Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2026-01-03 @ 10:57 AM
Study NCT ID:
NCT00291759
Status:
COMPLETED
Last Update Posted:
2013-01-30
First Post:
2006-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ABCSG 8 - Adjuvant Treatment in Patients With Hormone Receptor-positive Breast Cancer With Good to Moderate Differentiation.
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': 'D013629', 'term': 'Tamoxifen'}, {'id': 'D000077384', 'term': 'Anastrozole'}], 'ancestors': [{'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'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009570', 'term': 'Nitriles'}, {'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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3858}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1996-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-29', 'studyFirstSubmitDate': '2006-02-13', 'studyFirstSubmitQcDate': '2006-02-13', 'lastUpdatePostDateStruct': {'date': '2013-01-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the difference in event free survival and overall survival (subject to stand-alone or combined/meta-analysis) between postmenopausal women with HR +ve early BC who switched from tamoxifen to anastrozole and those who continued on tamoxifen.'}], 'secondaryOutcomes': [{'measure': 'To assess the difference in event free survival & overall survival (subject to stand-alone or combined/meta-analysis) plus side effects between postmenopausal women with HR+ve early BC who switched from tam to anastrozole and those who continued on tam.'}]}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '25332252', 'type': 'DERIVED', 'citation': 'Sestak I, Cuzick J, Dowsett M, Lopez-Knowles E, Filipits M, Dubsky P, Cowens JW, Ferree S, Schaper C, Fesl C, Gnant M. Prediction of late distant recurrence after 5 years of endocrine treatment: a combined analysis of patients from the Austrian breast and colorectal cancer study group 8 and arimidex, tamoxifen alone or in combination randomized trials using the PAM50 risk of recurrence score. J Clin Oncol. 2015 Mar 10;33(8):916-22. doi: 10.1200/JCO.2014.55.6894. Epub 2014 Oct 20.'}, {'pmid': '24347518', 'type': 'DERIVED', 'citation': 'Gnant M, Filipits M, Greil R, Stoeger H, Rudas M, Bago-Horvath Z, Mlineritsch B, Kwasny W, Knauer M, Singer C, Jakesz R, Dubsky P, Fitzal F, Bartsch R, Steger G, Balic M, Ressler S, Cowens JW, Storhoff J, Ferree S, Schaper C, Liu S, Fesl C, Nielsen TO; Austrian Breast and Colorectal Cancer Study Group. Predicting distant recurrence in receptor-positive breast cancer patients with limited clinicopathological risk: using the PAM50 Risk of Recurrence score in 1478 postmenopausal patients of the ABCSG-8 trial treated with adjuvant endocrine therapy alone. Ann Oncol. 2014 Feb;25(2):339-45. doi: 10.1093/annonc/mdt494. Epub 2013 Dec 16.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the difference in event-free survival between postmenopausal women with hormone receptor-positive early breast cancer who switched from tamoxifen to anastrozole and those who continued to receive tamoxifen.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Invasive mammary carcinoma after radical treatment, without prior chemo/hormone/radiation therapy.\n* At least 6 lymph nodes examined.\n* Good or intermediate tumour differentiation.\n* \\<6 weeks before start of adjuvant therapy.\n* Oestrogen or Progesterone positive\n\nExclusion Criteria:\n\n* Premenopausal.\n* Preoperative hormonal/antihormonal/radiation/cytoxic chemo. Second malignant tumour/status post second malignant tumour.\n* In-situ/T4 carcinoma.\n* Age \\>80 years.\n* World Health Organisation performance index \\>3.\n* Serious accompanying diseases'}, 'identificationModule': {'nctId': 'NCT00291759', 'briefTitle': 'ABCSG 8 - Adjuvant Treatment in Patients With Hormone Receptor-positive Breast Cancer With Good to Moderate Differentiation.', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Adjuvant Endocrine Therapy in Postmenopausal Patients With HR +ve BC With Good to Moderate Differentiation - ARNO (Arimidex + Nolvadex). Primary Treatment for 2 Years With Tamoxifen Thereafter Randomisation to: Tamoxifen 3 Years or Anastrozole 3 Years.', 'orgStudyIdInfo': {'id': '1033AU/0002'}, 'secondaryIdInfos': [{'id': 'ABCSG 8'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Tamoxifen', 'type': 'DRUG'}, {'name': 'Anastrozole', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amstetten', 'country': 'Austria', 'facility': 'Research Site', 'geoPoint': {'lat': 48.1229, 'lon': 14.87206}}, {'city': 'Bad Ischl', 'country': 'Austria', 'facility': 'Research Site', 'geoPoint': {'lat': 47.71109, 'lon': 13.61893}}, {'city': 'Baden', 'country': 'Austria', 'facility': 'Research Site', 'geoPoint': {'lat': 48.00543, 'lon': 16.23264}}, {'city': 'Bregenz', 'country': 'Austria', 'facility': 'Research Site', 'geoPoint': {'lat': 47.50311, 'lon': 9.7471}}, {'city': 'Bruck/Mur', 'country': 'Austria', 'facility': 'Research Site'}, {'city': 'Dornbirn', 'country': 'Austria', 'facility': 'Research Site', 'geoPoint': {'lat': 47.41427, 'lon': 9.74195}}, {'city': 'Eisenstadt', 'country': 'Austria', 'facility': 'Research Site', 'geoPoint': {'lat': 47.84565, 'lon': 16.52327}}, {'city': 'Feldbach', 'country': 'Austria', 'facility': 'Research Site', 'geoPoint': {'lat': 46.95306, 'lon': 15.88833}}, {'city': 'Feldkirch', 'country': 'Austria', 'facility': 'Research Site', 'geoPoint': {'lat': 47.23306, 'lon': 9.6}}, {'city': 'Freistadt', 'country': 'Austria', 'facility': 'Research Site', 'geoPoint': {'lat': 48.51103, 'lon': 14.50453}}, {'city': 'Fürstenfeld', 'country': 'Austria', 'facility': 'Research Site', 'geoPoint': {'lat': 47.05, 'lon': 16.08333}}, {'city': 'Gmünd', 'country': 'Austria', 'facility': 'Research Site', 'geoPoint': {'lat': 48.7683, 'lon': 14.9808}}, {'city': 'Graz', 'country': 'Austria', 'facility': 'Research Sites', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'city': 'Güssing', 'country': 'Austria', 'facility': 'Research Site', 'geoPoint': {'lat': 47.05936, 'lon': 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'Klosterneuburg', 'country': 'Austria', 'facility': 'Research Sites', 'geoPoint': {'lat': 48.30521, 'lon': 16.32522}}, {'city': 'Kufstein', 'country': 'Austria', 'facility': 'Research Site', 'geoPoint': {'lat': 47.58333, 'lon': 12.16667}}, {'city': 'Leoben', 'country': 'Austria', 'facility': 'Research Site', 'geoPoint': {'lat': 47.3765, 'lon': 15.09144}}, {'city': 'Linz', 'country': 'Austria', 'facility': 'Research Sites', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'city': 'Melk', 'country': 'Austria', 'facility': 'Research SIte', 'geoPoint': {'lat': 48.22737, 'lon': 15.33186}}, {'city': 'Mistelbach', 'country': 'Austria', 'facility': 'Research Site', 'geoPoint': {'lat': 48.57, 'lon': 16.57667}}, {'city': 'Mödling', 'country': 'Austria', 'facility': 'Research Site', 'geoPoint': {'lat': 48.08605, 'lon': 16.28921}}, {'city': 'Neunkirchen', 'country': 'Austria', 'facility': 'Research Site', 'geoPoint': {'lat': 47.72096, 'lon': 16.08107}}, {'city': 'Oberpullendorf', 'country': 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