3 Years of Anastrozole vs. no Treatment as Extended Adjuvant Therapy for Postmenopausal Women With Breast Cancer

NCT ID: NCT00300508

Last Updated: 2009-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

856 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Anastrozole

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* No disease recurrence at time of randomization,
* patients with breast cancer after surgery,
* 5 years (+/- 12 months) of prior endocrine therapy

Exclusion Criteria

* Premenopausal patients,
* unknown or negative receptor status,
* Secondary malignant tumor
Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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AstraZeneca Austria Medical Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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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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Countries

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Austria

References

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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.

Reference Type DERIVED
PMID: 38273214 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23868011 (View on PubMed)

Other Identifiers

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ABCSG 6A

Identifier Type: -

Identifier Source: secondary_id

1033AU/0001

Identifier Type: -

Identifier Source: org_study_id

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