Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2025-12-27 @ 9:31 PM
Study NCT ID:
NCT04478266
Status:
TERMINATED
Last Update Posted:
2025-09-11
First Post:
2020-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Amcenestrant (SAR439859) Plus Palbociclib as First Line Therapy for Patients With ER (+) HER2(-) Advanced Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Estonia', 'Puerto Rico']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C500026', 'term': 'palbociclib'}, {'id': 'D000077289', 'term': 'Letrozole'}, {'id': 'D017273', 'term': 'Goserelin'}], 'ancestors': [{'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}, {'id': 'D010906', 'term': 'Pituitary Hormone-Releasing Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Contact-US@sanofi.com', 'phone': '800-633-1610', 'title': 'Trial Transparency Team', 'phoneExt': '6#', 'organization': 'Sanofi aventis recherche & développement'}, 'certainAgreement': {'otherDetails': 'The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The study was terminated based on the review by an independent data monitoring committee of the prespecified interim analysis of the Phase 3 AMEERA-5 efficacy data.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events (AE) data was collected from Baseline up to 30 days after last dose of study treatment (maximum exposure: 112 weeks), deaths were collected from Baseline up to the end of study (26 May 2023)', 'description': 'Reported SAEs and NSAEs were assessed for safety population. All-Cause Mortality data collected during study was assessed for all randomized participants. Disease progression related death were not reported as AE.', 'eventGroups': [{'id': 'EG000', 'title': 'Letrozole + Palbociclib', 'description': 'Participants received letrozole 2.5 mg capsule along with amcenestrant-matching placebo once daily, continuously and palbociclib 125 mg, PO, QD from Day 1 to Day 21 of each 28-day treatment cycle until disease progression, death or study cut-off date, whichever comes first (maximum exposure: 112 weeks).', 'otherNumAtRisk': 533, 'deathsNumAtRisk': 534, 'otherNumAffected': 448, 'seriousNumAtRisk': 533, 'deathsNumAffected': 41, 'seriousNumAffected': 68}, {'id': 'EG001', 'title': 'Amcenestrant + Palbociclib', 'description': 'Participants received amcenestrant 200 mg tablet along with letrozole-matching placebo once daily, continuously and palbociclib 125 mg PO, QD from Day 1 to Day 21 of each 28-day treatment cycle until disease progression, death or study cut-off date, whichever comes first (maximum exposure: 109 weeks).', 'otherNumAtRisk': 533, 'deathsNumAtRisk': 534, 'otherNumAffected': 412, 'seriousNumAtRisk': 533, 'deathsNumAffected': 45, 'seriousNumAffected': 77}], 'otherEvents': [{'term': 'Covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 53, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 60, 'numAffected': 60}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 49, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 62, 'numAffected': 38}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 538, 'numAffected': 201}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 231, 'numAffected': 113}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Decreased Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 51, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 43, 'numAffected': 39}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 40, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 46, 'numAffected': 40}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 41, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 34, 'numAffected': 28}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 79, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 73, 'numAffected': 56}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hot Flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 86, 'numAffected': 82}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 90, 'numAffected': 87}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 27, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 42, 'numAffected': 31}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 32, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 34, 'numAffected': 30}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 35, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 36, 'numAffected': 32}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 31, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 24, 'numAffected': 24}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 84, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 76, 'numAffected': 70}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 115, 'numAffected': 82}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 74, 'numAffected': 62}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 112, 'numAffected': 92}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 102, 'numAffected': 84}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 131, 'numAffected': 93}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 88, 'numAffected': 64}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 64, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 51, 'numAffected': 39}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 72, 'numAffected': 72}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 45, 'numAffected': 44}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 128, 'numAffected': 102}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 136, 'numAffected': 110}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 60, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 50, 'numAffected': 45}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 34, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 30, 'numAffected': 27}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pain In Extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 24, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 52, 'numAffected': 45}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 57, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 55, 'numAffected': 45}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 107, 'numAffected': 100}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 107, 'numAffected': 93}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Alanine Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 20, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 44, 'numAffected': 39}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Neutrophil Count Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 252, 'numAffected': 114}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 118, 'numAffected': 67}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'White Blood Cell Count Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 72, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 20, 'numAffected': 17}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}], 'seriousEvents': [{'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Bronchitis Bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Covid-19 Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Device Related Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Focal Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Herpes Zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Neutropenic Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Paracancerous Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Adenocarcinoma Of Colon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cancer Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Colon Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Diffuse Large B-Cell Lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Gallbladder Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Metastases To Liver', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Rectal Adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Anaemia Of Malignant Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 533, 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'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition 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'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Non-Cardiac Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Alanine Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Aspartate Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Blood Follicle Stimulating Hormone Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Alcohol Poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Femur Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Foot Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Gastrointestinal Procedural Complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Gastrointestinal Stoma Complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Humerus Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Procedural Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Subdural Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Tibia Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 533, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 533, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression-free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '534', 'groupId': 'OG000'}, {'value': '534', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Letrozole + Palbociclib', 'description': 'Participants received letrozole 2.5 mg capsule along with amcenestrant-matching placebo once daily, continuously and palbociclib 125 mg PO, QD from Day 1 to Day 21 of each 28-day treatment cycle until disease progression, death or study cut-off date, whichever comes first (maximum exposure: 112 weeks).'}, {'id': 'OG001', 'title': 'Amcenestrant + Palbociclib', 'description': 'Participants received amcenestrant 200 mg tablet along with letrozole-matching placebo once daily, continuously and palbociclib 125 mg PO, QD from Day 1 to Day 21 of each 28-day treatment cycle until disease progression, death or study cut-off date, whichever comes first (maximum exposure: 109 weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': '16.6', 'comment': 'Upper limit of 95% confidence interval (CI) was not estimable due to the smaller number of participants with events.', 'groupId': 'OG000', 'lowerLimit': '14.1', 'upperLimit': 'NA'}, {'value': '14.1', 'comment': 'Upper limit of 95% confidence interval (CI) was not estimable due to the smaller number of participants with events.', 'groupId': 'OG001', 'lowerLimit': '13.9', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.9304', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.209', 'ciLowerLimit': '0.939', 'ciUpperLimit': '1.557', 'pValueComment': 'One-sided p-value based on Stratified log-rank test. Threshold for statistical significance at 0.025 level.', 'estimateComment': 'Letrozole + Palbociclib versus Amcenestrant + Palbociclib', 'groupDescription': 'A hierarchical testing procedure was used to ensure a strong control of the overall Type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at one-sided 2.5% for the primary and the first secondary outcome.', 'statisticalMethod': 'Stratified Log-Rank test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified on presence of De-novo metastatic disease, Postmenopausal women and Visceral metastasis according to IRT.'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to the date of first documented tumor progression or death due to any cause or data cut-off date whichever comes first (maximum duration: 81 weeks)', 'description': 'PFS was defined as the time interval (in months) from the date of randomization to the date of first documented tumor progression as per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) assessed by local radiologist or investigator, or death (due to any cause), whichever comes first. Progressive Disease (PD) as per RECIST 1.1: at least a 20 percent (%) increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Analysis was performed by Kaplan-Meier method.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the ITT population which included all enrolled participants (i.e., who signed the informed consent form and for whom there was a confirmation of successful allocation of a randomization number by Interactive Response Technology \\[IRT\\].'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '534', 'groupId': 'OG000'}, {'value': '534', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Letrozole + Palbociclib', 'description': 'Participants received letrozole 2.5 mg capsule along with amcenestrant-matching placebo once daily, continuously and palbociclib 125 mg PO, QD from Day 1 to Day 21 of each 28-day treatment cycle until disease progression, death or study cut-off date, whichever comes first (maximum exposure: 112 weeks).'}, {'id': 'OG001', 'title': 'Amcenestrant + Palbociclib', 'description': 'Participants received amcenestrant 200 mg tablet along with letrozole-matching placebo once daily, continuously and palbociclib 125 mg PO, QD from Day 1 to Day 21 of each 28-day treatment cycle until disease progression, death or study cut-off date, whichever comes first (maximum exposure: 109 weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median, upper limit and lower limit of 95% CI were not estimable due to the smaller number of participants with events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median, upper limit and lower limit of 95% CI were not estimable due to the smaller number of participants with events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to the death due to any cause or data cut-off date, whichever comes first (maximum duration: 81 weeks)', 'description': 'OS was defined as the interval (in months) from the date of randomization to the date of documented death (due to any cause). In the absence of observation of death, survival time was censored to last date the participant was known to be alive or at the cut-off date, whichever comes first. Analysis was performed by Kaplan-Meier method.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the ITT population.'}, {'type': 'SECONDARY', 'title': '12-month Progression-free Survival (PFS) Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '534', 'groupId': 'OG000'}, {'value': '534', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Letrozole + Palbociclib', 'description': 'Participants received letrozole 2.5 mg capsule along with amcenestrant-matching placebo once daily, continuously and palbociclib 125 mg PO, QD from Day 1 to Day 21 of each 28-day treatment cycle until disease progression, death or study cut-off date, whichever comes first (maximum exposure: 112 weeks).'}, {'id': 'OG001', 'title': 'Amcenestrant + Palbociclib', 'description': 'Participants received amcenestrant 200 mg tablet along with letrozole-matching placebo once daily, continuously and palbociclib 125 mg PO, QD from Day 1 to Day 21 of each 28-day treatment cycle until disease progression, death or study cut-off date, whichever comes first (maximum exposure: 109 weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': '68.2', 'groupId': 'OG000', 'lowerLimit': '61.2', 'upperLimit': '74.2'}, {'value': '65.5', 'groupId': 'OG001', 'lowerLimit': '59.1', 'upperLimit': '71.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12', 'description': 'Percentage of participants who were disease progression-free at Month 12 after randomization were reported in this outcome measure. PFS was defined as the time interval (in months) from the date of randomization to the date of first documented tumor progression as per RECIST 1.1 assessed by local radiologist or investigator, or death (due to any cause), whichever comes first. PD as per RECIST 1.1: at least a 20% increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. The PFS rate at Month 12 was estimated using the Kaplan-Meier method and provided an estimation of the percentage of participants who were disease progression-free at Month 12 after randomization.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the ITT population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Objective Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '534', 'groupId': 'OG000'}, {'value': '534', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Letrozole + Palbociclib', 'description': 'Participants received letrozole 2.5 mg capsule along with amcenestrant-matching placebo once daily, continuously and palbociclib 125 mg PO, QD from Day 1 to Day 21 of each 28-day treatment cycle until disease progression, death or study cut-off date, whichever comes first (maximum exposure: 112 weeks).'}, {'id': 'OG001', 'title': 'Amcenestrant + Palbociclib', 'description': 'Participants received amcenestrant 200 mg tablet along with letrozole-matching placebo once daily, continuously and palbociclib 125 mg PO, QD from Day 1 to Day 21 of each 28-day treatment cycle until disease progression, death or study cut-off date, whichever comes first (maximum exposure: 109 weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': '42.3', 'groupId': 'OG000', 'lowerLimit': '38.1', 'upperLimit': '46.6'}, {'value': '32.2', 'groupId': 'OG001', 'lowerLimit': '28.3', 'upperLimit': '36.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization to the date of first documented tumor progression, death due to any cause or data cut-off date whichever comes first (maximum duration: 81 weeks)', 'description': 'Objective response was defined as percentage of participants having a partial response (PR) or complete response (CR) according to the RECIST version 1.1 assessed by investigator. As per RECIST 1.1, CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\\<) 10 millimeters (mm). PR was defined as at least a 30%decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the ITT population.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Letrozole + Palbociclib', 'description': 'Participants received letrozole 2.5 mg capsule along with amcenestrant-matching placebo once daily, continuously and palbociclib 125 mg PO, QD from Day 1 to Day 21 of each 28-day treatment cycle until disease progression, death or study cut-off date, whichever comes first (maximum exposure: 112 weeks).'}, {'id': 'OG001', 'title': 'Amcenestrant + Palbociclib', 'description': 'Participants received amcenestrant 200 mg tablet along with letrozole-matching placebo once daily, continuously and palbociclib 125 mg PO, QD from Day 1 to Day 21 of each 28-day treatment cycle until disease progression, death or study cut-off date, whichever comes first (maximum exposure: 109 weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': '14.0', 'comment': 'Upper limit of 95% CI was not estimable due to small number of progression events or death.', 'groupId': 'OG000', 'lowerLimit': '11.1', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and upper limit of 95% CI was not estimable due to the small number of progression events or death.', 'groupId': 'OG001', 'lowerLimit': '11.4', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of first response of CR or PR until disease progression or death, or start of any anti-cancer therapy or data cut-off date, whichever comes first (maximum duration: 81 weeks)', 'description': 'DOR was defined as time (in months) from first documented evidence of CR or PR until disease progression determined by investigator as per RECIST 1.1, or start of any anti-cancer therapy, or death from any cause, whichever occurs first. For participants with ongoing response at the time of the analysis, DOR was censored at the date of the last valid disease assessment not showing documented progression performed before the initiation of a new anticancer treatment (if any). As per RECIST 1.1, CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\<10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters. PD: at least 20% increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Analysis was performed by Kaplan-Meier method.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on a subset of participants who had objective response.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinical Benefit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '534', 'groupId': 'OG000'}, {'value': '534', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Letrozole + Palbociclib', 'description': 'Participants received letrozole 2.5 mg capsule along with amcenestrant-matching placebo once daily, continuously and palbociclib 125 mg PO, QD from Day 1 to Day 21 of each 28-day treatment cycle until disease progression, death or study cut-off date, whichever comes first (maximum exposure: 112 weeks).'}, {'id': 'OG001', 'title': 'Amcenestrant + Palbociclib', 'description': 'Participants received amcenestrant 200 mg tablet along with letrozole-matching placebo once daily, continuously and palbociclib 125 mg PO, QD from Day 1 to Day 21 of each 28-day treatment cycle until disease progression, death or study cut-off date, whichever comes first (maximum exposure: 109 weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': '82.4', 'groupId': 'OG000', 'lowerLimit': '78.9', 'upperLimit': '85.5'}, {'value': '76.0', 'groupId': 'OG001', 'lowerLimit': '72.2', 'upperLimit': '79.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization until disease progression, or death, or data cut-off date, whichever comes first (maximum duration: 81 weeks)', 'description': 'Clinical Benefit was defined as the percentage of participants having a confirmed CR, PR, or stable disease (SD) for at least 24 weeks determined by investigator as per RECIST 1.1, from date of randomization until disease progression, or death, or data cut-off date, or initiation of post treatment anti-cancer therapy, whichever occurs first. As per RECIST 1.1; CR was defined as disappearance of all target, non-target lesions \\& normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\<10 mm. PR: at least a 30% decrease in sum of diameters of target lesions, taking as reference Baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference smallest sum diameters. PD: at least 20% increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the ITT population.'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival on Next Line of Therapy (PFS2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '534', 'groupId': 'OG000'}, {'value': '534', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Letrozole + Palbociclib', 'description': 'Participants received letrozole 2.5 mg capsule along with amcenestrant-matching placebo once daily, continuously and palbociclib 125 mg PO, QD from Day 1 to Day 21 of each 28-day treatment cycle until disease progression, death or study cut-off date, whichever comes first (maximum exposure: 112 weeks).'}, {'id': 'OG001', 'title': 'Amcenestrant + Palbociclib', 'description': 'Participants received amcenestrant 200 mg tablet along with letrozole-matching placebo once daily, continuously and palbociclib 125 mg PO, QD from Day 1 to Day 21 of each 28-day treatment cycle until disease progression, death or study cut-off date, whichever comes first (maximum exposure: 109 weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median, upper and lower limit of 95% CI was not estimable due to the smaller number of participants with events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median, upper and lower limit of 95% CI was not estimable due to the smaller number of participants with events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to date first documented disease progression on the next systemic anti-cancer therapy, or death due to any cause, or data cut-off date, whichever comes first (maximum duration: 81 weeks)', 'description': 'PFS2 was defined as the time interval (in months) from the date of randomization to the date of first documentation of PD on the next systemic anti-cancer therapy according to investigator, or death due to any cause in the absence of documented PD on the next systemic anti-cancer therapy, whichever occurs first. PD was defined as at least 20% increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Analysis was performed by Kaplan-Meier method.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the ITT population.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics: Plasma Concentrations of Amcenestrant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '531', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Amcenestrant + Palbociclib', 'description': 'Participants received amcenestrant 200 mg tablet along with letrozole-matching placebo once daily, continuously and palbociclib 125 mg PO, QD from Day 1 to Day 21 of each 28-day treatment cycle until disease progression, death or study cut-off date, whichever comes first (maximum exposure: 109 weeks).'}], 'classes': [{'title': 'Cycle 1 Day 1: 3 hr post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '473', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2890.0', 'spread': '1783.8', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 1 Day 15: pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '399.5', 'spread': '575.0', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2 Day 1: pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '255', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '387.5', 'spread': '685.6', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2 Day 1: 3 hr post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2729.3', 'spread': '1604.4', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2 Day 15: pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '361.3', 'spread': '572.8', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 3 Day 1: pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '303.4', 'spread': '315.7', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4 Day 1: pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '349.3', 'spread': '385.3', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 7 Day 1: pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '337.5', 'spread': '432.9', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 10 Day 1: pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '310.9', 'spread': '253.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 1: 3 hours (hr) post-dose, Cycle 1 Day 15: pre-dose, Cycle 2 Day 1: pre-dose, 3 hr post-dose, Cycle 2 Day 15: pre-dose, Cycle 3 Day 1: pre-dose, Cycle 4 Day 1: pre-dose, Cycle 7 Day 1: pre-dose, Cycle 10 Day 1: pre-dose', 'description': 'Amcenestrant plasma concentrations at specified time points were reported. Data for this outcome measure was not planned to be collected and analyzed for Letrozole+Palbociclib arm as pre-specified in protocol.', 'unitOfMeasure': 'nanograms per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on the Pharmacokinetic-evaluable (amcenestrant) population that included all participants who took at least 1 dose of study intervention, and with at least one evaluable plasma concentration of amcenestrant post-treatment. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'Number analyzed' = participants with available data for each specified category."}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics: Plasma Concentrations of Palbociclib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '532', 'groupId': 'OG000'}, {'value': '532', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Letrozole + Palbociclib', 'description': 'Participants received letrozole 2.5 mg capsule along with amcenestrant-matching placebo once daily, continuously and palbociclib 125 mg PO, QD from Day 1 to Day 21 of each 28-day treatment cycle until disease progression, death or study cut-off date, whichever comes first (maximum exposure: 112 weeks).'}, {'id': 'OG001', 'title': 'Amcenestrant + Palbociclib', 'description': 'Participants received amcenestrant 200 mg tablet along with letrozole-matching placebo once daily, continuously and palbociclib 125 mg PO, QD from Day 1 to Day 21 of each 28-day treatment cycle until disease progression, death or study cut-off date, whichever comes first (maximum exposure: 109 weeks).'}], 'classes': [{'title': 'Cycle 1 Day 1: 3 hr post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '479', 'groupId': 'OG000'}, {'value': '472', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.265', 'spread': '31.110', 'groupId': 'OG000'}, {'value': '37.780', 'spread': '31.005', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 1 Day 15: pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '274', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '82.541', 'spread': '38.671', 'groupId': 'OG000'}, {'value': '45.903', 'spread': '20.086', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2 Day 1: pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.409', 'spread': '8.498', 'groupId': 'OG000'}, {'value': '2.159', 'spread': '7.368', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2 Day 1: 3 hr post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '316', 'groupId': 'OG000'}, {'value': '385', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.234', 'spread': '26.967', 'groupId': 'OG000'}, {'value': '27.144', 'spread': '24.667', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2 Day 15: pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.176', 'spread': '35.210', 'groupId': 'OG000'}, {'value': '42.882', 'spread': '18.081', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 3 Day 1: pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.301', 'spread': '11.796', 'groupId': 'OG000'}, {'value': '1.615', 'spread': '4.283', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 4 Day 1: pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.767', 'spread': '17.787', 'groupId': 'OG000'}, {'value': '1.390', 'spread': '3.052', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 7 Day 1: pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.716', 'spread': '2.058', 'groupId': 'OG000'}, {'value': '1.461', 'spread': '1.722', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 10 Day 1: pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.793', 'spread': '7.675', 'groupId': 'OG000'}, {'value': '1.489', 'spread': '1.155', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 1: 3 hr post-dose, Cycle 1 Day 15: pre-dose, Cycle 2 Day 1: pre-dose, 3 hr post-dose, Cycle 2 Day 15: pre-dose, Cycle 3 Day 1: pre-dose, Cycle 4 Day 1: pre-dose, Cycle 7 Day 1: pre-dose, Cycle 10 Day 1: pre-dose', 'description': 'Palbociclib plasma concentrations at specified time points were reported.', 'unitOfMeasure': 'nanograms per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on the Pharmacokinetic-evaluable (palbociclib) population that included all participants who took at least 1 dose of study intervention, and with at least one evaluable plasma concentration of palbociclib post-treatment. Here, 'Number analyzed' = participants with available data for each specified category."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30) Domain Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '533', 'groupId': 'OG000'}, {'value': '533', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Letrozole + Palbociclib', 'description': 'Participants received letrozole 2.5 mg capsule along with amcenestrant-matching placebo once daily, continuously and palbociclib 125 mg PO, QD from Day 1 to Day 21 of each 28-day treatment cycle until disease progression, death or study cut-off date, whichever comes first (maximum exposure: 112 weeks).'}, {'id': 'OG001', 'title': 'Amcenestrant + Palbociclib', 'description': 'Participants received amcenestrant 200 mg tablet along with letrozole-matching placebo once daily, continuously and palbociclib 125 mg PO, QD from Day 1 to Day 21 of each 28-day treatment cycle until disease progression, death or study cut-off date, whichever comes first (maximum exposure: 109 weeks).'}], 'classes': [{'title': 'GHS/QoL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '491', 'groupId': 'OG000'}, {'value': '485', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.8', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '0.6', 'groupId': 'OG001'}]}]}, {'title': 'Physical functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '488', 'groupId': 'OG000'}, {'value': '484', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.3', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '0.6', 'groupId': 'OG001'}]}]}, {'title': 'Role functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '490', 'groupId': 'OG000'}, {'value': '482', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.8', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Emotional functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '490', 'groupId': 'OG000'}, {'value': '484', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.2', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Cognitive functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '491', 'groupId': 'OG000'}, {'value': '485', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '0.6', 'groupId': 'OG001'}]}]}, {'title': 'Social functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '489', 'groupId': 'OG000'}, {'value': '485', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.2', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '490', 'groupId': 'OG000'}, {'value': '484', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.6', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Nausea and vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '485', 'groupId': 'OG000'}, {'value': '478', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.3', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '0.4', 'groupId': 'OG001'}]}]}, {'title': 'Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '491', 'groupId': 'OG000'}, {'value': '485', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.8', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '-6.8', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Dyspnea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '488', 'groupId': 'OG000'}, {'value': '480', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.1', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Insomnia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '490', 'groupId': 'OG000'}, {'value': '483', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.9', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '-3.9', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'Appetite loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '485', 'groupId': 'OG000'}, {'value': '478', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.0', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '-2.7', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Constipation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '486', 'groupId': 'OG000'}, {'value': '477', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '490', 'groupId': 'OG000'}, {'value': '480', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.4', 'groupId': 'OG001'}]}]}, {'title': 'Financial difficulties', 'denoms': [{'units': 'Participants', 'counts': [{'value': '488', 'groupId': 'OG000'}, {'value': '485', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.1', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '-4.0', 'spread': '0.8', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, overall treatment duration (Cycle 1 up to Cycle 21 [i.e., 81 weeks])', 'description': 'EORTC-QLQ-C30: cancer-specific instrument with 30 questions for evaluation of new chemotherapy \\& assessment of participant reported outcome. These include 5 functional scales, 9 symptom scales, \\& Global Health Status/quality of life scale (GHS/QoL). All 14 items/domains were scored on scale of 1 (not at all) to 4 (very much) \\& GHS/QoL, scored on scale of 1 (very poor) to 7 (excellent). All scales are transformed from raw scores to linear scales ranging 0 to 100. Higher score for functional \\& GHS/QoL=higher level of functioning, \\& higher score for symptoms scales=higher symptom burden. Least Square (LS) mean and Standard Error (SE) were derived from MMRM model with change from Baseline values as response variable, treatment, time, treatment-by-time interaction, Baseline value and stratifications factors as fixed effect. Average of LS mean change from Baseline values of overall treatment (i.e., each cycle \\[Cycle 1 up to Cycle 21\\]) for each domain was reported in this outcome measure.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on safety population. Here, 'Number analyzed' = participants with available data for each specified category."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Breast Cancer Specific Module (EORTC-QLQ-BR23) Domain Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '533', 'groupId': 'OG000'}, {'value': '533', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Letrozole + Palbociclib', 'description': 'Participants received letrozole 2.5 mg capsule along with amcenestrant-matching placebo once daily, continuously and palbociclib 125 mg PO, QD from Day 1 to Day 21 of each 28-day treatment cycle until disease progression, death or study cut-off date, whichever comes first (maximum exposure: 112 weeks).'}, {'id': 'OG001', 'title': 'Amcenestrant + Palbociclib', 'description': 'Participants received amcenestrant 200 mg tablet along with letrozole-matching placebo once daily, continuously and palbociclib 125 mg PO, QD from Day 1 to Day 21 of each 28-day treatment cycle until disease progression, death or study cut-off date, whichever comes first (maximum exposure: 109 weeks).'}], 'classes': [{'title': 'Body image', 'denoms': [{'units': 'Participants', 'counts': [{'value': '463', 'groupId': 'OG000'}, {'value': '464', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Sexual functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '451', 'groupId': 'OG000'}, {'value': '450', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.4', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '0.6', 'groupId': 'OG001'}]}]}, {'title': 'Sexual enjoyment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-10.4', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '-8.7', 'spread': '1.9', 'groupId': 'OG001'}]}]}, {'title': 'Future perspective', 'denoms': [{'units': 'Participants', 'counts': [{'value': '467', 'groupId': 'OG000'}, {'value': '465', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.6', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '10.8', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'Systemic therapy side effects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '466', 'groupId': 'OG000'}, {'value': '466', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.9', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Breast symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '466', 'groupId': 'OG000'}, {'value': '465', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-7.6', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '-7.0', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Arm symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '466', 'groupId': 'OG000'}, {'value': '466', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.9', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '0.6', 'groupId': 'OG001'}]}]}, {'title': 'Upset by hair loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.7', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '2.5', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, overall treatment duration (Cycle 1 up to Cycle 21 [i.e., 81 weeks])', 'description': 'QLQ-BR23: disease-specific Health-related QOL assesses breast cancer impact \\& side effects of treatment. EORTCQLQ- BR23 contains 23 items: multi-item scales \\& single-item measures. 4 functional scales (body image, sexual functioning, sexual enjoyment, future perspective) \\& 4 scales related to symptoms of disease or treatment (arm symptoms, breast symptoms, systemic therapy side effects, \\& upset by hair loss). All items scored 1 (not at all) to 4 (very much). Scores of all scales transformed from raw scores to linear scales ranging 0-100. Higher score for functional scales=better outcome; higher score for symptoms scales=higher symptom burden. LS mean \\& SE were derived from MMRM model with change from Baseline values as response variable, treatment, time, treatment-by-time interaction, Baseline value \\& stratifications factors as fixed effect. Average of LS mean change from Baseline values of overall treatment (i.e., each cycle \\[Cycle 1 up to Cycle 21\\]) for each domain was reported.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on safety population. Here, 'Number analyzed' = participants with available data for each specified category."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Breast Cancer Specific Module (EORTC QLQ-BR45) Domain Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '533', 'groupId': 'OG000'}, {'value': '533', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Letrozole + Palbociclib', 'description': 'Participants received letrozole 2.5 mg capsule along with amcenestrant-matching placebo once daily, continuously and palbociclib 125 mg PO, QD from Day 1 to Day 21 of each 28-day treatment cycle until disease progression, death or study cut-off date, whichever comes first (maximum exposure: 112 weeks).'}, {'id': 'OG001', 'title': 'Amcenestrant + Palbociclib', 'description': 'Participants received amcenestrant 200 mg tablet along with letrozole-matching placebo once daily, continuously and palbociclib 125 mg PO, QD from Day 1 to Day 21 of each 28-day treatment cycle until disease progression, death or study cut-off date, whichever comes first (maximum exposure: 109 weeks).'}], 'classes': [{'title': 'Breast Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '378', 'groupId': 'OG000'}, {'value': '369', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.7', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': 'Endocrine Sexual Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.8', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Endocrine Therapy Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '437', 'groupId': 'OG000'}, {'value': '434', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '0.6', 'groupId': 'OG001'}]}]}, {'title': 'Skin Mucosis Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '438', 'groupId': 'OG000'}, {'value': '434', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, overall treatment duration (Cycle 1 up to Cycle 21 [i.e., 81 weeks])', 'description': 'EORTC QLQ-BR45: comprised of all 23 items from the QLQ-BR23 plus an additional 22 items assessing endocrine therapy symptoms (10 items), endocrine sexual symptoms (4 items), breast satisfaction (2 items), and skin mucosis symptoms (6 items). All items scored 1 (not at all) to 4 (very much). Scores of all scales transformed from raw scores to linear scales ranging 0 to 100. Higher score for functional scales = better outcome; higher score for symptoms scales = higher symptom burden. LS mean and SE are derived from Mixed Model Repeated Measures (MMRM) model with change from Baseline values as response variable, treatment, time, treatment-by-time interaction, Baseline value and stratifications factors as fixed effect. Average of LS mean change from Baseline values of overall treatment (i.e., each cycle \\[Cycle 1 up to Cycle 21\\]) for each domain (endocrine therapy symptoms, endocrine sexual symptoms, breast satisfaction and skin mucosis symptoms) was reported.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on safety population. Here, 'Number analyzed' = participants with available data for each specified category."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions (5D), 5 Levels (5L) (EQ-5D-5L) Score: Visual Analog Scale (VAS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '492', 'groupId': 'OG000'}, {'value': '489', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Letrozole + Palbociclib', 'description': 'Participants received letrozole 2.5 mg capsule along with amcenestrant-matching placebo once daily, continuously and palbociclib 125 mg PO, QD from Day 1 to Day 21 of each 28-day treatment cycle and were followed until disease progression, death or study cut-off date, whichever comes first (maximum exposure duration: 112 weeks).'}, {'id': 'OG001', 'title': 'Amcenestrant + Palbociclib', 'description': 'Participants received amcenestrant 200 mg tablet along with letrozole-matching placebo once daily, continuously and palbociclib 125 mg PO, QD from Day 1 to Day 21 of each 28-day treatment cycle until disease progression, death or study cut-off date, whichever comes first (maximum exposure: 109 weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': '3.2', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, overall treatment duration (Cycle 1 up to Cycle 21 [i.e., 81 weeks])', 'description': "EQ-5D-5L is a standardized measure of health status, provides a simple, generic measure of health for clinical and economic appraisal, and consists of 2 sections: the EQ-5D-5L health state utility index (descriptive system) and the EQ-5D-5L VAS. The Visual Analogue Scale is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. LS mean and SE are derived from MMRM model with change from Baseline values as response variable, treatment, time, treatment-by-time interaction, Baseline value and stratifications factors as fixed effect. Average of LS mean change from Baseline values of overall treatment (i.e., each cycle \\[Cycle 1 up to Cycle 21\\]) for VAS was reported in this outcome measure.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on safety population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions (5D), 5 Levels (5L) (EQ-5D-5L) Score: Health Utility Index Value Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '492', 'groupId': 'OG000'}, {'value': '489', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Letrozole + Palbociclib', 'description': 'Participants received letrozole 2.5 mg capsule along with amcenestrant-matching placebo once daily, continuously and palbociclib 125 mg PO, QD from Day 1 to Day 21 of each 28-day treatment cycle until disease progression, death or study cut-off date, whichever comes first (maximum exposure: 112 weeks).'}, {'id': 'OG001', 'title': 'Amcenestrant + Palbociclib', 'description': 'Participants received amcenestrant 200 mg tablet along with letrozole-matching placebo once daily, continuously and palbociclib 125 mg PO, QD from Day 1 to Day 21 of each 28-day treatment cycle until disease progression, death or study cut-off date, whichever comes first (maximum exposure: 109 weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, overall treatment duration (Cycle 1 up to Cycle 21 [i.e., 81 weeks])', 'description': 'EQ-5D-5L: consists of 2 sections: EQ-5D-5L health state utility index (descriptive system) \\& VAS. The EQ-5D descriptive system consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort \\& anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, \\& extreme problems. Response options are measured with 5-point Likert scale (for 5L version). The EQ-5D-5L responses are converted into single index utility score between 0 to 1, where higher score indicates better health state \\& lower score indicate worse health state. LS mean and SE were derived from MMRM model with change from Baseline values as response variable, treatment, time, treatment-by-time interaction, Baseline value and stratifications factors as fixed effect. Average of LS mean change from Baseline values overall treatment (i.e., each cycle \\[Cycle 1 up to Cycle 21\\]) for health utility index value score was reported in this outcome measure.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on safety population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Time to First Chemotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '534', 'groupId': 'OG000'}, {'value': '534', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Letrozole + Palbociclib', 'description': 'Participants received letrozole 2.5 mg capsule along with amcenestrant-matching placebo once daily, continuously and palbociclib 125 mg PO, QD from Day 1 to Day 21 of each 28-day treatment cycle until disease progression, death or study cut-off date, whichever comes first (maximum exposure: 112 weeks).'}, {'id': 'OG001', 'title': 'Amcenestrant + Palbociclib', 'description': 'Participants received amcenestrant 200 mg tablet along with letrozole-matching placebo once daily, continuously and palbociclib 125 mg PO, QD from Day 1 to Day 21 of each 28-day treatment cycle until disease progression, death or study cut-off date, whichever comes first (maximum exposure: 109 weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median, upper limit and lower limit of 95% CI was not estimable due to lower number of participants with events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median, upper limit and lower limit of 95% CI was not estimable due to lower number of participants with events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to the start date of the first chemotherapy (maximum duration: 81 weeks)', 'description': 'Time to chemotherapy was defined as the time interval (in months) from the date of randomization to the start date of the first chemotherapy after disease progression.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the ITT population.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Hematological Abnormalities During the Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '533', 'groupId': 'OG000'}, {'value': '533', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Letrozole + Palbociclib', 'description': 'Participants received letrozole 2.5 mg capsule along with amcenestrant-matching placebo once daily, continuously and palbociclib 125 mg PO, QD from Day 1 to Day 21 of each 28-day treatment cycle until disease progression, death or study cut-off date, whichever comes first (maximum exposure: 112 weeks).'}, {'id': 'OG001', 'title': 'Amcenestrant + Palbociclib', 'description': 'Participants received amcenestrant 200 mg tablet along with letrozole-matching placebo once daily, continuously and palbociclib 125 mg PO, QD from Day 1 to Day 21 of each 28-day treatment cycle until disease progression, death or study cut-off date, whichever comes first (maximum exposure: 109 weeks).'}], 'classes': [{'title': 'Anemia: Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '533', 'groupId': 'OG000'}, {'value': '532', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '309', 'groupId': 'OG000'}, {'value': '302', 'groupId': 'OG001'}]}]}, {'title': 'Anemia: Grade 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '533', 'groupId': 'OG000'}, {'value': '532', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '108', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}]}, {'title': 'Anemia: Grade 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '533', 'groupId': 'OG000'}, {'value': '532', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Anemia: Grade 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '533', 'groupId': 'OG000'}, {'value': '532', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocyte count decreased: Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '533', 'groupId': 'OG000'}, {'value': '532', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocyte count decreased: Grade 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '533', 'groupId': 'OG000'}, {'value': '532', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '138', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocyte count decreased: Grade 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '533', 'groupId': 'OG000'}, {'value': '532', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocyte count decreased: Grade 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '533', 'groupId': 'OG000'}, {'value': '532', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophil count decreased: Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '533', 'groupId': 'OG000'}, {'value': '532', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophil count decreased: Grade 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '533', 'groupId': 'OG000'}, {'value': '532', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '150', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophil count decreased: Grade 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '533', 'groupId': 'OG000'}, {'value': '532', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '277', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophil count decreased: Grade 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '533', 'groupId': 'OG000'}, {'value': '532', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'White blood cell decreased: Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '532', 'groupId': 'OG000'}, {'value': '531', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}]}, {'title': 'White blood cell decreased: Grade 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '532', 'groupId': 'OG000'}, {'value': '531', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '279', 'groupId': 'OG000'}, {'value': '267', 'groupId': 'OG001'}]}]}, {'title': 'White blood cell decreased: Grade 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '532', 'groupId': 'OG000'}, {'value': '531', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '163', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}]}, {'title': 'White blood cell decreased: Grade 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '532', 'groupId': 'OG000'}, {'value': '531', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Platelet count decreased: Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '533', 'groupId': 'OG000'}, {'value': '532', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '285', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}]}, {'title': 'Platelet count decreased: Grade 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '533', 'groupId': 'OG000'}, {'value': '532', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Platelet count decreased: Grade 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '533', 'groupId': 'OG000'}, {'value': '532', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Platelet count decreased: Grade 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '533', 'groupId': 'OG000'}, {'value': '532', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study treatment up to 30 days after last dose of study treatment (maximum duration: 112 weeks)', 'description': 'Hematological parameters assessed were anemia, lymphocyte count decreased, neutrophil count decreased, white blood cell decreased, platelet count decreased. Parameters were assessed as per the National Cancer Institute Common Terminology Criteria for Adverse Experience version 5.0 (NCI-CTCAE v 5.0), where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs. Treatment period was defined as the time from the first dose of study treatments up to 30 days after last dose of study treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on safety population. Here, 'Number analyzed' = participants with available data for each specified category."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Liver Function Abnormalities of Grade 3 and 4 During the Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '533', 'groupId': 'OG000'}, {'value': '533', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Letrozole + Palbociclib', 'description': 'Participants received letrozole 2.5 mg capsule along with amcenestrant-matching placebo once daily, continuously and palbociclib 125 mg PO, QD from Day 1 to Day 21 of each 28-day treatment cycle until disease progression, death or study cut-off date, whichever comes first (maximum exposure: 112 weeks).'}, {'id': 'OG001', 'title': 'Amcenestrant + Palbociclib', 'description': 'Participants received amcenestrant 200 mg tablet along with letrozole-matching placebo once daily, continuously and palbociclib 125 mg PO, QD from Day 1 to Day 21 of each 28-day treatment cycle until disease progression, death or study cut-off date, whichever comes first (maximum exposure: 109 weeks).'}], 'classes': [{'title': 'Aspartate aminotransferase increased: Grade 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '533', 'groupId': 'OG000'}, {'value': '532', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate aminotransferase increased: Grade 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '533', 'groupId': 'OG000'}, {'value': '532', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Alanine aminotransferase increased: Grade 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '533', 'groupId': 'OG000'}, {'value': '532', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'Alanine aminotransferase increased: Grade 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '533', 'groupId': 'OG000'}, {'value': '532', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline phosphatase increased: Grade 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '532', 'groupId': 'OG000'}, {'value': '532', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline phosphatase increased: Grade 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '532', 'groupId': 'OG000'}, {'value': '532', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Total bilirubin increased: Grade 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '533', 'groupId': 'OG000'}, {'value': '532', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Total bilirubin increased: Grade 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '533', 'groupId': 'OG000'}, {'value': '532', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Gamma-GT increased: Grade 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '533', 'groupId': 'OG000'}, {'value': '532', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Gamma-GT increased: Grade 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '533', 'groupId': 'OG000'}, {'value': '532', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study treatment up to 30 days after last dose of study treatment (maximum duration: 112 weeks)', 'description': 'Liver Function parameters assessed were aspartate aminotransferase increased, alanine aminotransferase increased, alkaline phosphatase increased, total bilirubin increased, gamma-glutamyl transferase increased. Parameters were assessed as per the NCI-CTCAE v 5.0, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs. Treatment period was defined as the time from the first dose of study treatments up to 30 days after last dose of study treatment. Participants with Grade 3 and 4 liver function abnormalities were reported in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on safety population. Here, 'Number analyzed' = participants with available data for each specified category."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Letrozole + Palbociclib', 'description': 'Participants received letrozole 2.5 milligram (mg) capsule along with amcenestrant-matching placebo once daily, continuously and palbociclib 125 mg orally (PO), once daily (QD) from Day 1 to Day 21 of each 28-day treatment cycle until disease progression, death or study cut-off date, whichever comes first (maximum exposure: 112 weeks).'}, {'id': 'FG001', 'title': 'Amcenestrant + Palbociclib', 'description': 'Participants received amcenestrant 200 mg tablet along with letrozole-matching placebo once daily, continuously and palbociclib 125 mg PO, QD from Day 1 to Day 21 of each 28-day treatment cycle until disease progression, death, or study cut-off date, whichever comes first (maximum exposure: 109 weeks).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '534'}, {'groupId': 'FG001', 'numSubjects': '534'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '533'}, {'groupId': 'FG001', 'numSubjects': '533'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '534'}, {'groupId': 'FG001', 'numSubjects': '534'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '146'}, {'groupId': 'FG001', 'numSubjects': '168'}]}, {'type': 'Poor compliance to protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'Data Monitoring Committee recommendation due to negative interim analysis', 'reasons': [{'groupId': 'FG000', 'numSubjects': '309'}, {'groupId': 'FG001', 'numSubjects': '286'}]}, {'type': 'Study terminated by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'Other: unspecified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Randomized but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The study was conducted at 249 active sites in 30 countries. A total of 1277 participants were screened between 14 October 2020 and 11 November 2021, of which 209 were screen failures. Screen failures were mainly due to not meeting selection criteria.', 'preAssignmentDetails': 'A total of 1068 participants were randomized, of which 2 participants were randomized but not exposed to study treatment. Randomization was stratified by De-novo metastatic disease (Yes or No); postmenopausal women (Yes or No); visceral metastasis defined by at least 1 liver, lung, brain metastasis, pleural, or peritoneal involvement (Yes or No).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '533', 'groupId': 'BG000'}, {'value': '533', 'groupId': 'BG001'}, {'value': '1066', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Letrozole + Palbociclib', 'description': 'Participants received letrozole 2.5 mg capsule along with amcenestrant-matching placebo once daily, continuously and palbociclib 125 mg, PO, QD from Day 1 to Day 21 of each 28-day treatment cycle until disease progression, death or study cut-off date, whichever comes first (maximum exposure: 112 weeks).'}, {'id': 'BG001', 'title': 'Amcenestrant + Palbociclib', 'description': 'Participants received amcenestrant 200 mg tablet along with letrozole-matching placebo once daily, continuously and palbociclib 125 mg PO, QD from Day 1 to Day 21 of each 28-day treatment cycle until disease progression, death or study cut-off date, whichever comes first (maximum exposure: 109 weeks).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.3', 'spread': '12.3', 'groupId': 'BG000'}, {'value': '57.8', 'spread': '12.1', 'groupId': 'BG001'}, {'value': '57.6', 'spread': '12.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '529', 'groupId': 'BG000'}, {'value': '524', 'groupId': 'BG001'}, {'value': '1053', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '179', 'groupId': 'BG000'}, {'value': '175', 'groupId': 'BG001'}, {'value': '354', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '306', 'groupId': 'BG000'}, {'value': '304', 'groupId': 'BG001'}, {'value': '610', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Analysis was performed on safety population which included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention, analyzed according to the treatment arm they actually received.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-09-02', 'size': 1564561, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-06-12T10:08', 'hasProtocol': True}, {'date': '2021-05-11', 'size': 995058, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-06-12T10:09', 'hasProtocol': False}]}}, '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': 1068}}, 'statusModule': {'whyStopped': 'The study was terminated based on the review by an independent data monitoring committee of the prespecified interim analysis of the Phase 3 AMEERA-5 efficacy data. No new safety signals were observed.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2023-05-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-10', 'studyFirstSubmitDate': '2020-07-10', 'resultsFirstSubmitDate': '2023-06-13', 'studyFirstSubmitQcDate': '2020-07-15', 'lastUpdatePostDateStruct': {'date': '2025-09-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2023-06-13', 'studyFirstPostDateStruct': {'date': '2020-07-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free Survival (PFS)', 'timeFrame': 'From randomization to the date of first documented tumor progression or death due to any cause or data cut-off date whichever comes first (maximum duration: 81 weeks)', 'description': 'PFS was defined as the time interval (in months) from the date of randomization to the date of first documented tumor progression as per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) assessed by local radiologist or investigator, or death (due to any cause), whichever comes first. Progressive Disease (PD) as per RECIST 1.1: at least a 20 percent (%) increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Analysis was performed by Kaplan-Meier method.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'From randomization to the death due to any cause or data cut-off date, whichever comes first (maximum duration: 81 weeks)', 'description': 'OS was defined as the interval (in months) from the date of randomization to the date of documented death (due to any cause). In the absence of observation of death, survival time was censored to last date the participant was known to be alive or at the cut-off date, whichever comes first. Analysis was performed by Kaplan-Meier method.'}, {'measure': '12-month Progression-free Survival (PFS) Rate', 'timeFrame': 'Month 12', 'description': 'Percentage of participants who were disease progression-free at Month 12 after randomization were reported in this outcome measure. PFS was defined as the time interval (in months) from the date of randomization to the date of first documented tumor progression as per RECIST 1.1 assessed by local radiologist or investigator, or death (due to any cause), whichever comes first. PD as per RECIST 1.1: at least a 20% increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. The PFS rate at Month 12 was estimated using the Kaplan-Meier method and provided an estimation of the percentage of participants who were disease progression-free at Month 12 after randomization.'}, {'measure': 'Percentage of Participants With Objective Response', 'timeFrame': 'From randomization to the date of first documented tumor progression, death due to any cause or data cut-off date whichever comes first (maximum duration: 81 weeks)', 'description': 'Objective response was defined as percentage of participants having a partial response (PR) or complete response (CR) according to the RECIST version 1.1 assessed by investigator. As per RECIST 1.1, CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\\<) 10 millimeters (mm). PR was defined as at least a 30%decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters.'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'From the date of first response of CR or PR until disease progression or death, or start of any anti-cancer therapy or data cut-off date, whichever comes first (maximum duration: 81 weeks)', 'description': 'DOR was defined as time (in months) from first documented evidence of CR or PR until disease progression determined by investigator as per RECIST 1.1, or start of any anti-cancer therapy, or death from any cause, whichever occurs first. For participants with ongoing response at the time of the analysis, DOR was censored at the date of the last valid disease assessment not showing documented progression performed before the initiation of a new anticancer treatment (if any). As per RECIST 1.1, CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\<10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters. PD: at least 20% increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Analysis was performed by Kaplan-Meier method.'}, {'measure': 'Percentage of Participants With Clinical Benefit', 'timeFrame': 'From randomization until disease progression, or death, or data cut-off date, whichever comes first (maximum duration: 81 weeks)', 'description': 'Clinical Benefit was defined as the percentage of participants having a confirmed CR, PR, or stable disease (SD) for at least 24 weeks determined by investigator as per RECIST 1.1, from date of randomization until disease progression, or death, or data cut-off date, or initiation of post treatment anti-cancer therapy, whichever occurs first. As per RECIST 1.1; CR was defined as disappearance of all target, non-target lesions \\& normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\<10 mm. PR: at least a 30% decrease in sum of diameters of target lesions, taking as reference Baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference smallest sum diameters. PD: at least 20% increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions.'}, {'measure': 'Progression-free Survival on Next Line of Therapy (PFS2)', 'timeFrame': 'From randomization to date first documented disease progression on the next systemic anti-cancer therapy, or death due to any cause, or data cut-off date, whichever comes first (maximum duration: 81 weeks)', 'description': 'PFS2 was defined as the time interval (in months) from the date of randomization to the date of first documentation of PD on the next systemic anti-cancer therapy according to investigator, or death due to any cause in the absence of documented PD on the next systemic anti-cancer therapy, whichever occurs first. PD was defined as at least 20% increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Analysis was performed by Kaplan-Meier method.'}, {'measure': 'Pharmacokinetics: Plasma Concentrations of Amcenestrant', 'timeFrame': 'Cycle 1 Day 1: 3 hours (hr) post-dose, Cycle 1 Day 15: pre-dose, Cycle 2 Day 1: pre-dose, 3 hr post-dose, Cycle 2 Day 15: pre-dose, Cycle 3 Day 1: pre-dose, Cycle 4 Day 1: pre-dose, Cycle 7 Day 1: pre-dose, Cycle 10 Day 1: pre-dose', 'description': 'Amcenestrant plasma concentrations at specified time points were reported. Data for this outcome measure was not planned to be collected and analyzed for Letrozole+Palbociclib arm as pre-specified in protocol.'}, {'measure': 'Pharmacokinetics: Plasma Concentrations of Palbociclib', 'timeFrame': 'Cycle 1 Day 1: 3 hr post-dose, Cycle 1 Day 15: pre-dose, Cycle 2 Day 1: pre-dose, 3 hr post-dose, Cycle 2 Day 15: pre-dose, Cycle 3 Day 1: pre-dose, Cycle 4 Day 1: pre-dose, Cycle 7 Day 1: pre-dose, Cycle 10 Day 1: pre-dose', 'description': 'Palbociclib plasma concentrations at specified time points were reported.'}, {'measure': 'Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30) Domain Scores', 'timeFrame': 'Baseline, overall treatment duration (Cycle 1 up to Cycle 21 [i.e., 81 weeks])', 'description': 'EORTC-QLQ-C30: cancer-specific instrument with 30 questions for evaluation of new chemotherapy \\& assessment of participant reported outcome. These include 5 functional scales, 9 symptom scales, \\& Global Health Status/quality of life scale (GHS/QoL). All 14 items/domains were scored on scale of 1 (not at all) to 4 (very much) \\& GHS/QoL, scored on scale of 1 (very poor) to 7 (excellent). All scales are transformed from raw scores to linear scales ranging 0 to 100. Higher score for functional \\& GHS/QoL=higher level of functioning, \\& higher score for symptoms scales=higher symptom burden. Least Square (LS) mean and Standard Error (SE) were derived from MMRM model with change from Baseline values as response variable, treatment, time, treatment-by-time interaction, Baseline value and stratifications factors as fixed effect. Average of LS mean change from Baseline values of overall treatment (i.e., each cycle \\[Cycle 1 up to Cycle 21\\]) for each domain was reported in this outcome measure.'}, {'measure': 'Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Breast Cancer Specific Module (EORTC-QLQ-BR23) Domain Scores', 'timeFrame': 'Baseline, overall treatment duration (Cycle 1 up to Cycle 21 [i.e., 81 weeks])', 'description': 'QLQ-BR23: disease-specific Health-related QOL assesses breast cancer impact \\& side effects of treatment. EORTCQLQ- BR23 contains 23 items: multi-item scales \\& single-item measures. 4 functional scales (body image, sexual functioning, sexual enjoyment, future perspective) \\& 4 scales related to symptoms of disease or treatment (arm symptoms, breast symptoms, systemic therapy side effects, \\& upset by hair loss). All items scored 1 (not at all) to 4 (very much). Scores of all scales transformed from raw scores to linear scales ranging 0-100. Higher score for functional scales=better outcome; higher score for symptoms scales=higher symptom burden. LS mean \\& SE were derived from MMRM model with change from Baseline values as response variable, treatment, time, treatment-by-time interaction, Baseline value \\& stratifications factors as fixed effect. Average of LS mean change from Baseline values of overall treatment (i.e., each cycle \\[Cycle 1 up to Cycle 21\\]) for each domain was reported.'}, {'measure': 'Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Breast Cancer Specific Module (EORTC QLQ-BR45) Domain Scores', 'timeFrame': 'Baseline, overall treatment duration (Cycle 1 up to Cycle 21 [i.e., 81 weeks])', 'description': 'EORTC QLQ-BR45: comprised of all 23 items from the QLQ-BR23 plus an additional 22 items assessing endocrine therapy symptoms (10 items), endocrine sexual symptoms (4 items), breast satisfaction (2 items), and skin mucosis symptoms (6 items). All items scored 1 (not at all) to 4 (very much). Scores of all scales transformed from raw scores to linear scales ranging 0 to 100. Higher score for functional scales = better outcome; higher score for symptoms scales = higher symptom burden. LS mean and SE are derived from Mixed Model Repeated Measures (MMRM) model with change from Baseline values as response variable, treatment, time, treatment-by-time interaction, Baseline value and stratifications factors as fixed effect. Average of LS mean change from Baseline values of overall treatment (i.e., each cycle \\[Cycle 1 up to Cycle 21\\]) for each domain (endocrine therapy symptoms, endocrine sexual symptoms, breast satisfaction and skin mucosis symptoms) was reported.'}, {'measure': 'Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions (5D), 5 Levels (5L) (EQ-5D-5L) Score: Visual Analog Scale (VAS) Score', 'timeFrame': 'Baseline, overall treatment duration (Cycle 1 up to Cycle 21 [i.e., 81 weeks])', 'description': "EQ-5D-5L is a standardized measure of health status, provides a simple, generic measure of health for clinical and economic appraisal, and consists of 2 sections: the EQ-5D-5L health state utility index (descriptive system) and the EQ-5D-5L VAS. The Visual Analogue Scale is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. LS mean and SE are derived from MMRM model with change from Baseline values as response variable, treatment, time, treatment-by-time interaction, Baseline value and stratifications factors as fixed effect. Average of LS mean change from Baseline values of overall treatment (i.e., each cycle \\[Cycle 1 up to Cycle 21\\]) for VAS was reported in this outcome measure."}, {'measure': 'Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions (5D), 5 Levels (5L) (EQ-5D-5L) Score: Health Utility Index Value Score', 'timeFrame': 'Baseline, overall treatment duration (Cycle 1 up to Cycle 21 [i.e., 81 weeks])', 'description': 'EQ-5D-5L: consists of 2 sections: EQ-5D-5L health state utility index (descriptive system) \\& VAS. The EQ-5D descriptive system consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort \\& anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, \\& extreme problems. Response options are measured with 5-point Likert scale (for 5L version). The EQ-5D-5L responses are converted into single index utility score between 0 to 1, where higher score indicates better health state \\& lower score indicate worse health state. LS mean and SE were derived from MMRM model with change from Baseline values as response variable, treatment, time, treatment-by-time interaction, Baseline value and stratifications factors as fixed effect. Average of LS mean change from Baseline values overall treatment (i.e., each cycle \\[Cycle 1 up to Cycle 21\\]) for health utility index value score was reported in this outcome measure.'}, {'measure': 'Time to First Chemotherapy', 'timeFrame': 'From randomization to the start date of the first chemotherapy (maximum duration: 81 weeks)', 'description': 'Time to chemotherapy was defined as the time interval (in months) from the date of randomization to the start date of the first chemotherapy after disease progression.'}, {'measure': 'Number of Participants With Hematological Abnormalities During the Treatment Period', 'timeFrame': 'From first dose of study treatment up to 30 days after last dose of study treatment (maximum duration: 112 weeks)', 'description': 'Hematological parameters assessed were anemia, lymphocyte count decreased, neutrophil count decreased, white blood cell decreased, platelet count decreased. Parameters were assessed as per the National Cancer Institute Common Terminology Criteria for Adverse Experience version 5.0 (NCI-CTCAE v 5.0), where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs. Treatment period was defined as the time from the first dose of study treatments up to 30 days after last dose of study treatment.'}, {'measure': 'Number of Participants With Liver Function Abnormalities of Grade 3 and 4 During the Treatment Period', 'timeFrame': 'From first dose of study treatment up to 30 days after last dose of study treatment (maximum duration: 112 weeks)', 'description': 'Liver Function parameters assessed were aspartate aminotransferase increased, alanine aminotransferase increased, alkaline phosphatase increased, total bilirubin increased, gamma-glutamyl transferase increased. Parameters were assessed as per the NCI-CTCAE v 5.0, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs. Treatment period was defined as the time from the first dose of study treatments up to 30 days after last dose of study treatment. Participants with Grade 3 and 4 liver function abnormalities were reported in this outcome measure.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '38889373', 'type': 'DERIVED', 'citation': "Cortes J, Hurvitz SA, O'Shaughnessy J, Delaloge S, Iwata H, Rugo HS, Neven P, Kanagavel D, Cohen P, Paux G, Cartot-Cotton S, Stefanova-Urena M, Deyme L, Aouni J, Sebastien B, Bardia A. Randomized Phase III Study of Amcenestrant Plus Palbociclib Versus Letrozole Plus Palbociclib in Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: Primary Results From AMEERA-5. J Clin Oncol. 2024 Aug 1;42(22):2680-2690. doi: 10.1200/JCO.23.02036. Epub 2024 Jun 18."}, {'pmid': '35309087', 'type': 'DERIVED', 'citation': "Bardia A, Cortes J, Hurvitz SA, Delaloge S, Iwata H, Shao ZM, Kanagavel D, Cohen P, Liu Q, Cartot-Cotton S, Pelekanou V, O'Shaughnessy J. AMEERA-5: a randomized, double-blind phase 3 study of amcenestrant plus palbociclib versus letrozole plus palbociclib for previously untreated ER+/HER2- advanced breast cancer. Ther Adv Med Oncol. 2022 Mar 15;14:17588359221083956. doi: 10.1177/17588359221083956. eCollection 2022."}], 'seeAlsoLinks': [{'url': 'https://www.trialsummaries.com/Study/StudyDetails?id=25234&tenant=MT_SNY_9011', 'label': 'EFC15935 Plain Language Results Summary'}]}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\nTo determine whether Amcenestrant (SAR439859) in combination with palbociclib improves progression free survival (PFS) when compared with letrozole in combination with palbociclib in participants with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who have not received any prior systemic anticancer therapies for advanced disease.\n\nSecondary Objective:\n\n* To compare the overall survival in both treatment arms.\n* To evaluate the objective response rate in both treatment arms.\n* To evaluate the duration of response in both treatment arms.\n* To evaluate the clinical benefit rate in both treatment arms.\n* To evaluate progression-free survival on next line of therapy.\n* To evaluate the pharmacokinetics of amcenestrant, and palbociclib.\n* To evaluate health-related quality of life in both treatment arms.\n* To evaluate the time to first chemotherapy in both treatment arms.\n* To evaluate safety in both treatment arms.', 'detailedDescription': 'Study duration per participant was approximately 59 months, which includes a 33- month treatment period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria :\n\n* Adult participants with loco-regional recurrent or metastatic disease not amenable to curative treatment.\n* Confirmed diagnosis of ER+/HER2- breast cancer.\n* No prior systemic treatment for loco-regional recurrent or metastatic disease.\n* Measurable disease evaluable per Response Evaluation Criterion in Solid Tumors (RECIST) v.1.1 or non-measurable bone-only disease.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n* Participants should be willing to provide tumor tissue.\n* Capable of giving informed consent.\n\nExclusion criteria:\n\n* Known active brain metastases.\n* Prior neo (adjuvant) treatment with any selective estrogen receptor degrader (SERD).\n* Inadequate organ and marrow function.\n* Disease recurrence while on, or within 12 months of completion of (neo)adjuvant endocrine therapy.\n* Pregnant, breastfeeding, or woman of childbearing potential unwilling to use recommended contraception methods.\n* Male participants who disagree to follow contraception.\n* Participants with advanced, symptomatic visceral spread, that are at risk of life-threatening complications in the short term.\n* Participants with significant concomitant illness.\n\nThe above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT04478266', 'acronym': 'AMEERA-5', 'briefTitle': 'Amcenestrant (SAR439859) Plus Palbociclib as First Line Therapy for Patients With ER (+) HER2(-) Advanced Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Randomized, Multicenter, Double-blind Phase 3 Study of Amcenestrant (SAR439859) Plus Palbociclib Versus Letrozole Plus Palbociclib for the Treatment of Patients With ER (+), HER2 (-) Breast Cancer Who Have Not Received Prior Systemic Anti-cancer Treatment for Advanced Disease', 'orgStudyIdInfo': {'id': 'EFC15935'}, 'secondaryIdInfos': [{'id': '2020-001824-33', 'type': 'EUDRACT_NUMBER'}, {'id': 'U1111-1233-0486', 'type': 'OTHER', 'domain': 'UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Letrozole + Palbociclib', 'description': 'Participants received letrozole 2.5 milligrams (mg) capsule along with amcenestrant-matching placebo once daily, continuously and palbociclib 125 mg orally (PO), once daily (QD) from Day 1 to Day 21 of each 28-day treatment cycle until disease progression, death or study cut-off date, whichever comes first (maximum exposure: 112 weeks). Goserelin once every 4 weeks in pre/peri menopausal women and men.', 'interventionNames': ['Drug: Amcenestrant-matching placebo', 'Drug: Palbociclib', 'Drug: Letrozole', 'Drug: Goserelin']}, {'type': 'EXPERIMENTAL', 'label': 'Amcenestrant + Palbociclib', 'description': 'Participants received amcenestrant 200 mg tablet along with letrozole-matching placebo once daily, continuously and palbociclib 125 mg PO, QD from Day 1 to Day 21 of each 28-day treatment cycle until disease progression, death, or study cut-off date, whichever comes first (maximum exposure: 109 weeks). Goserelin once every 4 weeks in pre/peri menopausal women and men.', 'interventionNames': ['Drug: SAR439859', 'Drug: Palbociclib', 'Drug: Goserelin', 'Drug: Letrozole-matching placebo']}], 'interventions': [{'name': 'Amcenestrant-matching placebo', 'type': 'DRUG', 'description': 'Pharmaceutical form: Tablets Route of Administration: Oral', 'armGroupLabels': ['Letrozole + Palbociclib']}, {'name': 'SAR439859', 'type': 'DRUG', 'otherNames': ['Amcenestrant'], 'description': 'Pharmaceutical form: Tablets Route of Administration: Oral', 'armGroupLabels': ['Amcenestrant + Palbociclib']}, {'name': 'Palbociclib', 'type': 'DRUG', 'otherNames': ['Ibrance'], 'description': 'Pharmaceutical form: Capsules/Tablets Route of Administration: Oral', 'armGroupLabels': ['Amcenestrant + Palbociclib', 'Letrozole + Palbociclib']}, {'name': 'Letrozole', 'type': 'DRUG', 'description': 'Pharmaceutical form: Capsules Route of Administration: Orally', 'armGroupLabels': ['Letrozole + Palbociclib']}, {'name': 'Goserelin', 'type': 'DRUG', 'description': 'Pharmaceutical form: Depot Injection Route of Administration: Subcutaneous', 'armGroupLabels': ['Amcenestrant + Palbociclib', 'Letrozole + Palbociclib']}, {'name': 'Letrozole-matching placebo', 'type': 'DRUG', 'description': 'Pharmaceutical form: Capsules Route of Administration: Orally', 'armGroupLabels': ['Amcenestrant + Palbociclib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36526', 'city': 'Daphne', 'state': 'Alabama', 'country': 'United States', 'facility': 'Investigational Site Number :8400075', 'geoPoint': {'lat': 30.60353, 'lon': -87.9036}}, {'zip': '85308', 'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigational Site Number :8400083', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigational Site Number :8400066', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': 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'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Investigational Site Number :8400004', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '89102', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Investigational Site Number :8400058', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '08901-1914', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Investigational Site Number :8400015', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '00000', 'city': 'Paramus', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Investigational Site Number :8400024', 'geoPoint': {'lat': 40.94454, 'lon': -74.07542}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Investigational Site Number :8400010', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11794-8121', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'Investigational Site Number :8400023', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Investigational Site Number :8400009', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '97223', 'city': 'Tigard', 'state': 'Oregon', 'country': 'United States', 'facility': 'Investigational Site Number :8400067', 'geoPoint': {'lat': 45.43123, 'lon': -122.77149}}, {'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Investigational Site Number :8400001', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '78745', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site Number :8400073', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational 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'77380', 'city': 'The Woodlands', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site Number :8400086', 'geoPoint': {'lat': 30.15799, 'lon': -95.48938}}, {'zip': '76712', 'city': 'Waco', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site Number :8400078', 'geoPoint': {'lat': 31.54933, 'lon': -97.14667}}, {'zip': '77598', 'city': 'Webster', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site Number :8400082', 'geoPoint': {'lat': 29.53773, 'lon': -95.11826}}, {'zip': '24060', 'city': 'Blacksburg', 'state': 'Virginia', 'country': 'United States', 'facility': 'Investigational Site Number :8400085', 'geoPoint': {'lat': 37.22957, 'lon': -80.41394}}, {'zip': '22601', 'city': 'Winchester', 'state': 'Virginia', 'country': 'United States', 'facility': 'Investigational Site Number :8400069', 'geoPoint': {'lat': 39.18566, 'lon': -78.16333}}, {'zip': 'C1012AAR', 'city': 'CABA', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Investigational Site Number :0320001'}, {'zip': 'C1019ABS', 'city': 'CABA', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Investigational Site Number :0320005'}, {'zip': 'C1417DTB', 'city': 'Capital Federal', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Investigational Site Number :0320008'}, {'zip': 'B2700CPM', 'city': 'Pergamino', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Investigational Site Number :0320006', 'geoPoint': {'lat': -33.89101, 'lon': -60.57462}}, {'zip': '5000', 'city': 'Córdoba', 'state': 'Córdoba Province', 'country': 'Argentina', 'facility': 'Investigational Site Number :0320010', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'zip': '2000', 'city': 'Rosario', 'state': 'Santa Fe Province', 'country': 'Argentina', 'facility': 'Investigational Site Number :0320002', 'geoPoint': {'lat': -32.94682, 'lon': -60.63932}}, {'zip': 'C1125ABD', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Investigational Site Number :0320004', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': '5300', 'city': 'La Rioja', 'country': 'Argentina', 'facility': 'Investigational Site Number :0320003', 'geoPoint': {'lat': -29.41328, 'lon': -66.85637}}, {'zip': 'B7600FYK', 'city': 'Mar del Plata', 'country': 'Argentina', 'facility': 'Investigational Site Number :0320009', 'geoPoint': {'lat': -38.00042, 'lon': -57.5562}}, {'zip': '4400', 'city': 'Salta', 'country': 'Argentina', 'facility': 'Investigational Site Number :0320007', 'geoPoint': {'lat': -24.80645, 'lon': -65.41999}}, {'zip': '2109', 'city': 'Macquarie Park', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Investigational Site Number :0360004', 'geoPoint': {'lat': -33.78105, 'lon': 151.12757}}, {'zip': '2031', 'city': 'Randwick', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Investigational Site Number :0360005', 'geoPoint': {'lat': -33.91439, 'lon': 151.24895}}, {'zip': '2076', 'city': 'Wahroonga', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Investigational Site Number :0360003', 'geoPoint': {'lat': -33.71816, 'lon': 151.11561}}, {'zip': '3121', 'city': 'Richmond', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Investigational Site Number :0360002', 'geoPoint': {'lat': -37.81819, 'lon': 145.00176}}, {'zip': '6009', 'city': 'Nedlands', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Investigational Site Number :0360001', 'geoPoint': {'lat': -31.98184, 'lon': 115.8073}}, {'zip': '8036', 'city': 'Graz', 'country': 'Austria', 'facility': 'Investigational Site Number :0400001', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': 'BE-1200', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Investigational Site Number :0560003', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': 'B-6000', 'city': 'Charleroi', 'country': 'Belgium', 'facility': 'Investigational Site Number :0560004', 'geoPoint': {'lat': 50.41136, 'lon': 4.44448}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'Investigational Site Number :0560001', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '5000', 'city': 'Namur', 'country': 'Belgium', 'facility': 'Investigational Site Number :0560002', 'geoPoint': {'lat': 50.4669, 'lon': 4.86746}}, {'zip': '90035 003', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Investigational Site Number :0760005', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '91350-250', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Investigational Site Number :0760006', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '01509-900', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Investigational Site Number :0760007', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '04014-002', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Investigational Site Number :0760003', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '20230-130', 'city': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Investigational Site Number :0760004', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'zip': '04321-120', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Investigational Site Number :0760008', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '8000', 'city': 'Burgas', 'country': 'Bulgaria', 'facility': 'Investigational Site Number :1000004', 'geoPoint': {'lat': 42.50651, 'lon': 27.46886}}, {'city': 'Dobrich', 'country': 'Bulgaria', 'facility': 'Investigational Site Number :1000005', 'geoPoint': {'lat': 43.56491, 'lon': 27.83138}}, {'zip': '7002', 'city': 'Rousse', 'country': 'Bulgaria', 'facility': 'Investigational Site Number :1000008', 'geoPoint': {'lat': 43.84872, 'lon': 25.9534}}, {'zip': '1797', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Investigational Site 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'city': 'La Serena', 'state': 'Coquimbo Region', 'country': 'Chile', 'facility': 'Investigational Site Number :1520005', 'geoPoint': {'lat': -29.90591, 'lon': -71.25014}}, {'zip': '4810561', 'city': 'Temuco', 'state': 'La Araucanía', 'country': 'Chile', 'facility': 'Investigational Site Number :1520004', 'geoPoint': {'lat': -38.73628, 'lon': -72.59738}}, {'city': 'Talca', 'state': 'Maule Region', 'country': 'Chile', 'facility': 'Investigational Site Number :1520009', 'geoPoint': {'lat': -35.4232, 'lon': -71.64974}}, {'zip': '8241470', 'city': 'Santaigo', 'state': 'Reg Metropolitana de Santiago', 'country': 'Chile', 'facility': 'Investigational Site Number :1520011'}, {'zip': '7650568', 'city': 'Santiago', 'state': 'Reg Metropolitana de Santiago', 'country': 'Chile', 'facility': 'Investigational Site Number :1520006', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'zip': '8420383', 'city': 'Santiago', 'state': 'Reg Metropolitana de Santiago', 'country': 'Chile', 'facility': 'Investigational Site Number :1520002', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'zip': '2520598', 'city': 'Viña del Mar', 'state': 'Región de Valparaíso', 'country': 'Chile', 'facility': 'Investigational Site Number :1520001', 'geoPoint': {'lat': -33.02457, 'lon': -71.55183}}, {'zip': '7500921', 'city': 'Santiago', 'country': 'Chile', 'facility': 'Investigational Site Number :1520007', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'city': 'Santiago', 'country': 'Chile', 'facility': 'Investigational Site Number :1520003', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'zip': '071000', 'city': 'Baoding', 'country': 'China', 'facility': 'Investigational Site Number :1560038', 'geoPoint': {'lat': 38.87288, 'lon': 115.46246}}, {'zip': '100142', 'city': 'Beijing', 'country': 'China', 'facility': 'Investigational Site Number :1560008', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100730', 'city': 'Beijing', 'country': 'China', 'facility': 'Investigational 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