Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-25 @ 8:27 PM
Study NCT ID:
NCT00327769
Status:
COMPLETED
Last Update Posted:
2011-01-25
First Post:
2006-05-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Faslodex Advanced Breast Cancer Local Chinese Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077267', 'term': 'Fulvestrant'}, {'id': 'D000077384', 'term': 'Anastrozole'}], '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'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 234}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-24', 'studyFirstSubmitDate': '2006-05-18', 'studyFirstSubmitQcDate': '2006-05-18', 'lastUpdatePostDateStruct': {'date': '2011-01-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-05-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Disease Progression (TTP)'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR)'}, {'measure': 'Clinical Benefit Rate (CBR)'}, {'measure': 'Time to Treatment Failure (TTF)'}, {'measure': 'Safety & Tolerability.'}]}, 'conditionsModule': {'keywords': ['Advanced breast cancer', 'fulvestrant', 'anastrozole'], 'conditions': ['Advanced Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '20938664', 'type': 'DERIVED', 'citation': 'Xu B, Jiang Z, Shao Z, Wang J, Feng J, Song S, Chen Z, Gu K, Yu S, Zhang Y, Wang C, Zhang F, Yang J. Fulvestrant 250 mg versus anastrozole for Chinese patients with advanced breast cancer: results of a multicentre, double-blind, randomised phase III trial. Cancer Chemother Pharmacol. 2011 Jan;67(1):223-30. doi: 10.1007/s00280-010-1483-x. Epub 2010 Oct 12.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the efficacy and safety of Faslodex as secondary-line treatment compared with Arimidex in oestrogen receptor positive postmenopausal advanced breast cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Postmenopausal advanced breast cancer with oestrogen receptor positive\n* Progression under first-line anti-oestrogen therapy.\n\nExclusion Criteria:\n\n* Life-threatening metastasis; contraindication to anastrozole\n* \\>2 regimens of hormonotherapy for advanced breast cancer'}, 'identificationModule': {'nctId': 'NCT00327769', 'briefTitle': 'Faslodex Advanced Breast Cancer Local Chinese Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Double Blind, Double Dummy, Randomised, Multicentre Study to Compare the Efficacy and Safety of Fulvestrant 250mg With Arimidex 1mg as a Secondary-line Therapy in the Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer', 'orgStudyIdInfo': {'id': 'D6997L00004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Anastrozole', 'interventionNames': ['Drug: Anastrozole']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Anastrozole + Fulvestrant', 'interventionNames': ['Drug: Fulvestrant', 'Drug: Anastrozole']}], 'interventions': [{'name': 'Fulvestrant', 'type': 'DRUG', 'otherNames': ['Faslodex', 'ZD9238'], 'description': '250 mg intramuscular injection', 'armGroupLabels': ['2']}, {'name': 'Anastrozole', 'type': 'DRUG', 'otherNames': ['Arimidex', 'ZD1033'], 'description': '1 mg tablet', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Dalian', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 38.91222, 'lon': 121.60222}}, {'city': 'Fuzhou', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'city': 'Guangzhou', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Hankou', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 30.57436, 'lon': 114.27713}}, {'city': 'Hefei', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'city': 'Huangzhou', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 30.45, 'lon': 114.8}}, {'city': 'Jinan', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'city': 'Nanjing', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Shanghai', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Wuhan', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': "Xi'an", 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'overallOfficials': [{'name': 'Breast Cancer Established Brands Team Medical Science Director, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}}}}