Ignite Creation Date:
2025-12-24 @ 3:24 PM
Ignite Modification Date:
2025-12-27 @ 12:46 PM
Study NCT ID:
NCT00391092
Status:
COMPLETED
Last Update Posted:
2015-08-28
First Post:
2006-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Avastin (Bevacizumab) in Combination With Herceptin (Trastuzumab)/Docetaxel in Patients With HER2 Positive Metastatic Breast Cancer.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium', 'Germany']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D000068878', 'term': 'Trastuzumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '800-821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann-LaRoche'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request the Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From time of first drug intake up to 28 days after last dose study treatment (up to 4.75 years).', 'description': 'Safety population included all participants who had received at least 1 dose of the trial medication, whether withdrawn prematurely or not.', 'eventGroups': [{'id': 'EG000', 'title': 'Trastuzumab + Docetaxel', 'description': "Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 mg/m\\^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m\\^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent, and for a minimum of 6 cycles, respectively.", 'otherNumAtRisk': 206, 'otherNumAffected': 198, 'seriousNumAtRisk': 206, 'seriousNumAffected': 63}, {'id': 'EG001', 'title': 'Trastuzumab + Bevacizumab + Docetaxel', 'description': "Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m\\^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m\\^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent.", 'otherNumAtRisk': 215, 'otherNumAffected': 202, 'seriousNumAtRisk': 215, 'seriousNumAffected': 72}], 'otherEvents': [{'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 141}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 135}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Nail disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 68}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 37}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 28}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Palmar-plantar erythrodysaesthesia syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 27}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 19}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Nail toxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 15}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 16}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Onycholysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 16}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 85}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 107}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 76}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 82}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 95}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 54}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 42}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 34}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 23}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 27}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Gingival bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Rectal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 76}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 75}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 69}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 72}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 37}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 51}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Spinal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 59}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 63}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 35}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 39}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 32}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 23}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 17}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 18}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 14}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 66}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 46}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 37}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 37}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 22}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 14}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 109}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 43}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 36}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 26}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 26}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 21}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Respiratory disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 75}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Conjuctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 22}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 12}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 27}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 21}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 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'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Lymphangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Mastitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Abdominal wall haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Duodenal ulcer perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Rectal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Jugular vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Comminuted fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Vascular access complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Wrist fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Cholestasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Breast discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Pathological fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Bipolar I Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'General physical condition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trastuzumab + Docetaxel', 'description': "Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 mg/m\\^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m\\^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent, and for a minimum of 6 cycles, respectively."}, {'id': 'OG001', 'title': 'Trastuzumab + Bevacizumab + Docetaxel', 'description': "Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m\\^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m\\^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent."}], 'classes': [{'categories': [{'measurements': [{'value': '13.7', 'groupId': 'OG000', 'lowerLimit': '11.4', 'upperLimit': '16.3'}, {'value': '16.5', 'groupId': 'OG001', 'lowerLimit': '14.1', 'upperLimit': '19.1'}]}]}], 'analyses': [{'pValue': '0.0775', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.82', 'ciLowerLimit': '0.65', 'ciUpperLimit': '1.02', 'statisticalMethod': 'Log Rank (unstratified)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)', 'description': "PFS was defined as the time from randomization to time of first documented disease progression (unequivocal progression of existing non-target lesions) or death, whichever occurred first as assessed by Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0). Progressive disease is defined using RECIST v1.0 as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started. Primary PFS variable was defined based on the investigators' assessments and the statistical conclusions on the primary efficacy endpoint were based on investigator assessed PFS. PFS was estimated using Kaplan-Meier methods.", 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trastuzumab + Docetaxel', 'description': "Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 mg/m\\^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m\\^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent, and for a minimum of 6 cycles, respectively."}, {'id': 'OG001', 'title': 'Trastuzumab + Bevacizumab + Docetaxel', 'description': "Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m\\^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m\\^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent."}], 'classes': [{'categories': [{'measurements': [{'value': '38.3', 'comment': 'The upper range of 95% confidence interval (CI) was not calculable due to immature OS data as greater than 50% of participants were censored at the time of clinical cutoff (30 June 2011).', 'groupId': 'OG000', 'lowerLimit': '34.3', 'upperLimit': 'NA'}, {'value': '38.5', 'comment': 'The upper range of 95% confidence interval (CI) was not calculable due to immature OS data as greater than 50% of participants were censored at the time of clinical cutoff (30 June 2011).', 'groupId': 'OG001', 'lowerLimit': '32.1', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.9543', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.74', 'ciUpperLimit': '1.38', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)', 'description': 'OS was defined as the time from randomization to the date of death, regardless of the cause of death. OS was estimated using Kaplan-Meier methods.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Partial Response (PR) in Participants With Measurable Disease at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trastuzumab + Docetaxel', 'description': "Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 mg/m\\^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m\\^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent, and for a minimum of 6 cycles, respectively."}, {'id': 'OG001', 'title': 'Trastuzumab + Bevacizumab + Docetaxel', 'description': "Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m\\^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m\\^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent."}], 'classes': [{'categories': [{'measurements': [{'value': '69.9', 'groupId': 'OG000', 'lowerLimit': '62.5', 'upperLimit': '76.6'}, {'value': '74.3', 'groupId': 'OG001', 'lowerLimit': '67.4', 'upperLimit': '80.5'}]}]}], 'analyses': [{'pValue': '0.3492', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Response rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.43', 'ciLowerLimit': '-5.2', 'ciUpperLimit': '14.0', 'estimateComment': '95% CI for the difference in response rates using Hauck-Anderson method.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)', 'description': 'Best OR was assessed using RECIST v1.0 criteria. Participants were classified as responders if their best OR was either confirmed CR (disappearance of all target lesions) or confirmed PR (at least a 30% decrease in the sum of the longest diameter \\[LD\\] of target lesions, taking as reference the baseline sum LD). Participants without any post-baseline assessments were regarded as non-responders. The 95% CI for the one sample binomial using Pearson-Clopper method.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population; only participants with measurable disease at baseline were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trastuzumab + Docetaxel', 'description': "Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 mg/m\\^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m\\^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent, and for a minimum of 6 cycles, respectively."}, {'id': 'OG001', 'title': 'Trastuzumab + Bevacizumab + Docetaxel', 'description': "Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m\\^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m\\^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent."}], 'classes': [{'categories': [{'measurements': [{'value': '11.4', 'groupId': 'OG000', 'lowerLimit': '9.1', 'upperLimit': '13.2'}, {'value': '14.6', 'groupId': 'OG001', 'lowerLimit': '12.0', 'upperLimit': '17.1'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.74', 'ciLowerLimit': '0.56', 'ciUpperLimit': '0.98', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)', 'description': 'DR was defined as the time when response (CR or PR per RECIST v1.0) was first documented to the date of disease progression per RECIST v1.0 (unequivocal progression of existing non-target lesions) or death. Progressive disease is defined using RECIST v1.0 as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population: only participants with a best OR of CR or PR were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Time to Treatment Failure (TTF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trastuzumab + Docetaxel', 'description': "Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 mg/m\\^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m\\^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent, and for a minimum of 6 cycles, respectively."}, {'id': 'OG001', 'title': 'Trastuzumab + Bevacizumab + Docetaxel', 'description': "Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m\\^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m\\^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent."}], 'classes': [{'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000', 'lowerLimit': '6.3', 'upperLimit': '8.6'}, {'value': '9.8', 'groupId': 'OG001', 'lowerLimit': '7.9', 'upperLimit': '10.9'}]}]}], 'analyses': [{'pValue': '0.5392', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '0.76', 'ciUpperLimit': '1.15', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)', 'description': 'TTF was defined as the time between randomization and date of disease progression (per RECIST v1.0; unequivocal progression of existing non-target lesions), death, or withdrawal of treatment due to adverse events, withdrawal of informed consent, insufficient therapeutic response, refusal of treatment/failure to co-operate, or failure to return, whichever occurred first. Progressive disease is defined using RECIST v1.0 as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trastuzumab + Docetaxel', 'description': "Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 mg/m\\^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m\\^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent, and for a minimum of 6 cycles, respectively."}, {'id': 'OG001', 'title': 'Trastuzumab + Bevacizumab + Docetaxel', 'description': "Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m\\^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m\\^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent."}], 'classes': [{'title': 'Physical Well-Being: Baseline (n=173,189)', 'categories': [{'measurements': [{'value': '21.20', 'spread': '5.74', 'groupId': 'OG000'}, {'value': '21.47', 'spread': '5.07', 'groupId': 'OG001'}]}]}, {'title': 'Social Well-Being: Baseline (n=173,189)', 'categories': [{'measurements': [{'value': '20.59', 'spread': '5.75', 'groupId': 'OG000'}, {'value': '20.88', 'spread': '5.77', 'groupId': 'OG001'}]}]}, {'title': 'Emotional Well-Being: Baseline (n=173,189)', 'categories': [{'measurements': [{'value': '14.95', 'spread': '4.95', 'groupId': 'OG000'}, {'value': '15.54', 'spread': '4.44', 'groupId': 'OG001'}]}]}, {'title': 'Functional Well-Being: Baseline (n=173,189)', 'categories': [{'measurements': [{'value': '16.34', 'spread': '5.83', 'groupId': 'OG000'}, {'value': '16.36', 'spread': '5.57', 'groupId': 'OG001'}]}]}, {'title': 'Total FACT-G Score: Baseline (n=173,189)', 'categories': [{'measurements': [{'value': '73.30', 'spread': '16.60', 'groupId': 'OG000'}, {'value': '74.49', 'spread': '14.50', 'groupId': 'OG001'}]}]}, {'title': 'Breast Specific: Baseline (n=173,189)', 'categories': [{'measurements': [{'value': '21.67', 'spread': '6.43', 'groupId': 'OG000'}, {'value': '22.84', 'spread': '5.85', 'groupId': 'OG001'}]}]}, {'title': 'Total FACT-B Score: Baseline (n=173,189)', 'categories': [{'measurements': [{'value': '94.97', 'spread': '20.50', 'groupId': 'OG000'}, {'value': '97.46', 'spread': '17.71', 'groupId': 'OG001'}]}]}, {'title': 'Trial Outcome Index: Baseline (n=173,189)', 'categories': [{'measurements': [{'value': '59.54', 'spread': '14.03', 'groupId': 'OG000'}, {'value': '60.85', 'spread': '12.61', 'groupId': 'OG001'}]}]}, {'title': 'Physical Well-Being: Cycle 3 (n=145,173)', 'categories': [{'measurements': [{'value': '20.19', 'spread': '4.89', 'groupId': 'OG000'}, {'value': '19.96', 'spread': '5.05', 'groupId': 'OG001'}]}]}, {'title': 'Social Well-Being: Cycle 3 (n=145,173)', 'categories': [{'measurements': [{'value': '20.64', 'spread': '5.32', 'groupId': 'OG000'}, {'value': '21.19', 'spread': '5.44', 'groupId': 'OG001'}]}]}, {'title': 'Emotional Well-Being: Cycle 3 (n=145,173)', 'categories': [{'measurements': [{'value': '16.47', 'spread': '4.19', 'groupId': 'OG000'}, {'value': '16.70', 'spread': '4.36', 'groupId': 'OG001'}]}]}, {'title': 'Functional Well-Being: Cycle 3 (n=145, 173)', 'categories': [{'measurements': [{'value': '15.43', 'spread': '5.33', 'groupId': 'OG000'}, {'value': '16.20', 'spread': '5.22', 'groupId': 'OG001'}]}]}, {'title': 'Total FACT-G Score: Cycle 3 (n=145,173)', 'categories': [{'measurements': [{'value': '72.94', 'spread': '14.81', 'groupId': 'OG000'}, {'value': '74.05', 'spread': '14.35', 'groupId': 'OG001'}]}]}, {'title': 'Breast Specific: Cycle 3 (n=145,173)', 'categories': [{'measurements': [{'value': '22.29', 'spread': '5.78', 'groupId': 'OG000'}, {'value': '23.17', 'spread': '5.34', 'groupId': 'OG001'}]}]}, {'title': 'Total FACT-B Score: Cycle 3 (n=145,173)', 'categories': [{'measurements': [{'value': '95.26', 'spread': '18.52', 'groupId': 'OG000'}, {'value': '97.23', 'spread': '17.81', 'groupId': 'OG001'}]}]}, {'title': 'Trial Outcome Index: Cycle 3 (n=145,173)', 'categories': [{'measurements': [{'value': '58.04', 'spread': '12.80', 'groupId': 'OG000'}, {'value': '59.33', 'spread': '12.49', 'groupId': 'OG001'}]}]}, {'title': 'Physical Well-Being: Cycle 5 (n=139, 166)', 'categories': [{'measurements': [{'value': '19.51', 'spread': '4.83', 'groupId': 'OG000'}, {'value': '19.67', 'spread': '4.56', 'groupId': 'OG001'}]}]}, {'title': 'Social Well-Being: Cycle 5 (n=139, 166)', 'categories': [{'measurements': [{'value': '19.36', 'spread': '5.26', 'groupId': 'OG000'}, {'value': '20.68', 'spread': '4.92', 'groupId': 'OG001'}]}]}, {'title': 'Emotional Well-Being: Cycle 5 (n=139, 166)', 'categories': [{'measurements': [{'value': '16.05', 'spread': '4.44', 'groupId': 'OG000'}, {'value': '17.07', 'spread': '4.30', 'groupId': 'OG001'}]}]}, {'title': 'Functional Well-Being: Cycle 5 (n=139, 166)', 'categories': [{'measurements': [{'value': '14.81', 'spread': '5.45', 'groupId': 'OG000'}, {'value': '15.78', 'spread': '4.77', 'groupId': 'OG001'}]}]}, {'title': 'Total FACT-G Score: Cycle 5 (n=139, 166)', 'categories': [{'measurements': [{'value': '69.78', 'spread': '15.04', 'groupId': 'OG000'}, {'value': '73.21', 'spread': '12.49', 'groupId': 'OG001'}]}]}, {'title': 'Breast Specific: Cycle 5 (n=139, 166)', 'categories': [{'measurements': [{'value': '21.65', 'spread': '5.83', 'groupId': 'OG000'}, {'value': '23.15', 'spread': '4.90', 'groupId': 'OG001'}]}]}, {'title': 'Total FACT-B Score: Cycle 5 (n=139, 166)', 'categories': [{'measurements': [{'value': '91.43', 'spread': '18.81', 'groupId': 'OG000'}, {'value': '96.36', 'spread': '15.63', 'groupId': 'OG001'}]}]}, {'title': 'Trial Outcome Index: Cycle 5 (n=139, 166)', 'categories': [{'measurements': [{'value': '55.99', 'spread': '13.09', 'groupId': 'OG000'}, {'value': '58.59', 'spread': '11.01', 'groupId': 'OG001'}]}]}, {'title': 'Physical Well-Being: Cycle 11 (n=100, 133)', 'categories': [{'measurements': [{'value': '21.71', 'spread': '4.54', 'groupId': 'OG000'}, {'value': '21.56', 'spread': '4.53', 'groupId': 'OG001'}]}]}, {'title': 'Social Well-Being: Cycle 11 (n=100, 133)', 'categories': [{'measurements': [{'value': '19.71', 'spread': '5.74', 'groupId': 'OG000'}, {'value': '20.78', 'spread': '4.92', 'groupId': 'OG001'}]}]}, {'title': 'Emotional Well-Being: Cycle 11 (n=100, 133)', 'categories': [{'measurements': [{'value': '15.96', 'spread': '4.50', 'groupId': 'OG000'}, {'value': '17.46', 'spread': '3.70', 'groupId': 'OG001'}]}]}, {'title': 'Functional Well-Being: Cycle 11 (n=100, 133)', 'categories': [{'measurements': [{'value': '16.25', 'spread': '5.16', 'groupId': 'OG000'}, {'value': '16.98', 'spread': '4.92', 'groupId': 'OG001'}]}]}, {'title': 'Total FACT-G Score: Cycle 11 (n=100, 133)', 'categories': [{'measurements': [{'value': '73.26', 'spread': '15.24', 'groupId': 'OG000'}, {'value': '76.55', 'spread': '13.56', 'groupId': 'OG001'}]}]}, {'title': 'Breast Specific: Cycle 11 (n=100, 133)', 'categories': [{'measurements': [{'value': '21.29', 'spread': '5.55', 'groupId': 'OG000'}, {'value': '23.80', 'spread': '4.92', 'groupId': 'OG001'}]}]}, {'title': 'Total FACT-B Score: Cycle 11 (n=100, 133)', 'categories': [{'measurements': [{'value': '94.57', 'spread': '18.58', 'groupId': 'OG000'}, {'value': '100.43', 'spread': '16.97', 'groupId': 'OG001'}]}]}, {'title': 'Trial Outcome Index: Cycle 11 (n=100, 133)', 'categories': [{'measurements': [{'value': '59.19', 'spread': '12.00', 'groupId': 'OG000'}, {'value': '62.34', 'spread': '11.79', 'groupId': 'OG001'}]}]}, {'title': 'Physical Well-Being: Post PD (n=33, 39)', 'categories': [{'measurements': [{'value': '19.94', 'spread': '4.99', 'groupId': 'OG000'}, {'value': '20.35', 'spread': '5.37', 'groupId': 'OG001'}]}]}, {'title': 'Social Well-Being: Post PD (n=33, 39)', 'categories': [{'measurements': [{'value': '19.02', 'spread': '5.61', 'groupId': 'OG000'}, {'value': '19.68', 'spread': '4.77', 'groupId': 'OG001'}]}]}, {'title': 'Emotional Well-Being: Post PD (n=33, 39)', 'categories': [{'measurements': [{'value': '14.76', 'spread': '4.83', 'groupId': 'OG000'}, {'value': '14.77', 'spread': '4.64', 'groupId': 'OG001'}]}]}, {'title': 'Functional Well-Being: Post PD (n=33, 39)', 'categories': [{'measurements': [{'value': '14.13', 'spread': '5.57', 'groupId': 'OG000'}, {'value': '15.08', 'spread': '5.16', 'groupId': 'OG001'}]}]}, {'title': 'Total FACT-G Score: Post PD (n=33, 39)', 'categories': [{'measurements': [{'value': '67.84', 'spread': '14.21', 'groupId': 'OG000'}, {'value': '70.04', 'spread': '15.08', 'groupId': 'OG001'}]}]}, {'title': 'Breast Specific: Post PD (n=33, 39)', 'categories': [{'measurements': [{'value': '22.90', 'spread': '4.48', 'groupId': 'OG000'}, {'value': '22.87', 'spread': '5.14', 'groupId': 'OG001'}]}]}, {'title': 'Total FACT-B Score: Post PD (n=33, 39)', 'categories': [{'measurements': [{'value': '90.74', 'spread': '16.59', 'groupId': 'OG000'}, {'value': '92.92', 'spread': '18.47', 'groupId': 'OG001'}]}]}, {'title': 'Trial Outcome Index: Post PD (n=33, 39)', 'categories': [{'measurements': [{'value': '56.97', 'spread': '11.16', 'groupId': 'OG000'}, {'value': '58.47', 'spread': '12.43', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Cycles 3, 5, 11, and post progressive disease (PD; 14 to 28 days after disease progression [up to the clinical cutoff of 30 June 2011, up to 4.75 years])', 'description': 'FACT-G is core questionnaire of Functional Assessment of Chronic Illness Therapy (FACIT) measurement system to evaluate quality of life (QoL) in cancer population. FACT-G consisted of 27 questions grouped in 4 domains of general Health-Related QoL (HRQoL): Physical Well-being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB) and Functional Well-Being (FWB); each ranged from 0 (not at all) to 4 (very much). FACT-G ranged between 0-108. Since questions could be reversed coded, as appropriate, before calculating FACT-G, 0 and 108 could be considered worst and best health states. FACT -B is used for assessment of HRQoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: 7 items for each physical, functional, social/family; all 3 ranged from 0-28, emotional (6 items) ranged from 0-24, and breast cancer subscale (9 items) ranged from 0-36. All single-item measures ranges from 0-144. High scale score represents a better QoL.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population; n (number) = number of participants assessed for the given parameter at the specified visit.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline for FACT-G and FACT-B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trastuzumab + Docetaxel', 'description': "Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 mg/m\\^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m\\^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent, and for a minimum of 6 cycles, respectively."}, {'id': 'OG001', 'title': 'Trastuzumab + Bevacizumab + Docetaxel', 'description': "Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m\\^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m\\^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent."}], 'classes': [{'title': 'Physical Well-Being: Cycle 3 (n=145,173)', 'categories': [{'measurements': [{'value': '-1.01', 'spread': '7.54', 'groupId': 'OG000'}, {'value': '-1.51', 'spread': '7.16', 'groupId': 'OG001'}]}]}, {'title': 'Social Well-Being: Cycle 3 (n=145,173)', 'categories': [{'measurements': [{'value': '0.05', 'spread': '7.83', 'groupId': 'OG000'}, {'value': '0.32', 'spread': '7.93', 'groupId': 'OG001'}]}]}, {'title': 'Emotional Well-Being: Cycle 3 (n=145,173)', 'categories': [{'measurements': [{'value': '1.52', 'spread': '6.49', 'groupId': 'OG000'}, {'value': '1.16', 'spread': '6.22', 'groupId': 'OG001'}]}]}, {'title': 'Functional Well-Being: Cycle 3 (n=145, 173)', 'categories': [{'measurements': [{'value': '-0.91', 'spread': '7.90', 'groupId': 'OG000'}, {'value': '-0.16', 'spread': '7.63', 'groupId': 'OG001'}]}]}, {'title': 'Total FACT-G Score: Cycle 3 (n=145,173)', 'categories': [{'measurements': [{'value': '-0.36', 'spread': '22.25', 'groupId': 'OG000'}, {'value': '-0.44', 'spread': '20.40', 'groupId': 'OG001'}]}]}, {'title': 'Breast Specific: Cycle 3 (n=145,173)', 'categories': [{'measurements': [{'value': '0.61', 'spread': '8.65', 'groupId': 'OG000'}, {'value': '0.34', 'spread': '7.92', 'groupId': 'OG001'}]}]}, {'title': 'Total FACT-B Score: Cycle 3 (n=145,173)', 'categories': [{'measurements': [{'value': '0.29', 'spread': '27.63', 'groupId': 'OG000'}, {'value': '-0.24', 'spread': '25.12', 'groupId': 'OG001'}]}]}, {'title': 'Trial Outcome Index: Cycle 3 (n=145,173)', 'categories': [{'measurements': [{'value': '-1.50', 'spread': '18.99', 'groupId': 'OG000'}, {'value': '-1.52', 'spread': '17.75', 'groupId': 'OG001'}]}]}, {'title': 'Physical Well-Being: Cycle 5 (n=139, 166)', 'categories': [{'measurements': [{'value': '-1.69', 'spread': '7.50', 'groupId': 'OG000'}, {'value': '-1.80', 'spread': '6.82', 'groupId': 'OG001'}]}]}, {'title': 'Social Well-Being: Cycle 5 (n=139, 166)', 'categories': [{'measurements': [{'value': '-1.23', 'spread': '7.79', 'groupId': 'OG000'}, {'value': '-0.20', 'spread': '7.58', 'groupId': 'OG001'}]}]}, {'title': 'Emotional Well-Being: Cycle 5 (n=139, 166)', 'categories': [{'measurements': [{'value': '1.09', 'spread': '6.65', 'groupId': 'OG000'}, {'value': '1.53', 'spread': '6.18', 'groupId': 'OG001'}]}]}, {'title': 'Functional Well-Being: Cycle 5 (n=139, 166)', 'categories': [{'measurements': [{'value': '-1.53', 'spread': '7.98', 'groupId': 'OG000'}, {'value': '-0.58', 'spread': '7.33', 'groupId': 'OG001'}]}]}, {'title': 'Total FACT-G Score: Cycle 5 (n=139, 166)', 'categories': [{'measurements': [{'value': '-3.53', 'spread': '22.40', 'groupId': 'OG000'}, {'value': '-1.28', 'spread': '19.14', 'groupId': 'OG001'}]}]}, {'title': 'Breast Specific: Cycle 5 (n=139, 166)', 'categories': [{'measurements': [{'value': '-0.03', 'spread': '8.68', 'groupId': 'OG000'}, {'value': '0.31', 'spread': '7.63', 'groupId': 'OG001'}]}]}, {'title': 'Total FACT-B Score: Cycle 5 (n=139, 166)', 'categories': [{'measurements': [{'value': '-3.55', 'spread': '27.82', 'groupId': 'OG000'}, {'value': '-1.10', 'spread': '23.62', 'groupId': 'OG001'}]}]}, {'title': 'Trial Outcome Index: Cycle 5 (n=139, 166)', 'categories': [{'measurements': [{'value': '-3.55', 'spread': '19.19', 'groupId': 'OG000'}, {'value': '-2.26', 'spread': '16.74', 'groupId': 'OG001'}]}]}, {'title': 'Physical Well-Being: Cycle 11 (n=100, 133)', 'categories': [{'measurements': [{'value': '0.51', 'spread': '7.32', 'groupId': 'OG000'}, {'value': '0.09', 'spread': '6.80', 'groupId': 'OG001'}]}]}, {'title': 'Social Well-Being: Cycle 11 (n=100, 133)', 'categories': [{'measurements': [{'value': '-0.89', 'spread': '8.13', 'groupId': 'OG000'}, {'value': '-0.10', 'spread': '7.58', 'groupId': 'OG001'}]}]}, {'title': 'Emotional Well-Being: Cycle 11 (n=100, 133)', 'categories': [{'measurements': [{'value': '1.00', 'spread': '6.69', 'groupId': 'OG000'}, {'value': '1.92', 'spread': '5.78', 'groupId': 'OG001'}]}]}, {'title': 'Functional Well-Being: Cycle 11 (n=100, 133)', 'categories': [{'measurements': [{'value': '-0.09', 'spread': '7.79', 'groupId': 'OG000'}, {'value': '0.62', 'spread': '7.43', 'groupId': 'OG001'}]}]}, {'title': 'Total FACT-G Score: Cycle 11 (n=100, 133)', 'categories': [{'measurements': [{'value': '-0.05', 'spread': '22.54', 'groupId': 'OG000'}, {'value': '2.06', 'spread': '19.85', 'groupId': 'OG001'}]}]}, {'title': 'Breast Specific: Cycle 11 (n=100, 133)', 'categories': [{'measurements': [{'value': '-0.38', 'spread': '8.49', 'groupId': 'OG000'}, {'value': '0.96', 'spread': '7.64', 'groupId': 'OG001'}]}]}, {'title': 'Total FACT-B Score: Cycle 11 (n=100, 133)', 'categories': [{'measurements': [{'value': '-0.41', 'spread': '27.67', 'groupId': 'OG000'}, {'value': '2.97', 'spread': '24.53', 'groupId': 'OG001'}]}]}, {'title': 'Trial Outcome Index: Cycle 11 (n=100, 133)', 'categories': [{'measurements': [{'value': '-0.35', 'spread': '18.46', 'groupId': 'OG000'}, {'value': '1.49', 'spread': '17.26', 'groupId': 'OG001'}]}]}, {'title': 'Physical Well-Being: Post PD (n=33, 39)', 'categories': [{'measurements': [{'value': '-1.25', 'spread': '7.61', 'groupId': 'OG000'}, {'value': '-1.12', 'spread': '7.39', 'groupId': 'OG001'}]}]}, {'title': 'Social Well-Being: Post PD (n=33, 39)', 'categories': [{'measurements': [{'value': '-1.58', 'spread': '8.03', 'groupId': 'OG000'}, {'value': '-1.19', 'spread': '7.48', 'groupId': 'OG001'}]}]}, {'title': 'Emotional Well-Being: Post PD (n=33, 39)', 'categories': [{'measurements': [{'value': '-0.20', 'spread': '6.92', 'groupId': 'OG000'}, {'value': '-0.78', 'spread': '6.42', 'groupId': 'OG001'}]}]}, {'title': 'Functional Well-Being: Post PD (n=33, 39)', 'categories': [{'measurements': [{'value': '-2.22', 'spread': '8.06', 'groupId': 'OG000'}, {'value': '-1.28', 'spread': '7.59', 'groupId': 'OG001'}]}]}, {'title': 'Total FACT-G Score: Post PD (n=33, 39)', 'categories': [{'measurements': [{'value': '-5.46', 'spread': '21.85', 'groupId': 'OG000'}, {'value': '-4.44', 'spread': '20.92', 'groupId': 'OG001'}]}]}, {'title': 'Breast Specific: Post PD (n=33, 39)', 'categories': [{'measurements': [{'value': '1.22', 'spread': '7.84', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '7.79', 'groupId': 'OG001'}]}]}, {'title': 'Total FACT-B Score: Post PD (n=33, 39)', 'categories': [{'measurements': [{'value': '-4.23', 'spread': '26.37', 'groupId': 'OG000'}, {'value': '-4.55', 'spread': '25.59', 'groupId': 'OG001'}]}]}, {'title': 'Trial Outcome Index: Post PD (n=33, 39)', 'categories': [{'measurements': [{'value': '-2.57', 'spread': '17.92', 'groupId': 'OG000'}, {'value': '-2.38', 'spread': '17.70', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Cycles 3, 5, 11, and post PD (14 to 28 days after disease progression [up to the clinical cutoff of 30 June 2011, up to 4.75 years])', 'description': 'FACT-G is core questionnaire of Functional Assessment of Chronic Illness Therapy (FACIT) measurement system to evaluate quality of life (QoL) in cancer population. FACT-G consisted of 27 questions grouped in 4 domains of general Health-Related QoL (HRQoL): Physical Well-being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB) and Functional Well-Being (FWB); each ranged from 0 (not at all) to 4 (very much). FACT-G ranged between 0-108. Since questions could be reversed coded, as appropriate, before calculating FACT-G, 0 and 108 could be considered worst and best health states. FACT -B is used for assessment of HRQoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: 7 items for each physical, functional, social/family; all 3 ranged from 0-28, emotional (6 items) ranged from 0-24, and breast cancer subscale (9 items) ranged from 0-36. All single-item measures ranges from 0-144. High scale score represents a better QoL.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population; n (number) = number of participants assessed for the given parameter at the specified visit.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Trastuzumab + Docetaxel', 'description': "Trastuzumab 8 milligrams per kilogram (mg/kg) loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 milligrams per square meter (mg/m\\^2) on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m\\^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent, and for a minimum of 6 cycles, respectively."}, {'id': 'FG001', 'title': 'Trastuzumab + Bevacizumab + Docetaxel', 'description': "Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m\\^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m\\^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '208'}, {'groupId': 'FG001', 'numSubjects': '216'}]}, {'type': 'Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '206'}, {'groupId': 'FG001', 'numSubjects': '215'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'This was using a data cutoff of 30 June 2011.', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'This was using a data cutoff of 30 June 2011.', 'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '208'}, {'groupId': 'FG001', 'numSubjects': '216'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '78'}, {'groupId': 'FG001', 'numSubjects': '81'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'Alive on treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'Alive in follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '88'}, {'groupId': 'FG001', 'numSubjects': '84'}]}]}], 'preAssignmentDetails': 'The participants were randomized 1:1 using a block design randomization procedure with stratification (for prior adjuvant/neo-adjuvant taxane, trastuzumab as part of adjuvant treatment versus no trastuzumab, estrogen/progesterone receptor hormone receptor status and measurable disease) to avoid an imbalance of important prognostic factors.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '424', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Trastuzumab + Docetaxel', 'description': "Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 mg/m\\^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m\\^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent, and for a minimum of 6 cycles, respectively."}, {'id': 'BG001', 'title': 'Trastuzumab + Bevacizumab + Docetaxel', 'description': "Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m\\^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m\\^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.0', 'spread': '11.71', 'groupId': 'BG000'}, {'value': '53.5', 'spread': '10.90', 'groupId': 'BG001'}, {'value': '53.7', 'spread': '11.29', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '208', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '424', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-treat (ITT) population: All randomized participants, regardless of whether they actually received study treatment or not.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 424}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-21', 'studyFirstSubmitDate': '2006-10-20', 'resultsFirstSubmitDate': '2015-07-21', 'studyFirstSubmitQcDate': '2006-10-20', 'lastUpdatePostDateStruct': {'date': '2015-08-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-07-21', 'studyFirstPostDateStruct': {'date': '2006-10-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-08-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)', 'description': "PFS was defined as the time from randomization to time of first documented disease progression (unequivocal progression of existing non-target lesions) or death, whichever occurred first as assessed by Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0). Progressive disease is defined using RECIST v1.0 as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started. Primary PFS variable was defined based on the investigators' assessments and the statistical conclusions on the primary efficacy endpoint were based on investigator assessed PFS. PFS was estimated using Kaplan-Meier methods."}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)', 'description': 'OS was defined as the time from randomization to the date of death, regardless of the cause of death. OS was estimated using Kaplan-Meier methods.'}, {'measure': 'Percentage of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Partial Response (PR) in Participants With Measurable Disease at Baseline', 'timeFrame': 'Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)', 'description': 'Best OR was assessed using RECIST v1.0 criteria. Participants were classified as responders if their best OR was either confirmed CR (disappearance of all target lesions) or confirmed PR (at least a 30% decrease in the sum of the longest diameter \\[LD\\] of target lesions, taking as reference the baseline sum LD). Participants without any post-baseline assessments were regarded as non-responders. The 95% CI for the one sample binomial using Pearson-Clopper method.'}, {'measure': 'Duration of Response (DR)', 'timeFrame': 'Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)', 'description': 'DR was defined as the time when response (CR or PR per RECIST v1.0) was first documented to the date of disease progression per RECIST v1.0 (unequivocal progression of existing non-target lesions) or death. Progressive disease is defined using RECIST v1.0 as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started.'}, {'measure': 'Time to Treatment Failure (TTF)', 'timeFrame': 'Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)', 'description': 'TTF was defined as the time between randomization and date of disease progression (per RECIST v1.0; unequivocal progression of existing non-target lesions), death, or withdrawal of treatment due to adverse events, withdrawal of informed consent, insufficient therapeutic response, refusal of treatment/failure to co-operate, or failure to return, whichever occurred first. Progressive disease is defined using RECIST v1.0 as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started.'}, {'measure': 'Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores', 'timeFrame': 'Baseline, Cycles 3, 5, 11, and post progressive disease (PD; 14 to 28 days after disease progression [up to the clinical cutoff of 30 June 2011, up to 4.75 years])', 'description': 'FACT-G is core questionnaire of Functional Assessment of Chronic Illness Therapy (FACIT) measurement system to evaluate quality of life (QoL) in cancer population. FACT-G consisted of 27 questions grouped in 4 domains of general Health-Related QoL (HRQoL): Physical Well-being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB) and Functional Well-Being (FWB); each ranged from 0 (not at all) to 4 (very much). FACT-G ranged between 0-108. Since questions could be reversed coded, as appropriate, before calculating FACT-G, 0 and 108 could be considered worst and best health states. FACT -B is used for assessment of HRQoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: 7 items for each physical, functional, social/family; all 3 ranged from 0-28, emotional (6 items) ranged from 0-24, and breast cancer subscale (9 items) ranged from 0-36. All single-item measures ranges from 0-144. High scale score represents a better QoL.'}, {'measure': 'Change From Baseline for FACT-G and FACT-B', 'timeFrame': 'Baseline, Cycles 3, 5, 11, and post PD (14 to 28 days after disease progression [up to the clinical cutoff of 30 June 2011, up to 4.75 years])', 'description': 'FACT-G is core questionnaire of Functional Assessment of Chronic Illness Therapy (FACIT) measurement system to evaluate quality of life (QoL) in cancer population. FACT-G consisted of 27 questions grouped in 4 domains of general Health-Related QoL (HRQoL): Physical Well-being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB) and Functional Well-Being (FWB); each ranged from 0 (not at all) to 4 (very much). FACT-G ranged between 0-108. Since questions could be reversed coded, as appropriate, before calculating FACT-G, 0 and 108 could be considered worst and best health states. FACT -B is used for assessment of HRQoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: 7 items for each physical, functional, social/family; all 3 ranged from 0-28, emotional (6 items) ranged from 0-24, and breast cancer subscale (9 items) ranged from 0-36. All single-item measures ranges from 0-144. High scale score represents a better QoL.'}]}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '23569311', 'type': 'DERIVED', 'citation': 'Gianni L, Romieu GH, Lichinitser M, Serrano SV, Mansutti M, Pivot X, Mariani P, Andre F, Chan A, Lipatov O, Chan S, Wardley A, Greil R, Moore N, Prot S, Pallaud C, Semiglazov V. AVEREL: a randomized phase III Trial evaluating bevacizumab in combination with docetaxel and trastuzumab as first-line therapy for HER2-positive locally recurrent/metastatic breast cancer. J Clin Oncol. 2013 May 10;31(14):1719-25. doi: 10.1200/JCO.2012.44.7912. Epub 2013 Apr 8.'}]}, 'descriptionModule': {'briefSummary': 'This 2 arm study will compare the efficacy and safety of Avastin plus Herceptin/docetaxel, versus Herceptin/docetaxel alone, in patients with HER2 positive locally recurrent or metastatic breast cancer who have not received prior chemotherapy for their metastatic disease. Patients will be randomized 1:1 to receive either Avastin (15mg/kg iv q3weeks) + Herceptin (8mg/kg iv loading dose and 6mg/kg iv q3weeks maintenance) + docetaxel (100mg/m2 iv q3weeks) or Herceptin + docetaxel alone. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients, \\>=18 years of age;\n* HER2 positive breast cancer with locally recurrent or metastatic lesions;\n* eligible for chemotherapy;\n* baseline LVEF \\>=50%.\n\nExclusion Criteria:\n\n* previous chemotherapy for metastatic or locally recurrent breast cancer;\n* previous radiotherapy for metastatic breast cancer (except for metastatic bone pain relief);\n* other primary tumor within last 5 years, with the exception of basal or squamous skin cancer, or in situ cancer of the cervix;\n* clinically significant cardiovascular disease;\n* chronic daily treatment with aspirin (\\>325mg/day) or clopidogrel (\\>75mg/day).'}, 'identificationModule': {'nctId': 'NCT00391092', 'briefTitle': 'A Study of Avastin (Bevacizumab) in Combination With Herceptin (Trastuzumab)/Docetaxel in Patients With HER2 Positive Metastatic Breast Cancer.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Randomized, Open-label Study to Compare the Effect of First-line Treatment With Avastin in Combination With Herceptin/Docetaxel and Herceptin/Docetaxel Alone on Progression-free Survival in Patients With HER2 Positive Locally Recurrent or Metastatic Breast Cancer.', 'orgStudyIdInfo': {'id': 'BO20231'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: bevacizumab [Avastin]', 'Drug: Docetaxel', 'Drug: Herceptin']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Docetaxel', 'Drug: Herceptin']}], 'interventions': [{'name': 'bevacizumab [Avastin]', 'type': 'DRUG', 'description': '15mg/kg iv every 3 weeks', 'armGroupLabels': ['1']}, {'name': 'Docetaxel', 'type': 'DRUG', 'description': '100mg/m2 iv every 3 weeks', 'armGroupLabels': ['1', '2']}, {'name': 'Herceptin', 'type': 'DRUG', 'description': '8mg/kg iv loading dose, followed by 6mg/kg iv every 3 weeks', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1417', 'city': 'Buenos Aires', 'country': 'Argentina', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': '5004', 'city': 'Córdoba', 'country': 'Argentina', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'zip': 'B1902CMK', 'city': 'La Plata', 'country': 'Argentina', 'geoPoint': {'lat': -34.92126, 'lon': -57.95442}}, {'zip': '7600', 'city': 'Mar del Plata', 'country': 'Argentina', 'geoPoint': {'lat': -38.00042, 'lon': -57.5562}}, {'zip': '5500', 'city': 'Mendoza', 'country': 'Argentina', 'geoPoint': {'lat': -32.88946, 'lon': -68.84582}}, {'zip': '4400', 'city': 'Salta', 'country': 'Argentina', 'geoPoint': {'lat': -24.80645, 'lon': -65.41999}}, {'zip': '1650', 'city': 'San Martín', 'country': 'Argentina', 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