Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2025-12-31 @ 9:54 PM
Study NCT ID:
NCT04251533
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-05
First Post:
2020-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Assessing the Efficacy and Safety of Alpelisib + Nab-paclitaxel in Subjects With Advanced TNBC Who Carry Either a PIK3CA Mutation or Have PTEN Loss
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Hong Kong', 'Jordan', 'Lebanon', 'Romania', 'Serbia'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D064726', 'term': 'Triple Negative Breast Neoplasms'}], 'ancestors': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C585539', 'term': 'Alpelisib'}, {'id': 'C520255', 'term': '130-nm albumin-bound paclitaxel'}, {'id': 'D000068196', 'term': 'Albumin-Bound Paclitaxel'}], 'ancestors': [{'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D000418', 'term': 'Albumins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'novartis.email@novartis.com', 'phone': '+ 1 862 778 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}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.', 'description': 'Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.', 'eventGroups': [{'id': 'EG000', 'title': 'Part A: Alpelisib + Nab-paclitaxelEdit', 'description': 'Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m\\^2 intravenously (IV) on Days 1, 8, and 15 of each 28-day cycle.', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 51, 'seriousNumAtRisk': 52, 'deathsNumAffected': 6, 'seriousNumAffected': 22}, {'id': 'EG001', 'title': 'Part A: Placebo + Nab-paclitaxelEdit', 'description': 'Participants received placebo + nab-paclitaxel 100 mg/m\\^2 IV on Days 1, 8, and 15 of each 28-day cycle.', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 47, 'seriousNumAtRisk': 50, 'deathsNumAffected': 6, 'seriousNumAffected': 15}, {'id': 'EG002', 'title': 'Part B1: Alpelisib + Nab-paclitaxelEdit', 'description': 'Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m\\^2 IV on Days 1, 8, and 15 of each 28-day cycle.', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 34, 'seriousNumAtRisk': 35, 'deathsNumAffected': 3, 'seriousNumAffected': 14}, {'id': 'EG003', 'title': 'Part A: Alpelisib + Nab-paclitaxel (Post-treatment Survival Follow-up)', 'description': 'Deaths collected in the post-treatment survival follow-up period (starting from Day 31 post-treatment). No AEs were collected during this period.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 46, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 19, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Part A: Placebo + Nab-paclitaxel (Post-treatment Survival Follow-up)', 'description': 'Deaths collected in the post-treatment survival follow-up period (starting from Day 31 post-treatment). No AEs were collected during this period.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 44, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 14, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Part B1: Alpelisib + Nab-paclitaxel (Post-treatment Survival Follow-up)', 'description': 'Deaths collected in the post-treatment survival follow-up period (starting from Day 31 post-treatment). No AEs were collected during this period.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 32, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 11, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Paronychia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Alpha hydroxybutyrate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 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'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Spinal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Infected neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Brain oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Haemorrhage intracranial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Bronchial fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Hydrothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression-free Survival (PFS) Per Investigator Assessment in Study Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Alpelisib + Nab-paclitaxel', 'description': 'Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m\\^2 intravenously (IV) on Days 1, 8, and 15 of each 28-day cycle.'}, {'id': 'OG001', 'title': 'Part A: Placebo + Nab-paclitaxel', 'description': 'Participants received placebo + nab-paclitaxel 100 mg/m\\^2 IV on Days 1, 8, and 15 of each 28-day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.2', 'groupId': 'OG000', 'lowerLimit': '3.71', 'upperLimit': '8.57'}, {'value': '5.6', 'groupId': 'OG001', 'lowerLimit': '3.75', 'upperLimit': '12.68'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.49', 'ciLowerLimit': '0.92', 'ciUpperLimit': '2.41', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Once all participants have completed at least 6 months of study treatment or have discontinued from study treatment, up to 35 months', 'description': 'PFS was defined as time from the date of randomization to the date of the first documented progressive disease (PD) or death due to any cause. PFS was assessed via a local radiology assessment according to RECIST 1.1. PD=At least a 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. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm\\^2. PFS was censored at the date of the last adequate tumor assessment, if no PFS event was observed prior to the analysis cut-off date.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Part A: The full analysis set included all participants to whom study treatment was assigned by randomization.'}, {'type': 'PRIMARY', 'title': 'Overall Response Rate (ORR) Based on Local Radiology Assessments in Participants With Measurable Disease at Baseline in Study Part B1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B1: Alpelisib + Nab-paclitaxel', 'description': 'Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m\\^2 IV on Days 1, 8, and 15 of each 28-day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000', 'lowerLimit': '4.8', 'upperLimit': '30.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 6 months', 'description': 'ORR was defined as the percentage of participants with best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1. BOR was defined as the best response recorded from the start of the study treatment until progressive disease (PD)/recurrence. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\< 10 mm. PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters; PD= At least a 20% increase in the sum of diameters of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition, the sum must also demonstrate an absolute increase of at least 5 mm.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Part B1: The full analysis set included all participants to whom study treatment was assigned.'}, {'type': 'SECONDARY', 'title': 'Overall Survival in Study Part A', 'timeFrame': 'Up to 66 months', 'description': 'Overall survival is defined as the time from date of randomization to date of death due to any cause.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2026-05'}, {'type': 'SECONDARY', 'title': 'Overall Response Rate (ORR) With Confirmed Response in Study Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Alpelisib + Nab-paclitaxel', 'description': 'Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m\\^2 intravenously (IV) on Days 1, 8, and 15 of each 28-day cycle.'}, {'id': 'OG001', 'title': 'Part A: Placebo + Nab-paclitaxel', 'description': 'Participants received placebo + nab-paclitaxel 100 mg/m\\^2 IV on Days 1, 8, and 15 of each 28-day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '40.4', 'groupId': 'OG000', 'lowerLimit': '27.0', 'upperLimit': '54.9'}, {'value': '34.0', 'groupId': 'OG001', 'lowerLimit': '21.2', 'upperLimit': '48.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Once all participants have completed at least 6 months of study treatment or have discontinued from study treatment, up to 35 months', 'description': 'ORR with confirmed response was the percentage of participants with best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), as per local review and according to RECIST 1.1. BOR was defined as the best response recorded from the start of the study treatment until progressive disease (PD)/recurrence. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\< 10 mm. PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters; PD= At least a 20% increase in the sum of diameters of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition, the sum must also demonstrate an absolute increase of at least 5 mm.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Part A: The full analysis set included all participants to whom study treatment was assigned by randomization.'}, {'type': 'SECONDARY', 'title': 'Clinical Benefit Rate (CBR) With Confirmed Response in Study Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Alpelisib + Nab-paclitaxel', 'description': 'Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m\\^2 intravenously (IV) on Days 1, 8, and 15 of each 28-day cycle.'}, {'id': 'OG001', 'title': 'Part A: Placebo + Nab-paclitaxel', 'description': 'Participants received placebo + nab-paclitaxel 100 mg/m\\^2 IV on Days 1, 8, and 15 of each 28-day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '35.8', 'upperLimit': '64.2'}, {'value': '44.0', 'groupId': 'OG001', 'lowerLimit': '30.0', 'upperLimit': '58.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Once all participants have completed at least 6 months of study treatment or have discontinued from study treatment, up to 35 months', 'description': "Clinical benefit rate (CBR) was defined as the percentage of participants with a best overall response of complete response (CR), or partial response (PR) or an overall lesion response of stable disease (SD), lasting as per local review, for a duration of at least 24 weeks. CR, PR and SD are defined according to RECIST 1.1 based on investigator's assessment. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\< 10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Part A: The full analysis set included all participants to whom study treatment was assigned by randomization.'}, {'type': 'SECONDARY', 'title': 'Clinical Benefit Rate (CBR) With Confirmed Response in Study Part B1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B1: Alpelisib + Nab-paclitaxel', 'description': 'Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m\\^2 IV on Days 1, 8, and 15 of each 28-day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.7', 'groupId': 'OG000', 'lowerLimit': '12.5', 'upperLimit': '43.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 6 months', 'description': "Clinical benefit rate (CBR) was defined as the percentage of participants with a best overall response of complete response (CR), or partial response (PR) or an overall lesion response of stable disease (SD), lasting as per local review, for a duration of at least 24 weeks. CR, PR and SD are defined according to RECIST 1.1 based on investigator's assessment. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\< 10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Part B1: The full analysis set included all participants to whom study treatment was assigned.'}, {'type': 'SECONDARY', 'title': 'Time to Response (TTR) in Study Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Alpelisib + Nab-paclitaxel', 'description': 'Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m\\^2 intravenously (IV) on Days 1, 8, and 15 of each 28-day cycle.'}, {'id': 'OG001', 'title': 'Part A: Placebo + Nab-paclitaxel', 'description': 'Participants received placebo + nab-paclitaxel 100 mg/m\\^2 IV on Days 1, 8, and 15 of each 28-day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'The median and upper limit of 95% CI were not estimable due to an insufficient number of participants with events.', 'groupId': 'OG000', 'lowerLimit': '4.14', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The median and lower and upper limit of 95% CI were not estimable due to an insufficient number of participants with events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Once all participants have completed at least 6 months of study treatment or have discontinued from study treatment, up to 35 months', 'description': 'Time to response (TTR) was defined as the time from the date of randomization/enrolment to the first documented response of either complete response (CR) or partial response (PR), which must be subsequently confirmed (although date of initial response is used, not date of confirmation). CR and PR were based on tumor response data as per local review and according to RECIST 1.1. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\< 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Part A: The full analysis set included all participants to whom study treatment was assigned by randomization.'}, {'type': 'SECONDARY', 'title': 'Time to Response (TTR) in Study Part B1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B1: Alpelisib + Nab-paclitaxel', 'description': 'Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m\\^2 IV on Days 1, 8, and 15 of each 28-day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'The median and lower and upper limit of 95% CI were not estimable due to an insufficient number of participants with events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 6 months', 'description': 'Time to response (TTR) was defined as the time from the date of randomization/enrolment to the first documented response of either complete response (CR) or partial response (PR), which must be subsequently confirmed (although date of initial response was used, not date of confirmation). CR and PR were based on tumor response data as per local review and according to RECIST 1.1. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\< 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Part B1: The full analysis set included all participants to whom study treatment was assigned.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR) With Confirmed Response in Study Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Alpelisib + Nab-paclitaxel', 'description': 'Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m\\^2 intravenously (IV) on Days 1, 8, and 15 of each 28-day cycle.'}, {'id': 'OG001', 'title': 'Part A: Placebo + Nab-paclitaxel', 'description': 'Participants received placebo + nab-paclitaxel 100 mg/m\\^2 IV on Days 1, 8, and 15 of each 28-day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.39', 'groupId': 'OG000', 'lowerLimit': '5.59', 'upperLimit': '9.53'}, {'value': 'NA', 'comment': 'The median and upper limit of 95% CI were not estimable due to an insufficient number of participants with events.', 'groupId': 'OG001', 'lowerLimit': '10.55', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Once all participants have completed at least 6 months of study treatment or have discontinued from study treatment, up to 35 months', 'description': 'Duration of response (DOR) with confirmed response only applied to participants whose best overall response (BOR) was confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1 based on tumor response data per local review. The start date was the date of first documented response of CR or PR (i.e. the start date of response, not the date when response was confirmed), and the end date was defined as the date of the first documented progressive disease (PD) or death due to underlying cancer. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\< 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Part A: The full analysis set included all participants to whom study treatment was assigned by randomization. Results are reported for participants whose best overall response was confirmed complete response (CR) or confirmed partial response (PR).'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR) With Confirmed Response in Study Part B1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B1: Alpelisib + Nab-paclitaxel', 'description': 'Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m\\^2 IV on Days 1, 8, and 15 of each 28-day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.04', 'comment': 'The upper limit of 95% CI was not estimable due to an insufficient number of participants with events.', 'groupId': 'OG000', 'lowerLimit': '7.46', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 20 months', 'description': 'Duration of response (DOR) with confirmed response only applied to participants whose best overall response (BOR) was confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1 based on tumor response data per local review. The start date was the date of first documented response of CR or PR (i.e. the start date of response, not the date when response was confirmed), and the end date was defined as the date of the first documented progressive disease (PD) or death due to underlying cancer. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\< 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Part B1: The full analysis set included all participants to whom study treatment was assigned. Results are reported for participants whose best overall response was confirmed complete response (CR) or confirmed partial response (PR).'}, {'type': 'SECONDARY', 'title': 'Overall Survival in Study Part B1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B1: Alpelisib + Nab-paclitaxelEdit', 'description': 'Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m\\^2 IV on Days 1, 8, and 15 of each 28-day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to approximately 26 months.', 'description': 'Overall survival for Part B1 was defined as the number of participants who were alive at the end of the post-treatment period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Part B1: All participants to whom study treatment was assigned.'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival (PFS) Per Investigator Assessment in Study Part B1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B1: Alpelisib + Nab-paclitaxel', 'description': 'Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m\\^2 IV on Days 1, 8, and 15 of each 28-day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.71', 'groupId': 'OG000', 'lowerLimit': '3.15', 'upperLimit': '5.88'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 6 months', 'description': 'PFS was defined as time from the date of enrolment to the date of the first documented progressive disease (PD) or death due to any cause. PFS was assessed via a local radiology assessment according to RECIST 1.1. PD=At least a 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. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm\\^2. PFS was censored at the date of the last adequate tumor assessment, if no PFS event was observed prior to the analysis cut-off date.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Part B1: The full analysis set included all participants to whom study treatment was assigned.'}, {'type': 'SECONDARY', 'title': 'PFS Based on Local Radiology Assessments Using RECIST 1.1 Criteria for Participants by PIK3CA Mutation Status Measured in Baseline Circulating Tumor Deoxyribonucleic Acid (ctDNA) in Study Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Alpelisib + Nab-paclitaxel', 'description': 'Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m\\^2 intravenously (IV) on Days 1, 8, and 15 of each 28-day cycle.'}, {'id': 'OG001', 'title': 'Part A: Placebo + Nab-paclitaxel', 'description': 'Participants received placebo + nab-paclitaxel 100 mg/m\\^2 IV on Days 1, 8, and 15 of each 28-day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.5', 'groupId': 'OG000', 'lowerLimit': '3.58', 'upperLimit': '9.17'}, {'value': '3.5', 'groupId': 'OG001', 'lowerLimit': '1.77', 'upperLimit': '5.85'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Once all participants have completed at least 6 months of study treatment or have discontinued from study treatment, up to 35 months', 'description': 'PFS in participants with PIK3CA mutation as measured in ctDNA. PFS was defined as time from the date of randomization to the date of the first documented progression or death due to any cause.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Part A: The full analysis set included all participants to whom study treatment was assigned by randomization. Results are reported for participants with available data.'}, {'type': 'SECONDARY', 'title': 'Post-Hoc: All Collected Deaths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Alpelisib + Nab-paclitaxel', 'description': 'Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m\\^2 intravenously (IV) on Days 1, 8, and 15 of each 28-day cycle.'}, {'id': 'OG001', 'title': 'Part A: Placebo + Nab-paclitaxel', 'description': 'Participants received placebo + nab-paclitaxel 100 mg/m\\^2 IV on Days 1, 8, and 15 of each 28-day cycle.'}, {'id': 'OG002', 'title': 'Part B1: Alpelisib + Nab-paclitaxelEdit', 'description': 'Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m\\^2 IV on Days 1, 8, and 15 of each 28-day cycle.'}], 'classes': [{'title': 'On-treatment deaths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Post-treatment survival follow-up deaths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'All deaths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'On-treatment deaths: Up to approximately 28 months (Part A) or approximately 17 months (Part B1). Post-treatment survival follow-up deaths: Up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1).', 'description': 'On-treatment deaths due to any cause were collected from first dose of study medication to 30 days after the last dose of study treatment. Post-treatment survival follow-up deaths were collected from Day 31 after last dose of study medication to the data cut-off date.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Parts A and B: All participants to whom study treatment was assigned.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part A: Alpelisib + Nab-paclitaxel', 'description': 'Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m\\^2 intravenously (IV) on Days 1, 8, and 15 of each 28-day cycle.'}, {'id': 'FG001', 'title': 'Part A: Placebo + Nab-paclitaxel', 'description': 'Participants received placebo + nab-paclitaxel 100 mg/m\\^2 IV on Days 1, 8, and 15 of each 28-day cycle.'}, {'id': 'FG002', 'title': 'Part B1: Alpelisib + Nab-paclitaxel', 'description': 'Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m\\^2 IV on Days 1, 8, and 15 of each 28-day cycle.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '36'}, {'groupId': 'FG002', 'numSubjects': '31'}]}], 'dropWithdraws': [{'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '22'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Participant decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '137', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Part A: Alpelisib + Nab-paclitaxel', 'description': 'Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m\\^2 intravenously (IV) on Days 1, 8, and 15 of each 28-day cycle.'}, {'id': 'BG001', 'title': 'Part A: Placebo + Nab-paclitaxel', 'description': 'Participants received placebo + nab-paclitaxel 100 mg/m\\^2 IV on Days 1, 8, and 15 of each 28-day cycle.'}, {'id': 'BG002', 'title': 'Part B1: Alpelisib + Nab-paclitaxel', 'description': 'Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m\\^2 IV on Days 1, 8, and 15 of each 28-day cycle.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.8', 'spread': '9.76', 'groupId': 'BG000'}, {'value': '59.1', 'spread': '11.34', 'groupId': 'BG001'}, {'value': '48.4', 'spread': '12.21', 'groupId': 'BG002'}, {'value': '55.5', 'spread': '11.74', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '136', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '85', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}]}, {'title': 'Multiple', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Black Or African American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-03-14', 'size': 2104462, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-05-28T14:35', 'hasProtocol': True}, {'date': '2023-07-03', 'size': 1131345, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-05-28T14:35', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 137}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-06-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-01-13', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-31', 'studyFirstSubmitDate': '2020-01-30', 'resultsFirstSubmitDate': '2024-05-28', 'studyFirstSubmitQcDate': '2020-01-30', 'lastUpdatePostDateStruct': {'date': '2025-11-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2024-07-08', 'studyFirstPostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free Survival (PFS) Per Investigator Assessment in Study Part A', 'timeFrame': 'Once all participants have completed at least 6 months of study treatment or have discontinued from study treatment, up to 35 months', 'description': 'PFS was defined as time from the date of randomization to the date of the first documented progressive disease (PD) or death due to any cause. PFS was assessed via a local radiology assessment according to RECIST 1.1. PD=At least a 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. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm\\^2. PFS was censored at the date of the last adequate tumor assessment, if no PFS event was observed prior to the analysis cut-off date.'}, {'measure': 'Overall Response Rate (ORR) Based on Local Radiology Assessments in Participants With Measurable Disease at Baseline in Study Part B1', 'timeFrame': 'Up to 6 months', 'description': 'ORR was defined as the percentage of participants with best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1. BOR was defined as the best response recorded from the start of the study treatment until progressive disease (PD)/recurrence. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\< 10 mm. PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters; PD= At least a 20% increase in the sum of diameters of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition, the sum must also demonstrate an absolute increase of at least 5 mm.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival in Study Part A', 'timeFrame': 'Up to 66 months', 'description': 'Overall survival is defined as the time from date of randomization to date of death due to any cause.'}, {'measure': 'Overall Response Rate (ORR) With Confirmed Response in Study Part A', 'timeFrame': 'Once all participants have completed at least 6 months of study treatment or have discontinued from study treatment, up to 35 months', 'description': 'ORR with confirmed response was the percentage of participants with best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), as per local review and according to RECIST 1.1. BOR was defined as the best response recorded from the start of the study treatment until progressive disease (PD)/recurrence. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\< 10 mm. PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters; PD= At least a 20% increase in the sum of diameters of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition, the sum must also demonstrate an absolute increase of at least 5 mm.'}, {'measure': 'Clinical Benefit Rate (CBR) With Confirmed Response in Study Part A', 'timeFrame': 'Once all participants have completed at least 6 months of study treatment or have discontinued from study treatment, up to 35 months', 'description': "Clinical benefit rate (CBR) was defined as the percentage of participants with a best overall response of complete response (CR), or partial response (PR) or an overall lesion response of stable disease (SD), lasting as per local review, for a duration of at least 24 weeks. CR, PR and SD are defined according to RECIST 1.1 based on investigator's assessment. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\< 10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease."}, {'measure': 'Clinical Benefit Rate (CBR) With Confirmed Response in Study Part B1', 'timeFrame': 'Up to 6 months', 'description': "Clinical benefit rate (CBR) was defined as the percentage of participants with a best overall response of complete response (CR), or partial response (PR) or an overall lesion response of stable disease (SD), lasting as per local review, for a duration of at least 24 weeks. CR, PR and SD are defined according to RECIST 1.1 based on investigator's assessment. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\< 10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease."}, {'measure': 'Time to Response (TTR) in Study Part A', 'timeFrame': 'Once all participants have completed at least 6 months of study treatment or have discontinued from study treatment, up to 35 months', 'description': 'Time to response (TTR) was defined as the time from the date of randomization/enrolment to the first documented response of either complete response (CR) or partial response (PR), which must be subsequently confirmed (although date of initial response is used, not date of confirmation). CR and PR were based on tumor response data as per local review and according to RECIST 1.1. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\< 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters.'}, {'measure': 'Time to Response (TTR) in Study Part B1', 'timeFrame': 'Up to 6 months', 'description': 'Time to response (TTR) was defined as the time from the date of randomization/enrolment to the first documented response of either complete response (CR) or partial response (PR), which must be subsequently confirmed (although date of initial response was used, not date of confirmation). CR and PR were based on tumor response data as per local review and according to RECIST 1.1. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\< 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters.'}, {'measure': 'Duration of Response (DOR) With Confirmed Response in Study Part A', 'timeFrame': 'Once all participants have completed at least 6 months of study treatment or have discontinued from study treatment, up to 35 months', 'description': 'Duration of response (DOR) with confirmed response only applied to participants whose best overall response (BOR) was confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1 based on tumor response data per local review. The start date was the date of first documented response of CR or PR (i.e. the start date of response, not the date when response was confirmed), and the end date was defined as the date of the first documented progressive disease (PD) or death due to underlying cancer. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\< 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters.'}, {'measure': 'Duration of Response (DOR) With Confirmed Response in Study Part B1', 'timeFrame': 'Up to approximately 20 months', 'description': 'Duration of response (DOR) with confirmed response only applied to participants whose best overall response (BOR) was confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1 based on tumor response data per local review. The start date was the date of first documented response of CR or PR (i.e. the start date of response, not the date when response was confirmed), and the end date was defined as the date of the first documented progressive disease (PD) or death due to underlying cancer. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\< 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters.'}, {'measure': 'Overall Survival in Study Part B1', 'timeFrame': 'Up to approximately 26 months.', 'description': 'Overall survival for Part B1 was defined as the number of participants who were alive at the end of the post-treatment period.'}, {'measure': 'Progression-free Survival (PFS) Per Investigator Assessment in Study Part B1', 'timeFrame': 'Up to 6 months', 'description': 'PFS was defined as time from the date of enrolment to the date of the first documented progressive disease (PD) or death due to any cause. PFS was assessed via a local radiology assessment according to RECIST 1.1. PD=At least a 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. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm\\^2. PFS was censored at the date of the last adequate tumor assessment, if no PFS event was observed prior to the analysis cut-off date.'}, {'measure': 'PFS Based on Local Radiology Assessments Using RECIST 1.1 Criteria for Participants by PIK3CA Mutation Status Measured in Baseline Circulating Tumor Deoxyribonucleic Acid (ctDNA) in Study Part A', 'timeFrame': 'Once all participants have completed at least 6 months of study treatment or have discontinued from study treatment, up to 35 months', 'description': 'PFS in participants with PIK3CA mutation as measured in ctDNA. PFS was defined as time from the date of randomization to the date of the first documented progression or death due to any cause.'}, {'measure': 'Post-Hoc: All Collected Deaths', 'timeFrame': 'On-treatment deaths: Up to approximately 28 months (Part A) or approximately 17 months (Part B1). Post-treatment survival follow-up deaths: Up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1).', 'description': 'On-treatment deaths due to any cause were collected from first dose of study medication to 30 days after the last dose of study treatment. Post-treatment survival follow-up deaths were collected from Day 31 after last dose of study medication to the data cut-off date.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Triple Negative Breast Cancer', 'alpelisib', 'BYL719', 'nab-paclitaxel', 'PIK3CA mutation', 'PTEN loss'], 'conditions': ['Triple Negative Breast Neoplasms']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to determine whether treatment with alpelisib in combination with nab-paclitaxel is safe and effective in subjects with advanced triple negative breast cancer (aTNBC) who carry either a PIK3CA mutation (Study Part A) or have PTEN loss (Study Part B1) or PTEN loss without PIK3CA mutation (Study Part B2)', 'detailedDescription': 'The recruitment of Part A was halted on 11-Nov-2022 due to slow recruitment. Since Part B1 did not meet its primary objective for confirmed overall response rate, the Part B2 was not initiated, and the recruitment was halted for the entire study.\n\nUpon confirming either PIK3CA mutation and/or PTEN loss status, advanced TNBC participants meeting all other eligibility criteria were assigned to either Part A (PIK3CA mutation regardless of PTEN loss) or Part B1 (PTEN loss with PIK3CA unknown or non-mutant).\n\nIn Part A, participants were randomized a 1:1 to receive either:\n\n* alpelisib 300 mg daily orally + nab-paclitaxel 100 mg/m\\^2 intravenously (IV) on Days 1, 8, and 15 of each 28-day cycle or\n* placebo + nab-paclitaxel 100 mg/m\\^2 IV on Days 1, 8, and 15 of each 28-day cycle.\n\nIn Part B1, participants received alpelisib 300 mg daily orally + nab-paclitaxel 100 mg/m\\^2 IV on Days 1, 8, and 15 of each 28-day cycle.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant has histologically confirmed diagnosis of advanced (loco-regionally recurrent and not amenable to curative therapy), or metastatic (stage IV) TNBC\n* Participant has either a measurable disease per RECIST 1.1 criteria or, if no measurable disease is present, then at least one predominantly lytic bone lesion or mixed lytic-blastic bone lesion with identifiable soft tissue component (that can be evaluated by CT/MRI) must be present. Part B1: Participants must have measurable disease\n* Participant has adequate tumor tissue to identify the PIK3CA mutation status (either carrying a mutation or without a mutation) and the PTEN loss status; both of which will determine whether the subject can be allocated to Part A - PIK3CA mutation regardless of PTEN status; or to Part B1 - PTEN loss or to Part B2 - PTEN loss without a PIK3CA mutation\n* Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Participant has received no more than one line of therapy for metastatic disease\n* Participant has adequate bone marrow and organ function\n\nExclusion Criteria:\n\n* Participant has received prior treatment with any PI3K, mTOR or AKT inhibitor\n* Participant has a known hypersensitivity to alpelisib, nab-paclitaxel or to any of their excipients\n* Participant has not recovered from all toxicities related to prior anticancer therapies to NCI CTCAE version 4.03 Grade ≤1; with the exception of alopecia\n* Participant has central nervous system (CNS) involvement which was not previously treated and/or was newly detected at screening\n* Participant with an established diagnosis of diabetes mellitus type I or uncontrolled type II based on Fasting Plasma Glucose and HbA1c\n* Participant has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection) based on investigator discretion\n* Participant has a history of acute pancreatitis within 1 year prior to screening or past medical history of chronic pancreatitis\n* Participant has currently documented pneumonitis/interstitial lung disease\n* Participant has a history of severe cutaneous reactions, such as Steven-Johnson Syndrome (SJS), erythema multiforme (EM),Toxic Epidermal Necrolysis (TEN) or Drug Reaction with Eosinophilia and Systemic Syndrome 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