NCT00300508

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

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
856

participants targeted

Target at P75+ for phase_3

Geographic Reach
1 country

51 active sites

Status
completed

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

Completed
10.2 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 9, 2006

Completed
Last Updated

May 1, 2009

Status Verified

April 1, 2009

First QC Date

March 7, 2006

Last Update Submit

April 30, 2009

Conditions

Keywords

Hormone receptor positive breast cancer

Outcome Measures

Primary Outcomes (1)

  • Recurrence-free and overall survival

Secondary Outcomes (1)

  • Secondary cancers

Interventions

Eligibility Criteria

AgeUp to 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

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

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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.

  • Gnant 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.

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Anastrozole

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • AstraZeneca Austria Medical Director, MD

    AstraZeneca

    STUDY DIRECTOR

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

Locations