Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-02-27 @ 10:33 AM
Study NCT ID:
NCT02614794
Status:
COMPLETED
Last Update Posted:
2023-08-14
First Post:
2015-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Tucatinib vs. Placebo in Combination With Capecitabine & Trastuzumab in Patients With Advanced HER2+ Breast Cancer
Sponsor:
Organization:
Raw JSON
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'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@seagen.com', 'phone': '(855)473-2436', 'title': 'Chief Medical Officer', 'organization': 'Seattle Genetics, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 60.1 months', 'eventGroups': [{'id': 'EG000', 'title': 'Tuc+Cap+Tra', 'description': 'Tucatinib in combination with capecitabine \\& trastuzumab', 'otherNumAtRisk': 404, 'deathsNumAtRisk': 410, 'otherNumAffected': 399, 'seriousNumAtRisk': 404, 'deathsNumAffected': 262, 'seriousNumAffected': 124}, {'id': 'EG001', 'title': 'Pbo+Cap+Tra', 'description': 'Placebo in combination with capecitabine \\& trastuzumab', 'otherNumAtRisk': 197, 'deathsNumAtRisk': 202, 'otherNumAffected': 188, 'seriousNumAtRisk': 197, 'deathsNumAffected': 152, 'seriousNumAffected': 62}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numEvents': 146, 'numAffected': 89}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 32, 'numAffected': 24}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numEvents': 87, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 40, 'numAffected': 17}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numEvents': 41, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 15, 'numAffected': 11}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numEvents': 25, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numEvents': 30, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 13, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numEvents': 98, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 40, 'numAffected': 32}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numEvents': 43, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 20, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numEvents': 90, 'numAffected': 69}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 46, 'numAffected': 40}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numEvents': 812, 'numAffected': 330}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 181, 'numAffected': 106}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG001', 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87}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numEvents': 146, 'numAffected': 105}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 35, 'numAffected': 28}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numEvents': 276, 'numAffected': 155}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 80, 'numAffected': 49}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numEvents': 46, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 19, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numEvents': 265, 'numAffected': 193}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 108, 'numAffected': 87}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numEvents': 31, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numEvents': 52, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 25, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numEvents': 35, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numEvents': 69, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 17, 'numAffected': 8}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numEvents': 28, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Paronychia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numEvents': 30, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numEvents': 70, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 18, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numEvents': 76, 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'numAffected': 92}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 32, 'numAffected': 23}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numEvents': 47, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numEvents': 154, 'numAffected': 81}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 31, 'numAffected': 21}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numEvents': 108, 'numAffected': 65}, {'groupId': 'EG001', 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'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numEvents': 57, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numEvents': 130, 'numAffected': 108}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 51, 'numAffected': 41}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numEvents': 40, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 13, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numEvents': 40, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numEvents': 105, 'numAffected': 71}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 32, 'numAffected': 24}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numEvents': 61, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numEvents': 50, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numEvents': 120, 'numAffected': 80}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 25, 'numAffected': 17}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numEvents': 73, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 27, 'numAffected': 25}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numEvents': 63, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numEvents': 25, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numEvents': 43, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numEvents': 66, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 22, 'numAffected': 18}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numEvents': 68, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 30, 'numAffected': 27}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numEvents': 33, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numEvents': 150, 'numAffected': 98}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 53, 'numAffected': 38}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numEvents': 32, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numEvents': 65, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 17, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numEvents': 45, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 18, 'numAffected': 17}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numEvents': 85, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 31, 'numAffected': 24}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numEvents': 60, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 27, 'numAffected': 23}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 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{'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Vena cava thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Cardiac Failure Congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Acetabulum fracture', 'stats': [{'groupId': 'EG000', 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[{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '36.1 months', 'description': 'As determined by assessment of AEs, clinical laboratory tests, and vital signs measurements. AEs were classified by system organ class (SOC) and preferred term using the Medical Dictionary for Regulatory Activities (MedDRA) Version 22.0 or higher; AE severities were classified using Version 4.03 of the (Common Terminology Criteria for Adverse Events) CTCAE criteria.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment (tucatinib/placebo, trastuzumab, or capecitabine), with participants allocated to the treatment group associated with the regimen actually received.'}, {'type': 'SECONDARY', 'title': 'Frequency of Dose Modifications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '404', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tuc+Cap+Tra', 'description': 'Tucatinib in combination with capecitabine \\& trastuzumab'}, {'id': 'OG001', 'title': 'Pbo+Cap+Tra', 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'categories': [{'measurements': [{'value': '243', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}]}, {'title': 'TEAEs resulting trastuzumab dose modification', 'categories': [{'measurements': [{'value': '104', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}, {'title': 'TEAEs resulting in trastuzumab dose hold', 'categories': [{'measurements': [{'value': '104', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '35.1 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment (tucatinib/placebo, trastuzumab, or capecitabine), with participants allocated to the treatment group associated with the regimen actually received.'}, {'type': 'SECONDARY', 'title': 'Incidence of Health Resources Utilization', 'denoms': [{'units': 'Participants', 'counts': 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[{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '36.1 months', 'description': 'Cumulative incidence of health resource utilization, including length of stay, hospitalizations, and ER visits using the EQ-5D-5L questionnaire.', 'unitOfMeasure': 'hospitalizations', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment (tucatinib/placebo, trastuzumab, or capecitabine), with participants allocated to the treatment group associated with the regimen actually received.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetic Measure: Ctrough of Tucatinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '373', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tuc+Cap+Tra', 'description': 'Tucatinib in combination with capecitabine \\& trastuzumab'}], 'classes': [{'title': 'Cycle 2, Day 1 (Pre-dose)', 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'populationDescription': 'Pharmacokinetics (PK) Analysis Set: Includes all randomized participants who received at least one dose of tucatinib and who had at least one evaluable PK assessment. Participants were evaluated by the treatment actually received.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetic Measure: ONT-993', 'denoms': [{'units': 'Participants', 'counts': [{'value': '373', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tuc+Cap+Tra', 'description': 'Tucatinib in combination with capecitabine \\& trastuzumab'}], 'classes': [{'title': 'Cycle 2, Day 1 (Pre-dose)', 'categories': [{'measurements': [{'value': '25.5', 'spread': '24.4', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 3, Day 1 (Pre-dose)', 'categories': [{'measurements': [{'value': '22.6', 'spread': '20.6', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 3, Day 1 (Post-dose)', 'categories': [{'measurements': [{'value': '47.7', 'spread': '47.2', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4, Day 1 (Pre-dose)', 'categories': [{'measurements': [{'value': '25.2', 'spread': '24.3', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 5, Day 1 (Pre-dose)', 'categories': [{'measurements': [{'value': '24.5', 'spread': '30.6', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 6, Day 1 (Pre-dose)', 'categories': [{'measurements': [{'value': '20.9', 'spread': '18.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3.5 months', 'description': 'Individual plasma primary metabolite concentrations at each sampling time', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis Set: Includes all randomized participants who received at least one dose of tucatinib and who had at least one evaluable PK assessment. Participants were evaluated by the treatment actually received.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS) at Time of Final Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '410', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tuc+Cap+Tra', 'description': 'Tucatinib in combination with capecitabine \\& trastuzumab'}, {'id': 'OG001', 'title': 'Pbo+Cap+Tra', 'description': 'Placebo in combination with capecitabine \\& trastuzumab'}], 'classes': [{'categories': [{'measurements': [{'value': '24.7', 'groupId': 'OG000', 'lowerLimit': '21.6', 'upperLimit': '28.9'}, {'value': '19.2', 'groupId': 'OG001', 'lowerLimit': '16.4', 'upperLimit': '21.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 60.1 months', 'description': 'Defined as time from randomization to death from any cause', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-OS Population: Includes all randomized participants evaluated by their randomized treatment assignment.'}, {'type': 'SECONDARY', 'title': 'PFS Per RECIST 1.1 as Determined by Investigator Assessment at Time of Final Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '410', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tuc+Cap+Tra', 'description': 'Tucatinib in combination with capecitabine \\& trastuzumab'}, {'id': 'OG001', 'title': 'Pbo+Cap+Tra', 'description': 'Placebo in combination with capecitabine \\& trastuzumab'}], 'classes': [{'categories': [{'measurements': [{'value': '7.6', 'groupId': 'OG000', 'lowerLimit': '4.1', 'upperLimit': '13.8'}, {'value': '4.9', 'groupId': 'OG001', 'lowerLimit': '2.7', 'upperLimit': '9.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 58.0 months', 'description': 'Defined as the time from the date of randomization to the date of documented disease progression', 'unitOfMeasure': 'months', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-OS Population: Includes all randomized participants evaluated by their randomized treatment assignment.'}, {'type': 'SECONDARY', 'title': 'Incidence of Adverse Events (AEs) at Time of Final Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '404', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tuc+Cap+Tra', 'description': 'Tucatinib in combination with capecitabine \\& trastuzumab'}, {'id': 'OG001', 'title': 'Pbo+Cap+Tra', 'description': 'Placebo in combination with capecitabine \\& trastuzumab'}], 'classes': [{'title': 'Any treatment-emergent AE (TEAE)', 'categories': [{'measurements': [{'value': '401', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}]}, {'title': 'Any Grade 3 or higher TEAE', 'categories': [{'measurements': [{'value': '248', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}]}, {'title': 'Any treatment-emergent serious AE', 'categories': [{'measurements': [{'value': '123', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}]}, {'title': 'TEAE leading to death', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 60.1 months', 'description': 'As determined by assessment of AEs, clinical laboratory tests, and vital signs measurements. 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'FG001', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Hospital closure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '410', 'groupId': 'BG000'}, {'value': '202', 'groupId': 'BG001'}, {'value': '612', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Tuc+Cap+Tra', 'description': 'Tucatinib in combination with capecitabine \\& trastuzumab'}, {'id': 'BG001', 'title': 'Pbo+Cap+Tra', 'description': 'Placebo in combination with capecitabine \\& trastuzumab'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '328', 'groupId': 'BG000'}, {'value': '168', 'groupId': 'BG001'}, {'value': '496', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000', 'lowerLimit': '22', 'upperLimit': '80'}, {'value': '54', 'groupId': 'BG001', 'lowerLimit': '25', 'upperLimit': '82'}, {'value': '54', 'groupId': 'BG002', 'lowerLimit': '22', 'upperLimit': '82'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, 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'0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '220', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '331', 'groupId': 'BG002'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}, {'title': 'Denmark', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': 'Israel', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '4', 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'Participants'}, {'title': 'Eastern Cooperative Oncology Group (ECOG) Performance Status', 'classes': [{'categories': [{'title': '0: Normal activity', 'measurements': [{'value': '204', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '298', 'groupId': 'BG002'}]}, {'title': '1: Symptoms, but ambulatory', 'measurements': [{'value': '206', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '314', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': '0=Normal activity; 1=Symptoms but ambulatory; 2=In bed \\<50% of the time; 3= In bed \\>50% of the time; 4=100% bedridden; 5=Dead', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-treat Overall Survival (ITT-OS) Population: Includes all randomized participants evaluated by their randomized treatment assignment.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-06-30', 'size': 2022879, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-07-26T11:59', 'hasProtocol': True}, {'date': '2019-08-07', 'size': 857000, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-07-26T11:59', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Masking applied only during the Double-blind phase of the trial. The Unblinded Phase is open-label.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 612}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT04220203', 'statusForNctId': 'APPROVED_FOR_MARKETING', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2022-08-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-26', 'studyFirstSubmitDate': '2015-11-20', 'resultsFirstSubmitDate': '2020-09-04', 'studyFirstSubmitQcDate': '2015-11-23', 'lastUpdatePostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-04', 'studyFirstPostDateStruct': {'date': '2015-11-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free Survival (PFS) Per RECIST 1.1 as Determined by Blinded Independent Central Review (BICR)', 'timeFrame': '34.6 months', 'description': 'Defined as the time from the date of randomization to the date of documented disease progression.'}], 'secondaryOutcomes': [{'measure': 'PFS in Patients With Brain Metastases at Baseline Using RECIST 1.1 as Determined by BICR', 'timeFrame': '34.6 months', 'description': 'Defined as the time from the date of randomization to the date of documented disease progression.'}, {'measure': 'Overall Survival (OS) at Time of Primary Analysis', 'timeFrame': '35.9 months', 'description': 'Defined as time from randomization to death from any cause'}, {'measure': 'Confirmed Objective Response Rate (ORR) Per RECIST 1.1 as Determined by BICR', 'timeFrame': '34.6 months', 'description': 'Defined as achieving a best overall response of confirmed complete response (CR) or confirmed partial response (PR).'}, {'measure': 'ORR Per RECIST 1.1 as Determined by Investigator Assessment', 'timeFrame': '34.6 months', 'description': 'Defined as achieving a best overall response of confirmed CR or confirmed PR.'}, {'measure': 'PFS Per RECIST 1.1 as Determined by Investigator Assessment at Time of Primary Analysis', 'timeFrame': '34.6 months', 'description': 'Defined as the time from the date of randomization to the date of documented disease progression'}, {'measure': 'Duration of Response (DOR) Per RECIST 1.1 as Determined by BICR', 'timeFrame': '24.6 months', 'description': 'Defined as the time from the first objective response to documented disease progression or death from any cause, whichever occurred first.'}, {'measure': 'DOR Per RECIST 1.1 as Determined by Investigator Assessment', 'timeFrame': '33.2 months', 'description': 'Defined as the time from the first objective response to documented disease progression or death from any cause, whichever occurred first.'}, {'measure': 'Clinical Benefit Rate (CBR) as Determined by BICR Per RECIST 1.1', 'timeFrame': '34.6 months', 'description': 'Clinical benefit was defined as achieving stable disease (SD) or non-complete response (CR)/non-progressive disease (PD) for at least 6 months or a best overall response of confirmed CR or confirmed partial response (PR).'}, {'measure': 'CBR Per RECIST 1.1 as Determined by Investigator Assessment', 'timeFrame': '34.6 months', 'description': 'Clinical benefit was defined as achieving stable disease (SD) or non-CR/non-PD for at least 6 months or a best overall response of confirmed CR or confirmed PR.'}, {'measure': 'Incidence of Adverse Events (AEs) at Time of Primary Analysis', 'timeFrame': '36.1 months', 'description': 'As determined by assessment of AEs, clinical laboratory tests, and vital signs measurements. AEs were classified by system organ class (SOC) and preferred term using the Medical Dictionary for Regulatory Activities (MedDRA) Version 22.0 or higher; AE severities were classified using Version 4.03 of the (Common Terminology Criteria for Adverse Events) CTCAE criteria.'}, {'measure': 'Frequency of Dose Modifications', 'timeFrame': '35.1 months'}, {'measure': 'Incidence of Health Resources Utilization', 'timeFrame': '36.1 months', 'description': 'Cumulative incidence of health resource utilization, including length of stay, hospitalizations, and ER visits using the EQ-5D-5L questionnaire.'}, {'measure': 'Pharmacokinetic Measure: Ctrough of Tucatinib', 'timeFrame': '3.5 months', 'description': 'Individual plasma tucatinib concentrations at each sampling time'}, {'measure': 'Pharmacokinetic Measure: ONT-993', 'timeFrame': '3.5 months', 'description': 'Individual plasma primary metabolite concentrations at each sampling time'}, {'measure': 'Overall Survival (OS) at Time of Final Analysis', 'timeFrame': 'Up to 60.1 months', 'description': 'Defined as time from randomization to death from any cause'}, {'measure': 'PFS Per RECIST 1.1 as Determined by Investigator Assessment at Time of Final Analysis', 'timeFrame': 'Up to 58.0 months', 'description': 'Defined as the time from the date of randomization to the date of documented disease progression'}, {'measure': 'Incidence of Adverse Events (AEs) at Time of Final Analysis', 'timeFrame': 'Up to 60.1 months', 'description': 'As determined by assessment of AEs, clinical laboratory tests, and vital signs measurements. AEs were classified by system organ class (SOC) and preferred term using the Medical Dictionary for Regulatory Activities (MedDRA) Version 22.0 or higher; AE severities were classified using Version 4.03 of the (Common Terminology Criteria for Adverse Events) CTCAE criteria.'}, {'measure': 'Frequency of Dose Modifications at Time of Final Analysis', 'timeFrame': 'Up to 60.1 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Tucatinib', 'Capecitabine', 'Trastuzumab', 'Xeloda', 'Herceptin', 'Breast Cancer', 'ARRY-380', 'ONT-380', 'HER2 Positive Breast Carcinoma', 'HER2 Positive Locally Advanced Breast Cancer', 'HER-2 Positive Breast Cancer', 'HER-2 Positive Breast Carcinoma', 'HER-2 Positive Locally Advanced Breast Cancer', 'Recurrent Breast Carcinoma', 'Stage IV Breast Cancer', 'Metastatic Breast Cancer', 'Breast Carcinoma', 'Metastatic Malignant Neoplasm in the Brain', 'Brain Metastases in Breast Cancer', 'Asymptomatic Brain Metastases in Breast Cancer', 'Low Symptomatic Brain Metastases in Breast Cancer', 'Seattle Genetics'], 'conditions': ['HER2 Positive Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '39024777', 'type': 'DERIVED', 'citation': 'Dai L, Gao T, Guo R, Chen Y, Wang J, Zhou S, Tang Y, Chen D, Huang S. Efficacy and safety of pyrotinib-based regimens in HER2 positive metastatic breast cancer: A retrospective real-world data study. Neoplasia. 2024 Oct;56:101029. doi: 10.1016/j.neo.2024.101029. Epub 2024 Jul 17.'}, {'pmid': '36454580', 'type': 'DERIVED', 'citation': 'Lin NU, Murthy RK, Abramson V, Anders C, Bachelot T, Bedard PL, Borges V, Cameron D, Carey LA, Chien AJ, Curigliano G, DiGiovanna MP, Gelmon K, Hortobagyi G, Hurvitz SA, Krop I, Loi S, Loibl S, Mueller V, Oliveira M, Paplomata E, Pegram M, Slamon D, Zelnak A, Ramos J, Feng W, Winer E. Tucatinib vs Placebo, Both in Combination With Trastuzumab and Capecitabine, for Previously Treated ERBB2 (HER2)-Positive Metastatic Breast Cancer in Patients With Brain Metastases: Updated Exploratory Analysis of the HER2CLIMB Randomized Clinical Trial. JAMA Oncol. 2023 Feb 1;9(2):197-205. doi: 10.1001/jamaoncol.2022.5610.'}, {'pmid': '34214937', 'type': 'DERIVED', 'citation': 'Mueller V, Wardley A, Paplomata E, Hamilton E, Zelnak A, Fehrenbacher L, Jakobsen E, Curtit E, Boyle F, Harder Brix E, Brenner A, Crouzet L, Ferrario C, Munoz-Mateu M, Arkenau HT, Iqbal N, Aithal S, Block M, Cold S, Cancel M, Hahn O, Poosarla T, Stringer-Reasor E, Colleoni M, Cameron D, Curigliano G, Siadak M, DeBusk K, Ramos J, Feng W, Gelmon K. Preservation of quality of life in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer treated with tucatinib or placebo when added to trastuzumab and capecitabine (HER2CLIMB trial). Eur J Cancer. 2021 Aug;153:223-233. doi: 10.1016/j.ejca.2021.05.025. Epub 2021 Jun 29.'}, {'pmid': '32468955', 'type': 'DERIVED', 'citation': "Lin NU, Borges V, Anders C, Murthy RK, Paplomata E, Hamilton E, Hurvitz S, Loi S, Okines A, Abramson V, Bedard PL, Oliveira M, Mueller V, Zelnak A, DiGiovanna MP, Bachelot T, Chien AJ, O'Regan R, Wardley A, Conlin A, Cameron D, Carey L, Curigliano G, Gelmon K, Loibl S, Mayor J, McGoldrick S, An X, Winer EP. Intracranial Efficacy and Survival With Tucatinib Plus Trastuzumab and Capecitabine for Previously Treated HER2-Positive Breast Cancer With Brain Metastases in the HER2CLIMB Trial. J Clin Oncol. 2020 Aug 10;38(23):2610-2619. doi: 10.1200/JCO.20.00775. Epub 2020 May 29."}, {'pmid': '31825569', 'type': 'DERIVED', 'citation': 'Murthy RK, Loi S, Okines A, Paplomata E, Hamilton E, Hurvitz SA, Lin NU, Borges V, Abramson V, Anders C, Bedard PL, Oliveira M, Jakobsen E, Bachelot T, Shachar SS, Muller V, Braga S, Duhoux FP, Greil R, Cameron D, Carey LA, Curigliano G, Gelmon K, Hortobagyi G, Krop I, Loibl S, Pegram M, Slamon D, Palanca-Wessels MC, Walker L, Feng W, Winer EP. Tucatinib, Trastuzumab, and Capecitabine for HER2-Positive Metastatic Breast Cancer. N Engl J Med. 2020 Feb 13;382(7):597-609. doi: 10.1056/NEJMoa1914609. Epub 2019 Dec 11.'}, {'pmid': '29804905', 'type': 'DERIVED', 'citation': 'Murthy R, Borges VF, Conlin A, Chaves J, Chamberlain M, Gray T, Vo A, Hamilton E. Tucatinib with capecitabine and trastuzumab in advanced HER2-positive metastatic breast cancer with and without brain metastases: a non-randomised, open-label, phase 1b study. Lancet Oncol. 2018 Jul;19(7):880-888. doi: 10.1016/S1470-2045(18)30256-0. Epub 2018 May 24.'}]}, 'descriptionModule': {'briefSummary': 'This study is being done to see if tucatinib works better than placebo to help patients who have a specific type of breast cancer called HER2 positive breast carcinoma. The breast cancer in this study is either metastatic (spread into other parts of the body) or cannot be removed completely with surgery. All patients in the study will get capecitabine and trastuzumab, two drugs that are often used to treat this cancer.\n\nThere are two parts to this study. The first part of the study is already complete. Patients were randomly assigned to get either tucatinib or placebo (a pill with no medicine). Since this part was "blinded," neither patients nor their doctors knew whether a patient got tucatinib or placebo.\n\nThe second part of the study is called the Unblinded Phase. In this part of the study, participants and their doctors know which drugs are being given. Participants who used to get or are currently getting placebo may be able to start taking tucatinib instead.\n\nEach treatment cycle lasts 21 days. Patients will swallow tucatinib pills two times every day. They will swallow capecitabine pills two times a day during the first two weeks of each cycle. Patients will get trastuzumab injections from the study site staff on the first day of every cycle.', 'detailedDescription': 'This is a randomized, international, multi-center study in patients with progressive unresectable locally advanced or metastatic HER2+ breast cancer who have had prior treatment with trastuzumab, pertuzumab and T-DM1. There are two phases to this trial: the Double-blind Phase and the Unblinded Phase. In the Double-blind phase, participants were randomized in a 2:1 ratio to receive tucatinib or placebo in combination with capecitabine and trastuzumab. In the Unblinded Phase, patients on placebo may be offered tucatinib.\n\nStratification factors include presence or history of treated or untreated brain metastases or brain lesions of equivocal significance (yes/no), Eastern Cooperative Oncology Group (ECOG) Performance Status (0 vs. 1), and region of world (US vs. Canada vs. Rest of World).\n\nSafety assessments will be performed at a minimum of once every three weeks throughout study treatment and 30 days after the last dose of study drugs. Laboratory assessments will be performed locally at sites. Left ventricular ejection fraction will be assessed by MUGA or ECHO at screening and once every 12 weeks thereafter.\n\nFor the blinded phase, contrast brain MRI was performed at baseline. Efficacy assessments (CT of chest, abdomen and pelvis at a minimum) utilized RECIST 1.1 and included patients with evaluable tumors defined as measurable target lesions and non-measurable non-target lesions. RECIST assessment was performed at baseline, every 6 weeks for the first 24 weeks, and then every 9 weeks thereafter. Repeat MRI of the brain was required on this same schedule only in those patients with brain metastases identified at baseline. All treatment decisions were made based upon investigator assessment. All patients underwent a repeat MRI of the brain within 30 days of the end of treatment unless previously performed at time of disease progression.\n\nFor the unblinded phase, RECIST assessments will be performed per standard clinical practice as determined by investigator with a maximum interval of 12 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Double-blind Phase Inclusion Criteria\n\n* Histologically confirmed HER2+ breast carcinoma, with HER2+ defined by in situ hybridization (ISH), immunohistochemistry (IHC), or fluorescence in situ hybridization (FISH) methodology\n* Received previous treatment with trastuzumab, pertuzumab, and T-DM1\n* Progression of unresectable locally advanced or metastatic breast cancer after last systemic therapy (as confirmed by investigator), or be intolerant of last systemic therapy\n* Have measurable or non-measurable disease assessable by RECIST 1.1\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n* Adequate hepatic and renal function and hematologic parameters\n* Left ventricular ejection fraction (LVEF) ≥ 50%\n* CNS Inclusion - Based on screening brain magnetic resonance imaging (MRI), patients must have one of the following:\n\n 1. No evidence of brain metastases\n 2. Untreated brain metastases not needing immediate local therapy\n 3. Previously treated brain metastases not needing immediate local therapy\n\n 1. Brain metastases previously treated with local therapy may either be stable since treatment or may have progressed since prior local CNS therapy\n 2. Patients treated with CNS local therapy for newly identified lesions found on contrast brain MRI performed during screening for this study may be eligible to enroll if the following criteria are met:\n\n i. Time since whole brain radiation therapy (WBRT) is ≥ 21 days prior to first dose of study treatment, time since stereotactic radiosurgery (SRS) is ≥ 7 days prior to first dose of study treatment, or time since surgical resection is ≥ 28 days.\n\n ii. Other sites of disease assessable by RECIST 1.1 are present\n 4. Relevant records of any CNS treatment must be available to allow for classification of target and non-target lesions\n\nDouble-blind Phase Exclusion Criteria\n\n* Previously been treated with:\n\n 1. lapatinib within 12 months of starting study treatment (except in cases where lapatinib was given for ≤ 21 days and was discontinued for reasons other than disease progression or toxicity)\n 2. neratinib, afatinib, or other investigational HER2/epidermal growth factor receptor (EGFR) or HER2 tyrosine kinase inhibitor (TKI) at any time previously\n 3. capecitabine (or other fluoropyrimidine) for metastatic disease except in cases where capecitabine was given for \\< 21 days and was discontinued for reasons other than disease progression or toxicity. Patients who have received capecitabine for adjuvant or neoadjuvant treatment at least 12 months prior to starting study treatment are eligible.\n* Clinically significant cardiopulmonary disease\n* Carriers of Hepatitis B or Hepatitis C or have other known chronic liver disease\n* Positive for human immunodeficiency virus (HIV)\n* Unable for any reason to undergo MRI of the brain\n* Have used a strong CYP3A4 or CYP2C8 inhibitor within 5 half-lives of the inhibitor, or a strong CYP3A4 or CYP2C8 inducer within 5 days prior to first dose of study treatment\n* Have known dihydropyrimidine dehydrogenase deficiency (DPD)\n* CNS Exclusion - Based on screening brain MRI, patients must not have any of the following:\n\n 1. Any untreated brain lesions \\> 2.0 cm in size, unless approved by medical monitor\n 2. Ongoing use of systemic corticosteroids for control of symptoms of brain metastases at a total daily dose of \\> 2 mg of dexamethasone (or equivalent)\n 3. Any brain lesion thought to require immediate local therapy. Patients who undergo local treatment for such lesions identified by screening contrast brain MRI may still be eligible for the study based on criteria described under CNS inclusion criteria\n 4. Known or suspected leptomeningeal disease (LMD)\n 5. Poorly controlled seizures Unblinded Phase Crossover Inclusion Criteria - Participants who were randomized to the control arm (placebo + trastuzumab + capecitabine) must meet the following criteria to be eligible to crossover to the experimental arm.\n* Have measurable or non-measurable disease assessable by RECIST 1.1\n* For patients who were randomized to the control arm and on the long-term follow-up period at the time of crossover screening: have progression of unresectable locally advanced or metastatic breast cancer after last systemic therapy (as confirmed by investigator), or be intolerant of last systemic therapy.\n* Have an ECOG Performance Status of 0 or 1\n* Have a life expectancy of at least 6 months\n* Have adequate hepatic and renal function and hematologic parameters\n* Left ventricular ejection fraction (LVEF) ≥ 50%\n* CNS Inclusion - Based on screening brain magnetic resonance imaging (MRI), patients must have one of the following:\n\n i. No evidence of brain metastases ii. Untreated brain metastases not needing immediate local therapy iii. Previously treated brain metastases not needing immediate local therapy\n* Brain metastases previously treated with local therapy may either be stable since treatment or may have progressed since prior local CNS therapy\n* Patients treated with CNS local therapy for newly identified lesions found on contrast brain MRI performed during screening for this study may be eligible to enroll if the following criteria are met:\n\n 1. Time since whole brain radiation therapy (WBRT) is ≥ 21 days prior to first dose of study treatment, time since stereotactic radiosurgery (SRS) is ≥ 7 days prior to first dose of study treatment, or time since surgical resection is ≥ 28 days.\n 2. Other sites of disease assessable by RECIST 1.1 are present Unblinded Phase Crossover Exclusion Criteria - Participants who were randomized to the control arm (placebo + trastuzumab + capecitabine) will be excluded from the crossover to the experimental arm for any of the following reasons.\n* Discontinuation of study treatment due to an adverse event while on the double-blind phase of the study. If the adverse event leading to discontinuation of study treatment has resolved, the patient may be allowed to crossover with approval from the medical monitor.\n* History of exposure to the following cumulative doses of anthracyclines:\n\n * Doxorubicin \\> 360 mg/m\\^2\n * Epirubicin \\> 720 mg/m\\^2\n * Mitoxantrone \\> 120 mg/m\\^2\n * Idarubicin \\> 90 mg/m\\^2\n * Liposomal doxorubicin \\> 550 mg/m\\^2\n* History of allergic reactions to trastuzumab, capecitabine, or compounds chemically or biologically similar to tucatinib\n\n o Exceptions for Grade 1 or 2 infusion related reactions to trastuzumab that were successfully managed, or known allergy to one of the excipients in the study drugs\n* Have received treatment with any systemic anti-cancer therapy, non-CNS radiation, or experimental agent within 3 weeks prior to start of crossover therapy\n* Any toxicity related to prior cancer therapies that has not resolved to ≤ Grade 1, with the following exceptions:\n\n * Alopecia and neuropathy (must have resolved to ≤ Grade 2)\n * CHF (must have been ≤ Grade 1 in severity at the time of occurrence and must have resolved completely)\n * Anemia (must have resolved to ≤ Grade 2)\n* Have clinically significant cardiopulmonary disease\n* Have known myocardial infarction or unstable angina within 6 months prior to start of crossover therapy\n* Require therapy with warfarin or other coumarin derivatives\n* Inability to swallow pills or significant gastrointestinal disease which would preclude the adequate oral absorption of medications\n* Have used a strong CYP2C8 inhibitor within 5 half-lives of the inhibitor or have used a strong CYP2C8 or CYP34A inducer within 5 days prior to start of the crossover (tucatinib) treatment.\n* Known dihydropyrimidine dehydrogenase deficiency\n* Unable to undergo contract MRI of the brain\n* Have evidence within 2 years prior to start of crossover therapy of another malignancy that required systemic treatment\n* CNS Exclusion:\n* CNS Exclusion - Based on screening brain MRI, patients must not have any of the following:\n\n * Any untreated brain lesions \\> 2.0 cm in size, unless approved by medical monitor\n * Ongoing use of systemic corticosteroids for control of symptoms of brain metastases at a total daily dose of \\> 2 mg of dexamethasone (or equivalent)\n * Any brain lesion thought to require immediate local therapy. Patients who undergo local treatment for such lesions identified by screening contrast brain MRI may still be eligible for the study based on criteria described under CNS inclusion criteria\n * Known or suspected leptomeningeal disease (LMD)\n * Poorly controlled seizures'}, 'identificationModule': {'nctId': 'NCT02614794', 'acronym': 'HER2CLIMB', 'briefTitle': 'A Study of Tucatinib vs. Placebo in Combination With Capecitabine & Trastuzumab in Patients With Advanced HER2+ Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Seagen Inc.'}, 'officialTitle': 'Phase 2 Randomized, Double-Blinded, Controlled Study of Tucatinib vs Placebo in Combination With Capecitabine and Trastuzumab in Patients With Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Carcinoma', 'orgStudyIdInfo': {'id': 'ONT-380-206'}, 'secondaryIdInfos': [{'id': '2015-002801-12', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tucatinib in combination with capecitabine & trastuzumab', 'description': 'Tucatinib + capecitabine + trastuzumab', 'interventionNames': ['Drug: tucatinib', 'Drug: capecitabine', 'Drug: trastuzumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo in combination with capecitabine & trastuzumab', 'description': 'Placebo + capecitabine + trastuzumab', 'interventionNames': ['Drug: capecitabine', 'Drug: trastuzumab', 'Drug: placebo']}], 'interventions': [{'name': 'tucatinib', 'type': 'DRUG', 'otherNames': ['ONT-380, ARRY-380'], 'description': '300 mg orally twice daily', 'armGroupLabels': ['Tucatinib in combination with capecitabine & trastuzumab']}, {'name': 'capecitabine', 'type': 'DRUG', 'otherNames': ['Xeloda'], 'description': '1000 mg/m2 orally twice daily on Days 1-14 of each 21-day cycle', 'armGroupLabels': ['Placebo in combination with capecitabine & trastuzumab', 'Tucatinib in combination with capecitabine & trastuzumab']}, {'name': 'trastuzumab', 'type': 'DRUG', 'otherNames': ['Herceptin, Herceptin Hycleta'], 'description': '8 mg/kg intravenously (IV) on Day 1 of Cycle 1, followed by 6 mg/kg on Day1 of each 21-day cycle. In regions where approved, trastuzumab may be given at 600mg subcutaneously once every 3-weeks at either study initiation or crossing over from previous IV trastuzumab.', 'armGroupLabels': ['Placebo in combination with capecitabine & trastuzumab', 'Tucatinib in combination with capecitabine & trastuzumab']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Oral dose twice daily', 'armGroupLabels': ['Placebo in combination with capecitabine & trastuzumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35249', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36604', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of South Alabama - Mitchell Cancer Institute', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85338', 'city': 'Goodyear', 'state': 'Arizona', 'country': 'United States', 'facility': 'Cancer Treatment Centers of America - Phoenix', 'geoPoint': {'lat': 33.43532, 'lon': -112.35821}}, {'zip': '85016', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Oncology Associates, PC - HAL', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '91010-3000', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope National Medical Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'TRIO - Central Regulatory Office', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Medical Center / David Geffen School of Medicine', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90277', 'city': 'Redondo Beach', 'state': 'California', 'country': 'United States', 'facility': 'Torrance Memorial Physician Network - TRIO', 'geoPoint': {'lat': 33.84918, 'lon': -118.38841}}, {'zip': '94134', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California at San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '92078', 'city': 'San Marcos', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente San Marcos Medical Offices', 'geoPoint': {'lat': 33.14337, 'lon': -117.16614}}, {'zip': '93454', 'city': 'Santa Maria', 'state': 'California', 'country': 'United States', 'facility': 'Central Coast Medical Oncology Corporation TRIO', 'geoPoint': {'lat': 34.95303, 'lon': -120.43572}}, {'zip': '94589', 'city': 'Vallejo', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Medical Center Northern California', 'geoPoint': {'lat': 38.10409, 'lon': -122.25664}}, {'zip': '80045-0510', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Hospital / University of Colorado', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale Cancer Center', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Lombardi Cancer Center / Georgetown University Medical Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33901', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Specialists - South Region', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '33021', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'Memorial Regional Hospital TRIO', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '32207', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Baptist MD Anderson Cancer Center', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33140', 'city': 'Miami Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Mount Sinai Medical Center / Florida', 'geoPoint': {'lat': 25.79065, 'lon': -80.13005}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Orlando Health, Inc. 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