Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
3484 participants
INTERVENTIONAL
2004-03-01
2017-06-30
Brief Summary
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Detailed Description
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Primary Endpoint:
1\. Proof of the effect of 2 years versus 5 years of Anastrozol after 5 years of adjuvant endocrine therapy on the disease free survival
Secondary endpoint:
1. Proof of the effect of 2 years versus 5 years of Anastrozol after 5 years of adjuvant endocrine therapy on the overall survival
2. Comparison of fracture rate in both therapy groups
3. Comparison of incidence of
1. a secondary carcinoma except the contralateral mammacarcinoma
2. contralateral mammacarcinoma in both therapie groups
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: Anastrozol
1 mg per day for 2 years
Anastrozole
1mg tablet daily
Arm B: Anastrozol
1 mg per day for 5 years
Anastrozole
1mg tablet daily
Interventions
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Anastrozole
1mg tablet daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. No distant metastasis at randomization
3. No relapse at randomization
4. TNM- classification at time of diagnosis: T1-3, N0 and N+, M0
5. Estrogen- and or progesterone positive before the beginningof primary endocrine therapy
6. Endocrine therapy for 5 years (maximum deviation ±12 months)
7. Therapy break (from the preliminary therapie) maximum 12 months.
8. Informed Consent before the randomisation
Exclusion Criteria
2. Apparent secondary malignant tumor or status after secondary malignant tumor (Exceptions: simultaniously appearing bilateral breast carcinoma, estrogen- and or progesteronereceptor positive on both sides at the time of diagnosis; in situ carcinomaof the cervix and basal cell carcinoma of the skin)
3. General contraindication respectively hypersensitivity to Anastrozol.
4. In-situ carcinoma of any size with or without Mb. Paget of the Mamilla respectively T4 tumor at the time of first diagnosis.
5. Receptor unknown or negative at time of diagnosis respectively at beginning of primary endocrine therapy
6. Known liver- and/or kidneyinsufficiency
7. Performance Index \>2 according to WHO
8. Regular intake of hormon supplement as well as Hormone Replacement Therapy (HRT) more than 6 months since primary surgery of the mamma carcinoma
9. Serious accessory disease, that prevents the adjuvant therapy according to protocol and/or the regular follow-up care.
10. Lacking compliance of the patient
11. Legal incompetence and/or other circumstances, that prevent the patient from understanding the nature, meaning and consequences of the clinical trial
12. Existing psychiatrical diseaseaccording to ICD (especially alcohol addiction) et the time of admission into the study
18 Years
80 Years
FEMALE
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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AstraZeneca Austria Medical Director, MD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Amstetten, , Austria
Research Site
Bad Ischl, , Austria
Research Site
Baden, , Austria
Research Site
Bregenz, , Austria
Research Site
Dornbirn, , Austria
Research Site
Eisenstadt, , Austria
Research Site
Feldbach, , Austria
Research Site
Feldkirch, , Austria
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Freistadt, , Austria
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Fürstenfeld, , Austria
Research Site
Gmunden, , Austria
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Graz, , Austria
Research Site
Güssing, , Austria
Research Site
Hainburg an der Donau, , Austria
Research Site
Hall in Tirol, , Austria
Research Site
Innsbruck, , Austria
Research Site
Kirchdorf, , Austria
Research Site
Klagenfurt, , Austria
Research Site
Klagenfurt, , Austria
Research Site
Klagenfurt, , Austria
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Krems, , Austria
Research Site
Kufstein, , Austria
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Leoben, , Austria
Research Site
Lienz, , Austria
Research Site
Linz, , Austria
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Linz, , Austria
Research Site
Mistelbach, , Austria
Research Site
Mödling, , Austria
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Neunkirchen, , Austria
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Oberpullendorf, , Austria
Research Site
Oberwart, , Austria
Research Site
Ried im Innkreis, , Austria
Research Site
Rottenmann, , Austria
Research Site
Salzburg, , Austria
Research Site
Sankt Pölten, , Austria
Research Site
Sankt Veit an der Glan, , Austria
Research Site
Scheibbs, , Austria
Research Site
Schladming, , Austria
Research Site
Schwarzach, , Austria
Research Site
Steyr, , Austria
Research Site
Vienna, , Austria
Research Site
Vienna, , Austria
Research Site
Vienna, , Austria
Research Site
Vienna, , Austria
Research Site
Vienna, , Austria
Research Site
Vienna, , Austria
Research Site
Vienna, , Austria
Research Site
Vienna, , Austria
Research Site
Vienna, , Austria
Research Site
Vienna, , Austria
Research Site
Vienna, , Austria
Research Site
Villach, , Austria
Research Site
Villach, , Austria
Research Site
Vöcklabruck, , Austria
Research Site
Waidhofen an der Thaya, , Austria
Research Site
Weiz, , Austria
Research Site
Wels, , Austria
Research Site
Wiener Neustadt, , Austria
Research Site
Wolfsberg, , Austria
Research Site
Zams, , Austria
Countries
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References
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Gnant M, Fitzal F, Rinnerthaler G, Steger GG, Greil-Ressler S, Balic M, Heck D, Jakesz R, Thaler J, Egle D, Manfreda D, Bjelic-Radisic V, Wieder U, Singer CF, Melbinger-Zeinitzer E, Haslbauer F, Sevelda P, Trapl H, Wette V, Wimmer K, Gampenrieder SP, Bartsch R, Kacerovsky-Strobl S, Suppan C, Brunner C, Deutschmann C, Soelkner L, Fesl C, Greil R; Austrian Breast and Colorectal Cancer Study Group. Duration of Adjuvant Aromatase-Inhibitor Therapy in Postmenopausal Breast Cancer. N Engl J Med. 2021 Jul 29;385(5):395-405. doi: 10.1056/NEJMoa2104162.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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ABCSG 16
Identifier Type: -
Identifier Source: secondary_id
D5392L00016
Identifier Type: -
Identifier Source: secondary_id
SALSA
Identifier Type: -
Identifier Source: secondary_id
1033AU/0003
Identifier Type: -
Identifier Source: org_study_id
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