Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2026-01-01 @ 4:19 PM
Study NCT ID:
NCT00334295
Status:
COMPLETED
Last Update Posted:
2012-07-31
First Post:
2006-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Fulvestrant for the Treatment of Recurrent or Metastatic Endometrial Carcinoma.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016889', 'term': 'Endometrial Neoplasms'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077267', 'term': 'Fulvestrant'}], 'ancestors': [{'id': 'D004958', 'term': 'Estradiol'}, {'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aztrial_results_posting@astrazeneca.com', 'title': 'Gerard Lynch', 'organization': 'AstraZeneca'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Fulvestrant', 'description': 'A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.', 'otherNumAffected': 32, 'seriousNumAffected': 11}], 'otherEvents': [{'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lymphoedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Procedural site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vaginal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 4}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Subileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Paresis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dyspnoe', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Vaginal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Determination (for ITT (Intet-to-Treat Set): Efficacy of a Monthly Administration of Fulvestrant in Patients With Recurrent or Metastatic Endometrial Carcinoma by Assessment of the Clinical Tumour Response After 3 Injections of Fulvestrant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fulvestrant', 'description': 'A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 1 year', 'description': 'Number of patients with Complete Remission (CR) and Partial Response (PR), as determined by an independent expert panel according to the WHO response criteria.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2011-12'}, {'type': 'SECONDARY', 'title': 'Time to Progression of Disease (TTP-Time To Progression, for ITT Set)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fulvestrant', 'description': 'A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000', 'lowerLimit': '2.6', 'upperLimit': '6.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'ICF (Informed Consent Form completed) to the date of objective progression or death (by any cause in the absence of progression)', 'description': 'median TTP', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2011-12'}, {'type': 'SECONDARY', 'title': 'Determination (for ITT Set): Median Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fulvestrant', 'description': 'A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000', 'lowerLimit': '8.6', 'upperLimit': '44.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'ICF to the date of death', 'description': 'median overall survival (OS)', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Determination (All Subjects Treated (AST) Set): Safety and Toxicity by Assessment of the Frequency of Grade I-IV Haematological and Non-haematological Toxicities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fulvestrant', 'description': 'A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.'}], 'classes': [{'categories': [{'measurements': [{'value': '169', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'ICF to Last Patient Out (LPO)', 'description': 'number of adverse events', 'unitOfMeasure': 'adverse events', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2011-12'}, {'type': 'SECONDARY', 'title': 'Evaluation (Patient-reported): Change From Baseline in Health-related Quality of Life (HR-QoL) at 12 Months (12 Visits)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fulvestrant', 'description': 'A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.0', 'spread': '1.3-', 'groupId': 'OG000', 'lowerLimit': '-1.3', 'upperLimit': '13.3'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'ICF (Baseline) up to 12 months (12 visits)', 'description': 'Patient-reported FACT-EN questionaire. Presented is the change from baseline after 12 visits/12 months. The overall total score of 43 single items was transformed to a scale from 0 to 100 (0 = worst level of well-being; 100 = highest level of well-being).', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FACT-En was evaluated descriptively for change from baseline of the total score using the AST population, presented for the first 12 visits. Due to death or other patients individual reasons only 4 participants were motivated to complete the FACT-En questionnaire form.', 'anticipatedPostingDate': '2011-12'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fulvestrant', 'description': 'A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Patients received fewer than 3 injection', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Fulvestrant', 'description': 'A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'measurements': [{'value': '69.5', 'groupId': 'BG000', 'lowerLimit': '45', 'upperLimit': '83'}]}]}], 'paramType': 'MEDIAN', 'description': 'post-menopausal', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '35', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-11', 'studyFirstSubmitDate': '2006-06-05', 'resultsFirstSubmitDate': '2012-01-11', 'studyFirstSubmitQcDate': '2006-06-05', 'lastUpdatePostDateStruct': {'date': '2012-07-31', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-06-11', 'studyFirstPostDateStruct': {'date': '2006-06-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-07-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determination (for ITT (Intet-to-Treat Set): Efficacy of a Monthly Administration of Fulvestrant in Patients With Recurrent or Metastatic Endometrial Carcinoma by Assessment of the Clinical Tumour Response After 3 Injections of Fulvestrant', 'timeFrame': 'up to 1 year', 'description': 'Number of patients with Complete Remission (CR) and Partial Response (PR), as determined by an independent expert panel according to the WHO response criteria.'}], 'secondaryOutcomes': [{'measure': 'Time to Progression of Disease (TTP-Time To Progression, for ITT Set)', 'timeFrame': 'ICF (Informed Consent Form completed) to the date of objective progression or death (by any cause in the absence of progression)', 'description': 'median TTP'}, {'measure': 'Determination (for ITT Set): Median Survival', 'timeFrame': 'ICF to the date of death', 'description': 'median overall survival (OS)'}, {'measure': 'Determination (All Subjects Treated (AST) Set): Safety and Toxicity by Assessment of the Frequency of Grade I-IV Haematological and Non-haematological Toxicities', 'timeFrame': 'ICF to Last Patient Out (LPO)', 'description': 'number of adverse events'}, {'measure': 'Evaluation (Patient-reported): Change From Baseline in Health-related Quality of Life (HR-QoL) at 12 Months (12 Visits)', 'timeFrame': 'ICF (Baseline) up to 12 months (12 visits)', 'description': 'Patient-reported FACT-EN questionaire. Presented is the change from baseline after 12 visits/12 months. The overall total score of 43 single items was transformed to a scale from 0 to 100 (0 = worst level of well-being; 100 = highest level of well-being).'}]}, 'conditionsModule': {'keywords': ['Recurrent or metastatic endometrial carcinoma'], 'conditions': ['Endometrial Carcinoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the efficacy of a monthly administration of Fulvestrant in patients with recurrent or metastatic endometrial carcinoma by assessment of the clinical tumour response after 3 injections.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed, recurrent or metastatic endometrial carcinoma\n* Postmenopausal\n* Hormonreceptor positive\n\nExclusion Criteria:\n\n* Pre-treatment with Fulvestrant\n* Previous endocrine therapy of the endometrial carcinoma\n* Previous malignancy less than 3 years ago other than in situ carcinoma of the cervix, basal cell carcinoma or squamous carcinoma of the skin'}, 'identificationModule': {'nctId': 'NCT00334295', 'briefTitle': 'Fulvestrant for the Treatment of Recurrent or Metastatic Endometrial Carcinoma.', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'An Open, Non-randomised Multicentre Phase II Study to Assess the Efficacy and Tolerability of a 250 mg Monthly Dose of i.m. Applied Fulvestrant for the Treatment of Recurrent or Metastatic Endometrial Carcinoma.', 'orgStudyIdInfo': {'id': '9238GR/0002'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Fulvestrant', 'type': 'DRUG', 'description': 'A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Erlangen', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}, {'city': 'Göttingen', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}, {'city': 'Halle', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'city': 'Jena', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'city': 'Lübeck', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}, {'city': 'Mainz', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'city': 'Münster', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'city': 'Neunkirchen', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 49.34449, 'lon': 7.18045}}, {'city': 'Rostock', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 54.0887, 'lon': 12.14049}}], 'overallOfficials': [{'name': 'AstraZeneca Germany Medical Director, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}