Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-26 @ 1:08 AM
Study NCT ID:
NCT00287534
Status:
COMPLETED
Last Update Posted:
2009-06-09
First Post:
2006-02-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Combination of Arimidex and Nolvadex in Adjuvant Therapy of Breast Carcinoma in Postmenopausal Women.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D013629', 'term': 'Tamoxifen'}], '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': 'D013267', 'term': 'Stilbenes'}, {'id': 'D001597', 'term': 'Benzylidene Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1059}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1996-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2004-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-06-07', 'studyFirstSubmitDate': '2006-02-06', 'studyFirstSubmitQcDate': '2006-02-06', 'lastUpdatePostDateStruct': {'date': '2009-06-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-02-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the difference in disease-free survival between post-menopausal women with hormone receptor-positive early breast cancer who switched from tamoxifen to anastrozole and those who continued to receive tamoxifen'}], 'secondaryOutcomes': [{'measure': 'To assess difference in overall survival between the two treatment arms'}, {'measure': 'To assess difference in disease recurrence between the two treatment arms'}, {'measure': 'To assess difference in safety and tolerability between the two treatment arms'}]}, 'conditionsModule': {'keywords': ['Early Breast Cancer'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine the efficacy and tolerability of 3 years treatment with anastrozole after a prior 2 years' treatment with tamoxifen versus 5 years treatment with tamoxifen in postmenopausal women with early breast cancer"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent,\n* Post-menopausal women ≤75 years,\n* histologically confirmed invasive breast carcinoma (no distant metastases),\n* positive hormone receptor status,\n* continuous 2-year adjuvant tamoxifen therapy 20 mg/30 mg with 4 weeks after primary surgery\n\nExclusion Criteria:\n\n* menopause status maintained by medication,\n* pre-operative chemotherapy or hormone therapy or radiation therapy,\n* relapse or second carcinoma or previous cancerous disease,\n* breast carcinoma in situ,\n* simultaneous carcinoma of the opposite side or secondary breast,\n* 10 or more tumour-infiltrated lymph nodes.\n* serious accompanying diseases'}, 'identificationModule': {'nctId': 'NCT00287534', 'acronym': 'ARNO-95', 'briefTitle': 'Effectiveness of Combination of Arimidex and Nolvadex in Adjuvant Therapy of Breast Carcinoma in Postmenopausal Women.', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': "A Prospective, Multi-Centre, Randomised, Open Parallel Group Study to Compare the Effectiveness and Compatibility of ARIMIDEX (ZD 1033) With NOLVADEX After a Prior 2 Years' Treatment With Tamoxifen in Adjuvant Therapy of Breast Carcinoma in Postmenopausal Women.", 'orgStudyIdInfo': {'id': '1033GR/0001'}, 'secondaryIdInfos': [{'id': 'ARNO-95'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Anastrozole', 'interventionNames': ['Drug: Anastrozole']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Tamoxifen', 'interventionNames': ['Drug: Tamoxifen']}], 'interventions': [{'name': 'Anastrozole', 'type': 'DRUG', 'otherNames': ['Arimidex', 'ZD1033'], 'description': 'oral', 'armGroupLabels': ['1']}, {'name': 'Tamoxifen', 'type': 'DRUG', 'otherNames': ['Nolvadex'], 'description': 'oral', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Albstadt', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 48.21644, 'lon': 9.02596}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Cloppenburg', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 52.84754, 'lon': 8.045}}, {'city': 'Eggenfelden', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 48.40509, 'lon': 12.75752}}, {'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'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': 'Hamburg', 'country': 'Germany', 'facility': 'Research 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'lon': 9.5}}, {'city': 'Kiel', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'city': 'Leonberg', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 48.8, 'lon': 9.01667}}, {'city': 'Lingen', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 52.52143, 'lon': 7.31845}}, {'city': 'Lübeck', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}, {'city': 'Magdeburg', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 52.13129, 'lon': 11.63189}}, {'city': 'Mainz', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'city': 'Mannheim', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}, {'city': 'München', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'city': 'Münster', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'city': 'Neustadt', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 53.55196, 'lon': 9.98558}}, {'city': 'Osnabrück', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 52.27264, 'lon': 8.0498}}, {'city': 'Paderborn', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 51.71905, 'lon': 8.75439}}, {'city': 'Pforzheim', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 48.88436, 'lon': 8.69892}}, {'city': 'Recklinghausen', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 51.61379, 'lon': 7.19738}}, {'city': 'Rosenheim', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 47.85637, 'lon': 12.12247}}, {'city': 'Rostock', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 54.0887, 'lon': 12.14049}}, {'city': 'Rüsselsheim am Main', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 49.98955, 'lon': 8.42251}}, {'city': 'Schleswig', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 54.52021, 'lon': 9.56829}}, {'city': 'Siegen', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 50.87481, 'lon': 8.02431}}, {'city': 'Titisee-Neustadt', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 47.92104, 'lon': 8.19063}}, {'city': 'Tübingen', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'city': 'Ulm', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}, {'city': 'Waiblingen', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 48.83241, 'lon': 9.31641}}, {'city': 'Westerstede', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 53.25682, 'lon': 7.92737}}, {'city': 'Worms', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 49.63278, 'lon': 8.35916}}, {'city': 'Würzburg', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}], 'overallOfficials': [{'name': 'Manfred Kaufmann, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'German Adjuvant Breast Cancer Group'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'German Adjuvant Breast Cancer Group', 'class': 'OTHER'}]}}}