3 Years of Anastrozole vs. no Treatment as Extended Adjuvant Therapy for Postmenopausal Women With Breast Cancer
A Randomized, Open, Comparative Multicentre Trial of 3 Years Anastrozole Treatment vs. 3 Years no Treatment in Postmenopausal Patients With Breast Cancer Who Have Completed 5 Years Adjuvant Hormone Therapy.
2 other identifiers
interventional
856
1 country
51
Brief Summary
The study assesses the effect of a further 3 years adjuvant treatment with anastrozole vs. an untreated control group after initial 5 years of adjuvant hormone-therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 1996
CompletedFirst Submitted
Initial submission to the registry
March 7, 2006
CompletedFirst Posted
Study publicly available on registry
March 9, 2006
CompletedMay 1, 2009
April 1, 2009
March 7, 2006
April 30, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Recurrence-free and overall survival
Secondary Outcomes (1)
Secondary cancers
Interventions
Eligibility Criteria
You may qualify if:
- No disease recurrence at time of randomization,
- patients with breast cancer after surgery,
- years (+/- 12 months) of prior endocrine therapy
You may not qualify if:
- Premenopausal patients,
- unknown or negative receptor status,
- Secondary malignant tumor
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (51)
Research Site
Amstetten, Austria
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Bad Ischl, Austria
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Baden, Austria
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Bregenz, Austria
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Bruck an der Mur, Austria
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Dornbirn, Austria
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Eisenstadt, Austria
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Feldbach, Austria
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Feldkirch, Austria
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Freistadt, Austria
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Fürstenfeld, Austria
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Graz, Austria
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Güssing, Austria
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Hainburg an der Donau, Austria
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Hartberg, Austria
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Hollabrunn, Austria
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Horn, Austria
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Innsbruck, Austria
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Kirchdorf, Austria
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Klagenfurt, Austria
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Klosterneuburg, Austria
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Krems, Austria
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Kufstein, Austria
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Leoben, Austria
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Linz, Austria
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Mistelbach, Austria
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Mödling, Austria
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Neunkirche, Austria
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Oberpullendorf, Austria
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Oberwart, Austria
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Ried im Innkreis, Austria
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Rohrbach, Austria
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Rottenmann, Austria
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Salzburg, Austria
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Sankt Pölten, Austria
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Sankt Veit an der Glan, Austria
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Schärding, Austria
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Scheibbs, Austria
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Schladming, Austria
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Schwarzach, Austria
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Spittal an der Drau, Austria
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Steyr, Austria
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Tulln, Austria
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Vienna, Austria
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Villach, Austria
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Vöcklabruck, Austria
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Waidhofen an der Ybbs, Austria
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Wels, Austria
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Wiener Neustadt, Austria
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Wolfsberg, Austria
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Zams, Austria
Related Publications (2)
Wimmer K, Hlauschek D, Balic M, Pfeiler G, Greil R, Singer CF, Halper S, Steger G, Suppan C, Gampenrieder SP, Helfgott R, Egle D, Filipits M, Jakesz R, Solkner L, Fesl C, Gnant M, Fitzal F. Is the CTS5 a helpful decision-making tool in the extended adjuvant therapy setting? Breast Cancer Res Treat. 2024 Jun;205(2):227-239. doi: 10.1007/s10549-023-07186-6. Epub 2024 Jan 25.
PMID: 38273214DERIVEDGnant M, Pfeiler G, Stoger H, Mlineritsch B, Fitzal F, Balic M, Kwasny W, Seifert M, Stierer M, Dubsky P, Greil R, Steger G, Samonigg H, Fesl C, Jakesz R. The predictive impact of body mass index on the efficacy of extended adjuvant endocrine treatment with anastrozole in postmenopausal patients with breast cancer: an analysis of the randomised ABCSG-6a trial. Br J Cancer. 2013 Aug 6;109(3):589-96. doi: 10.1038/bjc.2013.367. Epub 2013 Jul 18.
PMID: 23868011DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca Austria Medical Director, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 7, 2006
First Posted
March 9, 2006
Study Start
January 1, 1996
Last Updated
May 1, 2009
Record last verified: 2009-04