Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 9:58 PM
Study NCT ID:
NCT00871858
Status:
COMPLETED
Last Update Posted:
2021-02-24
First Post:
2009-03-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Anastrozole or Fulvestrant in Treating Postmenopausal Patients With Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'D000077384', 'term': 'Anastrozole'}, {'id': 'D000077267', 'term': 'Fulvestrant'}], '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': 'D004958', 'term': 'Estradiol'}, {'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'N.Quenel-Tueux@bordeaux.unicancer.fr', 'phone': '05.56.33.33.33', 'title': 'Dr. Nathalie Quenel-Tueux', 'organization': 'Institut Bergonié, Medical Oncology department'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Arm A (ANA)', 'description': 'Patients receive oral anastrozole as 1 mg film-coated tablets, once daily for 6 months.\n\nanastrozole: Given orally', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 48, 'seriousNumAtRisk': 60, 'deathsNumAffected': 6, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Arm B (FULV)', 'description': 'Patients receive fulvestrant intramuscularly ( 250 mg/5 ml solution) on days 1, 14, and 28 and then once a month thereafter until 6 months.\n\nfulvestrant: Given intramuscularly', 'otherNumAtRisk': 58, 'deathsNumAtRisk': 58, 'otherNumAffected': 43, 'seriousNumAtRisk': 58, 'deathsNumAffected': 6, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Fatigue', 'notes': 'SOC CTCAE V3.0 = constitutional symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 20, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Weight gain', 'notes': 'SOC CTCAE V3.0= Constitutional symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Injection site reaction', 'notes': 'SOC CTCAE V3.0= Dermatology/Skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hot flashes', 'notes': 'SOC CTCAE V3.0=Endocrine gastrointestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Dizziness', 'notes': 'SOC CTCAE V3.0= Neurology', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Agitation', 'notes': 'SOC CTCAE V3.0=Neurology / AE term CTCAE V3.0= Mood alteration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Arthralgia', 'notes': 'SOC CTCAE V3.0=PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'MYALGIA', 'notes': 'SOC CTCAE V3.0= PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}], 'seriousEvents': [{'term': 'Clear cell kidney cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Bronchial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Endometrial atrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Programmed peritoneal dialysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Objective Response Rate (ORR) Determined by Clinical Palpation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (ANA)', 'description': 'Patients receive oral anastrozole as 1 mg film-coated tablets, once daily for 6 months.\n\nanastrozole: Given orally'}, {'id': 'OG001', 'title': 'Arm B (FULV)', 'description': 'Patients receive fulvestrant intramuscularly ( 250 mg/5 ml solution) on days 1, 14, and 28 and then once a month thereafter until 6 months.\n\nfulvestrant: Given intramuscularly'}], 'classes': [{'categories': [{'measurements': [{'value': '58.9', 'groupId': 'OG000', 'lowerLimit': '45.0', 'upperLimit': '71.9'}, {'value': '53.8', 'groupId': 'OG001', 'lowerLimit': '39.5', 'upperLimit': '67.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Objective response rate is defined as the rate of participants with partial or complete responses according to RECIST V1.0.\n\nComplete response is defined as the disappearance of all target lesions and partial response is defined as at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD (RECIST V1.0.).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR) Determined by Ultrasound', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (ANA)', 'description': 'Patients receive oral anastrozole as 1 mg film-coated tablets, once daily for 6 months.\n\nanastrozole: Given orally'}, {'id': 'OG001', 'title': 'Arm B (FULV)', 'description': 'Patients receive fulvestrant intramuscularly ( 250 mg/5 ml solution) on days 1, 14, and 28 and then once a month thereafter until 6 months.\n\nfulvestrant: Given intramuscularly'}], 'classes': [{'categories': [{'measurements': [{'value': '35.1', 'groupId': 'OG000', 'lowerLimit': '20.2', 'upperLimit': '52.5'}, {'value': '52.4', 'groupId': 'OG001', 'lowerLimit': '29.8', 'upperLimit': '74.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Objective response rate is defined as the rate of participants with partial or complete responses according to RECIST V1.0.\n\nComplete response is defined as the disappearance of all target lesions and partial response is defined as at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD (RECIST V1.0.).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Out of 108 patients (56 arm A + 52 arm B) evaluable for efficacy ("completed" in flow chart) : 19 patients in Arm A and 31 in arm B with missing size at ultrasound examination'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR) Determined by Mammography', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (ANA)', 'description': 'Patients receive oral anastrozole as 1 mg film-coated tablets, once daily for 6 months.\n\nanastrozole: Given orally'}, {'id': 'OG001', 'title': 'Arm B (FULV)', 'description': 'Patients receive fulvestrant intramuscularly ( 250 mg/5 ml solution) on days 1, 14, and 28 and then once a month thereafter until 6 months.\n\nfulvestrant: Given intramuscularly'}], 'classes': [{'categories': [{'measurements': [{'value': '26.1', 'groupId': 'OG000', 'lowerLimit': '10.4', 'upperLimit': '48.4'}, {'value': '27.8', 'groupId': 'OG001', 'lowerLimit': '9.7', 'upperLimit': '53.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Objective response rate is defined as the rate of participants with partial or complete responses according to RECIST V1.0.\n\nComplete response is defined as the disappearance of all target lesions and partial response is defined as at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD (RECIST V1.0.).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Out of 108 patients (56 arm A + 52 arm B) evaluable for efficacy ("completed" in flow chart) : 33 patients in Arm A and 34 in arm B with missing size at mammography.'}, {'type': 'SECONDARY', 'title': 'Rate of Breast-conserving Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (ANA)', 'description': 'Patients receive oral anastrozole as 1 mg film-coated tablets, once daily for 6 months.\n\nanastrozole: Given orally'}, {'id': 'OG001', 'title': 'Arm B (FULV)', 'description': 'Patients receive fulvestrant intramuscularly ( 250 mg/5 ml solution) on days 1, 14, and 28 and then once a month thereafter until 6 months.\n\nfulvestrant: Given intramuscularly'}], 'classes': [{'categories': [{'measurements': [{'value': '60.7', 'groupId': 'OG000', 'lowerLimit': '46.8', 'upperLimit': '73.5'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '35.8', 'upperLimit': '64.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'breast-conserving surgery concerns patients who did not undergo mastectomy.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With 5-year Relapse-Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (ANA)', 'description': 'Patients receive oral anastrozole as 1 mg film-coated tablets, once daily for 6 months.\n\nanastrozole: Given orally'}, {'id': 'OG001', 'title': 'Arm B (FULV)', 'description': 'Patients receive fulvestrant intramuscularly ( 250 mg/5 ml solution) on days 1, 14, and 28 and then once a month thereafter until 6 months.\n\nfulvestrant: Given intramuscularly'}], 'classes': [{'categories': [{'measurements': [{'value': '82.8', 'groupId': 'OG000', 'lowerLimit': '69.6', 'upperLimit': '90.7'}, {'value': '74.7', 'groupId': 'OG001', 'lowerLimit': '60.4', 'upperLimit': '84.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 years', 'description': 'Relapse-Free survival (RFS) is measured from the date of randomization to the date of the following events, whichever occurs first according to the DATECAN recommendations for breast cancer:\n\n* Invasive ipsilateral breast tumor recurrence/ progression ;\n* Local invasive recurrence/progression ;\n* Regional invasive recurrence/progression (N+: regional progression) ;\n* Appearance/Occurrence of Metastatic recurrence;\n* Death whatever the cause.\n\nParticipants who did not experience events were censored at the date of last follow-up. RFS was estimated using the Kaplan-Meier method. No comparison test was performed between the two arms as this study is non-comparative.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm A (ANA)', 'description': 'Patients receive oral anastrozole as 1 mg film-coated tablets, once daily for 6 months.\n\nanastrozole: Given orally'}, {'id': 'FG001', 'title': 'Arm B (FULV)', 'description': 'Patients receive fulvestrant intramuscularly ( 250 mg/5 ml solution) on days 1, 14, and 28 and then once a month thereafter until 6 months.\n\nfulvestrant: Given intramuscularly'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '59'}]}, {'type': 'Evaluable for Safety', 'achievements': [{'comment': '1 patient refused to continue study and therefore did not received treatment.', 'groupId': 'FG000', 'numSubjects': '60'}, {'comment': '1 patient refused to continue study after randomization and therefore did not received treatment.', 'groupId': 'FG001', 'numSubjects': '58'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '52'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm A (ANA)', 'description': 'Patients receive oral anastrozole as 1 mg film-coated tablets, once daily for 6 months.\n\nanastrozole: Given orally'}, {'id': 'BG001', 'title': 'Arm B (FULV)', 'description': 'Patients receive fulvestrant intramuscularly ( 250 mg/5 ml solution) on days 1, 14, and 28 and then once a month thereafter until 6 months.\n\nfulvestrant: Given intramuscularly'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.1', 'groupId': 'BG000', 'lowerLimit': '64.1', 'upperLimit': '77.5'}, {'value': '70.5', 'groupId': 'BG001', 'lowerLimit': '64.0', 'upperLimit': '77.8'}, {'value': '69.8', 'groupId': 'BG002', 'lowerLimit': '64.0', 'upperLimit': '77.6'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'France', 'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2018-07-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-03', 'studyFirstSubmitDate': '2009-03-27', 'resultsFirstSubmitDate': '2021-01-13', 'studyFirstSubmitQcDate': '2009-03-27', 'lastUpdatePostDateStruct': {'date': '2021-02-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-01-13', 'studyFirstPostDateStruct': {'date': '2009-03-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate (ORR) Determined by Clinical Palpation', 'timeFrame': '6 months', 'description': 'Objective response rate is defined as the rate of participants with partial or complete responses according to RECIST V1.0.\n\nComplete response is defined as the disappearance of all target lesions and partial response is defined as at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD (RECIST V1.0.).'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR) Determined by Ultrasound', 'timeFrame': '6 months', 'description': 'Objective response rate is defined as the rate of participants with partial or complete responses according to RECIST V1.0.\n\nComplete response is defined as the disappearance of all target lesions and partial response is defined as at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD (RECIST V1.0.).'}, {'measure': 'Objective Response Rate (ORR) Determined by Mammography', 'timeFrame': '6 months', 'description': 'Objective response rate is defined as the rate of participants with partial or complete responses according to RECIST V1.0.\n\nComplete response is defined as the disappearance of all target lesions and partial response is defined as at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD (RECIST V1.0.).'}, {'measure': 'Rate of Breast-conserving Surgery', 'timeFrame': '6 months', 'description': 'breast-conserving surgery concerns patients who did not undergo mastectomy.'}, {'measure': 'Percentage of Participants With 5-year Relapse-Free Survival', 'timeFrame': '5 years', 'description': 'Relapse-Free survival (RFS) is measured from the date of randomization to the date of the following events, whichever occurs first according to the DATECAN recommendations for breast cancer:\n\n* Invasive ipsilateral breast tumor recurrence/ progression ;\n* Local invasive recurrence/progression ;\n* Regional invasive recurrence/progression (N+: regional progression) ;\n* Appearance/Occurrence of Metastatic recurrence;\n* Death whatever the cause.\n\nParticipants who did not experience events were censored at the date of last follow-up. RFS was estimated using the Kaplan-Meier method. No comparison test was performed between the two arms as this study is non-comparative.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stage II breast cancer', 'stage IIIA breast cancer', 'stage IIIB breast cancer', 'estrogen receptor-positive breast cancer', 'progesterone receptor-positive breast cancer'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '26171933', 'type': 'RESULT', 'citation': 'Quenel-Tueux N, Debled M, Rudewicz J, MacGrogan G, Pulido M, Mauriac L, Dalenc F, Bachelot T, Lortal B, Breton-Callu C, Madranges N, de Lara CT, Fournier M, Bonnefoi H, Soueidan H, Nikolski M, Gros A, Daly C, Wood H, Rabbitts P, Iggo R. Clinical and genomic analysis of a randomised phase II study evaluating anastrozole and fulvestrant in postmenopausal patients treated for large operable or locally advanced hormone-receptor-positive breast cancer. Br J Cancer. 2015 Aug 11;113(4):585-94. doi: 10.1038/bjc.2015.247. Epub 2015 Jul 14.'}, {'pmid': '32001832', 'type': 'DERIVED', 'citation': 'Lerebours F, Pulido M, Fourme E, Debled M, Becette V, Bonnefoi H, Rivera S, MacGrogan G, Mouret-Reynier MA, de Lara CT, Pierga JY, Breton-Callu C, Venat-Bouvet L, Mathoulin-Pelissier S, de la Motte Rouge T, Dalenc F, Sigal B, Bachelot T, Lemonnier J, Quenel-Tueux N. Predictive factors of 5-year relapse-free survival in HR+/HER2- breast cancer patients treated with neoadjuvant endocrine therapy: pooled analysis of two phase 2 trials. Br J Cancer. 2020 Mar;122(6):759-765. doi: 10.1038/s41416-020-0733-x. Epub 2020 Jan 31.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using anastrozole may fight breast cancer by lowering the amount of estrogen the body makes. Fulvestrant may fight breast cancer by blocking the use of estrogen by the tumor cells. Given the lack of clinical data on fulvestrant in patients with large operable or locally advanced hormone-receptor-positive breast cancer, and the potential to identify differences in the mechanism of resistance using the neoadjuvant model,we decided to perform a multicentre randomised phase II clinical trial of anastrozole and fulvestrant.\n\nPURPOSE: The aim of this study was to assess the efficacy of neoadjuvant anastrozole and fulvestrant treatment of large operable or locally advanced hormone-receptor-positive breast cancer not eligible for initial breast-conserving surgery, and to identify genomic changes occurring after treatment.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Evaluate clinical tumor response at 6 months in patients with hormone-sensitive non-metastatic breast cancer treated with neoadjuvant anastrozole and fulvestrant.\n\nSecondary\n\n* Evaluate tumor regression by mammography and ultrasound in these patients.\n* Evaluate the rate of breast conservation at 6 months of treatment in these patients.\n* Evaluate the tolerability of these regimens.\n* Estimate the relapse-free survival at 5 years.\n* Identify molecular signatures predictive of response in these patients.\n* Identify genes implicated in response in these patients.\n* Identify changes in mRNA splicing of genes involved in breast tumorigenesis.\n\nOUTLINE: This is a non-comparative multicentre randomised phase II study in which patients from three French centres were randomly assigned in a 1 : 1 ratio to receive either anatrozole or fulvestrant.\n\nAll patients undergo biopsy at baseline. Patients are randomized between the two treatment arms.\n\n* Arm I: Patients receive oral anastrozole once daily for 6 months.\n* Arm II: Patients receive fulvestrant intramuscularly on days 1, 14, and 28 and then once a month at 2-6 months.\n\nWithin 8 days after completion of hormone therapy, all patients undergo surgical resection of the residual lesion followed by radiotherapy. Patients then receive oral anastrozole once daily for 5 years.\n\nTissue samples from biopsy and surgery are analyzed to assess molecular signatures and sensitivity to treatment, and to compare gene expression variation with response.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed invasive breast cancer, meeting 1 of the following criteria:\n\n * SBR grade I-II disease (patients \\< 65 years of age)\n * SBR grade I-III disease (patients \\> 65 years of age)\n* T2 (2-5 cm), T3, or T4B, and N0-1 disease\n* No metastatic disease\n* Breast lesion not amenable to breast-conserving resection\n* No inflammatory breast cancer\n* No prior breast cancer\n* Hormone receptor status:\n\n * Estrogen receptor- and/or progesterone receptor-positive\n\nPATIENT CHARACTERISTICS:\n\n* Postmenopausal\n* No other cancer within the past 5 years except for adequately treated skin carcinoma or carcinoma in situ of the cervix\n* No contraindication to anti-hormonal treatment\n* No psychological, familial, social, or geographical reasons that would preclude follow up\n\nPRIOR CONCURRENT THERAPY:\n\n* At least 8 days since prior hormone replacement therapy\n* No concurrent anti-vitamin K treatment'}, 'identificationModule': {'nctId': 'NCT00871858', 'acronym': 'HORGEN', 'briefTitle': 'Anastrozole or Fulvestrant in Treating Postmenopausal Patients With Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Institut Bergonié'}, 'officialTitle': 'Response to Neoadjuvant Treatment With Anti-aromatase Anastrozole and Anti-estrogen Fulvestrant: a Randomized Phase II Study in Postmenopausal Patients With Hormone-sensitive Non-metastatic Breast Cancer and an Exploratory Study of Molecular Signatures of Response.', 'orgStudyIdInfo': {'id': 'CDR0000633329'}, 'secondaryIdInfos': [{'id': '2007-004216-31', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm A (ANA)', 'description': 'Patients receive oral anastrozole as 1 mg film-coated tablets, once daily for 6 months.', 'interventionNames': ['Drug: anastrozole']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B (FULV)', 'description': 'Patients receive fulvestrant intramuscularly ( 250 mg/5 ml solution) on days 1, 14, and 28 and then once a month thereafter until 6 months.', 'interventionNames': ['Drug: fulvestrant']}], 'interventions': [{'name': 'anastrozole', 'type': 'DRUG', 'description': 'Given orally', 'armGroupLabels': ['Arm A (ANA)']}, {'name': 'fulvestrant', 'type': 'DRUG', 'description': 'Given intramuscularly', 'armGroupLabels': ['Arm B (FULV)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Institut Bergonie', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}], 'overallOfficials': [{'name': 'Louis Mauriac, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut Bergonié'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Bergonié', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}