-off date of 31 Dec 2014 (up to 5 years, 11 months)', 'description': 'OS was defined as the time from the date of randomization to the date of death from any cause. The median duration of OS was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley. The results reported are from the final analysis. The final analysis is descriptive.'}, {'measure': 'Percentage of Participants Who Were Alive at Year 1', 'timeFrame': 'Year 1', 'description': '1 year survival was defined as the percentage of participants alive 1 year after starting treatment. The results reported are from the final analysis.'}, {'measure': 'Percentage of Participants Who Were Alive at Year 2', 'timeFrame': 'Year 2', 'description': '2 year survival was defined as the percentage of participants alive 2 years after starting treatment. The results reported are from the final analysis.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With PD or Death as Assessed by the Investigator', 'timeFrame': 'From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)', 'description': 'PD was assessed by the investigator using modified RECIST. All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as TLs and recorded at baseline. A sum of the longest diameter for all TLs was calculated as baseline SLD. PD for TLs was defined as \\>/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions. PD for non-TLs was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. The percentage of participants who died or experienced PD by Investigator was reported.'}, {'measure': 'PFS as Assessed by the Investigator', 'timeFrame': 'From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)', 'description': 'Tumor response was assessed by the investigator according to modified RECIST. All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as TLs and recorded at baseline. A sum of the longest diameter for all TLs was calculated as baseline SLD. PD for TLs was defined as \\>/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions. PD for non-TLs was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. PFS was defined as the time from randomization to first documented PD by Investigator or death from any cause (whichever occurred earlier). The median duration of PFS was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley.'}, {'measure': 'Percentage of Participants With Objective Response (OR) as Assessed by an IRC', 'timeFrame': 'From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)', 'description': 'Tumor response was assessed by an IRC according to modified RECIST. OR was defined as the percentage of participants with a complete response (CR) or partial response (PR). All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as TLs and recorded at baseline. A sum of the longest diameter for all TLs was calculated as baseline SLD. For TLs, a CR was defined as the disappearance of all TLs and a PR was defined as \\>/= 30% decrease in the SLD of TLs, taking as reference the baseline SLD. For non-TLs, a CR was defined as the disappearance of all non-TLs and a PR was defined as the persistence of 1 or more non-TLs. Confirmation of response at a consecutive tumor assessment at least 4 weeks apart was required. Participants without a post-baseline tumor assessment were considered non-responders. The percentage of participants with CR or PR by IRC was reported. The 95% CI was computed using Blyth-Still Casella exact CI method.'}, {'measure': 'Duration of Objective Response (DOR) as Assessed by an IRC', 'timeFrame': 'From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)', 'description': 'Tumor response was assessed by an IRC according to modified RECIST. DOR was defined as the time from first documented OR to first documented PD or death from any cause, whichever occurred earlier. OR was defined as a CR or PR determined on 2 consecutive tumor assessments at least 4 weeks apart. For TLs, CR was defined as the disappearance of all TLs; PR was defined as \\>/=30% decrease in the SLD of TLs, taking as reference the baseline SLD; and PD was defined as \\>/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions. For non-TLs, CR was defined as the disappearance of all non-TLs; PR was defined as the persistence of 1 or more non-TLs; and PD was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. The 95% CI was computed using the method of Brookmeyer and Crowley.'}, {'measure': 'Percentage of Participants With Clinical Benefit as Assessed by an IRC', 'timeFrame': 'From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)', 'description': 'Tumor response was assessed by an IRC according to modified RECIST. Participants were considered as experienced clinical benefit if they had an OR or maintained stable disease (SD) for at least 6 months from randomization. OR: CR or PR determined on 2 consecutive tumor assessments \\>/=4 weeks apart. For TLs, CR: disappearance of all TLs; PR: \\>/=30% decrease in the SLD of TLs, taking as reference the baseline SLD; PD: \\>/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or appearance of 1 or more new lesions; and SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. For non-TLs, CR: disappearance of all non-TLs; PR/SD: persistence of 1 or more non-TLs; and PD: appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. Participants without a post-baseline tumor assessment were considered non-responders. The 95% CI was computed using Blyth-Still Casella exact CI method.'}, {'measure': 'Percentage of Participants With Treatment Failure', 'timeFrame': 'From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)', 'description': 'Treatment failure was defined as discontinuation of treatment for any reason, including PD (per investigator review), treatment toxicity, or death from any cause. For "Lapatinib + Capecitabine" arm, a participant was considered as treatment failure only if both drugs were discontinued. For TLs, PD was defined as \\>/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions. For non-TLs, PD was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. Percentage of participants with treatment failure was reported.'}, {'measure': 'Time to Treatment Failure', 'timeFrame': 'From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)', 'description': 'Time to treatment failure was defined as the time from randomization to discontinuation of treatment for any reason, including PD (per investigator review), treatment toxicity, or death from any cause. For "Lapatinib + Capecitabine" arm, a participant was considered as treatment failure only if both drugs were discontinued with treatment failure date as the later of the 2 discontinuation dates. For TLs, PD was defined as \\>/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions. For non-TLs, PD was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. The median time to treatment failure was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley.'}, {'measure': 'Percentage of Participants With Symptom Progression', 'timeFrame': 'From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)', 'description': 'Symptom progression was defined as the documentation of a \\>/= 5-point decrease from baseline in the scoring of responses as measured by the Functional Assessment of Cancer Therapy-for participants with Breast Cancer (FACT-B) questionnaire with the Trial Outcomes Index-Physical/Functional/Breast (TOI-PFB) subscale. The FACT-B TOI-PFB subscale contained 24 items from 3 subsections of the FACT-B questionnaire: Physical well-being, functional well-being, and additional concerns for breast cancer participants (breast cancer subscale \\[BCS\\]). All items in the questionnaire were rated by the participant on a 5-point scale ranging from 0 ("not at all") to 4 ("very much"). The total score ranged from 0 to 96 with higher score indicating better perceived quality of life. The percentage of participants with symptom progression was reported.'}, {'measure': 'Time to Symptom Progression', 'timeFrame': 'From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)', 'description': 'Time to symptom progression was defined as the time from randomization to the first documentation of a \\>/= 5-point decrease from baseline in the scoring of responses as measured by the FACT-B questionnaire with the TOI-PFB subscale. The FACT-B TOI-PFB subscale contained 24 items from 3 subsections of the FACT-B questionnaire: Physical well-being, functional well-being, and additional concerns for breast cancer participants (BCS). All items in the questionnaire were rated by the participant on a 5-point scale ranging from 0 ("not at all") to 4 ("very much"). The total score ranged from 0 to 96 with higher score indicating better perceived quality of life. The median time to symptom progression was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '28526536', 'type': 'DERIVED', 'citation': 'Dieras V, Miles D, Verma S, Pegram M, Welslau M, Baselga J, Krop IE, Blackwell K, Hoersch S, Xu J, Green M, Gianni L. Trastuzumab emtansine versus capecitabine plus lapatinib in patients with previously treated HER2-positive advanced breast cancer (EMILIA): a descriptive analysis of final overall survival results from a randomised, open-label, phase 3 trial. Lancet Oncol. 2017 Jun;18(6):732-742. doi: 10.1016/S1470-2045(17)30312-1. Epub 2017 May 16.'}, {'pmid': '23020162', 'type': 'DERIVED', 'citation': 'Verma S, Miles D, Gianni L, Krop IE, Welslau M, Baselga J, Pegram M, Oh DY, Dieras V, Guardino E, Fang L, Lu MW, Olsen S, Blackwell K; EMILIA Study Group. Trastuzumab emtansine for HER2-positive advanced breast cancer. N Engl J Med. 2012 Nov 8;367(19):1783-91. doi: 10.1056/NEJMoa1209124. Epub 2012 Oct 1.'}, {'pmid': '22437872', 'type': 'DERIVED', 'citation': 'Scott AM, Wolchok JD, Old LJ. Antibody therapy of cancer. Nat Rev Cancer. 2012 Mar 22;12(4):278-87. doi: 10.1038/nrc3236.'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase III, randomized, multicenter, international, 2-arm, open-label clinical trial designed to compare the safety and efficacy of trastuzumab emtansine (T-DM1) with that of capecitabine + lapatinib in participants with human epidermal growth factor receptor 2 (HER2)-positive locally advanced or metastatic breast cancer. Participants will be treated until disease progression (PD), unmanageable toxicity, or study termination. Once disease progression is reported, all participants will be followed for survival every 3 months until death, loss to follow-up, withdrawal of consent, or study termination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HER2 status must be prospectively, centrally tested and be HER2-positive based on central laboratory assay results\n* Histologically or cytologically confirmed invasive breast cancer\n* Prior treatment for breast cancer in the adjuvant, unresectable, locally advanced, or metastatic setting must include both a taxane, alone or in combination with another agent, and trastuzumab, alone or in combination with another agent\n* Documented progression (which occur during or after most recent treatment or within 6 months after completing of adjuvant therapy) of incurable, unresectable, locally advanced or metastatic breast cancer, defined by the investigator\n* Measurable and/or nonmeasurable disease; participants with central nervous system-only disease are excluded\n* Cardiac ejection fraction greater than or equal to (\\>/=) 50 percent (%) by either echocardiogram or multi-gated acquisition scan\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* For women of childbearing potential and men with partners of childbearing potential, agreement to use a highly effective, non-hormonal form of contraception; contraception use should continue for the duration of the study treatment and for at least 6 months after the last dose of study treatment\n\nExclusion Criteria:\n\n* History of treatment with trastuzumab emtansine\n* Prior treatment with lapatinib or capecitabine\n* Peripheral neuropathy of Grade \\>/= 3 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 3.0\n* History of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage 1 uterine cancer, synchronous or previously diagnosed HER2-positive breast cancer, or cancers with a similar curative outcome as those mentioned above\n* History of receiving any anti-cancer drug/biologic or investigational treatment within 21 days prior to randomization except hormone therapy, which could be given up to 7 days prior to randomization; recovery of treatment-related toxicity consistent with other eligibility criteria\n* History of radiation therapy within 14 days of randomization\n* Brain metastases that are untreated, symptomatic, or require therapy to control symptoms, as well as any history of radiation, surgery, or other therapy, including steroids, to control symptoms from brain metastases within 2 months (60 days) of randomization\n* History of symptomatic congestive heart failure or serious cardiac arrhythmia requiring treatment\n* History of myocardial infarction or unstable angina within 6 months of randomization\n* Current dyspnea at rest due to complications of advanced malignancy or current requirement for continuous oxygen therapy\n* Current severe, uncontrolled systemic disease (for example, clinically significant cardiovascular, pulmonary, or metabolic disease)\n* Pregnancy or lactation\n* Current known active infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus\n* Presence of conditions that could affect gastrointestinal absorption: Malabsorption syndrome, resection of the small bowel or stomach, and ulcerative colitis\n* History of intolerance (such as Grade 3-4 infusion reaction) to trastuzumab\n* Known hypersensitivity to 5-fluorouracil or known dihydropyrimidine dehydrogenase deficiency\n* Current treatment with sorivudine or its chemically related analogs, such as brivudine'}, 'identificationModule': {'nctId': 'NCT00829166', 'acronym': 'EMILIA', 'briefTitle': 'A Study of Trastuzumab Emtansine Versus Capecitabine + Lapatinib in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Randomized, Multicenter, Phase III Open-label Study of the Efficacy and Safety of Trastuzumab MCC-DM1 vs. Capecitabine + Lapatinib in Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab-Based Therapy', 'orgStudyIdInfo': {'id': 'BO21977'}, 'secondaryIdInfos': [{'id': 'TDM4370g', 'type': 'OTHER', 'domain': 'Genentech'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Trastuzumab emtansine', 'description': 'Participants will receive trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) intravenous (IV) infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until disease progression (PD) (as assessed by the investigator), unmanageable toxicity, or study termination.', 'interventionNames': ['Drug: Trastuzumab emtansine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lapatinib + Capecitabine', 'description': 'Participants will receive lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 milligrams per square meter (mg/m\\^2) orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Eligible participants will cross over to receive trastuzumab emtansine if second interim analysis demonstrates statistically significant overall survival benefit in favor of trastuzumab emtansine.', 'interventionNames': ['Drug: Lapatinib', 'Drug: Capecitabine']}], 'interventions': [{'name': 'Trastuzumab emtansine', 'type': 'DRUG', 'otherNames': ['T-DM1', 'Trastuzumab-MCC-DM1', 'RO5304020'], 'description': 'Trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle.', 'armGroupLabels': ['Trastuzumab emtansine']}, {'name': 'Lapatinib', 'type': 'DRUG', 'otherNames': ['Tykerb', 'Tyverb'], 'description': 'Lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle.', 'armGroupLabels': ['Lapatinib + Capecitabine']}, {'name': 'Capecitabine', 'type': 'DRUG', 'otherNames': ['Xeloda'], 'description': 'Capecitabine 1000 mg/m\\^2 orally twice daily on Days 1-14 of each 21-day treatment cycle.', 'armGroupLabels': ['Lapatinib + Capecitabine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '85719', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '92807', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '93309', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '91706', 'city': 'Baldwin Park', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.08529, 'lon': -117.9609}}, {'zip': '90706', 'city': 'Bellflower', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 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