Ignite Creation Date:
2025-12-24 @ 10:31 PM
Ignite Modification Date:
2025-12-30 @ 2:38 PM
Study NCT ID:
NCT00444535
Status:
COMPLETED
Last Update Posted:
2021-10-25
First Post:
2007-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Lapatinib and Bevacizumab for Metastatic Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D010001', 'term': 'Osteitis Deformans'}], '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'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077341', 'term': 'Lapatinib'}, {'id': 'D000068258', 'term': 'Bevacizumab'}], 'ancestors': [{'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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': {'phone': '8620778-8300', 'title': 'Clinical Disclosure Office', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs).', 'eventGroups': [{'id': 'EG000', 'title': 'Lapatinib + Bevacizumab', 'description': 'Lapatinib + Bevacizumab', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 52, 'seriousNumAtRisk': 52, 'deathsNumAffected': 0, 'seriousNumAffected': 13}], 'otherEvents': [{'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 41}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Gingival bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Haemorrhoidal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 25}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 32}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 24}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Memory impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 6}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Vulvovaginal dryness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 3}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 21}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Nasal dryness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Upper-airway cough syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Nail disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 32}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 13}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Blood loss anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Left ventricular dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Gastric haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Lower gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Ejection fraction decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Bronchiectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Investigator-evaluated Crude Progression-free Survival Rate After 12 Weeks of Study Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lapatinib + Bevacizumab', 'description': 'Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously \\[IV\\] every two weeks)'}], 'classes': [{'title': 'No disease progression by Week 12', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}]}]}, {'title': 'Disease progression or death by Week 12', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Exact binomial procedure', 'ciPctValue': '95', 'paramValue': '69.2', 'ciLowerLimit': '54.9', 'ciUpperLimit': '81.3', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Clopper-Pearson exact test (binomial)'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to week 12', 'description': 'The PFS rate is defined as the percentage of subjects who have shown no evidence of disease progression or death from any cause following 12 weeks of treatment. Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.\n\nSince there is no independent reviewer, only the investigator response was reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all enrolled participants, regardless of whether or not they received any study medication'}, {'type': 'SECONDARY', 'title': 'Overall Tumor Response - Best Response Per Investigator Assessment (RECIST)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lapatinib + Bevacizumab', 'description': 'Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously \\[IV\\] every two weeks)'}], 'classes': [{'title': 'Complete response', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Partial response', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Stable disease', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': 'Progressive Disease', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'This endpoint was defined in the original protocol but was cancelled per Amendment 3, which was implemented Nov 2015. The timeframe therefore is from treatment start to Nov 2015, with a maximum timeframe of approx. 8.7 years.', 'description': "Overall Tumor Response - Best Response per Investigator Assessment Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by image including CT, MRI or bone scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \\>=30% decrease in the sum of the longest diameter of target lesions.\n\nFor each subject, the best tumor response during the study was considered to be the 'Overall Tumor Response' per the Response Evaluation Criteria in Solid Tumors (RECIST).", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Overall Tumor Response Rate Per Investigator Assessment (RECIST)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lapatinib + Bevacizumab', 'description': 'Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously \\[IV\\] every two weeks)'}], 'classes': [{'categories': [{'measurements': [{'value': '13.5', 'groupId': 'OG000', 'lowerLimit': '5.6', 'upperLimit': '25.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'This endpoint was defined in the original protocol but was cancelled per Amendment 3, which was implemented Nov 2015. The timeframe therefore is from treatment start to Nov 2015, with a maximum timeframe of approx. 8.7 years.', 'description': "Overall Tumor Response Rate is defined as the percentage of subjects achieving either a confirmed complete (CR) or partial (PR) tumor response by investigator and per the Response Evaluation Criteria in Solid Tumors (RECIST). For each subject, the best tumor response during the study are considered the 'Overall Tumor Response.' Subjects with unknown or missing response are treated as non-responders; i.e. they are included in the denominator when calculating the percentage.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population.'}, {'type': 'SECONDARY', 'title': 'Investigator-Assessed Clinical Benefit Response Rate (%) (RECIST)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lapatinib + Bevacizumab', 'description': 'Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously \\[IV\\] every two weeks)'}], 'classes': [{'categories': [{'measurements': [{'value': '38.5', 'groupId': 'OG000', 'lowerLimit': '15.4', 'upperLimit': '59.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'This endpoint was defined in the original protocol but was cancelled per Amendment 3, which was implemented Nov 2015. The timeframe therefore is from treatment start to Nov 2015, with a maximum timeframe of approx. 8.7 years.', 'description': 'Clinical Benefit Rate is defined as the percentage of subjects with evidence of confirmed complete or partial tumor responses at any time or stable disease for at least 24 weeks per the Response Evaluation Criteria in Solid Tumors (RECIST). Subjects with unknown or missing response are treated as non-responders (i.e. not Complete response (CR), Partial response (PR) or Stable Disease (SD)).', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population.'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lapatinib + Bevacizumab', 'description': 'Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously \\[IV\\] every two weeks)'}], 'classes': [{'title': 'Progressed or Died (event)', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}]}]}, {'title': 'Censored, Follow-up ended', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'This endpoint was defined in the original protocol but was cancelled per Amendment 3, which was implemented Nov 2015. The timeframe therefore is from treatment start to Nov 2015, with a maximum timeframe of approx. 8.7 years.', 'description': 'Progression-free survival (PFS) = time from treatment start date until the first documented sign of disease progression, as defined by the investigator, or death due to any cause. For participants who did not progress or die at the time of reporting, PFS data were censored at the time of the last radiological assessment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival - Kaplan-Meier Estimates for Progression-free Survival (Weeks) - Median', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lapatinib + Bevacizumab', 'description': 'Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously \\[IV\\] every two weeks)'}], 'classes': [{'categories': [{'measurements': [{'value': '24.7', 'groupId': 'OG000', 'lowerLimit': '20.9', 'upperLimit': '33.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'This endpoint was defined in the original protocol but was cancelled per Amendment 3, which was implemented Nov 2015. The timeframe therefore is from treatment start to Nov 2015, with a maximum timeframe of approx. 8.7 years.', 'description': "Progression-free survival (PFS) = time from treatment start date until the first documented sign of disease progression, as defined by the investigator, or death due to any cause. For participants who did not progress or die at the time of reporting, PFS data were censored at the time of the last radiological assessment. Greenwood's formula was used to calculate the standard error of the estimates from the Kaplan-Meier curve.", 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival - Kaplan-Meier Estimates for Progression-free Survival (Weeks) - 1st and 3rd Quartile', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lapatinib + Bevacizumab', 'description': 'Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously \\[IV\\] every two weeks)'}], 'classes': [{'title': 'Estimates for progression-free survival 1st Quartile (weeks)', 'categories': [{'measurements': [{'value': '12.9', 'groupId': 'OG000', 'lowerLimit': '6.1', 'upperLimit': '21.4'}]}]}, {'title': 'Estimates for progression-free survival 3rd Quartile (weeks)', 'categories': [{'measurements': [{'value': '35.6', 'groupId': 'OG000', 'lowerLimit': '31.1', 'upperLimit': '61.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'This endpoint was defined in the original protocol but was cancelled per Amendment 3, which was implemented Nov 2015. The timeframe therefore is from treatment start to Nov 2015, with a maximum timeframe of approx. 8.7 years.', 'description': "Progression-free survival (PFS) = time from treatment start date until the first documented sign of disease progression, as defined by the investigator, or death due to any cause. For participants who did not progress or die at the time of reporting, PFS data were censored at the time of the last radiological assessment. Greenwood's formula was used to calculate the standard error of the estimates from the Kaplan-Meier curve.", 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lapatinib + Bevacizumab', 'description': 'Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously \\[IV\\] every two weeks)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Lapatinib + Bevacizumab', 'description': 'Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously \\[IV\\] every two weeks)'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.5', 'spread': '10.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '52', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White/Caucasian/European Heritage', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}]}]}, {'title': 'African American/African Heritage', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Asian and White', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2020-06-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-28', 'studyFirstSubmitDate': '2007-03-06', 'resultsFirstSubmitDate': '2009-07-09', 'studyFirstSubmitQcDate': '2007-03-06', 'lastUpdatePostDateStruct': {'date': '2021-10-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-07-09', 'studyFirstPostDateStruct': {'date': '2007-03-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-08-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Investigator-evaluated Crude Progression-free Survival Rate After 12 Weeks of Study Treatment', 'timeFrame': 'up to week 12', 'description': 'The PFS rate is defined as the percentage of subjects who have shown no evidence of disease progression or death from any cause following 12 weeks of treatment. Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.\n\nSince there is no independent reviewer, only the investigator response was reported.'}], 'secondaryOutcomes': [{'measure': 'Overall Tumor Response - Best Response Per Investigator Assessment (RECIST)', 'timeFrame': 'This endpoint was defined in the original protocol but was cancelled per Amendment 3, which was implemented Nov 2015. The timeframe therefore is from treatment start to Nov 2015, with a maximum timeframe of approx. 8.7 years.', 'description': "Overall Tumor Response - Best Response per Investigator Assessment Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by image including CT, MRI or bone scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \\>=30% decrease in the sum of the longest diameter of target lesions.\n\nFor each subject, the best tumor response during the study was considered to be the 'Overall Tumor Response' per the Response Evaluation Criteria in Solid Tumors (RECIST)."}, {'measure': 'Overall Tumor Response Rate Per Investigator Assessment (RECIST)', 'timeFrame': 'This endpoint was defined in the original protocol but was cancelled per Amendment 3, which was implemented Nov 2015. The timeframe therefore is from treatment start to Nov 2015, with a maximum timeframe of approx. 8.7 years.', 'description': "Overall Tumor Response Rate is defined as the percentage of subjects achieving either a confirmed complete (CR) or partial (PR) tumor response by investigator and per the Response Evaluation Criteria in Solid Tumors (RECIST). For each subject, the best tumor response during the study are considered the 'Overall Tumor Response.' Subjects with unknown or missing response are treated as non-responders; i.e. they are included in the denominator when calculating the percentage."}, {'measure': 'Investigator-Assessed Clinical Benefit Response Rate (%) (RECIST)', 'timeFrame': 'This endpoint was defined in the original protocol but was cancelled per Amendment 3, which was implemented Nov 2015. The timeframe therefore is from treatment start to Nov 2015, with a maximum timeframe of approx. 8.7 years.', 'description': 'Clinical Benefit Rate is defined as the percentage of subjects with evidence of confirmed complete or partial tumor responses at any time or stable disease for at least 24 weeks per the Response Evaluation Criteria in Solid Tumors (RECIST). Subjects with unknown or missing response are treated as non-responders (i.e. not Complete response (CR), Partial response (PR) or Stable Disease (SD)).'}, {'measure': 'Progression-free Survival', 'timeFrame': 'This endpoint was defined in the original protocol but was cancelled per Amendment 3, which was implemented Nov 2015. The timeframe therefore is from treatment start to Nov 2015, with a maximum timeframe of approx. 8.7 years.', 'description': 'Progression-free survival (PFS) = time from treatment start date until the first documented sign of disease progression, as defined by the investigator, or death due to any cause. For participants who did not progress or die at the time of reporting, PFS data were censored at the time of the last radiological assessment.'}, {'measure': 'Progression-free Survival - Kaplan-Meier Estimates for Progression-free Survival (Weeks) - Median', 'timeFrame': 'This endpoint was defined in the original protocol but was cancelled per Amendment 3, which was implemented Nov 2015. The timeframe therefore is from treatment start to Nov 2015, with a maximum timeframe of approx. 8.7 years.', 'description': "Progression-free survival (PFS) = time from treatment start date until the first documented sign of disease progression, as defined by the investigator, or death due to any cause. For participants who did not progress or die at the time of reporting, PFS data were censored at the time of the last radiological assessment. Greenwood's formula was used to calculate the standard error of the estimates from the Kaplan-Meier curve."}, {'measure': 'Progression-free Survival - Kaplan-Meier Estimates for Progression-free Survival (Weeks) - 1st and 3rd Quartile', 'timeFrame': 'This endpoint was defined in the original protocol but was cancelled per Amendment 3, which was implemented Nov 2015. The timeframe therefore is from treatment start to Nov 2015, with a maximum timeframe of approx. 8.7 years.', 'description': "Progression-free survival (PFS) = time from treatment start date until the first documented sign of disease progression, as defined by the investigator, or death due to any cause. For participants who did not progress or die at the time of reporting, PFS data were censored at the time of the last radiological assessment. Greenwood's formula was used to calculate the standard error of the estimates from the Kaplan-Meier curve."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['VEGF', 'Tyrosine kinase', 'ErbB2', 'Her2-neu', 'metastatic breast cancer', 'EGFR', 'ErbB1', 'bevacizumab', 'lapatinib', 'breast carcinoma', 'breast cancer', 'breast lump', 'breast cancer positive for human epidermal growth factor receptor 2 (HER2)', 'HER2 positive metastatic breast cancer', 'breast cancer progression', 'estrogen-receptor (ER) positive(+) breast cancer', "Paget's disease"], 'conditions': ['Neoplasms, Breast']}, 'referencesModule': {'references': [{'pmid': '22198412', 'type': 'BACKGROUND', 'citation': 'Rugo HS, Chien AJ, Franco SX, Stopeck AT, Glencer A, Lahiri S, Arbushites MC, Scott J, Park JW, Hudis C, Nulsen B, Dickler MN. A phase II study of lapatinib and bevacizumab as treatment for HER2-overexpressing metastatic breast cancer. Breast Cancer Res Treat. 2012 Jul;134(1):13-20. doi: 10.1007/s10549-011-1918-z. Epub 2011 Dec 24.'}]}, 'descriptionModule': {'briefSummary': 'This study will examine the efficacy and safety of lapatinib and bevacizumab in patients with ErbB2-overexpressing breast cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Females that are at least 18 years of age.\n* Women of childbearing potential must have a negative serum pregnancy test at screening.\n* Documented evidence of HER2-overexpressing unresectable or metastatic breast cancer. Disease may/may not have been treated in metastatic setting.\n* Subjects are permitted (but not required) to have previously-treated brain metastases that are stable and asymptomatic.\n* Adequate hepatic, renal and cardiac function\n* ECOG score 0-1 and a life expectancy of at least 12 weeks.\n* Able to swallow oral medication\n* Signed informed consent\n\nExclusion criteria:\n\n* Pregnancy\n* Unstable or symptomatic CNS metastases\n* Major surgery within 28 days of enrollment (minor surgery within 7 days).\n* Prior anti-cancer treatment within 14 days of enrollment, or unresolved treatment-related toxicities.\n* A serious non-healing wound, ulcer, or bone fracture at baseline.\n* Class II, III or IV heart failure as defined by the NYHA functional classification system\n* History of significant vascular disease, arterial thrombosis, unstable INR, hypertensive crisis, or uncontrolled hypertension.\n* History of myocardial infarction, stenting procedure, or angioplasty within 6 months of enrollment.\n* History of abdominal fistulae, gastrointestinal perforation, or intra-abdominal abscess within 6 months of enrollment.\n* History of malabsorption syndrome, ulcerative colitis, or bowel obstruction.\n* Proteinuria\n* Requires concurrent anti-cancer treatment or investigational treatment.\n* Known hypersensitivity to either study medication\n* Received investigational treatment within 28 days or 5 half-lives, whichever is longer\n* Concurrent disease or circumstances that would lead the investigator would consider the subject an inappropriate candidate for the study\n* Requires medication that has been excluded during study participation'}, 'identificationModule': {'nctId': 'NCT00444535', 'briefTitle': 'Lapatinib and Bevacizumab for Metastatic Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase II, Open-Label Study of the Clinical Activity, Safety, and Tolerability of Lapatinib in Combination With Bevacizumab in Subjects With Advanced or Metastatic ErbB2-Overexpressing Breast Cancer', 'orgStudyIdInfo': {'id': 'EGF103890'}, 'secondaryIdInfos': [{'id': 'CLAP016A2201', 'type': 'OTHER', 'domain': 'Novartis'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oral lapatinib tablets in combination with IV bevacizumab', 'description': '1500 mg oral lapatinib (once daily) plus 10 mg/kg intravenous bevacizumab (every two weeks)', 'interventionNames': ['Drug: lapatinib', 'Drug: bevacizumab']}], 'interventions': [{'name': 'lapatinib', 'type': 'DRUG', 'otherNames': ['Tykerb/Tyverb'], 'description': '1500 mg oral lapatinib (once daily)', 'armGroupLabels': ['Oral lapatinib tablets in combination with IV bevacizumab']}, {'name': 'bevacizumab', 'type': 'DRUG', 'description': '10 mg/kg intravenous bevacizumab (every two weeks)', 'armGroupLabels': ['Oral lapatinib tablets in combination with IV bevacizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '33021', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '07920', 'city': 'Basking Ridge', 'state': 'New York', 'country': 'United States', 'facility': 'Novartis Investigative Site'}, {'zip': '11725', 'city': 'Commack', 'state': 'New York', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.84288, 'lon': -73.29289}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11570', 'city': 'Rockville Centre', 'state': 'New York', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.65871, 'lon': -73.64124}}, {'zip': '10591', 'city': 'Sleepy Hollow', 'state': 'New York', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 41.08565, 'lon': -73.85847}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'url': 'https://www.clinicalstudydatarequest.com/', 'ipdSharing': 'YES', 'description': 'Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.\n\nThis trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}