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.

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.

Study Overview

• Status: Completed
• Conditions: Breast Neoplasms
• Intervention / Treatment: Drug: Anastrozole

• Study Type: Interventional
• Enrollment: 856
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • 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
  • Wien, Austria
    • Research Site
  • Wiener Neustadt, Austria
    • Research Site
  • Wolfsberg, Austria
    • Research Site
  • Zams, Austria
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Recurrence-free and overall survival

Secondary Outcome Measures

Outcome Measure
Secondary cancers

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: AstraZeneca Austria Medical Director, MD, AstraZeneca

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: January 1, 1996

Study Registration Dates

• First Submitted: March 7, 2006
• First Submitted That Met QC Criteria: March 7, 2006
• First Posted (Estimate): March 9, 2006

Study Record Updates

• Last Update Posted (Estimate): May 1, 2009
• Last Update Submitted That Met QC Criteria: April 30, 2009
• Last Verified: April 1, 2009

More Information

Terms related to this study

• Keywords: Hormone receptor positive breast cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Hormone Antagonists; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Anastrozole
• Other Study ID Numbers: 1033AU/0001; ABCSG 6A