Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-02-04 @ 5:19 AM
Study NCT ID:
NCT01633060
Status:
TERMINATED
Last Update Posted:
2019-01-30
First Post:
2012-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase III Study of BKM120 With Fulvestrant in Patients With HR+,HER2-, AI Treated, Locally Advanced or Metastatic Breast Cancer Who Progressed on or After mTORi
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Russia']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D009477', 'term': 'Hereditary Sensory and Autonomic Neuropathies'}], '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'}, {'id': 'D009421', 'term': 'Nervous System Malformations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D011115', 'term': 'Polyneuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077267', 'term': 'Fulvestrant'}, {'id': 'C571178', 'term': 'NVP-BKM120'}], 'ancestors': [{'id': 'D004958', 'term': 'Estradiol'}, {'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, '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 the pooled data (ie, data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The primary efficacy analysis was completed by 23May16 (primary PFS analysis cutoff date). The study was later terminated and the final safety analysis was conducted up to 08Sep17. One CRF was collecting on 21Sep2017 for survival follow up (LPLV).'}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment (FPFT) until end of treatment exposure + 30 days safety follow-up.', 'description': 'Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.', 'eventGroups': [{'id': 'EG000', 'title': 'BKM120 100 mg + Fulvestrant', 'description': 'BKM120 100 mg per day and fulvestrant given until progression or as described in the protocol test.', 'otherNumAtRisk': 288, 'deathsNumAtRisk': 288, 'otherNumAffected': 271, 'seriousNumAtRisk': 288, 'deathsNumAffected': 123, 'seriousNumAffected': 74}, {'id': 'EG001', 'title': 'Placebo + Fulvestrant', 'description': 'BKM120 matching placebo daily and fulvestrant given until progression or as described in the protocol.', 'otherNumAtRisk': 140, 'deathsNumAtRisk': 140, 'otherNumAffected': 113, 'seriousNumAtRisk': 140, 'deathsNumAffected': 68, 'seriousNumAffected': 26}, {'id': 'EG002', 'title': 'All Patients', 'description': 'All Patients', 'otherNumAtRisk': 428, 'deathsNumAtRisk': 428, 'otherNumAffected': 384, 'seriousNumAtRisk': 428, 'deathsNumAffected': 191, 'seriousNumAffected': 100}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 27}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 42}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 76}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 89}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 28}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 31}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 100}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 124}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 38}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 40}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 67}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 69}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 94}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 20}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 28}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 113}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 123}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 108}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 122}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 31}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 34}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 56}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 104}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 108}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 33}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 38}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 20}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 26}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 29}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 45}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 23}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 42}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 18}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 66}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 71}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 37}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Mood altered', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 17}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 36}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 34}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 25}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 29}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 40}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 21}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 41}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Haemolytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Cardiac tamponade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Intracardiac mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 428, 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'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': "Horner's syndrome", 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Hydrocephalus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Neurological symptom', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Posterior reversible encephalopathy syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Resting tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Vith nerve paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Vocal cord paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Disorientation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Mania', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Mental disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Mood altered', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Homicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 428, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression Free Survival (PFS) Based on Local Investigator Assessment - Full Analysis Set (FAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BKM120 100mg + Fulvestrant', 'description': 'BKM120 100 mg per 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randomization up to a maximum of 4 years', 'description': 'Progression Free Survival (PFS) is defined as the time from date of randomization to the date of first radiologically documented progression or death due to any cause. If a patient did not progress or die at the time of the analysis data cut-off or start of new antineoplastic therapy, PFS was censored at the date of the last adequate tumor assessment before the earliest of the cut-off date or the start date of additional anti-neoplastic therapy. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria RECIST v1.1, as 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline and/or unequivocal progression of the non-target lesions and/or appearance of a new lesion. In addition to the relative increase of 20%, the sum must demonstrate an absolute increase of at least 5 mm. Patients were followed up for approximately every 6 weeks after randomization.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) based on Primary Analysis.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS) - Full Analysis Set (FAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BKM120 100mg + Fulvestrant', 'description': 'BKM120 100 mg per day and fulvestrant given until progression or as described in the protocol.'}, {'id': 'OG001', 'title': 'Placebo + Fulvestrant', 'description': 'BKM120 matching placebo daily and fulvestrant given until progression or as described in the protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.2', 'groupId': 'OG000', 'lowerLimit': '18.2', 'upperLimit': '23.4'}, {'value': '22.1', 'comment': 'NA: Not estimable (preliminary OS analyses). Final OS analyses not done due to early study termination (OS data collection stopped early)', 'groupId': 'OG001', 'lowerLimit': '17.3', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Every 6 weeks after randomization up to a maximum of 5 years', 'description': 'Overall Survival (OS) is defined as the time from date of randomization to date of death due to any cause. If a patient was not known to have died by the date of analysis cut-off, OS was censored at the date of last known date patient alive. Patients were followed up approximately every 6 weeks after randomization and every 3 months during survival follow-up.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) based on Primary Analysis.'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS) by PIK3CA Mutational Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BKM120 100mg + Fulvestrant', 'description': 'BKM120 100 mg per day and fulvestrant given until progression or as described in the protocol.'}, {'id': 'OG001', 'title': 'Placebo + Fulvestrant', 'description': 'BKM120 matching placebo daily and fulvestrant given until progression or as described in the protocol.'}], 'classes': [{'title': 'FAS ctDNA PIK3CA mutant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '6.7'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.4', 'upperLimit': '2.8'}]}]}, {'title': 'FAS ctDNA PIK3CA non-mutant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.9', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '4.3'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '1.5', 'upperLimit': '3.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Every 6 weeks after randomization up to a maximum of 5 years', 'description': 'Progression Free Survival (PFS) is defined as the time from date of randomization to the date of first radiologically documented progression or death due to any cause. If a patient did not progress or die at the time of the analysis data cut-off or start of new antineoplastic therapy, PFS was censored at the date of the last adequate tumor assessment before the earliest of the cut-off date or the start date of additional anti-neoplastic therapy. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria RECIST v1.1, as 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline and/or unequivocal progression of the non-target lesions and/or appearance of a new lesion. In addition to the relative increase of 20%, the sum must demonstrate an absolute increase of at least 5 mm. Patients were followed up for approximately every 6 weeks after randomization.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) -ctDNA PIK3CA mutant, Full Analysis Set (FAS) - ctDNA PIK3CA non-mutant based on Primary Analysis.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS) by PIK3CA Mutational Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BKM120 100mg + Fulvestrant', 'description': 'BKM120 100 mg per day and fulvestrant given until progression or as described in the protocol.'}, {'id': 'OG001', 'title': 'Placebo + Fulvestrant', 'description': 'BKM120 matching placebo daily and fulvestrant given until progression or as described in the protocol.'}], 'classes': [{'title': 'FAS ctDNA PIK3CA mutant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.8', 'groupId': 'OG000', 'lowerLimit': '14.7', 'upperLimit': '25.8'}, {'value': 'NA', 'comment': 'NA: Not estimable (preliminary OS analyses). Final OS analyses not done due to early study termination (OS data collection stopped early)', 'groupId': 'OG001', 'lowerLimit': '14.5', 'upperLimit': 'NA'}]}]}, {'title': 'FAS ctDNA PIK3CA non-mutant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.4', 'comment': 'NA: Not estimable (preliminary OS analyses). Final OS analyses not done due to early study termination (OS data collection stopped early)', 'groupId': 'OG000', 'lowerLimit': '17.3', 'upperLimit': 'NA'}, {'value': '21.4', 'comment': 'NA: Not estimable (preliminary OS analyses). Final OS analyses not done due to early study termination (OS data collection stopped early)', 'groupId': 'OG001', 'lowerLimit': '17.3', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Every 6 weeks after randomization up to a maximum of 5 years', 'description': 'Overall Survival (OS) by PIK3CA mutational status based on ctDNA is defined as the time from date of randomization to date of death due to any cause. If a patient was not known to have died by the date of analysis cut-off, OS was censored at the date of last known date patient alive. Patients were followed up approximately every 6 weeks after randomization and every 3 months during survival follow-up.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) -ctDNA PIK3CA mutant, Full Analysis Set (FAS) - ctDNA PIK3CA non-mutant based on Primary Analysis.'}, {'type': 'SECONDARY', 'title': 'Overall Response Rate (ORR) by PIK3CA Mutational Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BKM120 100mg + Fulvestrant', 'description': 'BKM120 100 mg per day and fulvestrant given until progression or as described in the protocol.'}, {'id': 'OG001', 'title': 'Placebo + Fulvestrant', 'description': 'BKM120 matching placebo daily and fulvestrant given until progression or as described in the protocol.'}], 'classes': [{'title': 'Full Analysis Set (FAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.6', 'groupId': 'OG000', 'lowerLimit': '4.8', 'upperLimit': '11.3'}, {'value': '2.1', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '6.0'}]}]}, {'title': 'FAS ctDNA PIK3CA mutant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000', 'lowerLimit': '4.9', 'upperLimit': '17.6'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '10.0'}]}]}, {'title': 'FAS ctDNA PIK3CA non-mutant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.6', 'groupId': 'OG000', 'lowerLimit': '3.7', 'upperLimit': '13.5'}, {'value': '3.7', 'groupId': 'OG001', 'lowerLimit': '0.8', 'upperLimit': '10.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Every 6 weeks after randomization up to a maximum of 5 years', 'description': "Overall Response Rate (ORR) is defined as the proportion of participants with best overall response of complete response (CR) or partial response (PR) based on local investigator's assessment according to RECIST 1.1. ORR was analyzed in the full population and by PIK3CA mutational status based on ctDNA. Response Evaluation Criteria in Solid Tumors (RECIST v1.1) for target/non target lesions: Complete Response (CR), disappearance of all target/non target lesions (all lymph nodes assigned as non-target lesions must be non-pathological in size (\\< 10 mm short axis)); Partial response (PR), \\>=30% decrease in the sum of the longest diameter of target lesions ; Overall Response (OR)= CR+PR. Patients were followed up for the duration of the study and for approximately every 6 weeks after randomization.", 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS), Full Analysis Set (FAS) -ctDNA PIK3CA mutant, Full Analysis Set (FAS) - ctDNA PIK3CA non-mutant based on Primary Analysis.'}, {'type': 'SECONDARY', 'title': 'Clinical Benefit Rate (CBR) by PIK3CA Mutational Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BKM120 100mg + Fulvestrant', 'description': 'BKM120 100 mg per day and fulvestrant given until progression or as described in the protocol.'}, {'id': 'OG001', 'title': 'Placebo + Fulvestrant', 'description': 'BKM120 matching placebo daily and fulvestrant given until progression or as described in the protocol.'}], 'classes': [{'title': 'CBR>=14wks(FAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.2', 'groupId': 'OG000', 'lowerLimit': '27.8', 'upperLimit': '39.0'}, {'value': '20.3', 'groupId': 'OG001', 'lowerLimit': '14.0', 'upperLimit': '27.8'}]}]}, {'title': 'CBR>=24wks(FAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.6', 'groupId': 'OG000', 'lowerLimit': '19.7', 'upperLimit': '29.9'}, {'value': '15.4', 'groupId': 'OG001', 'lowerLimit': '9.9', 'upperLimit': '22.4'}]}]}, {'title': 'CBR>=14wks(FAS ctDNA PIK3CA mutant)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38.0', 'groupId': 'OG000', 'lowerLimit': '28.5', 'upperLimit': '48.3'}, {'value': '14.3', 'groupId': 'OG001', 'lowerLimit': '4.8', 'upperLimit': '30.3'}]}]}, {'title': 'CBR>=24wks(FAS ctDNA PIK3CA mutant)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.0', 'groupId': 'OG000', 'lowerLimit': '21.2', 'upperLimit': '40.0'}, {'value': '11.4', 'groupId': 'OG001', 'lowerLimit': '3.2', 'upperLimit': '26.7'}]}]}, {'title': 'CBR>=14wks(FAS ctDNA PIK3CA non-mutant)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.4', 'groupId': 'OG000', 'lowerLimit': '28.2', 'upperLimit': '45.2'}, {'value': '21.0', 'groupId': 'OG001', 'lowerLimit': '12.7', 'upperLimit': '31.5'}]}]}, {'title': 'CBR>= 24wks(FAS ctDNA PIK3CA non-mutant)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.8', 'groupId': 'OG000', 'lowerLimit': '18.5', 'upperLimit': '34.1'}, {'value': '14.8', 'groupId': 'OG001', 'lowerLimit': '7.9', 'upperLimit': '24.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 14, Week 24', 'description': "Clinical Benefit Rate (CBR) is defined as the proportion of participants with a best overall response of complete response (CR) or partial response (PR) or stable disease (SD) or Non-CR/non-PD lasting more than 14 or 24 weeks based on local investigator's assessment according to RECIST 1.1. CBR was analyzed in the full population and by PIK3CA mutational status based on ctDNA. Patients were followed up for the duration of the study and approximately every 6 weeks after randomization.", 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS), Full Analysis Set (FAS) -ctDNA PIK3CA mutant, Full Analysis Set (FAS) - ctDNA PIK3CA non-mutant based on Primary Analysis.'}, {'type': 'SECONDARY', 'title': 'Long-term Safety and Tolerability in the Two Treatment Arms - Safety Set (SS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BKM120 100mg + Fulvestrant', 'description': 'BKM120 100 mg per day and fulvestrant given until progression or as described in the protocol.'}, {'id': 'OG001', 'title': 'Placebo + Fulvestrant', 'description': 'BKM120 matching placebo daily and fulvestrant given until progression or as described in the protocol.'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '97.9', 'groupId': 'OG000'}, {'value': '92.9', 'groupId': 'OG001'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '25.7', 'groupId': 'OG000'}, {'value': '18.6', 'groupId': 'OG001'}]}]}, {'title': 'Deaths', 'categories': [{'measurements': [{'value': '42.7', 'groupId': 'OG000'}, {'value': '48.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose of study treatment to 30 days after last dose of study treatment, up to 5 years', 'description': 'Analysis of frequencies for treatment emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set (SS) based on Final Analysis'}, {'type': 'SECONDARY', 'title': 'Plasma Concentration-time Profiles of BKM120 in Combination With Fulvestrant at Cycle 1 Day 1 - Pharmacokinetic Analysis Set (PAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BKM120 100mg + Fulvestrant', 'description': 'BKM120 100 mg per day and fulvestrant given until progression or as described in the protocol.'}], 'classes': [{'title': 'C1D1 - 1 hour post dose', 'categories': [{'measurements': [{'value': '425.178', 'spread': '149.6', 'groupId': 'OG000'}]}]}, {'title': 'C1D1 - 2 hour post dose', 'categories': [{'measurements': [{'value': '615.441', 'spread': '70.9', 'groupId': 'OG000'}]}]}, {'title': 'C1D1 - 6 hour post dose', 'categories': [{'measurements': [{'value': '314.094', 'spread': '41.9', 'groupId': 'OG000'}]}]}, {'title': 'C1D1 - 9 hour post dose', 'categories': [{'measurements': [{'value': '302.899', 'spread': '58.3', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'C1D1 1 hour post dose, C1D1 2 hour post dose, C1D1 6 hour post dose and C1D1 9 hour post dose', 'description': 'Plasma samples were collected from the first 100 BKM120-treated patients on Cycle 1 Day 1 (at 1h, 2h, and 6h post-dose and a recommended 9h post-dose sample).', 'unitOfMeasure': 'nanogram per milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Analysis Set (PAS) based on Primary Analysis'}, {'type': 'SECONDARY', 'title': 'Predose Trough Concentration-time Profile of BKM120 in Combination With Fulvestrant Over Time - Pharmacokinetic Analysis Set (PAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BKM120 100mg + Fulvestrant', 'description': 'BKM120 100 mg per day and fulvestrant given until progression or as described in the protocol.'}], 'classes': [{'title': 'C1D15', 'categories': [{'measurements': [{'value': '939.978', 'spread': '36.8', 'groupId': 'OG000'}]}]}, {'title': 'C2D1', 'categories': [{'measurements': [{'value': '880.074', 'spread': '38.4', 'groupId': 'OG000'}]}]}, {'title': 'C3D1', 'categories': [{'measurements': [{'value': '777.026', 'spread': '131.0', 'groupId': 'OG000'}]}]}, {'title': 'C4D1', 'categories': [{'measurements': [{'value': '1088.074', 'spread': '27.0', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'C1D15, C2D1, C3D1 and C4D1', 'description': 'Pre-dose samples were collected for trough concentrations at Cycle 1 Day 15, Cycle 2 Day 1, Cycle 3 Day 1 and Cycle 4 Day 1.', 'unitOfMeasure': 'nanogram per milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Analysis Set (PAS) based on Primary Analysis'}, {'type': 'SECONDARY', 'title': 'Health-related Quality of Life (HRQoL):Time to 10% Definitive Deterioration in the Global Health Status/Quality of Life Per EORTC-QLQ-C30 - Full Analysis Set (FAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BKM120 100mg + Fulvestrant', 'description': 'BKM120 100 mg per day and fulvestrant given until progression or as described in the protocol.'}, {'id': 'OG001', 'title': 'Placebo + Fulvestrant', 'description': 'BKM120 matching placebo daily and fulvestrant given until progression or as described in the protocol.'}], 'classes': [{'title': 'EORTC QLQ-30 - Global QoL score', 'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000', 'lowerLimit': '4.4', 'upperLimit': '8.1'}, {'value': '6.3', 'groupId': 'OG001', 'lowerLimit': '3.0', 'upperLimit': '9.9'}]}]}, {'title': 'EORTC QLQ-30 - PF scale score', 'categories': [{'measurements': [{'value': '11.8', 'comment': 'NA: Not estimable (preliminary OS analyses). Final OS analyses not done due to early study termination (OS data collection stopped early)', 'groupId': 'OG000', 'lowerLimit': '8.1', 'upperLimit': 'NA'}, {'value': '10.1', 'groupId': 'OG001', 'lowerLimit': '7.5', 'upperLimit': '14.6'}]}]}, {'title': 'EORTC QLQ-30 - EF scale score', 'categories': [{'measurements': [{'value': '10.0', 'comment': 'NA: Not estimable (preliminary OS analyses). Final OS analyses not done due to early study termination (OS data collection stopped early)', 'groupId': 'OG000', 'lowerLimit': '6.2', 'upperLimit': 'NA'}, {'value': '10.0', 'comment': 'NA: Not estimable (preliminary OS analyses). Final OS analyses not done due to early study termination (OS data collection stopped early)', 'groupId': 'OG001', 'lowerLimit': '4.9', 'upperLimit': 'NA'}]}]}, {'title': 'EORTC QLQ-30 - SF scale score', 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000', 'lowerLimit': '6.2', 'upperLimit': '20.2'}, {'value': '11.5', 'groupId': 'OG001', 'lowerLimit': '6.4', 'upperLimit': '14.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 6 (C2D15), Week 12 (C4D1), then every 8 weeks until discontinuation (a cycle [C] = 4 weeks) up to 5 years.', 'description': 'The global health status/QoL scale score of the QLQ-C30 is identified as the primary PRO variable of interest. Physical Functioning (PF), Emotional Functioning (EF) and Social Functioning (SF) scale scores of the QLQ-C30. The time to definitive 10% deterioration is defined as the time from the randomization date to the date of an event, which is defined as a worsening (decrease) in score by at least 10% compared to baseline, with no later increase above this threshold observed during the course of the study or death due to any cause. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. A high score for a functional scale represents a high /healthy level of functioning, a high score for the global health status / QoL represents a high QoL.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis (FAS) based on Primary Analysis'}, {'type': 'SECONDARY', 'title': 'Time to Definitive Deterioration of ECOG Performance Status From Baseline - Full Analysis Set (FAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BKM120 100mg + Fulvestrant', 'description': 'BKM120 100 mg per day and fulvestrant given until progression or as described in the protocol.'}, {'id': 'OG001', 'title': 'Placebo + Fulvestrant', 'description': 'BKM120 matching placebo daily and fulvestrant given until progression or as described in the protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.3', 'comment': 'NA: Not estimable (preliminary OS analyses). Final OS analyses not done due to early study termination (OS data collection stopped early)', 'groupId': 'OG000', 'lowerLimit': '6.9', 'upperLimit': 'NA'}, {'value': '12.0', 'groupId': 'OG001', 'lowerLimit': '6.4', 'upperLimit': '14.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Screening, Baseline (Cycle 1 Day 1) and then at day 1 of each cycle and at the EOT visit', 'description': "The Eastern Cooperative Oncology Group (ECOG) Performance Status is a scale used to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis. The ECOG Performance Scores has 5 grades: 0 = fully active, able to carry on all pre-disease performance without restriction, 1 = restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work, 2 = ambulatory and capable of all self-care but unable to carry out any work activities, up and about more than 50% of waking hours, 3 = capable of only limited self-care, confined to bed or chair more than 50% of waking hours, 4 = completely disabled, cannot carry on any self-care, totally confined to bed or chair and 5 = dead. Definitive deterioration is defined as no improvement in the ECOG status following observation of the deterioration.", 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis (FAS) based on Primary Analysis'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BKM120 100mg + Fulvestrant', 'description': 'BKM120 100 mg per day and fulvestrant given until progression or as described in the protocol.'}, {'id': 'FG001', 'title': 'Placebo + Fulvestrant', 'description': 'BKM120 matching placebo daily and fulvestrant given until progression or as described in the protocol.'}], 'periods': [{'title': 'Randomization Phase', 'milestones': [{'type': 'STARTED', 'comment': 'All randomized patients', 'achievements': [{'comment': 'All randomized patients', 'groupId': 'FG000', 'numSubjects': '289'}, {'comment': 'All randomized patients', 'groupId': 'FG001', 'numSubjects': '143'}]}, {'type': 'COMPLETED', 'comment': 'Randomized and treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '288'}, {'groupId': 'FG001', 'numSubjects': '140'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Protocol deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Technical problem', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Treatment Phase', 'milestones': [{'type': 'STARTED', 'comment': 'All patients in FAS that were treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '288'}, {'groupId': 'FG001', 'numSubjects': '140'}]}, {'type': 'FAS - ctDNA PIK3CA Mutant', 'comment': 'All patients in FAS with ctDNA sample and PIK3CA mutation', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'FAS - ctDNA PIK3CA Non-mutant', 'comment': 'All patients in FAS with ctDNA sample and no PIK3CA mutation', 'achievements': [{'groupId': 'FG000', 'numSubjects': '132'}, {'groupId': 'FG001', 'numSubjects': '81'}]}, {'type': 'Safety Set (SS)', 'comment': 'At least 1 dose of study treatment and a 1 post baseline safety assessment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '288'}, {'groupId': 'FG001', 'numSubjects': '140'}]}, {'type': 'Pharmacokinetic Analysis Set (PAS)', 'comment': 'At least one dose of Buparlisib and had at least 1 evaluable buparlisib concentration measurement', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '288'}, {'groupId': 'FG001', 'numSubjects': '140'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '210'}, {'groupId': 'FG001', 'numSubjects': '120'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Study Terminated by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Subject/guardian decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}, {'title': 'Post-Treatment Efficacy Follow-Up Phase', 'milestones': [{'type': 'STARTED', 'comment': 'All patients who discontinued treatment and entered Post-Treatment Efficacy Follow-Up Phase', 'achievements': [{'comment': 'All patients who entered Post-Treatment Efficacy Fup Phase', 'groupId': 'FG000', 'numSubjects': '16'}, {'comment': 'All patients who entered Post-Treatment Efficacy Fup Phase', 'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Study terminated by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Subject/Guardian Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study was conducted at 201 centers in 22 countries worldwide (Argentina, Austria, Belgium, Bulgaria, Canada, Colombia, Finland, France, Germany, Greece, Hungary, Italy, Republic of Korea, Lebanon, The Netherlands, Norway, Poland, Spain, Sweden, Thailand, UK and USA).', 'preAssignmentDetails': 'At least 420 patients were planned to be enrolled, randomized in a 2:1 ratio (two buparlisib, one placebo). A total of 432 patients were actually enrolled and analyzed (buparlisib arm: N=289; placebo arm: N=143). Not completed: in Randomization Phase=Randomized and not Treated; in Treatment Phase=Discontinued study treatment per Protocol.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '432', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'BKM120 100mg + Fulvestrant', 'description': 'BKM120 100 mg per day and fulvestrant given until progression or as described in the protocol.'}, {'id': 'BG001', 'title': 'Placebo + Fulvestrant', 'description': 'BKM120 matching placebo daily and fulvestrant given until progression or as described in the protocol.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.5', 'spread': '9.76', 'groupId': 'BG000'}, {'value': '61.5', 'spread': '9.23', 'groupId': 'BG001'}, {'value': '60.8', 'spread': '9.59', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Full Analysis Set (FAS)'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '289', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '432', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Full Analysis Set (FAS)'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '249', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '370', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Full Analysis Set (FAS)'}], 'populationDescription': 'Full Analysis Set (FAS)'}}, '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': 432}}, 'statusModule': {'whyStopped': 'Novartis decided not to pursue further development of buparlisib program (assessment of moderate PFS benefit with know, but manageable, buparlisib profile).', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-10-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2017-09-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-09', 'studyFirstSubmitDate': '2012-06-29', 'resultsFirstSubmitDate': '2018-09-20', 'studyFirstSubmitQcDate': '2012-06-29', 'lastUpdatePostDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-01-08', 'studyFirstPostDateStruct': {'date': '2012-07-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-05-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival (PFS) Based on Local Investigator Assessment - Full Analysis Set (FAS)', 'timeFrame': 'Every 6 weeks after randomization up to a maximum of 4 years', 'description': 'Progression Free Survival (PFS) is defined as the time from date of randomization to the date of first radiologically documented progression or death due to any cause. If a patient did not progress or die at the time of the analysis data cut-off or start of new antineoplastic therapy, PFS was censored at the date of the last adequate tumor assessment before the earliest of the cut-off date or the start date of additional anti-neoplastic therapy. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria RECIST v1.1, as 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline and/or unequivocal progression of the non-target lesions and/or appearance of a new lesion. In addition to the relative increase of 20%, the sum must demonstrate an absolute increase of at least 5 mm. Patients were followed up for approximately every 6 weeks after randomization.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS) - Full Analysis Set (FAS)', 'timeFrame': 'Every 6 weeks after randomization up to a maximum of 5 years', 'description': 'Overall Survival (OS) is defined as the time from date of randomization to date of death due to any cause. If a patient was not known to have died by the date of analysis cut-off, OS was censored at the date of last known date patient alive. Patients were followed up approximately every 6 weeks after randomization and every 3 months during survival follow-up.'}, {'measure': 'Progression Free Survival (PFS) by PIK3CA Mutational Status', 'timeFrame': 'Every 6 weeks after randomization up to a maximum of 5 years', 'description': 'Progression Free Survival (PFS) is defined as the time from date of randomization to the date of first radiologically documented progression or death due to any cause. If a patient did not progress or die at the time of the analysis data cut-off or start of new antineoplastic therapy, PFS was censored at the date of the last adequate tumor assessment before the earliest of the cut-off date or the start date of additional anti-neoplastic therapy. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria RECIST v1.1, as 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline and/or unequivocal progression of the non-target lesions and/or appearance of a new lesion. In addition to the relative increase of 20%, the sum must demonstrate an absolute increase of at least 5 mm. Patients were followed up for approximately every 6 weeks after randomization.'}, {'measure': 'Overall Survival (OS) by PIK3CA Mutational Status', 'timeFrame': 'Every 6 weeks after randomization up to a maximum of 5 years', 'description': 'Overall Survival (OS) by PIK3CA mutational status based on ctDNA is defined as the time from date of randomization to date of death due to any cause. If a patient was not known to have died by the date of analysis cut-off, OS was censored at the date of last known date patient alive. Patients were followed up approximately every 6 weeks after randomization and every 3 months during survival follow-up.'}, {'measure': 'Overall Response Rate (ORR) by PIK3CA Mutational Status', 'timeFrame': 'Every 6 weeks after randomization up to a maximum of 5 years', 'description': "Overall Response Rate (ORR) is defined as the proportion of participants with best overall response of complete response (CR) or partial response (PR) based on local investigator's assessment according to RECIST 1.1. ORR was analyzed in the full population and by PIK3CA mutational status based on ctDNA. Response Evaluation Criteria in Solid Tumors (RECIST v1.1) for target/non target lesions: Complete Response (CR), disappearance of all target/non target lesions (all lymph nodes assigned as non-target lesions must be non-pathological in size (\\< 10 mm short axis)); Partial response (PR), \\>=30% decrease in the sum of the longest diameter of target lesions ; Overall Response (OR)= CR+PR. Patients were followed up for the duration of the study and for approximately every 6 weeks after randomization."}, {'measure': 'Clinical Benefit Rate (CBR) by PIK3CA Mutational Status', 'timeFrame': 'Week 14, Week 24', 'description': "Clinical Benefit Rate (CBR) is defined as the proportion of participants with a best overall response of complete response (CR) or partial response (PR) or stable disease (SD) or Non-CR/non-PD lasting more than 14 or 24 weeks based on local investigator's assessment according to RECIST 1.1. CBR was analyzed in the full population and by PIK3CA mutational status based on ctDNA. Patients were followed up for the duration of the study and approximately every 6 weeks after randomization."}, {'measure': 'Long-term Safety and Tolerability in the Two Treatment Arms - Safety Set (SS)', 'timeFrame': 'From first dose of study treatment to 30 days after last dose of study treatment, up to 5 years', 'description': 'Analysis of frequencies for treatment emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths.'}, {'measure': 'Plasma Concentration-time Profiles of BKM120 in Combination With Fulvestrant at Cycle 1 Day 1 - Pharmacokinetic Analysis Set (PAS)', 'timeFrame': 'C1D1 1 hour post dose, C1D1 2 hour post dose, C1D1 6 hour post dose and C1D1 9 hour post dose', 'description': 'Plasma samples were collected from the first 100 BKM120-treated patients on Cycle 1 Day 1 (at 1h, 2h, and 6h post-dose and a recommended 9h post-dose sample).'}, {'measure': 'Predose Trough Concentration-time Profile of BKM120 in Combination With Fulvestrant Over Time - Pharmacokinetic Analysis Set (PAS)', 'timeFrame': 'C1D15, C2D1, C3D1 and C4D1', 'description': 'Pre-dose samples were collected for trough concentrations at Cycle 1 Day 15, Cycle 2 Day 1, Cycle 3 Day 1 and Cycle 4 Day 1.'}, {'measure': 'Health-related Quality of Life (HRQoL):Time to 10% Definitive Deterioration in the Global Health Status/Quality of Life Per EORTC-QLQ-C30 - Full Analysis Set (FAS)', 'timeFrame': 'Baseline, Week 6 (C2D15), Week 12 (C4D1), then every 8 weeks until discontinuation (a cycle [C] = 4 weeks) up to 5 years.', 'description': 'The global health status/QoL scale score of the QLQ-C30 is identified as the primary PRO variable of interest. Physical Functioning (PF), Emotional Functioning (EF) and Social Functioning (SF) scale scores of the QLQ-C30. The time to definitive 10% deterioration is defined as the time from the randomization date to the date of an event, which is defined as a worsening (decrease) in score by at least 10% compared to baseline, with no later increase above this threshold observed during the course of the study or death due to any cause. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. A high score for a functional scale represents a high /healthy level of functioning, a high score for the global health status / QoL represents a high QoL.'}, {'measure': 'Time to Definitive Deterioration of ECOG Performance Status From Baseline - Full Analysis Set (FAS)', 'timeFrame': 'Screening, Baseline (Cycle 1 Day 1) and then at day 1 of each cycle and at the EOT visit', 'description': "The Eastern Cooperative Oncology Group (ECOG) Performance Status is a scale used to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis. The ECOG Performance Scores has 5 grades: 0 = fully active, able to carry on all pre-disease performance without restriction, 1 = restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work, 2 = ambulatory and capable of all self-care but unable to carry out any work activities, up and about more than 50% of waking hours, 3 = capable of only limited self-care, confined to bed or chair more than 50% of waking hours, 4 = completely disabled, cannot carry on any self-care, totally confined to bed or chair and 5 = dead. Definitive deterioration is defined as no improvement in the ECOG status following observation of the deterioration."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['BKM120', 'fulvestrant', 'breast cancer', 'metastatic', 'locally advanced', 'AI treated', 'mTOR inhibitor', 'PI3K', 'PIK3CA', 'PTEN', 'HER2-', 'HR+'], 'conditions': ['Metastatic Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '29223745', 'type': 'DERIVED', 'citation': "Di Leo A, Johnston S, Lee KS, Ciruelos E, Lonning PE, Janni W, O'Regan R, Mouret-Reynier MA, Kalev D, Egle D, Csoszi T, Bordonaro R, Decker T, Tjan-Heijnen VCG, Blau S, Schirone A, Weber D, El-Hashimy M, Dharan B, Sellami D, Bachelot T. Buparlisib plus fulvestrant in postmenopausal women with hormone-receptor-positive, HER2-negative, advanced breast cancer progressing on or after mTOR inhibition (BELLE-3): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2018 Jan;19(1):87-100. doi: 10.1016/S1470-2045(17)30688-5. Epub 2017 Dec 7."}]}, 'descriptionModule': {'briefSummary': 'This study was a multicenter, randomized, double-blind, placebo-controlled Phase III study to determine the efficacy and safety of treatment with Buparlisib plus Fulvestrant vs. Placebo plus Fulvestrant in postmenopausal women with hormone Receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative), aromatase inhibitor (AI)-treated, locally advanced or metastatic breast cancer whose disease progressed on or after mammalian target of rapamycin inhibitor (mTORi)-based treatment.\n\nPatients were randomized in 2:1 ratio to treatment with buparlisib 100 mg daily in combination with fulvestrant 500 mg or placebo daily in combination with fulvestrant 500 mg. Randomization was stratified according to visceral disease status (present or absent).', 'detailedDescription': 'Novartis decided not to pursue further development of buparlisib program. On 19 Dec 2016, Novartis notified the Investigators about this decision; accordingly the CBKM120F2303 study was terminated.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key inclusion criteria\n\n* Female patients age 18 years or older\n* Histologically and/or cytologically confirmed diagnosis of breast cancer\n* Radiologic evidence of inoperable locally advanced or metastatic breast cancer\n* Adequate tumor tissue for the analysis of PI3K-related biomarkers\n* Human epidermal growth factor receptor-2 (HER2) negative disease, and a known positive hormone receptor status\n* Postmenopausal women\n* Prior treatment with aromatase inhibitors\n* Evidence of progression to the combination of mTORi and endocrine therapy given as the last therapy prior to study entry\n* Adequate bone marrow and organ function\n* ECOG performance status ≤ 2\n\nKey exclusion criteria\n\n* Previous treatment with PI3K inhibitors, protein kinase B inhibitors or fulvestrant\n* More than one chemotherapy line for metastatic disease\n* Hypersensitivity to any of the excipients of buparlisib or fulvestrant\n* Symptomatic central nervous system metastases\n* Concurrent malignancy or malignancy within 3 years of study enrollment\n* Certain drugs or radiation within 2-4 weeks of enrollment\n* Increasing or chronic treatment (\\>5 days) with corticosteroids or another immunosuppressive agent\n* Certain scores on an anxiety and depression mood questionnaire given at screening\n* Acute viral hepatitis or a history of chronic or active hepatitis B virus or hepatitis C virus\n* Active cardiac disease or a history of cardiac dysfunction'}, 'identificationModule': {'nctId': 'NCT01633060', 'acronym': 'BELLE-3', 'briefTitle': 'A Phase III Study of BKM120 With Fulvestrant in Patients With HR+,HER2-, AI Treated, Locally Advanced or Metastatic Breast Cancer Who Progressed on or After mTORi', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase III Randomized, Double Blind, Placebo Controlled Study of BKM120 With Fulvestrant, in Postmenopausal Women With Hormone Receptor-positive HER2-negative AI Treated, Locally Advanced or Metastatic Breast Cancer Who Progressed on or After mTOR Inhibitor Based Treatment', 'orgStudyIdInfo': {'id': 'CBKM120F2303'}, 'secondaryIdInfos': [{'id': '2012-002571-34', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BKM120 100mg + Fulvestrant', 'description': 'BKM120 100 mg per day and fulvestrant given until progression or as described in the protocol.', 'interventionNames': ['Drug: Fulvestrant', 'Drug: BKM120']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo + Fulvestrant', 'description': 'BKM120 matching placebo daily and fulvestrant given until progression or as described in the protocol.', 'interventionNames': ['Drug: Fulvestrant', 'Drug: BKM120 matching placebo']}], 'interventions': [{'name': 'Fulvestrant', 'type': 'DRUG', 'description': 'Intramuscular fulvestrant 500 mg (Day 1 and Day 15 of Cycle 1 and Day 1 of every cycle thereafter)', 'armGroupLabels': ['BKM120 100mg + Fulvestrant', 'Placebo + Fulvestrant']}, {'name': 'BKM120', 'type': 'DRUG', 'description': 'BKM120 100 mg once daily', 'armGroupLabels': ['BKM120 100mg + Fulvestrant']}, {'name': 'BKM120 matching placebo', 'type': 'DRUG', 'description': 'BKM120 matching placebo, once daily', 'armGroupLabels': ['Placebo + Fulvestrant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36688', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of South Alabama / Mitchell Cancer Institute Univ South AL', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'Ironwood Cancer and Research Centers SC', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '72703', 'city': 'Fayetteville', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Highlands Oncology Group', 'geoPoint': {'lat': 36.06258, 'lon': -94.15743}}, {'zip': '92708', 'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'facility': 'Compassionate Cancer Care Medical Group CCCMG', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '90017', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Los Angeles Hematology/Oncology Medical Group Onc Dept.', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars Sinai Medical Center SC-5', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California at Los Angeles UCLA SC', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '93940', 'city': 'Monterey', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Cancer Care', 'geoPoint': {'lat': 36.60024, 'lon': -121.89468}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rocky Mountain Cancer Centers SC', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '30607', 'city': 'Athens', 'state': 'Georgia', 'country': 'United States', 'facility': 'University Cancer & Blood Center, LLC', 'geoPoint': {'lat': 33.96095, 'lon': -83.37794}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University School of Medicine/Winship Cancer Institute Emory', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '96817', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Moanalua Medical Center. Attn: Oncology Dept', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '60540', 'city': 'Naperville', 'state': 'Illinois', 'country': 'United States', 'facility': 'Edward Hospital Edward Hospital', 'geoPoint': {'lat': 41.78586, 'lon': -88.14729}}, {'zip': '70006', 'city': 'Metairie', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Crescent City Research Consortium, LLC SC', 'geoPoint': {'lat': 29.98409, 'lon': -90.15285}}, {'zip': '70115', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Lsu Health Sciences Center/ Lsu School of Medicine Lsu', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '70121', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'John Ochsner Heart and Vascular Institute Clinical Trials Ochsner 2', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '70122-2822', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'LSU 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