Ignite Creation Date:
2025-12-24 @ 2:01 PM
Ignite Modification Date:
2025-12-27 @ 9:10 PM
Study NCT ID:
NCT00876395
Status:
COMPLETED
Last Update Posted:
2018-12-19
First Post:
2009-04-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Everolimus in Combination With Trastuzumab and Paclitaxel in the Treatment of HER2 Positive Locally Advanced or Metastatic Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Hungary', 'Poland']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], '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': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068338', 'term': 'Everolimus'}, {'id': 'D000068878', 'term': 'Trastuzumab'}, {'id': 'D017239', 'term': 'Paclitaxel'}], 'ancestors': [{'id': 'D020123', 'term': 'Sirolimus'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'novartis.email@novartis.com', 'phone': '862-778-8300', 'title': 'Study Director', '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 pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Of the 480 patients enrolled in the Everolimus arm, 8 were untreated and in the Placebo arm, of the 239 patients enrolled, 1 was untreated.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until 30 days after Last Patient Last Visit.', 'eventGroups': [{'id': 'EG000', 'title': 'Everolimus+ Paclitaxel+ Trastuzumab', 'description': 'Everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22', 'otherNumAtRisk': 472, 'deathsNumAtRisk': 472, 'otherNumAffected': 466, 'seriousNumAtRisk': 472, 'deathsNumAffected': 23, 'seriousNumAffected': 173}, {'id': 'EG001', 'title': 'Placebo+ Paclitaxel+ Trastuzumab', 'description': 'Placebo of everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22', 'otherNumAtRisk': 238, 'deathsNumAtRisk': 238, 'otherNumAffected': 236, 'seriousNumAtRisk': 238, 'deathsNumAffected': 2, 'seriousNumAffected': 40}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 143}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 38}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 71}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 24}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 177}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 59}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Left ventricular dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 10}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 71}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 29}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 26}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Aphthous ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 101}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 51}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 267}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 112}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 26}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 154}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 83}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 315}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 77}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 122}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 55}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 94}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 41}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 168}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 87}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 156}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 59}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 181}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 63}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 24}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 90}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 47}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Paronychia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 34}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 95}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 45}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 72}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 29}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Ejection fraction decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 15}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 23}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 99}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 13}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 26}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 14}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 110}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 36}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 88}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 23}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Hypertriglyceridaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 17}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 80}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 41}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 72}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 42}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 14}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 17}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 78}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 45}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 86}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 39}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 74}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 37}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 24}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 130}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 70}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 36}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 136}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 58}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Neurotoxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 24}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 25}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 37}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 12}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 12}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 78}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 39}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 9}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Breast pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 12}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Cough', 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'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Hypovolaemic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Jugular vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Lymphoedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 472, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Progression-free Survival (PFS) Per Investigators' Assessment Based on Local Radiology Review - Full Population", 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus + Paclitaxel + Trastuzumab', 'description': 'Everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22'}, {'id': 'OG001', 'title': 'Placebo + Paclitaxel + Trastuzumab', 'description': 'Placebo of everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22'}], 'classes': [{'categories': [{'measurements': [{'value': '14.95', 'groupId': 'OG000', 'lowerLimit': '14.55', 'upperLimit': '17.91'}, {'value': '14.49', 'groupId': 'OG001', 'lowerLimit': '12.29', 'upperLimit': '17.08'}]}]}], 'analyses': [{'pValue': '0.1166', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.89', 'ciLowerLimit': '0.73', 'ciUpperLimit': '1.08', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first, reported between day of first patient randomized up to about 56 months', 'description': 'PFS is defined as the time from the date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first. This was assessed in the full patient population.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) consists of all randomized patients. Following the intent-to-treat principle patients will be analyzed according to the treatment and stratum they were assigned to at randomization.'}, {'type': 'PRIMARY', 'title': "Progression-free Survival (PFS) Per Investigators' Assessment Based on Local Radiology Review - (Hormone Receptor (HR)-Negative Population", 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus + Paclitaxel + Trastuzumab', 'description': 'Everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22'}, {'id': 'OG001', 'title': 'Placebo + Paclitaxel + Trastuzumab', 'description': 'Placebo of everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22'}], 'classes': [{'categories': [{'measurements': [{'value': '20.27', 'groupId': 'OG000', 'lowerLimit': '14.95', 'upperLimit': '24.08'}, {'value': '13.08', 'groupId': 'OG001', 'lowerLimit': '10.05', 'upperLimit': '16.56'}]}]}], 'analyses': [{'pValue': '0.0049', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.66', 'ciLowerLimit': '0.48', 'ciUpperLimit': '0.91', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first, reported between day of first patient randomized up to about 56 months', 'description': 'PFS is defined as the time from the date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first. This was assessed in the HR-negative patient population.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'HR-negative Full Analysis Set (HR-negative FAS) consists of subset of patients from the FAS population with HR-negative status at Baseline.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS) - Full Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus + Paclitaxel + Trastuzumab', 'description': 'Everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22'}, {'id': 'OG001', 'title': 'Placebo + Paclitaxel + Trastuzumab', 'description': 'Placebo of everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22'}], 'classes': [{'categories': [{'measurements': [{'value': '48.56', 'groupId': 'OG000', 'lowerLimit': '40.94', 'upperLimit': '58.94'}, {'value': '49.97', 'comment': 'N/A = The upper limit of the Confidence Interval was not estimable as there were not enough events.', 'groupId': 'OG001', 'lowerLimit': '40.84', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to about 76 months', 'description': 'OS is defined as the time from date of randomization to the date of death due to any cause. For patients with documented progression, survival follow up was performed either by telephone or clinic visit at least every 3 months. Additional survival updates were requested prior to interim or final analysis or prior to providing data to the health authorities. This was assessed in the full patient population.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) consists of all randomized patients. Following the intent-to-treat principle patients will be analyzed according to the treatment and stratum they were assigned to at randomization. Due to the exploratory nature of the OS analysis, OS was not statistically tested'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS) - HR-negative Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus + Paclitaxel + Trastuzumab', 'description': 'Everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22'}, {'id': 'OG001', 'title': 'Placebo + Paclitaxel + Trastuzumab', 'description': 'Placebo of everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22'}], 'classes': [{'categories': [{'measurements': [{'value': '56.97', 'comment': 'N/A = The upper limit of the Confidence Interval was not estimable as there were not enough events.', 'groupId': 'OG000', 'lowerLimit': '44.09', 'upperLimit': 'NA'}, {'value': '41.63', 'comment': 'N/A = The upper limit of the Confidence Interval was not estimable as there were not enough events.', 'groupId': 'OG001', 'lowerLimit': '34.83', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to about 76 months', 'description': 'OS is defined as the time from date of randomization to the date of death due to any cause. For patients with documented progression, survival follow up was performed either by telephone or clinic visit at least every 3 months. Additional survival updates were requested prior to interim or final analysis or prior to providing data to the health authorities. This was assessed in the HR-negative patient population.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'HR-negative Full Analysis Set (HR-negative FAS) consists of subset of patients from the FAS population with HR-negative status at Baseline. Due to the exploratory nature of the OS analysis, OS was not statistically tested.'}, {'type': 'SECONDARY', 'title': 'Overall Response Rate (ORR) - Full Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus + Paclitaxel + Trastuzumab', 'description': 'Everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22'}, {'id': 'OG001', 'title': 'Placebo + Paclitaxel + Trastuzumab', 'description': 'Placebo of everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22'}], 'classes': [{'categories': [{'measurements': [{'value': '67.1', 'groupId': 'OG000', 'lowerLimit': '62.7', 'upperLimit': '71.3'}, {'value': '69.0', 'groupId': 'OG001', 'lowerLimit': '62.8', 'upperLimit': '74.8'}]}]}], 'analyses': [{'pValue': '0.7276', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Exact Cochran-Mantel-Haenzel chi-square', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'up to about 23 months', 'description': 'ORR is defined as the percentage of participants whose best overall response is either complete response (CR) or partial response (PR) according to RECIST. This was assessed in the full patient population. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) consists of all randomized patients. Following the intent-to-treat principle patients will be analyzed according to the treatment and stratum they were assigned to at randomization.'}, {'type': 'SECONDARY', 'title': 'Overall Response Rate (ORR) - HR-negative Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus + Paclitaxel + Trastuzumab', 'description': 'Everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22'}, {'id': 'OG001', 'title': 'Placebo + Paclitaxel + Trastuzumab', 'description': 'Placebo of everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22'}], 'classes': [{'categories': [{'measurements': [{'value': '73.1', 'groupId': 'OG000', 'lowerLimit': '66.5', 'upperLimit': '79.0'}, {'value': '70.9', 'groupId': 'OG001', 'lowerLimit': '61.1', 'upperLimit': '79.4'}]}]}], 'analyses': [{'pValue': '0.4085', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Exact Cochran-Mantel-Haenzel chi-square', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'up to about 23 months', 'description': 'ORR is defined as the percentage of participants whose best overall response is either complete response (CR) or partial response (PR) according to RECIST. This was assessed in a subset of patients with Hormone Receptor Negative disease. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'HR-negative Full Analysis Set (HR-negative FAS) consists of subset of patients from the FAS population with HR-negative status at Baseline'}, {'type': 'SECONDARY', 'title': 'Clinical Benefit Rate (CBR) Equal to or Greater Than 24 Weeks - Full Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus + Paclitaxel + Trastuzumab', 'description': 'Everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22'}, {'id': 'OG001', 'title': 'Placebo + Paclitaxel + Trastuzumab', 'description': 'Placebo of everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22'}], 'classes': [{'categories': [{'measurements': [{'value': '75.8', 'groupId': 'OG000', 'lowerLimit': '71.7', 'upperLimit': '79.6'}, {'value': '81.2', 'groupId': 'OG001', 'lowerLimit': '75.6', 'upperLimit': '85.9'}]}]}], 'analyses': [{'pValue': '0.9573', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Exact Cochran-Mantel-Haenzel chi-square', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'up to about 23 months', 'description': 'CBR is defined as the percentage of participants whose best overall response is either complete response (CR), a partial response (PR) or stable disease (SD) lasting for at least 24 weeks, according to RECIST. This was assessed in the full patient population. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) consists of all randomized patients. Following the intent-to-treat principle patients will be analyzed according to the treatment and stratum they were assigned to at randomization.'}, {'type': 'SECONDARY', 'title': 'Clinical Benefit Rate (CBR) Equal to or Greater Than 24 Weeks - HR-negative Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus + Paclitaxel + Trastuzumab', 'description': 'Everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22'}, {'id': 'OG001', 'title': 'Placebo + Paclitaxel + Trastuzumab', 'description': 'Placebo of everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22'}], 'classes': [{'categories': [{'measurements': [{'value': '78.8', 'groupId': 'OG000', 'lowerLimit': '72.7', 'upperLimit': '84.2'}, {'value': '79.6', 'groupId': 'OG001', 'lowerLimit': '70.5', 'upperLimit': '86.9'}]}]}], 'analyses': [{'pValue': '0.6382', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Exact Cochran-Mantel-Haenzel chi-square', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'up to about 23 months', 'description': 'CBR is defined as the percentage of participants whose best overall response is either complete response (CR), a partial response (PR) or stable disease (SD) lasting for at least 24 weeks, according to RECIST. This was assessed in a subset of patients with Hormone Receptor Negative disease. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'HR-negative Full Analysis Set (HR-negative FAS) consists of subset of patients from the FAS population with HR-negative status at Baseline'}, {'type': 'SECONDARY', 'title': 'Time to Overall Response Based on Investigator - Full Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus + Paclitaxel + Trastuzumab', 'description': 'Everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22'}, {'id': 'OG001', 'title': 'Placebo + Paclitaxel + Trastuzumab', 'description': 'Placebo of everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22'}], 'classes': [{'categories': [{'measurements': [{'value': '2.10', 'groupId': 'OG000', 'lowerLimit': '2.00', 'upperLimit': '3.58'}, {'value': '2.00', 'groupId': 'OG001', 'lowerLimit': '1.94', 'upperLimit': '2.27'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to about 23 months', 'description': 'Time to overall response defined as the time between date of randomization until first documented response Complete reseponse (CR) or partial response (PR) ), according to RECIST. This was assessed in the full patient population and in a subset of patients with Hormone Receptor Negative disease. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) consists of all randomized patients. Following the intent-to-treat principle patients will be analyzed according to the treatment and stratum they were assigned to at randomization.'}, {'type': 'SECONDARY', 'title': 'Time to Overall Response Based on Investigator - HR-negative Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus + Paclitaxel + Trastuzumab', 'description': 'Everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22'}, {'id': 'OG001', 'title': 'Placebo + Paclitaxel + Trastuzumab', 'description': 'Placebo of everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22'}], 'classes': [{'categories': [{'measurements': [{'value': '1.94', 'groupId': 'OG000', 'lowerLimit': '1.87', 'upperLimit': '2.00'}, {'value': '1.97', 'groupId': 'OG001', 'lowerLimit': '1.87', 'upperLimit': '3.58'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to about 23 months', 'description': 'Time to overall response defined as the time between date of randomization until first documented response Complete reseponse (CR) or partial response (PR) ), according to RECIST. This was assessed in the full patient population and in a subset of patients with Hormone Receptor Negative disease. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'HR-negative Full Analysis Set (HR-negative FAS) consists of subset of patients from the FAS population with HR-negative status at Baseline'}, {'type': 'SECONDARY', 'title': 'Overall Response (OR) - Full Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus + Paclitaxel + Trastuzumab', 'description': 'Everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22'}, {'id': 'OG001', 'title': 'Placebo + Paclitaxel + Trastuzumab', 'description': 'Placebo of everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22'}], 'classes': [{'title': 'Complete Response (CR)', 'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000'}, {'value': '5.9', 'groupId': 'OG001'}]}]}, {'title': 'Partial Response (PR)', 'categories': [{'measurements': [{'value': '61.5', 'groupId': 'OG000'}, {'value': '63.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to about 23 months', 'description': 'OR applies only to patients whose best OR was CR or PR. Start date = date of first documented response (CR or PR) and end date = date of documented response (CR or PR) and end date = date of event defined as the first documented progression or death due to underlying cause. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Response (OR) - HR-negative Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus + Paclitaxel + Trastuzumab', 'description': 'Everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22'}, {'id': 'OG001', 'title': 'Placebo + Paclitaxel + Trastuzumab', 'description': 'Placebo of everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22'}], 'classes': [{'title': 'Complete Response (CR)', 'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000'}, {'value': '2.9', 'groupId': 'OG001'}]}]}, {'title': 'Partial Response (PR)', 'categories': [{'measurements': [{'value': '65.4', 'groupId': 'OG000'}, {'value': '68.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to about 23 months', 'description': 'OR applies only to patients whose best OR was CR or PR. Start date = date of first documented response (CR or PR) and end date = date of documented response (CR or PR) and end date = date of event defined as the first documented progression or death due to underlying cause. This was assessed in the HR-negative patient population. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'HR-negative Full Analysis Set (HR-negative FAS) consists of subset of patients from the FAS population with HR-negative status at Baseline'}, {'type': 'SECONDARY', 'title': 'Everolimus Blood Level Concentrations at Steady States for Everolimus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus 10 mg/Day', 'description': 'Everolimus 10 mg daily'}, {'id': 'OG001', 'title': 'Everolimus 5 mg/Day', 'description': 'Everolimus 5 mg daily'}], 'classes': [{'title': 'Pre-dose (Cmin) @ C2D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.380', 'spread': '10.0169', 'groupId': 'OG000'}, {'value': '7.959', 'spread': '8.1546', 'groupId': 'OG001'}]}]}, {'title': '2 hrs post administration (C2h) @ C2D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44.485', 'spread': '22.1986', 'groupId': 'OG000'}, {'value': '23.449', 'spread': '10.4112', 'groupId': 'OG001'}]}]}, {'title': 'Pre-dose (Cmin) @ C2D15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.206', 'spread': '9.9821', 'groupId': 'OG000'}, {'value': '5.473', 'spread': '3.9690', 'groupId': 'OG001'}]}]}, {'title': '2 hrs post administration (C2h) @ C2D15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43.494', 'spread': '21.5940', 'groupId': 'OG000'}, {'value': '20.329', 'spread': '7.9518', 'groupId': 'OG001'}]}]}, {'title': 'Pre-dose (Cmin) @ C2D22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.432', 'spread': '13.2782', 'groupId': 'OG000'}, {'value': '7.494', 'spread': '5.8503', 'groupId': 'OG001'}]}]}, {'title': '2 hrs post administration (C2h) @ C2D22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43.947', 'spread': '28.0107', 'groupId': 'OG000'}, {'value': '22.192', 'spread': '10.9277', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'predose, 2 hours post-dose at Cycle 2/Day 1, Cycle 2/Day 15, Cycle 2/ Day 22', 'description': 'Blood levels at steady states for everolimus 10 mg/day and 5 mg/day. Only valid samples are included. Some patients had dose reduction to 5 mg daily dose therefore the everolimus blood concentration for them have been summarized separately. Cycle = 28 days', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set: consists of all patients who received at least 1 dose of study treatment \\& have at least 1 valid post-baseline safety assessment. Patients were analyzed according to the treatment actually received. If patient took at least 1 dose of treatment to which he/she was randomized then the treatment actually received was the rand. treatment.'}, {'type': 'SECONDARY', 'title': 'Paclitaxel Plasma Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus', 'description': 'Everolimus 10 mg/day'}, {'id': 'OG001', 'title': 'Everolimus Placebo', 'description': 'Placebo of everolimus 10 mg daily'}], 'classes': [{'title': 'Pre-infusion (Cmin) @ C2D15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.424', 'spread': '5.8645', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'End of infusion (Cmax) @ C2D15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5159.338', 'spread': '15473.636', 'groupId': 'OG000'}, {'value': '4296.697', 'spread': '7431.0799', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 2/Day 15 (Pre-infusion and end of infusion)', 'description': 'Blood levels at steady states for everolimus/placebo', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set: consists of all patients who received at least 1 dose of study treatment \\& have at least 1 valid post-baseline safety assessment. Patients were analyzed according to the treatment actually received. If patient took at least 1 dose of treatment to which he/she was randomized then the treatment actually received was the rand. treatment.'}, {'type': 'SECONDARY', 'title': 'Trastuzumab Serum Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus + Trastuzumab', 'description': 'Everolimus plus trastuzumab'}, {'id': 'OG001', 'title': 'Everolimus Placebo', 'description': 'Placebo of everolimus 10 mg daily'}], 'classes': [{'title': 'Pre-infusion (Cmin) @ C4D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.606', 'spread': '9.6548', 'groupId': 'OG000'}, {'value': '29.180', 'spread': '12.1252', 'groupId': 'OG001'}]}]}, {'title': 'End of infusion (Cmax) @ C4D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '64.296', 'spread': '23.4635', 'groupId': 'OG000'}, {'value': '67.643', 'spread': '20.8852', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 4/Day 1 (Pre-infusion and end of infusion)', 'description': 'Blood levels at steady states for everolimus/placebo', 'unitOfMeasure': 'microgram/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set: consists of all patients who received at least 1 dose of study treatment \\& have at least 1 valid post-baseline safety assessment. Patients were analyzed according to the treatment actually received. If patient took at least 1 dose of treatment to which he/she was randomized then the treatment actually received was the rand. treatment.'}, {'type': 'SECONDARY', 'title': 'Time to Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG-PS) Score - Full Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus + Paclitaxel + Trastuzumab', 'description': 'Everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22'}, {'id': 'OG001', 'title': 'Placebo + Paclitaxel + Trastuzumab', 'description': 'Placebo of everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22'}], 'classes': [{'categories': [{'measurements': [{'value': '39.20', 'comment': 'N/A = not enough number of events in a treatment arm, so the upper limit of 95% CI was not reached and hence data was presented as N/A', 'groupId': 'OG000', 'lowerLimit': '31.31', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'N/A = not enough number of events in a treatment arm, so the median was not reached and hence data was presented as N/A', 'groupId': 'OG001', 'lowerLimit': '30.39', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to about 56 months', 'description': 'Time to definitive deterioration of the ECOG PS by one category of the score from baseline will be performed. Baseline is the last available assessment on or before randomization date. A deterioration is considered definitive if no improvements in the ECOG PS status is observed at a subsequent time of measurement during the treatment period following the time point where the deterioration is observed.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) consists of all randomized patients. Following the intent-to-treat principle patients will be analyzed according to the treatment and stratum they were assigned to at randomization.'}, {'type': 'SECONDARY', 'title': 'Time to Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG-PS) Score - HR-negative Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus + Paclitaxel + Trastuzumab', 'description': 'Everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22'}, {'id': 'OG001', 'title': 'Placebo + Paclitaxel + Trastuzumab', 'description': 'Placebo of everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'N/A = not enough number of events in a treatment arm, so the median and upper limit of 95% CI were not reached and hence data was presented as N/A', 'groupId': 'OG000', 'lowerLimit': '25.56', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'N/A = not enough number of events in a treatment arm, so the median and upper limit of 95% CI were not reached and hence data was presented as N/A', 'groupId': 'OG001', 'lowerLimit': '26.91', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to about 56 months', 'description': 'Time to definitive deterioration of the ECOG PS by one category of the score from baseline will be performed. Baseline is the last available assessment on or before randomization date. A deterioration is considered definitive if no improvements in the ECOG PS status is observed at a subsequent time of measurement during the treatment period following the time point where the deterioration is observed.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'HR-negative Full Analysis Set (HR-negative FAS) consists of subset of patients from the FAS population with HR-negative status at Baseline'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Everolimus + Paclitaxel + Trastuzumab', 'description': 'Everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22'}, {'id': 'FG001', 'title': 'Placebo + Paclitaxel + Trastuzumab', 'description': 'Placebo of everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '480'}, {'groupId': 'FG001', 'numSubjects': '239'}]}, {'type': 'Untreated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '480'}, {'groupId': 'FG001', 'numSubjects': '239'}]}], 'dropWithdraws': [{'type': 'Untreated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Abnormal test procedure result(s)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '259'}, {'groupId': 'FG001', 'numSubjects': '162'}]}, {'type': 'New cancer therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Administrative problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '717 patients were planned to be randomized. A total of 719 patients were randomized between 10-Sep-2009 and 16-Dec-2012.\n\nNot completed reasons = primary reasons for end of treatment'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'BG000'}, {'value': '239', 'groupId': 'BG001'}, {'value': '719', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Everolimus + Paclitaxel + Trastuzumab', 'description': 'Everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22'}, {'id': 'BG001', 'title': 'Placebo + Paclitaxel + Trastuzumab', 'description': 'Placebo of everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.4', 'spread': '11.46', 'groupId': 'BG000'}, {'value': '52.1', 'spread': '11.63', 'groupId': 'BG001'}, {'value': '53.0', 'spread': '11.53', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '480', 'groupId': 'BG000'}, {'value': '239', 'groupId': 'BG001'}, {'value': '719', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '214', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '311', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '198', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '303', 'groupId': 'BG002'}]}]}, {'title': 'Native American', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The FAS consisted of all randomized patients. Following the intent-to-treat principle patients were analyzed according to the treatment and stratum they were assigned to at randomization.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 719}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2017-10-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-18', 'studyFirstSubmitDate': '2009-04-02', 'resultsFirstSubmitDate': '2018-10-23', 'studyFirstSubmitQcDate': '2009-04-03', 'lastUpdatePostDateStruct': {'date': '2018-12-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-12-18', 'studyFirstPostDateStruct': {'date': '2009-04-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Progression-free Survival (PFS) Per Investigators' Assessment Based on Local Radiology Review - Full Population", 'timeFrame': 'date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first, reported between day of first patient randomized up to about 56 months', 'description': 'PFS is defined as the time from the date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first. This was assessed in the full patient population.'}, {'measure': "Progression-free Survival (PFS) Per Investigators' Assessment Based on Local Radiology Review - (Hormone Receptor (HR)-Negative Population", 'timeFrame': 'date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first, reported between day of first patient randomized up to about 56 months', 'description': 'PFS is defined as the time from the date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first. This was assessed in the HR-negative patient population.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS) - Full Population', 'timeFrame': 'up to about 76 months', 'description': 'OS is defined as the time from date of randomization to the date of death due to any cause. For patients with documented progression, survival follow up was performed either by telephone or clinic visit at least every 3 months. Additional survival updates were requested prior to interim or final analysis or prior to providing data to the health authorities. This was assessed in the full patient population.'}, {'measure': 'Overall Survival (OS) - HR-negative Population', 'timeFrame': 'up to about 76 months', 'description': 'OS is defined as the time from date of randomization to the date of death due to any cause. For patients with documented progression, survival follow up was performed either by telephone or clinic visit at least every 3 months. Additional survival updates were requested prior to interim or final analysis or prior to providing data to the health authorities. This was assessed in the HR-negative patient population.'}, {'measure': 'Overall Response Rate (ORR) - Full Population', 'timeFrame': 'up to about 23 months', 'description': 'ORR is defined as the percentage of participants whose best overall response is either complete response (CR) or partial response (PR) according to RECIST. This was assessed in the full patient population. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit.'}, {'measure': 'Overall Response Rate (ORR) - HR-negative Population', 'timeFrame': 'up to about 23 months', 'description': 'ORR is defined as the percentage of participants whose best overall response is either complete response (CR) or partial response (PR) according to RECIST. This was assessed in a subset of patients with Hormone Receptor Negative disease. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit.'}, {'measure': 'Clinical Benefit Rate (CBR) Equal to or Greater Than 24 Weeks - Full Population', 'timeFrame': 'up to about 23 months', 'description': 'CBR is defined as the percentage of participants whose best overall response is either complete response (CR), a partial response (PR) or stable disease (SD) lasting for at least 24 weeks, according to RECIST. This was assessed in the full patient population. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit.'}, {'measure': 'Clinical Benefit Rate (CBR) Equal to or Greater Than 24 Weeks - HR-negative Population', 'timeFrame': 'up to about 23 months', 'description': 'CBR is defined as the percentage of participants whose best overall response is either complete response (CR), a partial response (PR) or stable disease (SD) lasting for at least 24 weeks, according to RECIST. This was assessed in a subset of patients with Hormone Receptor Negative disease. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit.'}, {'measure': 'Time to Overall Response Based on Investigator - Full Population', 'timeFrame': 'up to about 23 months', 'description': 'Time to overall response defined as the time between date of randomization until first documented response Complete reseponse (CR) or partial response (PR) ), according to RECIST. This was assessed in the full patient population and in a subset of patients with Hormone Receptor Negative disease. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit.'}, {'measure': 'Time to Overall Response Based on Investigator - HR-negative Population', 'timeFrame': 'up to about 23 months', 'description': 'Time to overall response defined as the time between date of randomization until first documented response Complete reseponse (CR) or partial response (PR) ), according to RECIST. This was assessed in the full patient population and in a subset of patients with Hormone Receptor Negative disease. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit.'}, {'measure': 'Overall Response (OR) - Full Population', 'timeFrame': 'up to about 23 months', 'description': 'OR applies only to patients whose best OR was CR or PR. Start date = date of first documented response (CR or PR) and end date = date of documented response (CR or PR) and end date = date of event defined as the first documented progression or death due to underlying cause. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit.'}, {'measure': 'Overall Response (OR) - HR-negative Population', 'timeFrame': 'up to about 23 months', 'description': 'OR applies only to patients whose best OR was CR or PR. Start date = date of first documented response (CR or PR) and end date = date of documented response (CR or PR) and end date = date of event defined as the first documented progression or death due to underlying cause. This was assessed in the HR-negative patient population. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit.'}, {'measure': 'Everolimus Blood Level Concentrations at Steady States for Everolimus', 'timeFrame': 'predose, 2 hours post-dose at Cycle 2/Day 1, Cycle 2/Day 15, Cycle 2/ Day 22', 'description': 'Blood levels at steady states for everolimus 10 mg/day and 5 mg/day. Only valid samples are included. Some patients had dose reduction to 5 mg daily dose therefore the everolimus blood concentration for them have been summarized separately. Cycle = 28 days'}, {'measure': 'Paclitaxel Plasma Concentrations', 'timeFrame': 'Cycle 2/Day 15 (Pre-infusion and end of infusion)', 'description': 'Blood levels at steady states for everolimus/placebo'}, {'measure': 'Trastuzumab Serum Concentrations', 'timeFrame': 'Cycle 4/Day 1 (Pre-infusion and end of infusion)', 'description': 'Blood levels at steady states for everolimus/placebo'}, {'measure': 'Time to Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG-PS) Score - Full Population', 'timeFrame': 'up to about 56 months', 'description': 'Time to definitive deterioration of the ECOG PS by one category of the score from baseline will be performed. Baseline is the last available assessment on or before randomization date. A deterioration is considered definitive if no improvements in the ECOG PS status is observed at a subsequent time of measurement during the treatment period following the time point where the deterioration is observed.'}, {'measure': 'Time to Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG-PS) Score - HR-negative Population', 'timeFrame': 'up to about 56 months', 'description': 'Time to definitive deterioration of the ECOG PS by one category of the score from baseline will be performed. Baseline is the last available assessment on or before randomization date. A deterioration is considered definitive if no improvements in the ECOG PS status is observed at a subsequent time of measurement during the treatment period following the time point where the deterioration is observed.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast Cancer', 'HER2+', 'mTOR', 'everolimus', 'RAD001', 'first line', 'metastatic', 'locally advanced', 'Trastuzumab', 'Paclitaxel', 'First Line Therapy', 'HER2 Positive', 'Metastatic Breast Cancer'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '28399902', 'type': 'DERIVED', 'citation': 'Toi M, Shao Z, Hurvitz S, Tseng LM, Zhang Q, Shen K, Liu D, Feng J, Xu B, Wang X, Lee KS, Ng TY, Ridolfi A, Noel-Baron F, Ringeisen F, Jiang Z. Efficacy and safety of everolimus in combination with trastuzumab and paclitaxel in Asian patients with HER2+ advanced breast cancer in BOLERO-1. Breast Cancer Res. 2017 Apr 11;19(1):47. doi: 10.1186/s13058-017-0839-0.'}, {'pmid': '26861602', 'type': 'DERIVED', 'citation': 'Buyse M, Hurvitz SA, Andre F, Jiang Z, Burris HA, Toi M, Eiermann W, Lindsay MA, Slamon D. Statistical controversies in clinical research: statistical significance-too much of a good thing .... Ann Oncol. 2016 May;27(5):760-2. doi: 10.1093/annonc/mdw047. Epub 2016 Feb 9.'}, {'pmid': '26092818', 'type': 'DERIVED', 'citation': 'Hurvitz SA, Andre F, Jiang Z, Shao Z, Mano MS, Neciosup SP, Tseng LM, Zhang Q, Shen K, Liu D, Dreosti LM, Burris HA, Toi M, Buyse ME, Cabaribere D, Lindsay MA, Rao S, Pacaud LB, Taran T, Slamon D. Combination of everolimus with trastuzumab plus paclitaxel as first-line treatment for patients with HER2-positive advanced breast cancer (BOLERO-1): a phase 3, randomised, double-blind, multicentre trial. Lancet Oncol. 2015 Jul;16(7):816-29. doi: 10.1016/S1470-2045(15)00051-0. Epub 2015 Jun 16.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this Phase III study was to confirm the value of adding everolimus to weekly paclitaxel and trastuzumab as treatment of HER2-overexpressing metastatic breast cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult Women (≥ 18 years old).\n* Histologically or cytologically confirmed invasive breast carcinoma with local recurrence or radiological evidence of metastatic disease.\n* Must have at least one lesion that can be accurately measured or bone lesions in the absence of measurable disease.\n* HER2+ patients by local laboratory testing (IHC 3+ staining or in situ hybridization positive).\n* Prior trastuzumab and/or chemotherapy (taxanes included) as neo-adjuvant or adjuvant treatment is allowed but should be discontinued \\> 12 months prior to randomization.\n* Prior treatment for breast cancer with endocrine therapy (adjuvant or metastatic settings) is allowed but should be discontinued at randomization. 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