Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2026-01-20 @ 6:08 PM
Study NCT ID:
NCT02598557
Status:
COMPLETED
Last Update Posted:
2023-08-22
First Post:
2015-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Alternative Dosing of Exemestane Before Surgery in Treating Postmenopausal Patients With Stage 0-II Estrogen Positive Breast Cancer
Sponsor:
Organization:
Raw JSON
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Thomas, MD., Associate Professor, Clinical Cancer Prevention', 'organization': 'UT MD Anderson Cancer Center'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From the first dose of exemestane through 30 days after the surgery', 'eventGroups': [{'id': 'EG000', 'title': 'Exemestane 25 mg QD', 'description': '1 tablet of exemestane 25 mg a day for up to 6 weeks', 'otherNumAtRisk': 57, 'deathsNumAtRisk': 57, 'otherNumAffected': 36, 'seriousNumAtRisk': 57, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Exemestane 25 mg TIW', 'description': '1 tablet of exemestane 25 mg a day (on days 1, 3, 5) and 1 tablet of placebo on days 2, 4, 6, 7 for up to 6 weeks', 'otherNumAtRisk': 57, 'deathsNumAtRisk': 57, 'otherNumAffected': 40, 'seriousNumAtRisk': 57, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Exemestane 25 mg QW', 'description': '1 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'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Upper respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'GGT increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Breast pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hot Flashes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'seriousEvents': [{'term': 'Bone Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change in Time of Circulating Estradiol SPE in Each Arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Exemestane 25 mg QD', 'description': '1 tablet of exemestane 25 mg a day for up to 6 weeks'}, {'id': 'OG001', 'title': 'Exemestane 25 mg TIW', 'description': '1 tablet of exemestane 25 mg a day (on 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change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change of Circulating Androstenedione', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Exemestane 25 mg QD', 'description': '1 tablet of exemestane 25 mg a day for up to 6 weeks'}, {'id': 'OG001', 'title': 'Exemestane 25 mg TIW', 'description': '1 tablet of exemestane 25 mg a day (on days 1, 3, 5) and 1 tablet of placebo on days 2, 4, 6, 7 for up to 6 weeks'}, {'id': 'OG002', 'title': 'Exemestane 25 mg QW', 'description': '1 tablet of exemestane 25 mg a day (on day 1) and 1 tablet of placebo on days 2 to 7 for up to 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-18', 'upperLimit': '18'}, {'value': '11', 'groupId': 'OG001', 'lowerLimit': '-20', 'upperLimit': 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exemestane 25 mg a day for up to 6 weeks'}, {'id': 'OG001', 'title': 'Exemestane 25 mg TIW', 'description': '1 tablet of exemestane 25 mg a day (on days 1, 3, 5) and 1 tablet of placebo on days 2, 4, 6, 7 for up to 6 weeks'}, {'id': 'OG002', 'title': 'Exemestane 25 mg QW', 'description': '1 tablet of exemestane 25 mg a day (on day 1) and 1 tablet of placebo on days 2 to 7 for up to 6 weeks'}], 'classes': [{'title': 'cancer tissue', 'categories': [{'measurements': [{'value': '8.7', 'groupId': 'OG000', 'lowerLimit': '4.5', 'upperLimit': '21.7'}, {'value': '28.1', 'groupId': 'OG001', 'lowerLimit': '17.8', 'upperLimit': '41.6'}, {'value': '138.9', 'groupId': 'OG002', 'lowerLimit': '53.2', 'upperLimit': '246.7'}]}]}, {'title': 'non cancer adjacent tissue', 'categories': [{'measurements': [{'value': '17.4', 'groupId': 'OG000', 'lowerLimit': '4.8', 'upperLimit': '33.0'}, {'value': '37.8', 'groupId': 'OG001', 'lowerLimit': '21.7', 'upperLimit': '67.5'}, {'value': '140.5', 'groupId': 'OG002', 'lowerLimit': '68.2', 'upperLimit': '233.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '4-6 weeks', 'description': 'Final biomarker concentration', 'unitOfMeasure': 'fmol/g wet weight', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Androstenedione Tissue Concentration at Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Exemestane 25 mg QD', 'description': '1 tablet of exemestane 25 mg a day for up to 6 weeks'}, {'id': 'OG001', 'title': 'Exemestane 25 mg TIW', 'description': '1 tablet of exemestane 25 mg a day (on days 1, 3, 5) and 1 tablet of placebo on days 2, 4, 6, 7 for up to 6 weeks'}, {'id': 'OG002', 'title': 'Exemestane 25 mg QW', 'description': '1 tablet of exemestane 25 mg a day (on day 1) and 1 tablet of placebo on days 2 to 7 for up to 6 weeks'}], 'classes': [{'title': 'cancer tissue', 'categories': [{'measurements': [{'value': '6864', 'groupId': 'OG000', 'lowerLimit': '3324', 'upperLimit': '8890'}, {'value': '5314', 'groupId': 'OG001', 'lowerLimit': '3692', 'upperLimit': '6642'}, {'value': '5564', 'groupId': 'OG002', 'lowerLimit': '3194', 'upperLimit': '8116'}]}]}, {'title': 'non cancer adjacent tissue', 'categories': [{'measurements': [{'value': '10251', 'groupId': 'OG000', 'lowerLimit': '6541', 'upperLimit': '16103'}, {'value': '12366', 'groupId': 'OG001', 'lowerLimit': '8702', 'upperLimit': '18654'}, {'value': '10580', 'groupId': 'OG002', 'lowerLimit': '5403', 'upperLimit': '15003'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '4-6 weeks', 'description': 'Final biomarker concentration.', 'unitOfMeasure': 'fmol/g wet weight', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Testosterone Tissue Concentration at Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Exemestane 25 mg QD', 'description': '1 tablet of exemestane 25 mg a day for up to 6 weeks'}, {'id': 'OG001', 'title': 'Exemestane 25 mg TIW', 'description': '1 tablet of exemestane 25 mg a day (on days 1, 3, 5) and 1 tablet of placebo on days 2, 4, 6, 7 for up to 6 weeks'}, {'id': 'OG002', 'title': 'Exemestane 25 mg QW', 'description': '1 tablet of exemestane 25 mg a day (on day 1) and 1 tablet of placebo on days 2 to 7 for up to 6 weeks'}], 'classes': [{'title': 'cancer tissue', 'categories': [{'measurements': [{'value': '395', 'groupId': 'OG000', 'lowerLimit': '273', 'upperLimit': '567'}, {'value': '396', 'groupId': 'OG001', 'lowerLimit': '346', 'upperLimit': '790'}, {'value': '453', 'groupId': 'OG002', 'lowerLimit': '314', 'upperLimit': '700'}]}]}, {'title': 'non cancer adjacent tissue', 'categories': [{'measurements': [{'value': '436', 'groupId': 'OG000', 'lowerLimit': '273', 'upperLimit': '654'}, {'value': '464', 'groupId': 'OG001', 'lowerLimit': '341', 'upperLimit': '787'}, {'value': '399', 'groupId': 'OG002', 'lowerLimit': '299', 'upperLimit': '570'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '4-6 weeks', 'description': 'Final biomarker concentration', 'unitOfMeasure': 'fmol/g wet weight', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Exemestane Tissue Concentration at Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Exemestane 25 mg QD', 'description': '1 tablet of exemestane 25 mg a day for up to 6 weeks'}, {'id': 'OG001', 'title': 'Exemestane 25 mg TIW', 'description': '1 tablet of exemestane 25 mg a day (on days 1, 3, 5) and 1 tablet of placebo on days 2, 4, 6, 7 for up to 6 weeks'}, {'id': 'OG002', 'title': 'Exemestane 25 mg QW', 'description': '1 tablet of exemestane 25 mg a day (on day 1) and 1 tablet of placebo on days 2 to 7 for up to 6 weeks'}], 'classes': [{'title': 'cancer tissue', 'categories': [{'measurements': [{'value': '3807', 'groupId': 'OG000', 'lowerLimit': '1663', 'upperLimit': '7194'}, {'value': '44', 'groupId': 'OG001', 'lowerLimit': '44', 'upperLimit': '291'}, {'value': '44', 'groupId': 'OG002', 'lowerLimit': '44', 'upperLimit': '44'}]}]}, {'title': 'non cancer adjacent tissue', 'categories': [{'measurements': [{'value': '17485', 'groupId': 'OG000', 'lowerLimit': '6791', 'upperLimit': '31985'}, {'value': '435', 'groupId': 'OG001', 'lowerLimit': '44', 'upperLimit': '791'}, {'value': '44', 'groupId': 'OG002', 'lowerLimit': '44', 'upperLimit': '44'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '4-6 weeks', 'description': 'Final drug concentration', 'unitOfMeasure': 'fmol/g wet weight', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '17 OH Exemestane Tissue Concentration at Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Exemestane 25 mg QD', 'description': '1 tablet of exemestane 25 mg a day for up to 6 weeks'}, {'id': 'OG001', 'title': 'Exemestane 25 mg TIW', 'description': '1 tablet of exemestane 25 mg a day (on days 1, 3, 5) and 1 tablet of placebo on days 2, 4, 6, 7 for up to 6 weeks'}, {'id': 'OG002', 'title': 'Exemestane 25 mg QW', 'description': '1 tablet of exemestane 25 mg a day (on day 1) and 1 tablet of placebo on days 2 to 7 for up to 6 weeks'}], 'classes': [{'title': 'cancer tissue', 'categories': [{'measurements': [{'value': '338', 'groupId': 'OG000', 'lowerLimit': '64', 'upperLimit': '1360'}, {'value': '65', 'groupId': 'OG001', 'lowerLimit': '65', 'upperLimit': '65'}, {'value': '65', 'groupId': 'OG002', 'lowerLimit': '65', 'upperLimit': '65'}]}]}, {'title': 'non cancer adjacent tissue', 'categories': [{'measurements': [{'value': '1343', 'groupId': 'OG000', 'lowerLimit': '262', 'upperLimit': '2758'}, {'value': '65', 'groupId': 'OG001', 'lowerLimit': '65', 'upperLimit': '65'}, {'value': '65', 'groupId': 'OG002', 'lowerLimit': '65', 'upperLimit': '65'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '4-6 weeks', 'description': 'Final drug concentration', 'unitOfMeasure': 'fmol/g wet weight', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in MenQoL Questionnaire Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Exemestane 25 mg QD', 'description': '1 tablet of exemestane 25 mg a day for up to 6 weeks'}, {'id': 'OG001', 'title': 'Exemestane 25 mg TIW', 'description': '1 tablet of exemestane 25 mg a day (on days 1, 3, 5) and 1 tablet of placebo on days 2, 4, 6, 7 for up to 6 weeks'}, {'id': 'OG002', 'title': 'Exemestane 25 mg QW', 'description': '1 tablet of exemestane 25 mg a day (on day 1) and 1 tablet of placebo on days 2 to 7 for up to 6 weeks'}], 'classes': [{'title': 'Vasomotor domain', 'categories': [{'measurements': [{'value': '0.41', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '0.28', 'spread': '1.4', 'groupId': 'OG001'}, {'value': '0.51', 'spread': '1.5', 'groupId': 'OG002'}]}]}, {'title': 'Psychosocial domain', 'categories': [{'measurements': [{'value': '-0.19', 'spread': '0.98', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '-0.06', 'spread': '1.1', 'groupId': 'OG002'}]}]}, {'title': 'Physical domain', 'categories': [{'measurements': [{'value': '-0.37', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '0.07', 'spread': '0.86', 'groupId': 'OG001'}, {'value': '-0.09', 'spread': '0.67', 'groupId': 'OG002'}]}]}, {'title': 'Sexual domain', 'categories': [{'measurements': [{'value': '-0.45', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '1.7', 'groupId': 'OG001'}, {'value': '-0.52', 'spread': '1.7', 'groupId': 'OG002'}]}]}, {'title': 'Overall', 'categories': [{'measurements': [{'value': '-0.15', 'spread': '0.58', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.79', 'groupId': 'OG001'}, {'value': '-0.06', 'spread': '0.71', 'groupId': 'OG002'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline and 4-6 weeks', 'description': 'MenQOL questionnaire assessed how bothered participants were with 31 symptoms. It contains domains: vasomotor (items 1-3); psychosocial (items 4-10); physical (items 11-26); sexual (items 27-29); in addition to nausea and indigestion. 31 individual symptoms are rated on a scale of 0 (not at all bothered) to 6 (extremely bothered). Total possible score ranged from 0 to 186. MenQOL summary score was calculated as mean of four domain scores (Physical function, Psychosocial function, Sexual function and Vasomotor function) ranging from 1 to 8, with higher scores indicating worse quality of life. Final score-baseline score', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Proteomic Analysis', 'timeFrame': '4-6 weeks', 'description': 'The Proteomic Analysis was not performed.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Exemestane 25 mg QD', 'description': '1 tablet of exemestane 25 mg a day for up to 6 weeks'}, {'id': 'FG001', 'title': 'Exemestane 25 mg TIW', 'description': '1 tablet of exemestane 25 mg a day (on days 1, 3, 5) and 1 tablet of placebo on days 2, 4, 6, 7 for up to 6 weeks'}, {'id': 'FG002', 'title': 'Exemestane 25 mg QW', 'description': '1 tablet of exemestane 25 mg a day (on day 1) and 1 tablet of placebo on days 2 to 7 for up to 6 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '58'}, {'groupId': 'FG002', 'numSubjects': '63'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '56'}, {'groupId': 'FG002', 'numSubjects': '60'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Participant did not start treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Unavailable specimen for endpoint evaluations', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '50 participants were not randomized (25 not eligible, 20 withdrew consent, 5 other reasons)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '176', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Exemestane 25 mg QD', 'description': '1 tablet of exemestane 25 mg a day for up to 6 weeks'}, {'id': 'BG001', 'title': 'Exemestane 25 mg TIW', 'description': '1 tablet of exemestane 25 mg a day (on days 1, 3, 5) and 1 tablet of placebo on days 2, 4, 6, 7 for up to 6 weeks'}, {'id': 'BG002', 'title': 'Exemestane 25 mg QW', 'description': '1 tablet of exemestane 25 mg a day (on day 1) and 1 tablet of placebo on days 2 to 7 for up to 6 weeks'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '176', 'groupId': 'BG003'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '86', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '176', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000', 'lowerLimit': '60', 'upperLimit': '71'}, {'value': '63', 'groupId': 'BG001', 'lowerLimit': '60', 'upperLimit': '69'}, {'value': '65', 'groupId': 'BG002', 'lowerLimit': '61', 'upperLimit': '70'}, {'value': '64', 'groupId': 'BG003', 'lowerLimit': '60', 'upperLimit': '70'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '176', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '176', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '176', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '152', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '176', 'groupId': 'BG003'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '155', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '176', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '93', 'groupId': 'BG003'}]}]}, {'title': 'Italy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '176', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '83', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Circulating levels of unconjugated estradiol SPE (Solid phase extraction)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '171', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '21.6', 'groupId': 'BG000', 'lowerLimit': '12.0', 'upperLimit': '35.6'}, {'value': '22.4', 'groupId': 'BG001', 'lowerLimit': '12.7', 'upperLimit': '33.4'}, {'value': '20.6', 'groupId': 'BG002', 'lowerLimit': '13.6', 'upperLimit': '31.5'}, {'value': '21.3', 'groupId': 'BG003', 'lowerLimit': '12.5', 'upperLimit': '32.8'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'pmol/L', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'The numbers are lower because there were no specimen available for analysis.'}, {'title': 'Circulating levels of unconjugated estradiol LLE (Liquid liquid extraction)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '171', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '21.2', 'groupId': 'BG000', 'lowerLimit': '13.5', 'upperLimit': '34.1'}, {'value': '20.9', 'groupId': 'BG001', 'lowerLimit': '12.6', 'upperLimit': '32.5'}, {'value': '19.7', 'groupId': 'BG002', 'lowerLimit': '11.9', 'upperLimit': '28.9'}, {'value': '20.5', 'groupId': 'BG003', 'lowerLimit': '12.4', 'upperLimit': '33.8'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'pmol/L', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'The numbers are lower because there were no specimen available for analysis.'}, {'title': 'Circulating levels of unconjugated estrone SPE(Solid phase extraction)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '171', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '104.3', 'groupId': 'BG000', 'lowerLimit': '73.8', 'upperLimit': '141.0'}, {'value': '99.4', 'groupId': 'BG001', 'lowerLimit': '69.4', 'upperLimit': '137.6'}, {'value': '92.2', 'groupId': 'BG002', 'lowerLimit': '66.7', 'upperLimit': '122.8'}, {'value': '98.7', 'groupId': 'BG003', 'lowerLimit': '70.0', 'upperLimit': '132.5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'pmol/L', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'The numbers are lower because there were no specimen available for analysis.'}, {'title': 'Circulating levels of unconjugated estrone LLE (Liquid liquid extraction)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '171', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '101.0', 'groupId': 'BG000', 'lowerLimit': '69.6', 'upperLimit': '143.0'}, {'value': '96.2', 'groupId': 'BG001', 'lowerLimit': '72.1', 'upperLimit': '147.5'}, {'value': '93.4', 'groupId': 'BG002', 'lowerLimit': '69.5', 'upperLimit': '132.0'}, {'value': '98.3', 'groupId': 'BG003', 'lowerLimit': '70.2', 'upperLimit': '137.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'pmol/L', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'The numbers are lower because there were no specimen available for analysis.'}, {'title': 'Circulating levels of total estrone', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '171', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '294.7', 'groupId': 'BG000', 'lowerLimit': '182.6', 'upperLimit': '451.4'}, {'value': '302.2', 'groupId': 'BG001', 'lowerLimit': '160.0', 'upperLimit': '429.9'}, {'value': '246.1', 'groupId': 'BG002', 'lowerLimit': '164.0', 'upperLimit': '362.1'}, {'value': '279.9', 'groupId': 'BG003', 'lowerLimit': '169.9', 'upperLimit': '419.2'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'pmol/L', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'The numbers are lower because there were no specimen available for analysis.'}, {'title': 'Circulating levels of estrone sulfate', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '171', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '581.9', 'groupId': 'BG000', 'lowerLimit': '363.6', 'upperLimit': '918.9'}, {'value': '625.8', 'groupId': 'BG001', 'lowerLimit': '324.7', 'upperLimit': '955.6'}, {'value': '452.3', 'groupId': 'BG002', 'lowerLimit': '315.1', 'upperLimit': '710.6'}, {'value': '560.4', 'groupId': 'BG003', 'lowerLimit': '330.8', 'upperLimit': '853.4'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'pmol/L', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'The numbers are lower because there were no specimen available for analysis.'}, {'title': 'Circulating levels of androstenedione', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '171', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'BG000', 'lowerLimit': '1.0', 'upperLimit': '1.9'}, {'value': '1.7', 'groupId': 'BG001', 'lowerLimit': '1.1', 'upperLimit': '2.5'}, {'value': '1.4', 'groupId': 'BG002', 'lowerLimit': '1.1', 'upperLimit': '2.0'}, {'value': '1.5', 'groupId': 'BG003', 'lowerLimit': '1.1', 'upperLimit': '2.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'The numbers are lower because there were no specimen available for analysis.'}, {'title': 'Circulating levels of testosterone', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '171', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'BG000', 'lowerLimit': '0.4', 'upperLimit': '0.9'}, {'value': '0.7', 'groupId': 'BG001', 'lowerLimit': '0.4', 'upperLimit': '1.1'}, {'value': '0.6', 'groupId': 'BG002', 'lowerLimit': '0.4', 'upperLimit': '0.9'}, {'value': '0.6', 'groupId': 'BG003', 'lowerLimit': '0.4', 'upperLimit': '0.9'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'The numbers are lower because there were no specimen available for analysis.'}, {'title': 'Circulating levels of testosterone CLIA (Chemiluminescent immunoassay)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '171', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0.447', 'groupId': 'BG000', 'lowerLimit': '0.259', 'upperLimit': '0.853'}, {'value': '0.512', 'groupId': 'BG001', 'lowerLimit': '0.331', 'upperLimit': '0.860'}, {'value': '0.425', 'groupId': 'BG002', 'lowerLimit': '0.238', 'upperLimit': '0.702'}, {'value': '0.477', 'groupId': 'BG003', 'lowerLimit': '0.284', 'upperLimit': '0.797'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'The numbers are lower because there were no specimen available for analysis.'}, {'title': 'Circulating levels of SHBG (Sex Hormone-Binding Globulin)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '171', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '53.4', 'groupId': 'BG000', 'lowerLimit': '39.1', 'upperLimit': '64.0'}, {'value': '47.9', 'groupId': 'BG001', 'lowerLimit': '36.6', 'upperLimit': '65.1'}, {'value': '50.1', 'groupId': 'BG002', 'lowerLimit': '31.9', 'upperLimit': '67.8'}, {'value': '50.6', 'groupId': 'BG003', 'lowerLimit': '35.6', 'upperLimit': '65.5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'The numbers are lower because there were no specimen available for analysis.'}, {'title': 'Circulating levels of total cholesterol', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '171', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '205', 'groupId': 'BG000', 'lowerLimit': '181', 'upperLimit': '233'}, {'value': '208', 'groupId': 'BG001', 'lowerLimit': '182', 'upperLimit': '226'}, {'value': '220', 'groupId': 'BG002', 'lowerLimit': '202', 'upperLimit': '247'}, {'value': '213', 'groupId': 'BG003', 'lowerLimit': '188', 'upperLimit': '240'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'The numbers are lower because there were no specimen available for analysis.'}, {'title': 'Circulating levels of High density lipoprotein (HDL) cholesterol', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '171', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000', 'lowerLimit': '55', 'upperLimit': '72'}, {'value': '59', 'groupId': 'BG001', 'lowerLimit': '48', 'upperLimit': '71'}, {'value': '57', 'groupId': 'BG002', 'lowerLimit': '50', 'upperLimit': '67'}, {'value': '59', 'groupId': 'BG003', 'lowerLimit': '51', 'upperLimit': '69'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'The numbers are lower because there were no specimen available for analysis.'}, {'title': 'Circulating levels of Low density lipoprotein (LDL) cholesterol', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '171', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '122.7', 'groupId': 'BG000', 'lowerLimit': '95', 'upperLimit': '145.6'}, {'value': '120.4', 'groupId': 'BG001', 'lowerLimit': '101.2', 'upperLimit': '147.6'}, {'value': '132.3', 'groupId': 'BG002', 'lowerLimit': '110.4', 'upperLimit': '162.8'}, {'value': '123.6', 'groupId': 'BG003', 'lowerLimit': '103.6', 'upperLimit': '151.8'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'The numbers are lower because there were no specimen available for analysis.'}, {'title': 'Circulating levels of triglycerides', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '171', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '104', 'groupId': 'BG000', 'lowerLimit': '89', 'upperLimit': '142'}, {'value': '92', 'groupId': 'BG001', 'lowerLimit': '75', 'upperLimit': '151'}, {'value': '119', 'groupId': 'BG002', 'lowerLimit': '94', 'upperLimit': '169'}, {'value': '108', 'groupId': 'BG003', 'lowerLimit': '81', 'upperLimit': '148'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'The numbers are lower because there were no specimen available for analysis.'}, {'title': 'Circulating levels of insulin', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '171', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '7.6', 'groupId': 'BG000', 'lowerLimit': '5.8', 'upperLimit': '10.6'}, {'value': '8.1', 'groupId': 'BG001', 'lowerLimit': '5.8', 'upperLimit': '12.4'}, {'value': '7.9', 'groupId': 'BG002', 'lowerLimit': '5.3', 'upperLimit': '12.9'}, {'value': '8.0', 'groupId': 'BG003', 'lowerLimit': '5.7', 'upperLimit': '11.5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'uU/mL', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'The numbers are lower because there were no specimen available for analysis.'}, {'title': 'Baseline levels of serum glucose', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '171', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '96', 'groupId': 'BG000', 'lowerLimit': '89', 'upperLimit': '103'}, {'value': '98', 'groupId': 'BG001', 'lowerLimit': '92', 'upperLimit': '110'}, {'value': '95', 'groupId': 'BG002', 'lowerLimit': '90', 'upperLimit': '105'}, {'value': '97', 'groupId': 'BG003', 'lowerLimit': '90', 'upperLimit': '106'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'The numbers are lower because there were no specimen available for analysis.'}, {'title': 'HOMA IR', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '171', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '1.76', 'groupId': 'BG000', 'lowerLimit': '1.34', 'upperLimit': '2.61'}, {'value': '1.99', 'groupId': 'BG001', 'lowerLimit': '1.49', 'upperLimit': '3.25'}, {'value': '1.96', 'groupId': 'BG002', 'lowerLimit': '1.32', 'upperLimit': '3.15'}, {'value': '1.94', 'groupId': 'BG003', 'lowerLimit': '1.35', 'upperLimit': '2.90'}]}]}], 'paramType': 'MEDIAN', 'description': 'Insulin Resistance Index (HOMA-IR) measures insulin resistance, calculated by fasting insulin (mU/L) multiplied by fasting glucose (mmol/L), and divided by a constant (22.5). A higher score indicates higher insulin resistance.', 'unitOfMeasure': 'HOMA IR Index', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'The numbers are lower because there were no specimen available for analysis.'}, {'title': 'Circulating levels of adiponectin', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '171', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '10.99', 'groupId': 'BG000', 'lowerLimit': '7.84', 'upperLimit': '14.21'}, {'value': '8.82', 'groupId': 'BG001', 'lowerLimit': '6.54', 'upperLimit': '11.66'}, {'value': '8.99', 'groupId': 'BG002', 'lowerLimit': '6.56', 'upperLimit': '12.92'}, {'value': '9.5', 'groupId': 'BG003', 'lowerLimit': '6.81', 'upperLimit': '13.28'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'µg/mL', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'The numbers are lower because there were no specimen available for analysis.'}, {'title': 'Circulating levels of leptin', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '171', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '35.1', 'groupId': 'BG000', 'lowerLimit': '23.9', 'upperLimit': '75.8'}, {'value': '41.7', 'groupId': 'BG001', 'lowerLimit': '18.7', 'upperLimit': '65.1'}, {'value': '38.5', 'groupId': 'BG002', 'lowerLimit': '22.5', 'upperLimit': '72.1'}, {'value': '36.6', 'groupId': 'BG003', 'lowerLimit': '20.6', 'upperLimit': '69.3'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'The numbers are lower because there were no specimen available for analysis.'}, {'title': 'Tissue biopsy estrogen receptor level (centralized evaluation)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '160', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '99', 'groupId': 'BG000', 'lowerLimit': '95', 'upperLimit': '99'}, {'value': '99', 'groupId': 'BG001', 'lowerLimit': '97', 'upperLimit': '99'}, {'value': '99', 'groupId': 'BG002', 'lowerLimit': '95', 'upperLimit': '99'}, {'value': '99', 'groupId': 'BG003', 'lowerLimit': '95', 'upperLimit': '99'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Percentage of positive tumor cells', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'The numbers are lower because there were no specimen available for analysis.'}, {'title': 'Tissue biopsy progesteron receptor level (centralized evaluation)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '160', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '65', 'groupId': 'BG000', 'lowerLimit': '10', 'upperLimit': '95'}, {'value': '70', 'groupId': 'BG001', 'lowerLimit': '10', 'upperLimit': '99'}, {'value': '70', 'groupId': 'BG002', 'lowerLimit': '8', 'upperLimit': '95'}, {'value': '70', 'groupId': 'BG003', 'lowerLimit': '10', 'upperLimit': '95'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Percentage of positive tumor cells', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'The numbers are lower because there were no specimen available for analysis.'}, {'title': 'Tissue biopsy Ki-67 cancer tissue (centralized evaluation)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '160', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000', 'lowerLimit': '7', 'upperLimit': '17'}, {'value': '13', 'groupId': 'BG001', 'lowerLimit': '7', 'upperLimit': '20'}, {'value': '12', 'groupId': 'BG002', 'lowerLimit': '6', 'upperLimit': '19'}, {'value': '12', 'groupId': 'BG003', 'lowerLimit': '7', 'upperLimit': '18'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Percentage of positive tumor cells', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'The numbers are lower because there were no specimen available for analysis.'}, {'title': 'Tissue biopsy Ki-67 adjacent non cancer tissue (centralized evaluation)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '77', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000', 'lowerLimit': '1', 'upperLimit': '2'}, {'value': '1', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '1', 'groupId': 'BG002', 'lowerLimit': '1', 'upperLimit': '2'}, {'value': '1', 'groupId': 'BG003', 'lowerLimit': '1', 'upperLimit': '2'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Percentage of positive tumor cells', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'The numbers are lower because there were no specimen available for analysis.'}, {'title': 'UGT2B17 Copy number variation distribution by arm', 'classes': [{'title': '2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '164', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '64', 'groupId': 'BG003'}]}]}, {'title': '1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '164', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '78', 'groupId': 'BG003'}]}]}, {'title': '0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '164', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'count', 'populationDescription': 'The numbers are lower because there were no specimen available for analysis.'}, {'title': 'CYP19A1 rs10046 distribution by arm', 'classes': [{'title': 'wt/wt', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '164', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}]}]}, {'title': 'wt/v', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '164', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '95', 'groupId': 'BG003'}]}]}, {'title': 'v/v', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '164', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The numbers are lower because there were no specimen available for analysis.'}, {'title': 'CYP19A1 rs4646 distribution by arm', 'classes': [{'title': 'wt/wt', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '164', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '89', 'groupId': 'BG003'}]}]}, {'title': 'wt/v', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '164', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}]}]}, {'title': 'v/v', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '164', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The numbers are lower because there were no specimen available for analysis.'}, {'title': 'CYP3A4*22 rs35599367 distribution by arm', 'classes': [{'title': 'wt/wt', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '164', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}, {'value': '156', 'groupId': 'BG003'}]}]}, {'title': 'wt/v', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '164', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}, {'title': 'v/v', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '164', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The numbers are lower because there were no specimen available for analysis.'}, {'title': 'SLCO1B1 rs4149056 distribution by arm', 'classes': [{'title': 'wt/wt', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '164', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '116', 'groupId': 'BG003'}]}]}, {'title': 'wt/v', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '164', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}]}]}, {'title': 'v/v', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '164', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The numbers are lower because there were no specimen available for analysis.'}, {'title': 'SLCO1B1 rs10841753 distribution by arm', 'classes': [{'title': 'wt/wt', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '164', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '112', 'groupId': 'BG003'}]}]}, {'title': 'wt/v', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '164', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}]}, {'title': 'v/v', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '164', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The numbers are lower because there were no specimen available for analysis.'}, {'title': 'Menopause specific quality of life questionnaire mean score', 'classes': [{'title': 'Vasomotor domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '159', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '2.2', 'spread': '1.9', 'groupId': 'BG000'}, {'value': '2.5', 'spread': '1.9', 'groupId': 'BG001'}, {'value': '2.6', 'spread': '1.9', 'groupId': 'BG002'}, {'value': '2.4', 'spread': '1.8', 'groupId': 'BG003'}]}]}, {'title': 'Psychosocial domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '159', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '2.5', 'spread': '1.3', 'groupId': 'BG000'}, {'value': '2.3', 'spread': '1.2', 'groupId': 'BG001'}, {'value': '2.6', 'spread': '1.5', 'groupId': 'BG002'}, {'value': '2.5', 'spread': '1.4', 'groupId': 'BG003'}]}]}, {'title': 'Physical domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '159', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '2.5', 'spread': '1.1', 'groupId': 'BG000'}, {'value': '2.3', 'spread': '0.9', 'groupId': 'BG001'}, {'value': '2.6', 'spread': '1.4', 'groupId': 'BG002'}, {'value': '2.5', 'spread': '1.2', 'groupId': 'BG003'}]}]}, {'title': 'Sexual domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '159', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '1.4', 'groupId': 'BG000'}, {'value': '1.9', 'spread': '1.9', 'groupId': 'BG001'}, {'value': '2.2', 'spread': '1.8', 'groupId': 'BG002'}, {'value': '2.1', 'spread': '1.6', 'groupId': 'BG003'}]}]}, {'title': 'Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '159', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '2.3', 'spread': '0.9', 'groupId': 'BG000'}, {'value': '2.2', 'spread': '1.0', 'groupId': 'BG001'}, {'value': '2.5', 'spread': '1.1', 'groupId': 'BG002'}, {'value': '2.4', 'spread': '1.0', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'MRS is a self-report questionnaire for evaluating the severity of menopausal symptoms in women, which contains 11 items. Each of the 11 symptoms contained a scoring scale from "0" (no complaints) to "4" (very severe symptoms). The total score will be calculated as the all items ranging from 0 to 44, with higher scores indicating worse symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The numbers are lower because there were no specimen available for analysis.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-02-10', 'size': 830530, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-11-06T14:42', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'dispFirstSubmitDate': '2020-07-20', 'completionDateStruct': {'date': '2023-02-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-03', 'studyFirstSubmitDate': '2015-11-05', 'dispFirstSubmitQcDate': '2020-07-20', 'resultsFirstSubmitDate': '2023-03-31', 'studyFirstSubmitQcDate': '2015-11-05', 'dispFirstPostDateStruct': {'date': '2020-07-23', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2023-08-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-08-03', 'studyFirstPostDateStruct': {'date': '2015-11-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Proteomic Analysis', 'timeFrame': '4-6 weeks', 'description': 'The Proteomic Analysis was not performed.'}], 'primaryOutcomes': [{'measure': 'Percent Change in Time of Circulating Estradiol SPE in Each Arm', 'timeFrame': 'baseline and 4-6 weeks', 'description': 'LS means of percent change'}], 'secondaryOutcomes': [{'measure': 'Percent Change in Time of Circulating Estradiol LLE in Each Arm', 'timeFrame': 'baseline and 4-6 weeks', 'description': 'LS means of percent change'}, {'measure': 'Percent Change of Circulating Estrone SPE', 'timeFrame': 'baseline and 4-6 weeks', 'description': '\\[(Final levels-baseline levels)/baseline levels\\]\\*100'}, {'measure': 'Percent Change of Circulating Estrone LLE', 'timeFrame': 'baseline and 4-6 weeks', 'description': '\\[(Final levels-baseline levels)/baseline levels\\]\\*100'}, {'measure': 'Percent Change of Circulating Total Estrone', 'timeFrame': 'baseline and 4-6 weeks', 'description': '\\[(Final levels-baseline levels)/baseline levels\\]\\*100'}, {'measure': 'Percent Change of Circulating Estrone Sulfate', 'timeFrame': 'baseline and 4-6 weeks', 'description': '\\[(Final levels-baseline levels)/baseline levels\\]\\*100'}, {'measure': 'Percent Change of Circulating Androstenedione', 'timeFrame': 'baseline and 4-6 weeks', 'description': '\\[(Final levels-baseline levels)/baseline levels\\]\\*100'}, {'measure': 'Percent Change of Circulating Testosterone', 'timeFrame': 'baseline and 4-6 weeks', 'description': '\\[(Final levels-baseline levels)/baseline levels\\]\\*100'}, {'measure': 'Percent Change of Circulating Testosterone CLIA', 'timeFrame': 'baseline and 4-6 weeks', 'description': '\\[(Final levels-baseline levels)/baseline levels\\]\\*100'}, {'measure': 'Percent Change of Circulating SHBG', 'timeFrame': 'baseline and 4-6 weeks', 'description': '\\[(Final levels-baseline levels)/baseline levels\\]\\*100'}, {'measure': 'Percent Change of Circulating Total Cholesterol', 'timeFrame': 'baseline and 4-6 weeks', 'description': '\\[(Final levels-baseline levels)/baseline levels\\]\\*100'}, {'measure': 'Percent Change of Circulating HDL Cholesterol', 'timeFrame': 'baseline and 4-6 weeks', 'description': '\\[(Final levels-baseline levels)/baseline levels\\]\\*100'}, {'measure': 'Percent Change of Circulating LDL Cholesterol', 'timeFrame': 'baseline and 4-6 weeks', 'description': '\\[(Final levels-baseline levels)/baseline levels\\]\\*100'}, {'measure': 'Percent Change of Circulating Triglycerides', 'timeFrame': 'baseline and 4-6 weeks', 'description': '\\[(Final levels-baseline levels)/baseline levels\\]\\*100'}, {'measure': 'Percent Change of Circulating Insulin', 'timeFrame': 'baseline and 4-6 weeks', 'description': '\\[(Final levels-baseline levels)/baseline levels\\]\\*100'}, {'measure': 'Percent Change of Serum Glucose', 'timeFrame': 'baseline and 4-6 weeks', 'description': '\\[(Final levels-baseline levels)/baseline levels\\]\\*100'}, {'measure': 'Percent Change of HOMA IR', 'timeFrame': 'baseline and 4-6 weeks', 'description': 'Insulin Resistance Index (HOMA-IR) measures insulin resistance, calculated by fasting insulin (mU/L) multiplied by fasting glucose (mmol/L), and divided by a constant (22.5). A higher score indicates higher insulin resistance.'}, {'measure': 'Percent Change of Circulating Adiponectin', 'timeFrame': 'baseline and 4-6 weeks', 'description': '\\[(Final levels-baseline levels)/baseline levels\\]\\*100'}, {'measure': 'Percent Change of Circulating Leptin', 'timeFrame': 'baseline and 4-6 weeks', 'description': '\\[(Final levels-baseline levels)/baseline levels\\]\\*100'}, {'measure': 'Exemestane Blood Concentration at Surgery', 'timeFrame': 'at surgery', 'description': 'Final drug concentration'}, {'measure': '17-OH Exemestane Blood Concentration at Surgery', 'timeFrame': 'at surgery', 'description': 'Final drug concentration'}, {'measure': 'Change of ER Expression (Cancer Tissue), Central Review', 'timeFrame': '4-6 weeks', 'description': 'Surgery level-biopsy level.'}, {'measure': 'Change of PgR Expression (Cancer Tissue), Central Review', 'timeFrame': '4-6 weeks', 'description': 'Surgery level-biopsy level.'}, {'measure': 'Change of Ki67% Expression (Cancer Tissue), Central Review', 'timeFrame': '4-6 weeks', 'description': 'Surgery level-biopsy level.'}, {'measure': 'Change of Ki67% Expression (Adjacent Non Cancer Tissue), Central Review', 'timeFrame': '4-6 weeks', 'description': 'Surgery level-biopsy level.'}, {'measure': 'Estradiol Tissue Concentration at Surgery', 'timeFrame': '4-6 weeks', 'description': 'Final biomarker concentration'}, {'measure': 'Estrone Tissue Concentration at Surgery', 'timeFrame': '4-6 weeks', 'description': 'Final biomarker concentration'}, {'measure': 'Androstenedione Tissue Concentration at Surgery', 'timeFrame': '4-6 weeks', 'description': 'Final biomarker concentration.'}, {'measure': 'Testosterone Tissue Concentration at Surgery', 'timeFrame': '4-6 weeks', 'description': 'Final biomarker concentration'}, {'measure': 'Exemestane Tissue Concentration at Surgery', 'timeFrame': '4-6 weeks', 'description': 'Final drug concentration'}, {'measure': '17 OH Exemestane Tissue Concentration at Surgery', 'timeFrame': '4-6 weeks', 'description': 'Final drug concentration'}, {'measure': 'Change in MenQoL Questionnaire Score', 'timeFrame': 'baseline and 4-6 weeks', 'description': 'MenQOL questionnaire assessed how bothered participants were with 31 symptoms. It contains domains: vasomotor (items 1-3); psychosocial (items 4-10); physical (items 11-26); sexual (items 27-29); in addition to nausea and indigestion. 31 individual symptoms are rated on a scale of 0 (not at all bothered) to 6 (extremely bothered). Total possible score ranged from 0 to 186. MenQOL summary score was calculated as mean of four domain scores (Physical function, Psychosocial function, Sexual function and Vasomotor function) ranging from 1 to 8, with higher scores indicating worse quality of life. Final score-baseline score'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Stage 0 Breast Cancer AJCC v6 and v7', 'Stage I Breast Cancer AJCC v7', 'Stage IA Breast Cancer AJCC v7', 'Stage IB Breast Cancer AJCC v7', 'Stage II Breast Cancer AJCC v6 and v7', 'Stage IIA Breast Cancer AJCC v6 and v7', 'Stage IIB Breast Cancer AJCC v6 and v7']}, 'referencesModule': {'references': [{'pmid': '39110531', 'type': 'DERIVED', 'citation': "Serrano D, Johansson H, Bertelsen BE, Gandini S, Mellgren G, Thomas P, Crew KD, Kumar NB, Macis D, Aristarco V, Guerrieri-Gonzaga A, Lazzeroni M, D'Amico M, Buttiron-Webber T, Briata IM, Spinaci S, Galimberti V, Vornik LA, Vilar E, Brown PH, Heckman-Stoddard BM, Szabo E, Bonanni B, DeCensi A. Drug and biomarker tissue levels in a randomized presurgical trial on exemestane alternative schedules. J Natl Cancer Inst. 2024 Dec 1;116(12):1979-1982. doi: 10.1093/jnci/djae183."}, {'pmid': '36951827', 'type': 'DERIVED', 'citation': "Serrano D, Gandini S, Thomas P, Crew KD, Kumar NB, Vornik LA, Lee JJ, Veronesi P, Viale G, Guerrieri-Gonzaga A, Lazzeroni M, Johansson H, D'Amico M, Guasone F, Spinaci S, Bertelsen BE, Mellgren G, Bedrosian I, Weber D, Castile T, Dimond E, Heckman-Stoddard BM, Szabo E, Brown PH, DeCensi A, Bonanni B. Efficacy of Alternative Dose Regimens of Exemestane in Postmenopausal Women With Stage 0 to II Estrogen Receptor-Positive Breast Cancer: A Randomized Clinical Trial. JAMA Oncol. 2023 May 1;9(5):664-672. doi: 10.1001/jamaoncol.2023.0089."}], 'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'MD Anderson Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'This phase IIb trial studies how well alternative dosing of exemestane before surgery works in treating in postmenopausal patients with stage 0-II estrogen positive breast cancer. Chemoprevention is the use of drugs to keep breast cancer from forming or coming back. The use of exemestane may treat early stage (stage 0-II) breast cancer. Comparing the exemestane standard dose regimen versus two alternative, less frequent dose regimens may decrease undesirable symptoms and have similar efficacy in reducing serum estradiol.', 'detailedDescription': 'We have conducted an international, multicenter, pre-surgical double-blind non-inferiority phase IIb study in which a total of 180 participants have been randomized to receive either exemestane 25 mg/day (Exemestane 25 mg QD) or 25 mg/ three times a week (Exemestane 25 mg TIW) or a single dose of 25 mg/week (Exemestane 25 mg QW) for a minimum of 4 up to 6 weeks. Participants were stratified by center and BMI (\\<25 kg/m2 vs \\>25 kg/m2).\n\nParticipants were histologically confirmed ER-positive (ER \\>10%) primary breast cancer patients who were candidates for breast surgery. Postmenopausal women younger than 76 years of age with cT0-2, cN0-1, Mx or women with larger tumors who refuse neo-adjuvant therapy before surgery were eligible. No previous treatment for breast cancer was allowed.\n\nComplete physical exam and safety lab tests have been performed at baseline and at the end of treatment (28+1, 35+1, 42+1 days). Phone contact occurred on day 1 and a week before surgery (+3 days). Participants experiencing persistent adverse events (certainly, probably, and possibly treatment-related) have been monitored 20-30 days after study completion.\n\nBiomarkers: blood samples were collected at baseline and the end of treatment (fasting blood for biomarkers collected prior to randomization and either on the day of surgery or the day before; fasting strongly recommended but not mandated), tissue samples collected from the diagnostic or research biopsy and at the time of surgery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Postmenopausal women (postmenopausal: age \\>= 60 years, or amenorrhea \\>= 12 months, or bilateral oophorectomy, or - in women with hysterectomy only - follicle stimulating hormone \\[FSH\\] in the menopausal levels as per local institutional guidelines if \\< 60 years old) with histologically-confirmed estrogen receptor (ER)-positive (\\>= 10%) primary breast cancer stage cT0-2, cN0-1, Mx; women with larger tumors who refuse chemotherapy (chemo) and/or endocrine neoadjuvant therapy can be eligible\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\< 1 (Karnofsky \\>= 70%)\n* Leukocytes \\>= 3,000/microliter\n* Absolute neutrophil count \\>= 1,500/microliter\n* Platelets \\>= 100,000/microliter\n* Total bilirubin =\\< 2 x institutional upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\< 1.5 x institutional ULN\n* Serum creatinine =\\< 1.5 times institutional ULN\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Body mass index (BMI) \\< 18.5 Kg/m\\^2\n* Previous treatment for breast cancer including chemotherapy, endocrine therapy and radiotherapy; women with prior ductal breast carcinoma in situ (DCIS) who were treated with surgery only and whose treatment ended \\>= 2 years prior to enrollment are eligible for the trial\n* Women who are planned to receive neoadjuvant therapy\n* Participants may not be receiving investigational agents\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to exemestane\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements\n* Other co-existing invasive malignancies (with the exclusion of basal cell carcinoma or skin squamous cell carcinoma) diagnosed during the last 2 years before randomization\n* History of severe osteoporosis (T score =\\< -4 either spine or hip), or presence of vertebral fracture\n* Use of systemic hormone replacement therapy (HRT) in the last 30 days prior to the randomization; the use of non-systemic estrogen (such as vaginal estrogen use) is allowed\n* Use of any chemopreventive agents (selective estrogen receptor modulators \\[SERM\\]) in the last 3 months\n* Concomitant use of CYP3A4 inducer medication (rifampicin, phenytoin, carbamazepine, phenobarbital, and St. John's wort)"}, 'identificationModule': {'nctId': 'NCT02598557', 'briefTitle': 'Alternative Dosing of Exemestane Before Surgery in Treating Postmenopausal Patients With Stage 0-II Estrogen Positive Breast Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Alternative Dosing of Exemestane in Postmenopausal Women With Stage 0-II ER-Positive Breast Cancer: A Randomized Presurgical Trial', 'orgStudyIdInfo': {'id': 'NCI-2015-01821'}, 'secondaryIdInfos': [{'id': 'NCI-2015-01821', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'HHSN26120120034I'}, {'id': 'N01-CN-2012-00034'}, {'id': '2016-0276', 'type': 'OTHER', 'domain': 'M D Anderson Cancer Center'}, {'id': 'MDA2014-04-01', 'type': 'OTHER', 'domain': 'DCP'}, {'id': 'N01CN00034', 'link': 'https://reporter.nih.gov/quickSearch/N01CN00034', 'type': 'NIH'}, {'id': 'P30CA016672', 'link': 'https://reporter.nih.gov/quickSearch/P30CA016672', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I: Exemestane 25 mg QD', 'description': 'Patients receive exemestane PO QD on days 1-7. Cycles repeat every 7 days for 4-6 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery on days 29, 36, or 43.', 'interventionNames': ['Drug: Exemestane', 'Other: Laboratory Biomarker Analysis', 'Other: Pharmacological Study', 'Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration', 'Procedure: Therapeutic Conventional Surgery']}, {'type': 'EXPERIMENTAL', 'label': 'Arm II: Exemestane 25 TIW (exemestane, placebo)', 'description': 'Patients receive exemestane PO QD on days 1, 3, and 5. Patients also receive placebo PO QD on days 2, 4, 6, and 7. Cycles repeat every 7 days for 4-6 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery on days 29, 36, or 43.', 'interventionNames': ['Drug: Exemestane', 'Other: Laboratory Biomarker Analysis', 'Other: Pharmacological Study', 'Other: Placebo Administration', 'Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration', 'Procedure: Therapeutic Conventional Surgery']}, {'type': 'EXPERIMENTAL', 'label': 'Arm III: Exemestane 25 mg QW (exemestane, placebo)', 'description': 'Patients receive exemestane PO QD on day 1 and placebo PO QD on days 2-7. Cycles repeat every 7 days for 4-6 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery on days 29, 36, or 43.', 'interventionNames': ['Drug: Exemestane', 'Other: Laboratory Biomarker Analysis', 'Other: Pharmacological Study', 'Other: Placebo Administration', 'Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration', 'Procedure: Therapeutic Conventional Surgery']}], 'interventions': [{'name': 'Exemestane', 'type': 'DRUG', 'otherNames': ['Aromasin', 'FCE-24304'], 'description': 'Given PO', 'armGroupLabels': ['Arm I: Exemestane 25 mg QD', 'Arm II: Exemestane 25 TIW (exemestane, placebo)', 'Arm III: Exemestane 25 mg QW (exemestane, placebo)']}, {'name': 'Laboratory Biomarker Analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Arm I: Exemestane 25 mg QD', 'Arm II: Exemestane 25 TIW (exemestane, placebo)', 'Arm III: Exemestane 25 mg QW (exemestane, placebo)']}, {'name': 'Pharmacological Study', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Arm I: Exemestane 25 mg QD', 'Arm II: Exemestane 25 TIW (exemestane, placebo)', 'Arm III: Exemestane 25 mg QW (exemestane, placebo)']}, {'name': 'Placebo Administration', 'type': 'OTHER', 'description': 'Given PO', 'armGroupLabels': ['Arm II: Exemestane 25 TIW (exemestane, placebo)', 'Arm III: Exemestane 25 mg QW (exemestane, placebo)']}, {'name': 'Quality-of-Life Assessment', 'type': 'OTHER', 'otherNames': ['Quality of Life Assessment'], 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I: Exemestane 25 mg QD', 'Arm II: Exemestane 25 TIW (exemestane, placebo)', 'Arm III: Exemestane 25 mg QW (exemestane, placebo)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I: Exemestane 25 mg QD', 'Arm II: Exemestane 25 TIW (exemestane, placebo)', 'Arm III: Exemestane 25 mg QW (exemestane, placebo)']}, {'name': 'Therapeutic Conventional Surgery', 'type': 'PROCEDURE', 'description': 'Undergo surgery', 'armGroupLabels': ['Arm I: Exemestane 25 mg QD', 'Arm II: Exemestane 25 TIW (exemestane, placebo)', 'Arm III: Exemestane 25 mg QW (exemestane, placebo)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Moffitt Cancer Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'M D Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '16128', 'city': 'Genoa', 'country': 'Italy', 'facility': 'Galliera Hospital', 'geoPoint': {'lat': 44.40478, 'lon': 8.94439}}, {'zip': '20141', 'city': 'Milan', 'country': 'Italy', 'facility': 'European Institute of Oncology', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}], 'overallOfficials': [{'name': 'Bernardo Bonanni', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'European Institute of Oncology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}