ABCSG 8 - Adjuvant Treatment in Patients With Hormone Receptor-positive Breast Cancer With Good to Moderate Differentiation.
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.
2 other identifiers
interventional
3,858
1 country
52
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 breast-cancer
Started Jan 1996
Longer than P75 for phase_3 breast-cancer
52 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 1996
CompletedFirst Submitted
Initial submission to the registry
February 13, 2006
CompletedFirst Posted
Study publicly available on registry
February 15, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedJanuary 30, 2013
January 1, 2013
13.4 years
February 13, 2006
January 29, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Secondary Outcomes (1)
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.
Interventions
Eligibility Criteria
You may qualify if:
- Invasive mammary carcinoma after radical treatment, without prior chemo/hormone/radiation therapy.
- At least 6 lymph nodes examined.
- Good or intermediate tumour differentiation.
- \<6 weeks before start of adjuvant therapy.
- Oestrogen or Progesterone positive
You may not qualify if:
- Premenopausal.
- Preoperative hormonal/antihormonal/radiation/cytoxic chemo. Second malignant tumour/status post second malignant tumour.
- In-situ/T4 carcinoma.
- Age \>80 years.
- World Health Organisation performance index \>3.
- Serious accompanying diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (52)
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/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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Gmünd, 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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Judenburg, Austria
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Kirchdorf, Austria
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Klagenfurt, Austria
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Klosterneuburg, Austria
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Kufstein, Austria
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Leoben, Austria
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Linz, Austria
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Melk, Austria
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Mistelbach, Austria
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Mödling, Austria
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Neunkirchen, 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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Saint Poelton, Austria
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Saint Veit/Glan, Austria
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Salzburg, Austria
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Schärding, Austria
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Scheibbs, Austria
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Schladming, Austria
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Schwarzach/Pongau, Austria
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Spittal/Drau, Austria
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Steyr, Austria
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Tulln, Austria
Research Sites
Vienna, Austria
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Villach, Austria
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Vöcklabruck, Austria
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Waidhofen/Thaya, Austria
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Wels, Austria
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Wolfsberg, Austria
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Zams, Austria
Related Publications (2)
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: 25332252DERIVEDGnant 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.
PMID: 24347518DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Raimund Jakesz, MD
Austrian Breast and Colorectal Cancer Study Group
- 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
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2006
First Posted
February 15, 2006
Study Start
January 1, 1996
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
January 30, 2013
Record last verified: 2013-01