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CompletedNCT00300508Updated May 1, 2009

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

A Phase 3 interventional study of Anastrozole in Breast Neoplasms, sponsored by AstraZeneca. Completed at 52 sites in Austria. Open to female participants aged Up to 80 Years. Per ClinicalTrials.gov, last updated 2009-05-01.

Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
856
Allocation
Randomized
Ages
Up to 80 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Breast Neoplasms

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Keywords

  • Hormone receptor positive breast cancer
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 856 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Premenopausal patients,
  • unknown or negative receptor status,
  • Secondary malignant tumor
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
856 participants

Interventions

  • DrugAnastrozole
06

What researchers measure

Primary outcomes

  1. Recurrence-free and overall survival

Secondary outcomes

  1. Secondary cancers

07

Study locations

52 sites
  • Research Site
    Amstetten, Austria
  • Research Site
    Bad Ischl, Austria
  • Research Site
    Baden, Austria
  • Research Site
    Bregenz, Austria
  • Research Site
    Bruck an der Mur, Austria
  • Research Site
    Dornbirn, Austria
  • Research Site
    Eisenstadt, Austria
  • Research Site
    Feldbach, Austria
  • Research Site
    Feldkirch, Austria
  • Research Site
    Freistadt, Austria
  • Research Site
    Fuerstenfeld, Austria
  • Research Site
    Graz, Austria
  • Research Site
    Guessing, Austria
  • Research Site
    Hainburg, Austria
  • Research Site
    Hartberg, Austria
  • Research site
    Hollabrunn, Austria
  • Research Site
    Horn, Austria
  • Research Site
    Innsbruck, Austria
  • Research Site
    Kirchdorf, Austria
  • Research Site
    Klagenfurt, Austria
  • Research Site
    Klosterneuburg, Austria
  • Research Site
    Krems, Austria
  • Research Site
    Kufstein, Austria
  • Research Site
    Leoben, Austria
  • Research Site
    Linz, Austria
  • Research Site
    Mistelbach, Austria
  • Research Site
    Moedling, Austria
  • Research Site
    Neunkirche, Austria
  • Research Site
    Oberpullendorf, Austria
  • Research Site
    Oberwart, Austria
  • Research Site
    Ried im Innkreis, Austria
  • Research Site
    Rohrbach, Austria
  • Research Site
    Rottenmann, Austria
  • Research Site
    Salzburg, Austria
  • Research Site
    Sankt Pölten, Austria
  • Research Site
    Schaerding, Austria
  • Research Site
    Scheibbs, Austria
  • Research Site
    Schladming, Austria
  • Research Site
    Schwarzach, Austria
  • Research Site
    Spittal an der Drau, Austria
  • Research Site
    St. Poelten, Austria
  • Research Site
    St. Veit an der Glan, Austria
  • Research Site
    Steyr, Austria
  • Research Site
    Tulln, Austria
  • Research Site
    Villach, Austria
  • Research Site
    Voecklabruck, Austria
  • Research Site
    Waidhofen an der Ybbs, Austria
  • Research Site
    Wels, Austria
  • Research Site
    Wiener Neustadt, Austria
  • Research Site
    Wien, Austria
  • Research Site
    Wolfsberg, Austria
  • Research Site
    Zams, Austria
08

References and documents

Publications

  • 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. PubMed 23868011 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00300508
Lead sponsor
AstraZeneca
First posted
Mar 9, 2006
Start date
Jan 1996
Last update
May 1, 2009

Study contacts

AstraZeneca Austria Medical Director, MD
study director · AstraZeneca
View the source record on ClinicalTrials.gov ↗

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